Vda 6.1

VDA
Quality Management
in the Automotive Industry
Quality
System Audit
Part 1
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
4rd Revised Edition 2000
Quality
System Audit
Based on DIN EN ISO 9001

and DIN EN ISO 9004, Part 1
th
4 Revised Edition 2000
Verband der Automobilindustrie e.V. (VDA)
Non-Obligatory VDA Standard Recommendation.

The Association of German Automotive Industry (VDA) recommends its
members apply the following standard when introducing and maintaining
quality systems.
Exclusion of Liability
This VDA volume is a recommendation which is available to everyone.
Anyone applying it is responsible for ensuring that it is used correctly in each
case.
This VDA volume takes into account state of the art technology, current at
the time of issue. Implementation of VDA recommendations excludes no
one from responsibility for their own actions. In this respect everyone acts at
their own risk. The VDA and those involved in VDA recommendations shall
bear no liability.
If during the use of VDA recommendations, errors or the possibility of misinterpretation are found, it is requested that these be notified to the VDA
immediately so that any possible faults can be corrected.
Referenced standards
The quotations from standards identified with their DIN number and date of
publication are reproduced with the permission of the DIN Deutsches Institut
fr Normung e.V. The version with the latest issue date, available from the
publishers Beuth Verlag GmbH, 10772 Berlin, is definitive for the use of the
standard.
Copyright
This publication is protected by copyright. Any use outside the strict limits of
copyright law is not permissible without the consent of the VDA and is liable
to prosecution. This applies particularly to copying, translations, microfilming
and the storage or processing in electronic systems.
Translations
This publication will also be issued in other languages. The current status
must be requested from VDA-QMC.
ISSN 0943-9412
Copyright 2000 by
Verband der Automobilindustrie e. V. (VDA)
Quality Management Center (QMC)
D-60325 Frankfurt am Main, Lindenstrae 5
Printed and published by:
Druckerei Henrich GmbH
D-60528 Frankfurt am Main, Schwanheimer Str. 110
Printed on chlorine-free bleached paper
th
Foreword to the 4 Edition

Quality assurance has a new dimension today - it covers and integrates all
divisions of the company in its vertical and horizontal structures (crosssectional function).
Quality assurance has become an interdisciplinary key function (cooperation
of all involved divisions at the right time). Quality assurance therefore has a
decisive influence on the company's result.
Shorter model cycles and development times, greater international competition and increasing cost pressure, new organization forms (just in time),
greater expectations placed on products and a stricter product liability
demand highly effective quality assurance systems (quality systems) in all
areas of the automotive industry among automotive manufacturers as well
as their suppliers. In order to do justice to this development, a working circle
of the VDA/DGQ specialist group "Quality Control in the Automotive
Industry" has drawn up a questionnaire on quality system evaluation based
on DIN EN ISO 9004 (Edition 5/90) which was published with the first edition
in 1991.
This VDA Volume 6 very quickly received a good response both outside the
industry and on an international level. Practical experience has shown that
this publication is not only suitable for the preparation of internal audits, but
also represents an excellent aid for preparation of a certification.
The practical experience of auditors led to the volume being revised and
defined in more precise terms as a second edition (12/92). This simplified
handling and a uniform assessment method was achieved.
The new edition of the standard series DIN EN ISO 9000 (Edition 8/94)
made revision of the second edition necessary.
rd
The 3 Edition also includes requirements from the guidelines EAQF/94

(France) and QS-9000/95 (America). This allows comparison of the audit
results. Furthermore, certification notes were incorporated.
th
In the 4 Edition further corrections and up-dates were included. Comments

from the users and the auditors symposia were considered (see Para.
12.1). The audited organization is now referred to as the company
throughout the questionnaire.
The element Z1, so far only required for companies with international business activities, now has to be considered generally during audits/certification.
In order to make the decision on the issuance of a VDA 6.1 certificate
supplement even more definite certain questions which are particularly
important for product and process and for which noncompliance could lead
to the failure of the quality system have been specially identified. These
questions lead to determined consequences during the overall evaluation,
see Para. 3.3.3. and 3.3.4.
DIN EN ISO 9001 (Edition 8/94) was used as the basis for the Quality
system audit which describes a comprehensive system of industrial quality
management with its elements. Questions were formulated from the
requirements profile of this standard relating to the explanation of a quality
management system, together with specific requirements from DIN EN ISO
9004 (Edition 8/94) and supplemented with the practical experience of the
automotive industry. In contrast to the standard which treats the same
subject matter partially in various places and varying depth the questionnaire in this publication normally contains the subject matter only once in
order to, as far as possible, avoid the repetitions contained in the standard.
Quality and quality management problems are predominantly not of a purely
technical nature, but often related to management, organization and structure. The questionnaire is therefore divided up into the following two parts:
- M Company Management
- P Product and Process.
Since the company management and the lower management levels have a
decisive influence on the definition, implementation and monitoring of quality
assurance, its incorporation is the fundamental requirement of the
standard. This is expressed in the structure of the questionnaire and is
taken into account in the questions accordingly. The questions are therefore
to be answered by the person responsible for the particular division of the
company.
This VDA Volume represents a supplement to those volumes already published and serves the evaluation of quality management systems under
comparable conditions. It is intended to help identify weaknesses, to remedy
them through corrective actions and thereby continually improve the company's productivity.
The aim of this work is to unify the necessary audits in order to reduce the
working expenditure for the auditor as well as for those to be audited. Car
manufacturers and suppliers agree to mutually recognize, as far as
possible, audits carried out on the basis of this uniform questionnaire and
evaluation system for rationalization reasons. Recognition of the systemrelated audit allows concentration on more specific product- and processrelated audits.
The quality standard of the German Automotive Industry contains further
types of audits which are described in the following VDA Volumes.
Quality Standard of the
german Automotive Industrie
VDA 6
VDA 6
Part 1
Basics for
Quality Audits
VDA 6
Part 3
Process Audit
VDA 6
Part 4
Quality System Audit

Production Means
Auditing and
Certification
VDA 6
Part 5
Product Audit
VDA 6
Part 2
VDA 6
Part 6

Services
Services Audit
We thank those companies involved and their employees for their work in
drawing up these guidelines:
-
Audi AG, Ingolstadt

Adam Opel AG, Rsselsheim
BMW AG, Munich
BOGE GmbH, Eitorf
Robert Bosch GmbH, Stuttgart
Daimler-Benz AG, Stuttgart
DNV (Det Norske Veritas Zertifizierung GmbH, Essen
DQS (Deutsche Gesellschaft zur Zertifizierung von Qualittssicherungssystemen mbH), Frankfurt, Berlin
Edscha Gruppe, Remscheid
FORD-Werke AG, Cologne
General Motors Europe, Zurich
GLYCO-Metall-Werke, GLYCO B.V. & Co. KG, Wiesbaden
Happich Fahrzeug und Industrieteile GmbH, Wuppertal
Hella KG, Hueck & Co., Lippstadt
ITT Automotive Europe GmbH, Frankfurt
Keiper Recaro GmbH & Co., Remscheid
Lemfrder AG & Co., Fahrwerktechnik Lemfrde
Mahle GmbH, Stuttgart
Mannesmann Sachs AG, Schweinfurt
Mannesmann VDO AG, Babenhausen
Pierburg AG, Neuss
Dr. Ing. h.c. F. Porsche AG, Stuttgart
SIEMENS AG, Wrzburg
SKF GmbH, Schweinfurt
Teroson GmbH, Heidelberg
TRW Fahrwerkssysteme GmbH & Co. KG, Dsseldorf
WABCO Standard GmbH, UB Fahrzeugbremsen, Hannover
Volkswagen AG, Wolfsburg
YMOS AG, Obertshausen.
Thanks also to all those who offered suggestions for improvement and
those companies represented in the editorial circle.
Frankfurt/Main, May 2000
VERBAND DER AUTOMOBILINDUSTRIE E. V. (VDA)
Contents
Page
INTRODUCTION
13
2
2.1
2.2
QUALITY SYSTEM ACCORDING TO THE

DIN EN ISO 9000 SERIES
Explanations to DIN EN ISO 9004 (Edition 8/94)
Quality Assurance Model
15
15
16
3
3.1
3.2
3.3
3.3.1
3.3.2
3.3.3
3.3.4
3.4
3.5
3.6
3.7
QUALITY SYSTEM AUDIT

General
Selection of the Quality Elements and Relevant Questions
Evaluation and Rating
Individual Rating of Questions and Quality Elements
Overall Rating of Audit Result
nd
Rating during Customer/Supplier Audits (2 Party)
rd
Awarding of the VDA 6.1 Certificate Supplement (3 Party):
Summary of Results
Close out Meeting and Report
Corrective Actions
VDA 6.1 Certificate
18
18
19
20
20
22
23
24
25
25
25
25
4
4.1
#.1.1
#.1.2
#.1.3
#.1.4
#.1.5
#.1.7
#.1.8
#.1.9
#.1.10
4.2
DEFINITIONS
General terms according to DIN EN ISO 8402/1995 (Extract)
Unit
Process
Procedure
Product
Service
Organization
Organizational structure
Customer
Supplier
Quality-related Definitions according to
DIN EN ISO 8402/1995 (Extract)
Quality Requirements
Inspection and Testing
Verification
Validation
Evidence
27
27
27
27
27
28
28
28
28
29
29
#.2.3
#.2.15
#.2.17
#.2.18
#.2.19
29
29
30
30
30
30
4.3
#.3.1
#.3.6
#.3.12
4.4
#.4.9
#.4.10
#.4.14
4.5
4.5.1
4.5.2
4.5.3
4.5.4
4.5.5
5
7
01
02
03
04
05
06
Z1
07
08
09
10
10
Definitions for Quality Systems according to

DIN EN ISO 8402/1995 (Extract)
Quality Policy
Quality System
Quality Manual
Definitions for Tools and Techniques according
to DIN EN ISO 8402/1995 (Extract)
Quality Audit
Quality Audit Findings
Corrective Action
Additional Terms (Definitions for the present volume)
System
Method
Serial Production
Quality Procedures
Work Instructions (Inspection and Testing Instructions)
32
32
32
33
33
33
33
33
34
34
CROSS-REFERENCE LIST OF PARAGRAPH NUMBERS

FOR CORRESPONDING TOPICS
35
STRUCTURE AND NUMBER OF QUESTIONS

PER QUALITY ELEMENT
36
QUALITY SYSTEM AUDIT QUESTIONNAIRE

Management Responsibility
Quality System
Internal Quality Audits
Training
Financial Considerations to Quality Systems
Product Safety
Corporate Strategy
Contract Review, Quality in Marketing
Design Control, (Product Design and Development)
Process Planning (Process Development)
Document and Data Control
31
31
31
31
38
39
47
57
63
71
75
81
87
93
101
111
11
12
13
117
125
14
15
16
17
18
19
20
21
22
Purchasing
Control of Customer-Supplied Product
Product Identification and Traceability
(Process Control, Inspection and Test Status)
Process Control
Inspection and Testing (Product Verification)
Control of Inspection, Measuring and Test Equipment
Control of Nonconforming Product
Corrective and Preventive Action
Handling, Storage, Packaging, Preservation and Delivery
Control of Quality Records
Servicing, (After Sales, Post-production Activities)
Statistical Methods
FORMS FOR THE QUALITY SYSTEM AUDIT
191
9
9.1
LITERATURE
VDA-Series "Quality Management in the
Automotive Industry":
199
10
10.1
10.2
10.3
AGREEMENT WITH INDUSTRIAL ASSOCIATIONS

Introduction
Summary of the National Associations
International Agreement on Mutual Recognition
203
203
203
204
11
NOTES ON A CERTIFICATION ACCORDING TO VDA 6.1
206
12
12.1
12.2
12.2.1
12.2.2
APPENDIX
th
rd
Changes of the 4 Edition compared to the 3 Edition
Comparison Tables
Comparison Matrix VDA 6.1 / DIN EN ISO 900194
Comparison Matrix DIN EN ISO 900494 / VDA6.1
207
207
210
210
214
Other VDA-Forms
129
137
147
153
159
163
169
175
181
187
199
218
11
12
Introduction
*
Quality management is an interdisciplinary key function. The quality of

products and services is always the combined result of activities in every
phase of the total business process. Effective quality management assigns
priority to planning and prevention activities for identification of interrelations
and interdependencies, as well as for appropriate measures to prevent nonconformities occurring - in contrast to the previous practices of identifying,
analyzing and rectifying nonconformities which have already occurred.
A well-functioning quality system* described in a quality manual,* is an
essential requirement for every business in order to fulfil the demands for
quality deliveries and services in a proactive and economic way. Quality
management affects all areas of the business. It is therefore a primary
function of business management.
Management must prove that due diligence has been shown in all areas of
the business, from planning to design, procurement, production, sales and
user information through to the observation of a product's market position.
This applies especially in the event of a claim for damages.
It is not only sensible, but essential that all quality management activities be
planned, implemented and combined in a quality system. Only a well
planned and purposefully selected quality system gives business partners,
authorities and, increasingly, insurers confidence in the business's ability to
comply with quality requirements.
The original understanding of quality, mainly shaped by the product, and the
associated duties of quality management have changed in recent years and
include new additional content and dimensions.
The main duties of management are, therefore:
-
Definition of the quality policy, agreeing and monitoring quality

objectives
Assuring cross-functional activities and interfaces during interdisciplinary co-operation
Note: The terms "Quality Management, Quality System" and "Quality Manual", according
to DIN EN ISO 8402 replace the earlier used terms "Quality Assurance, Quality
Assurance System" and "Quality Assurance Manual".
13
Definition and monitoring of quality-related costs

Consideration of product safety and product liability
Involving all employees in the responsibility for quality
These duties are covered in part M of the questionnaire with respect to the
quality management system.
As operations and the interrelations of systems and processes become
more extensive and complex, cross-functional activities gain in importance.
Here, many resources are available, which have a great influence on productivity, overall economic performance and quality.
The product- and process-related elements are covered in part P of the
questionnaire with respect to the quality management system.
Through the evaluation of the quality system with the help of the questionnaire, the customer is given a general view of the supplier's ability to deliver
products and services which meet his quality requirements.
The purpose of this volume is to define an agreed general procedure for the
uniform evaluation of a defined quality system. In this way, the working
expenditure required for further quality system audits, for example, by other
customers, can be reduced.
The result of the evaluation shall show the audited company where his
quality system meets the requirements and in which elements improvements are necessary.
The audit result is signed by the auditor and the audited company. The
audited company confirms with its signature that the identified result has
been discussed with him. He is free to provide his own response.
Information acquired during the performance of the audit is, other than for
the use of the audit itself, to be handled confidentially.
Following written release by the auditing company, or respectively, the certification body, in the appropriate field of the coversheet of the quality system
audit, the audited company is free to present the audit result to other
customers.
This VDA Volume 6, Part 1 is the basis for internal quality system
st
nd
audits (1 Party), customer/supplier audits (2 Party) and for audits
with VDA 6.1 Certificate Supplement through VDA approved
rd
certification bodies (3 Party).
14
Quality system according to the DIN EN ISO 9000 Series
The DIN EN ISO 9000 series is applied as a standard in the European

Union (EU) and EFTA. The German edition is identical in Austria, Germany
and Switzerland.
When delivering in accordance with the regulations of the EU it is compulsory to comply with the contents of the EN standard in order to guarantee
free movement of goods under the same conditions. This also applies to the
contents of the European Standard on quality management. Their
compliance is therefore to be proven upon request.
2.1
Explanations to DIN EN ISO 9004 (Edition 8/94)

Quality Management and Quality System Elements,
Part 1: Guideline
This standard is an internationally agreed guideline in which the elements of

a quality system (quality elements) are described. It represents a further
development of formerly known national and branch-specific regulations
with the express objective of showing, descriptively and clearly, which
quality elements may nowadays be included in a quality system
corresponding to the "State of the Art Technology".
In addition, it describes the obligations of the business with respect to
quality management, in fulfillment of which the critical preconditions for
achieving quality capability within the company should be created.
Users of this standard are enabled to select from the presented basis of
elements according to extent, depth and overall requirements of the
business in order to be able to completely fulfill the tasks of their own
company-specific quality system.
The scope of application is not limited. The standard is to be viewed as a
universal set of regulations for quality management to achieve the quality of
products and services. It can be assumed that branch-specific quality
regulations will thereby be replaced. In the meantime, this standard has
gained a fundamental significance.
15
2.2
Quality Assurance Model

(according to the introduction to DIN EN ISO 9001)
The scope and depth of the quality system may depend on the type of products to be supplied, the applied technology and the size of the evaluated
company.
The following paragraphs are taken from the national foreword and the
introduction of DIN EN ISO 9001: 1994-08. There it is appropriately stated:
Gaining confidence in the suppliers ability to fulfill the defined
minimum requirements on his quality system is nowadays becoming more and more a precondition throughout the world for
cooperation between the customer and his supplier. This confidence can be built up by presenting the quality system to the
customer or an authorized body. All systematic and confidencebuilding activities planned within the scope of this are designated
by DIN EN ISO 8402 as quality assurance or quality management
systems (or quality systems).
The standards DIN EN ISO 9001, DIN EN ISO 9002 and DIN EN
ISO 9003 each contain a quality assurance model. Only these
three standards of the DIN EN ISO 9000 series are intended for
demonstration purposes. They show a way to create confidence
in the capability of a supplier.
It has to be emphasized that the quality system requirements
specified in the International Standards ISO 9001, ISO 9002 and
ISO 9003 are a supplement (not an alternative) to the established
1)
quality requirements (on products ).
It is intended that these International Standards are applied in their
present form. However, occasionally they may need to be tailored
for special contractual situations by the addition or omission of
certain requirements. ISO 9000-1 provides guidance on such
tailoring as well as on the selection of the appropriate model,
namely ISO 9001, ISO 9002 or ISO 9003.
1)
16
According to DIN EN ISO 8402, 1.4 may include product as well as services.
The following alternative models for quality assurance described in three

international standards represent three differing forms of "the functional or
organizational quality capability" which are suitable for use in contracts
between two partners (see Chapter 5: Cross-Reference List of Section
Numbers)
ISO 9001Quality systems 2)
Model for quality assurance in design , development, production,

installation and servicing.
To be applied, when conformance with specified requirements is
to be ensured by the supplier/contractor during design, development, production, installation and servicing.
ISO 9003 Quality systems Model for quality assurance in production, installation and servicing.
To be applied, when conformance with specified requirements is
to be ensured by the supplier/contractor during production, installation and servicing.
ISO 9002 Quality systems Model for quality assurance at final inspection and testing.
To be applied, when conformance to specified requirements is to
be ensured by the supplier/contractor only during final inspection
and testing.
17
3.1
General
Evaluation of the quality system is performed with the help of a questionnaire. The questions of the present VDA 6.1 volume are primarily
foreseen for the evaluation of companies which produce material (or
tangible) products (For non-material or non-tangible products/services
- see VDA Volume 6, Part 2).
The evaluation of a company is performed either as an internal audit by the
st
nd
company itself (1 Party), through a representative of the customer (2
rd
Party) or through an accredited certification body (3 Party). Auditors must
be competent in the elements which they have to evaluate, as well as in the
quality techniques used. They must be qualified to judge the suitability of the
implemented quality measures, taking into account the production processes used, the state of technology and the required product quality.
The extensive commercial and technical evaluation of a company in line
with this quality system audit places great requirements on the auditor. In
addition to this, the auditor must have, among other things, relevant training
and industrial experience, integrity and the ability to deal with people.
Particularly the following quality elements:
-
management responsibility
quality system
internal quality audits
training/personnel
financial considerations to quality systems
product safety
corporate strategy
demand special qualification requirements of the auditors, as they must be

competent to discuss the above topics with the companys management.
Department-specific questions are to be answered by the persons responsible in the company for marketing, design, procurement, production
planning, production or personnel and not by the Quality Manager. He,
generally, only answers specific questions about quality function issues, e.g.
about testing and documentation.
18
If the quality system of a company, on the occasion of a system audit, has

been found to be satisfactory in accordance Paragraph 3.3, then a periodic
quality system audit is to be carried out at appropriately defined intervals.
In the case of an unsatisfactory result during a quality system audit,
corrective actions and a time schedule are to be established to improve the
system. The evaluation of their effectiveness is the subject of a follow-up
audit that examines the unsatisfactory areas.
3.2
Selection of the Quality Elements and Relevant Questions
The relevant elements and corresponding questions for the evaluation of the
quality system of a company are to be defined. The elements 08, 12 and 21
can, under special circumstances, be completely/ partly omitted. Comments
regarding this are given with the relevant elements.
st
nd
During internal quality audits (1 Party) and customer audits (2 Party)

further quality elements and questions may also be added. Furthermore,
elements of a quality system may be adapted, deleted (in exceptional
cases) or extended to meet company or product-specific needs. Additional
questions to the quality system must be communicated to the company/
organization to be audited beforehand.
rd
During certification audits (3 Party) additional requirements can only be

added if they form part of the quality system of the company to be audited.
In this case, their compliance and effectiveness are to be assessed. The
point rating according to VDA 6 Part 1, Paragraph 3.3.1 is not applicable.
Individual questions can only be omitted if they are unusual or not able to be
evaluated for the company size or branch. In cases of doubt, clarification
with the customer is sensible.
Questions that are not applicable and supplementary questions are to be
identified and justified in the audit report (Identification for non-applicable i.e.
questions that have not be evaluated = na).
In the following questionnaire, elements of a quality system which
have a particular influence on product and process or which can lead
to the failure of the quality system are identified by the relevant
19
questions with an *. Non compliance with these requirements has

particular influence on the overall rating or awarding of a VDA 6.1
Certificate Supplement (see 3.3.3 and 3.3.4).
The Requirements/Explanations to the question are always to be
seen as an example and not as a complete checklist. The type of evidence or records listed as examples must not be supplied if they are
not appropriate to the industry sector.
Some questions concerning the quality system can only be answered in
conjunction with an evaluation of the product to be supplied and/or the
corresponding technology or process applied. This can make a separate
assessment (product / process audit) necessary.
3.3
Evaluation and Rating
3.3.1
The auditor evaluates the definition and effectiveness of the quality management activities in complying with the respective requirements by initially
determining:
-
Is the subject in question defined in writing in the quality

system, in operational procedures with relationships and
responsibilities? (e.g.: in the quality manual, in a documented
procedure or work instruction)?
He must then further evaluate:

-
20
Is the subject in question proven to be effective in practice?
According to the following table, answers to the questions lead to a rating for
each relevant question. This rating can result in 0, 4, 6, ,8 or 10 points per
question. Thereby, the following point rating is valid for each question:
Subject in question
Rating of answers
Defined completely in the

quality system
yes
no
Proven effective in
practice
yes
yes
Point score
10
yes
no
mainly *)
yes/no
no
Under "mainly" it is understood that all applicable requirements are

proven effective in more than 3/4 of all relevant application cases and
that no special risk exists.
Rating
10 points:
completely defined in the quality system and proven to be

effective
8 points:
not completely defined in the quality system but proven to

be effective
6 points:
completely defined in the quality system and mainly proven

to be effective
4 points:
not completely defined in the quality system but mainly

proven to be effective
0 points:
not proven to be effective regardless of completeness of

definition in the quality system
When compiling a summarized rating for a quality element, every question

is equally weighted. Questions which are not applicable are not considered
in the rating.
The element rating is expressed as a percentage which results from the
total points assessed for all relevant questions related to the total points
possible for all relevant questions.
If all relevant answers in an element achieve 10 points, then the level of
compliance CE is 100%.
21
Calculation of element ratings:
CF
total points assessed for relevant questions

x 100 [%]
total possible points for relevant questions
3.3.2
Overall Rating of Audit Result
For the two parts of the audit, M (management) and P (product and process), the individual levels of compliance CM and CP are calculated. They
are established by calculating the average value of the levels of compliance
for the relevant evaluated quality elements
CM resp. CP =
sum of levels of compliance of all relevant elements

[%]
no. of relevant quality elements
The two levels of compliance CM and CP are combined to give an overall

rating, whereby the management-specific section is given one third weighting and the product-related and process-related section is given a two
thirds weighting:
CTOT =
CM + 2 * CP
[%].
3
The rating system may also be applied if further elements or questions are
added or if elements or questions are omitted. If additional questions relate
to product, services or applied process technology, it may then be necessary to adapt the point and rating system accordingly.
22
Note on the formula for CTOT*

The formula arises from the following consideration:
On condition that the 7 quality elements concerning management and the 16 quality elements
concerning product and process (from Chapter 6) are equally weighted in CTOT
Then:
CTOT =
7 * CM + 16 * CP

23
= 0,30 * CM + 0,70 * CP
should be calculated.
In order to retain a simple formula and also to give more weight to the Part M quality elements, the committee defined the formula for CTOT as presented above (no mathematical
background). The elements of CM are therefore more heavily weighted by a factor of 0.33/
0.30 = 1,1.
Thereby the elements of management, as an essential part of quality assurance, are treated
with more importance in the quality rating system.
* CTOT is referred to as E
GES in the original German version
3.3.3
nd
Rating during Customer/Supplier Audits (2
Party)
Overall level of compliance

in percent
Evaluation
of quality system
Description of
rating
90 to 100
full compliance
80 to less than 90
mainly compliant
60 to less than 80
conditionally compliant
less than 60
not compliant
A *)
AB *)
*) Notes
1. Companies audited and having received an overall level of compliance exceeding 90% (or
respectively 80 %) but which have a level of compliance for one or more elements of less
than 75% will have their rating dropped from A to AB (or respectively AB to B), as
appropriate.
2. If a question marked with * which has particular influence on product and process or which
can lead to a failure of the quality system is graded with less than 8 points then the
company being audited is to be downgraded from A to AB or from AB to B.
3. If a question not marked with * is graded with 0 points, then the audited company is to be
downgraded from A to AB.
4. Downgrading according to 1, 2) or 3) above may be applied only once.
5. Downgrading are to be justified in a commentary sheet.
23
3.3.4
rd
Awarding of the VDA 6.1 Certificate Supplement (3 Party):
1. A VDA 6.1 Certificate Supplement to an ISO 9001/9002 certificate is

awarded at an overall level of compliance exceeding 90% (the level of
compliance [%] is not shown on the VDA 6.1 Certificate Supplement).
Exception:
A VDA 6.1 Certificate Supplement will not be awarded, if
- one or more quality elements achieve a level of compliance below 75%
or
- one or more questions marked with * are graded with less than 8 points
or
- one question not marked with * is graded with 0 points.
2. Follow-up /Re-audit
A follow-up audit is possible within 90 days after completion of the audit
under the following conditions (Status : Open):
a) a maximum of one question marked with * was graded with 0 points
and/or
b) one or more questions marked with * were graded with 4 or 6 points
and/or
c) one or more questions not marked with * were graded with 0 points
and/or
d) no element achieved a level of compliance below 75%
A VDA 6.1 Certificate Supplement is awarded after a follow-up audit, if all
questions marked with * are rated with at least 8 points and all questions
not marked with * are rated with at least 4 points.
A follow-up audit is not possible if more than one question marked with *
is rated with 0 points (Status : failed)
A re-audit is only possible at the earliest after 90 days. The same rules
apply as for a follow-up audit.
24
3.4
Summary of Results
The results of the quality system audit of Part M (management) and Part P
(product and process) are to be presented as shown in the sample forms
(Chapter 8). The results of each element will be entered on the sheet
"Summary of Results".
3.5
Close out Meeting and Report
In the course of a close out meeting regarding the quality system audit, the
auditor informs the audited company's management which nonconformances are present and to what extent corrective actions are necessary. These
will be presented in an summary sheet "Nonconformances/Corrective
Actions". After completion of the quality system audit, the auditor raises an
audit repot and establishes a time schedule with the audited company for
the corrective actions (see sample forms Chapter 8). If necessary, a
follow-up audit date is agreed.
3.6
Corrective Actions
The result of the quality system audit, presented as shown in the main
paragraphs 3.4 and 3.5 above, serves the management of the audited company as a basis for corrective actions. It is the duty of the audited company
to work out and implement an improvement program. This has to be
communicated to the lead auditor responsible for heading the audit. The
auditor decides on the basis of the presented improvement program to what
extent a follow-up audit is carried out.
3.7
VDA 6.1 Certificate
A VDA 6.1 certificate can only be awarded if the overall rating achieved is A
(see 3.3.3). A precondition for this is that the auditor is registered as a Lead
Auditor with the VDA. The representative of the certifying body applies for
the VDA 6.1 certificate from the VDA at the request of the company being
audited.
The awarding of a VDA 6.1 certificate may also be carried out under
consideration of existing certificates according to DIN EN ISO 9001/9002 or
QS 9000 with supplementary auditing (see VDA Volume 6).
The certificate is valid for 3 years after the date of issue.
25
VDA
VERBAND DER
AUTOMOBILINDUSTRIE E. V.
VDA 6.1-URKUNDE
Unternehemen:
Betriebsteil:
Produktgruppe/n:
Es wurde nachgewiesen, da das Unternehmen ein

Qualittsmanagement-System nach VDA 6, Teil 1
des Qualittsstandards der deutschen
Automobilindustrie
auf Grundlage DIN EN ISO 9001 / 9004-1
wirksam eingefhrt hat.
Nachweis mit/ohne Produktentwicklung.
Ausgestellt am:
gltig bis:
Das Audit wurde durchgefhrt von:
Registriert VDA Nr. ________
_________________________
Firma / Unterschrift des Bevollmchtigten
VDA-Stempel
Lead-Auditor(en): __________________
_________________________________
Datum ___________________
Unterschrift _____________________
________________________________________________________________________________
26
Definitions
For each of the individual elements definitions and explanations of terms

are given within the questionnaire. Generic terms are briefly summarized in
the following. (The numbering according to # corresponds to the DIN EN
ISO Standard 8402/1995).
4.1
General terms according to DIN EN ISO 8402/1995 (Extract)
#.1.1
Unit
That which can be individually described and examined.

Note:
#.1.2
A unit can be e.g.:

- an activity or a process (1.2)
- a product (1.4)
- an organization (1.7), a system or a person or any combination thereof.
Process
A set of interactive resources and activities which transform inputs into outputs.
Note:
#.1.3
Resources can include personnel, finances, plants, equipment, techniques

and methods.
Procedure
A defined manner in which an activity is carried out.

Note 1:
In many cases procedures are documented (e.g. procedures of a quality

system (3.6)).
Note 2:
When a procedure is documented, the terms "written procedure" or a "documented procedure" are often used.
Note 3:
A written or documented procedure normally contains the purpose and scope

of application of an activity; what needs be done and by whom; when, where
and how it needs be done; which materials, equipment and documents have
to be used; and how these must be controlled and recorded.
27
#.1.4
Product
The result of activities and processes (1.2).

Note 1:
The term product may include a service (1.5), hardware, processed materials,
software or combinations thereof.
Note 2:
A product can be tangible (e.g. assemblies or processed materials) or

intangible (e.g. knowledge or concepts) or a combination thereof.
Note 3:
A product can be intended (e.g. offered product to customers (1.9)) or

unintended (e.g. pollutants or unwanted effects).
#.1.5
Service
The result generated at the interface between the supplier (1.10) and the
customer (1.9), as well as by internal activities of the supplier (1.10) to meet
the customer needs.
Note 1:
The supplier or the customer may be represented at the interface by

personnel or equipment.
Note 2:
Customer activities at the interface with the supplier may be essential to the
service provision (1.6).
Note 3:
Supply or use of tangible products (1.4) may form part of the service provision.
Note 4:
A service may be linked with the manufacture and supply of tangible product.
#.1.7
Organization
A company, corporation, business, enterprise or institution or part thereof,

registered or non-registered, public or private, with its own functions and
administration.
#.1.8
The responsibilities, authorities and relationships, arranged in a pattern

through which an organization (1.7) performs its functions.
28
#.1.9
Customer
The recipient of a product (1.4) provided by the supplier (1.10).

Note 1:
In a contractual situation, the "customer" may be called "purchaser" (1.11).
Note 2:
The customer can be, for example, the end user, user, beneficiary or
purchaser.
Note 3:
The customer, in relation to the organization, may be either external or

internal.
#.1.10
Supplier
The organization (1.7) which provides a product (1.4) to the customer (1.9).
Note 1:
In a contractual situation, the supplier may be called the "contractor" (1.12).
Note 2:
A supplier may be, for example, the producer, distributor, importer, assembler
or service organization.
Note 3:
The supplier can be either external or internal.
4.2
Quality-related Definitions according to DIN EN ISO 8402/1995

(Extract)
#.2.3
Quality Requirements
The formulation of needs or their conversion into a set of established quantitative or qualitative requirements for the characteristics of a unit (1.1), to
enable its realization and verification.
Note 1:
It is essential that quality requirements fully reflect the established and given
needs of the customer.
Note 2:
The term "requirement" includes market-based, contractual, as well as internal

requirements of a company (1.7). They may be developed, defined and
updated in the various planning phases.
Note 3:
Established quantitative requirements of the characteristics include e.g.

nominal values, ratings, limit deviations and tolerances.
Note 4:
The quality requirements should be expressed in functional conditions and be

documented.
29
#.2.15
Activities such as the measuring and examining of one or more characteristics of a unit (1.1), as well as comparing of the results with set requirements, to establish, whether conformity (2.9) for every characteristic has
been reached.
#.2.17
Verification
Confirmation based on an examination and the provision of evidence (2.19)

that established requirements have been met.
Note 1:
In design and development, verification concerns the process of evaluating

the result of a given activity to determine the conformity (2.9) of this activity
with the set requirements.
Note 2:
"Verified" is used to describe the corresponding status.
#.2.18
Validation
Confirmation based on an examination and provision of evidence (2.19) that

the special requirements have been fulfilled for a given application.
Note 1:
In design and development, validation concerns the process (1.2) of examining a product (1.4) to determine its conformity (2.9) with the needs of the
user.
Note 2:
Validation is normally performed on the end product under defined operating

conditions. It may be necessary at an earlier stage.
Note 3:
The term "validated" is used to describe the corresponding status.
Note 4:
Multiple validations can be carried out, if different applications are intended.
#.2.19
Evidence
Information which can be proven to be correct and which is based on facts

obtained through observation, measurement, examination or other means of
investigation.
30
4.3
Definitions for Quality Systems according to DIN EN ISO

8402/1995 (Extract)
#.3.1
Quality Policy
Comprehensive intentions and objectives of an organization (1.7) with

regard to quality (2.1), as formally defined by management.
Note:
#.3.6
The quality policy is an element of the corporate policy and is approved by the
management.
Quality System
The organizational structure (1.8), procedures (1.3), processes (1.2) and

resources required for the realization of quality management.
Note 1:
The quality system should be as comprehensive as required to meet the quality objectives.
Note 2:
The quality system of a company (1.7) is aimed primarily at satisfying the

internal needs of the company. It is more extensive then the requirements of a
single customer (1.9) who only evaluates the part of the quality system
relevant (to him).
Note 3:
For contractual or other obligatory purposes of quality assessment (4.6), demonstration of the implementation of defined quality system elements may be
required.
#.3.12
Quality Manual
A document stating the quality policy (3.1) and describing the quality system
(3.6) of an organization (1.7).
Note 1:
A quality manual may relate to the entire company activity or just parts of it.
Title and purpose of the manual reflect the scope of application.
Note 2:
A quality manual normally contains or refers at least to:

a) he quality policy;
b) the responsibilities and authorities (jurisdiction), as well as the interrelations
personnel who manage, perform, assess or evaluate quality-related activities;
31
c) the procedures (1.3) of the quality system (3.6) and corresponding instructions;
d) a stipulation for reviewing, revision and administration of the manual.
Note 3:
A quality manual may differ in comprehensiveness and format in order to

refelct the needs of a company. It may consist of more then one document.
Depending on the purpose of the manual, a title may be used such as Quality
assurance manual.
4.4
Definitions for Tools and Techniques according to DIN EN

ISO 8402/1995 (Extract)
#.4.9
Quality Audit
Systematic and independent examination to determine, whether the qualityrelated activities and related results comply with planned instructions and
whether these instructions are actually implemented and are suitable to
meet the objectives.
Note 1:
The quality audit is typically applied, but is not limited to a quality system (3.6)
or elements thereof, processes (1.2) or products (1.4) (including services
(1.5)). Such quality audits are often called "System Audit", "Process Audit",
"Product Audit" or "Service Audit".
Note 2:
Quality audits are carried out by persons who have no direct responsibility in
the area to be audited, however, preferably they should be working together
with the relevant personnel.
Note 3:
One purpose of a quality audit is to evaluate the need for improvement or

corrective action (4.14). A quality audit should not be confused with the
activities of quality monitoring (4.7) or reviewing (2.15) which are carried out
for process control or material receiving.
Note 4:
Quality audits may be carried out for internal or external purposes.
#.4.10
Quality Audit Findings
A statement of fact made during a quality audit (4.9) and substantiated by

evidence (2.19).
32
#.4.14
Corrective Action
An action taken to eliminate the causes of an existing nonconformity (2.10),

defect (2.11) or other undesirable situation in order to prevent its recurrence.
Note 1:
Corrective actions can bring about changes in e.g. procedures (1.3) and
systems to achieve quality improvement at any stage of the quality cycle (4.1).
Note 2:
One has to differentiate between a "correction" and a "corrective action":

- A " correction" concerns a repair (4.18), a rework (4.19) or an adjustment
and refers to the treatment of an existing nonconformity;
- A " corrective action" refers to the elimination of the cause of the nonconformity.
4.5
Additional Terms (Definitions for the present volume)
4.5.1
System
The structure of a company in which the jurisdiction (responsibilities, authorities) and interrelations, as well as procedures (#.1.3) and processes (#.1.2)
are defined with the necessary resources for the realization of a task.
4.5.2
Method
A scheduled procedure (#.1.3) to given means and a given purpose which

leads to technical proficiency in the solution of theoretical and practical
tasks.
4.5.3
Serial Production
The manufacturing of products (#.1.4) of the same type and design, in

recurrent orders.
33
4.5.4
Quality Procedures
Quality procedures are specific instructions that are required in order to fulfil
given quality-related activities. They are to be put into force by signature.
4.5.5
Work Instructions (Inspection and Testing Instructions)
Detailed description of the working steps of an activity. Definition of individual activities and detailed instructions, order-neutral, as well as order-related.
Note:
34
Includes technical know-how.
Cross-reference List of Paragraph Numbers for Corresponding Topics (according to DIN EN ISO 9000-1, Appendix D,
1994-08)
Cross-reference list which gives the paragraph numbers for corresponding

topics of the questionnaire of Chapter 7 to the paragraphs and subparagraphs of the standards DIN EN ISO 9001, 9002, 9003 and 9004-1.
VDAQuestionnaire
N.
01
Management responsibility
Corresponding paragraph or subparagraph No. in the standard

DIN EN ISO
9001 9002 9003
9004-1
4, 5
4.1 l
l m
02
Quality system (quality system elements)
03
Internal quality audits (auditing the quality system)
5.4, 5.5
04
Training (Personnel)
18
05
Financial considerations of quality systems
06
Product safety
19
Z1
Corporate strategy
07
Contract review (Quality in marketing)

Design control - product design
(Quality in specification and design)
Process planning - process design
11
Document and data control (Quality documents)

Purchasing (Quality in purchasing)
17, 17.3, 5,3 4.5

9
4.6
12
Control of customer-supplied product
4.7
13
Product identification and traceability (Material

control, traceability and identification)
(Process control)
11.2
4.8
11.4-11.6
4.9
Insp. and test status (control of insp. & test status)

Process control (quality of processes)
11.7
10
4.12
4.9
08
09
10
14
Paragraph Title
according to 9001 / (9004-1)
15
7
8
l
l
4.18 l
4.3 l
4.4 l
l
l
l
m
m
m
(8)
(4.4)
l
l
l
l
l
l
l
l
l
m
l
l
l
l
l
l
l
l
l
l
l
l
l
l
m
l
m
m
4.16
4.19
l
l
l
l
l
l
l
m
4.20
Inspection and testing (Product verification)

12
Control of inspection, measuring and test equipment 13
17
Control of nonconforming product
14
18
Corrective and preventive action
15
19
Handling, storage, packaging, preservation and
16.1, 16.2
delivery (post-production activities)
10.4
20
Control of quality records (quality documents/records)
17, 17.2
21
Servicing,
16.4, 16.5,
(post-production activities)
16.6, 7.3
22
Statistical techniques
20
Italic: Elements which extend beyond the scope of the standard
Key:
l
ffull requirement
16
4.2
4.17
4.10
4.11
4.13
4.14
4.15
less comprehensive than ISO 9001 and 9002

quality element not present
35
Structure and Number of Questions per Quality Element
Management
01
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.1
Section 4
Quality System
DIN EN ISO 9001
DIN EN ISO 9004-1,
Section 4.2
Section 5
Internal Audits
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.17
Section 5
Training, Personnel
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.18
Section 18
02
03
04
Page
No. of
questions
39
47
57
63
05
Financial Considerations of Quality Systems

DIN EN ISO 9004-1,
Section 6
71
06
Product Safety
DIN EN ISO 9004-1,
75
81
Z1
Section 19
Company Strategy
Subtotal of questions in section M
36
36
P
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
Product and Process

9001, Section 4.3 / 9004-1, Section 7
Design Control (Product Design)
9001, Section 4.4 / 9004-1, Section 8
Process Planning (Process Design)
9001, Section 4.4 / 9004-1, Section 8
9001, Section 4.5 / 9004-1, Section 17.3
Purchasing
9001, Section 4.6 / 9004-1, Section 9
Control of Customer Supplied Product.
9001, Section 4.
Product Identification and Traceability (Process
Control, Inspection and Test Status)
9001, Section 4.8 (4.9, 4.11, 4.12)/9004-1, Section11
Process Control
9001, Section 4.9 / 9004-1, Section 10
9001, Section 4.10 / 9004-1, Section 12
Control of Inspection Measuring and Test Equipment.
9001, Section 4.11 / 9004-1, Section 13
Control of Nonconforming product
9001, Section 4.13 / 9004-1, Section 14
Corrective and Preventive action
9001, Section 4.14 / 9004-1, Section 15
Handling, Storage, Packaging, Preservation and
Delivery
9001, Section 4.15 / 9004-1, Section 16
9001, Section 4.16 / 9004-1, Section 17.2
Servicing, (After Sales and Post-production Activities)
9001, Section 4.19 / 9004-1, Section 16
Statistical Techniques
9001, Section 4.20 / 9004-1, Section 20
Page
No. of
questions
77
83
91
99
105
113
117
125
133
139
145
149
155
159
163
167
Sub-total of questions in section P
89
Total of all questions
125
37
Quality System Audit Questionnaire
For application in companies which manufacture tangible products

STRUCTURE
For every quality element the general requirements are described in an introduction, the subject in its context is briefly explained and the questions
are stated..
In addition, reference is made to other applicable VDA Volumes which are
to be considered during the realization of the quality system. Equal procedures and processes are permitted.
Questions on the quality system which have a special influence on the
product or process or may lead to the failure of the quality system are marked with an *.
Each question is structures as follows:
1.
2.
The Question
Definition
Where required, the terms used in the question are defined according to the
relevant standard and the standard or an extract thereof is cited. The source
is stated respectively.
Explanation of terms
Where required, the terms used in the question are explained, if no definition is given, to provide a better understanding.
3.
Requirements/Explanations
In the section Requirements/Explanations, requirements on the quality

system are defined and supplemented by an explanations, if necessary.
Note:
For each applicable question, the auditor has to evaluate the definition nad
effectiveness of the quality measures.
The requirements and explanations are partially described in an abreviated

form. Therefore, further VDA Volumes which are significant and which have
to be considered are referenced (see the note in the introduction to the
quality elements).
Usually there is a special note in the respective question.
38
Part M: Company Management

01
DIN EN ISO 9001,
Section 4.1
DIN EN ISO 9004-1,
Section 4, 5
The Management (e.g. Board of Management, Plant Management, Section Management) develops the quality policy for the
company, defines it and commits all areas and levels to it. Hereby
specific quality objectives and a quality management system
(quality system) are to be agreed. Quality must be regarded as an
overall management task.
"Management" describes the organizational unit within the company that is responsible for profit and loss.
Reference
DIN EN ISO
9001
9004-1
01.1
*
Has the quality policy been defined by management and has it been made known to all
levels?
4.1.1
4.2
01.2
*
Have quality objectives been defined within

the scope of corporate planning and the
quality policy and are the results monitored?
4.1.1
4.3.1
01.3
*
Is a continuous improvement process part of

the quality policy?
--
--
01.4
Have the necessary resources been provided

by the company management?
4.1.2.2 5.2.4
01.5
*
Has a management representative been

assigned and are his duties, authorities and
responsibilities defined?
4.1.2.1 5.2.2
4.1.2.3 5.2.3
01.6
*
Does management regularly evaluate the

effectiveness of the quality system?
4.1.3
5.5
39
01.1*
Has the quality policy been defined by management and has

it been made known to all levels?
Definition:
Quality Policy (according to EN ISO 8402/3.1):
The overall intentions and objectives of an organization with regard to quality as formally expressed by the management.
Note:
The quality policy forms one element of the corporate policy and is approved by
management.
Requirements/Explanation:
The quality policy must be formulated in such a way that it can be understood, implemented and applied by employees at all levels The principles of
the quality policy are to be described in a quality manual or an equivalent
document (see Question 02.1).
The publication of the quality policy is achieved, for example, by
-
notices
memoranda
organizational guidelines and instructions
informative presentations about the quality policy.
The quality objectives of the company are established from the quality policy
(see Question 01.2) which are authoritative for the organization of the
company and which incorporate the expectations of the customer(s).
Evidence is given by, for example, a declaration of commitment from
management within the scope of the quality policy, according to which all
quality requirements for activities, not only in production but in all organizational units, are reliably fulfilled and the prevention of nonconformances has
significant priority over the detection of nonconformances (Zero Defect
Strategy).
40
01.2*
Have quality objectives been defined within the scope of corporate planning and the quality policy and are the results
monitored?
Explanation of terms:
"Quality objectives" are specifications for products, processes, operations
and services, that are defined for all levels. These objectives are derived
from customer requirements, the competitive situation, the legal environment and internal requirements, as well as adherence to the zero defect
strategy.
Objectives for quality within the scope of the quality policy might be, for
example:
a) Corporate-wide objectives
Fulfillment of the general company requirements (laws, regulations,
directives)
Improving market acceptance
Making profit
Ensuring the continued existence of the company
Continuous quality improvement (see Question 01.3).
b) Product-related objectives
Scrap-/ failure rates (%)
Supplier delivery quality (ppm)
Improving product quality
Improving process capability (Cpk)
Improving reliability
Environmental tolerance.
c) Customer-related objectives
Shortening of order processing time (inquiries, orders etc.)
(difference in days)
Improving customer satisfaction (e.g. reducing the number of customer
complaints change %)
Reduction in the reaction time when dealing with complaints (difference
in days)
Improving delivery reliability (on-time performance).
41
d) Higher objectives
Reducing costs but not to the detriment of quality
Advance quality planning (see Question 02.5)
Increasing improvement suggestion activities (methods, equipment,
operations etc.)
Calculating and evaluating the costs assigned to all quality elements in
order to minimize any loss of quality
Monitoring the effectiveness of corrective actions on the basis of audit
results
Quality of the development of products and processes (time, implemenation, practicability, feasibility etc.)
Quality system upgrade from ISO 9001/2 to VDA 6.1. Further development towards TQM, EQA etc.
Note:
The demonstration of achieved quality in comparison to objectives

- see Question 04.7
The quality objectives to be agreed must be achievable and, if possible,

measurable, as well as periodically revised and presented in a suitable
format, e.g. using data processing systems. The achievement of objectives
must be monitored thoroughly at all management levels (specified/actual
comparison).
The objectives must be practically, clearly and comprehensively explained
to the employees during informative discussions.
Without the definition of objectives, no efficient improvement in quality and
increase in productivity in all company areas can be followed or achieved.
42
01.3*
Is a continuous improvement process part of the quality

policy?
Improvement programs for the operating units and for the commercial and
technical functional units of a company must be introduced and maintained.
The methods cited elsewhere (see Questions 04.2 and 04.5) must be used
here.
Items for improvement include, for example:
Note:
Reducing non-value-adding activities (e.g. rework, repairs)

Simplification of processes/Optimization of production
methods.
Minimization of waste
Reducing unplanned down-time of machines
Shortening setting-up and tool change times
Increasing service life/cycle times of products and equipment
Improving the ease of repair of products and equipment
Reducing water, air and energy expenditures
Optimization of activity times
Improved handling in all areas
Connections to Question 01.2 are possible. The working methods applied can
be selected on a company-specific basis.
In the continuous improvement process, careful handling and economical

use of resources must also be taken into account. This includes, for
example:
-
the logistical chain

the building / factory area
the equipment
environmental protection
The strategy of continuous improvement applies to employees, all production processes, services and business operations of a company. It does not
replace necessary innovative improvements. Improvements refer to, for
example:
-
Quality
Price
Service
Delivery reliability.
43
01.4*
Have the necessary resources been provided by the company

management?
So that the quality system can operate effectively, the company management has the task of providing the financial and personnel resources
needed to fulfil the requirements in the quality elements. These include, for
example:
-
qualified staff with task-related capabilities for management,

implementation and inspection activities (including project
management)
inspection and testing equipment for product development and
manufacture
computer support, e.g. for data analysis, graphic displays, statistics, quality plans.
The effectiveness and efficiency of the quality system depends on the provision of the necessary resources for the realization of the quality policy and
the quality objectives.
Note:
44
This question cannot be finally evaluated until the entire quality system has
become transparent as a result of the audit and until it has been ascertained
that all necessary resources are available.
01.5*
Has a management representative been assigned and are his

duties, authorities and responsibilities defined?
The "Management representative" is the person who represents the interests of management regarding strategic quality management at all management levels.
The representative must belong to the management team of the company,
but does not have to be a member of the management. He/she always reports to that level of management, which is responsible for profit and loss.
Responsibilities and authorities of the representative include:
-
Note:
Reporting on the quality situation

Defining, realizing and maintaining the quality system in accordance with the requirements of this questionnaire, which includes branch-specific adjustments
Monitoring the strategic quality objectives
Controlling and coordinating quality activities using interdisciplinary cooperation
Demonstrating the effectiveness of the quality system and
determining possible improvements.
The representative may at the same time be responsible for the organizational
functions "quality department", "quality assurance", "quality managementetc.
45
01.6*
Does management regularly evaluate the effectiveness of the

quality system?
Definition:
Management Review (in accordance with DIN EN ISO 8402/3.9):
A formal evaluation by top management of the status and adequacy of the
quality system (quality management system) with respect to the quality
policy and quality objectives.
Company management must periodically (at least once each year) assess
and satisfy itself about the effectiveness of the established quality system.
The aim of this assessment is to achieve a continuous optimization and
adaptation to changed conditions (market, technology etc.). This can be
done by collecting and evaluating the following information, for example:
-
Reports on the quality situation

Regularly scheduled quality meetings
Quality indices with respect to objectives (see Question 01.2)
Internal quality audit reports with derived measures (see Question 03.2 and 03.3)
Status of the continuous improvement process (see Question
01.3)
Results of product and process analysis with corrective actions
Reports on customer satisfaction (see question Z1.4).
The review is carried out by comparing the findings with the objectives of the quality policy and usually results in preventive and corrective actions.
46
02
Quality System
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.2
Section 5
A quality system consists of the organizational structure, the responsibilities, procedures, processes and resources for the implementation of quality management.
The quality system is intended to promote continuous quality improvement.
The quality system shall be defined and implemented by management, preferably in a quality manual and in supplementary documented procedures or equivalent documentation.
Note:
VDA Volume 4.3 is also applicable for this element.
Reference
DIN EN ISO
9001
9004-1
02.1
*
Is the quality system described in a quality

manual or an equivalent document?
4.2.1
4.2.2
5.3.2
02.2
Does the quality system encompass all areas,

levels and employees of the company?
4.1.2
5.1
5.2,
5.6
02.3
*
Are there documented procedures defining

duties, responsibilities and authority levels for
quality activities?
4.1.2.1 5.2.2
02.4
*
Is there a cross-functional project

management established which includes the
quality planning process?
(4.4.3)
5.2.6
02.5
*
Is there a quality planning process for the

necessary measures and procedures for
fulfilling quality requirements?
4.2.3
5.3.3
02.6
*
Are there quality plans resulting from the

quality planning process?
4.4.3
5.3.3
47
02.1*
Is the quality system described in a quality manual or an

equivalent document?
Definition:
Quality manual (according to DIN EN ISO 8402/3.12):
A document stating the quality policy and describing the quality management system of an organization. (see Paragraph 4.3 #3.12).
All quality elements necessary for conducting the business of a company
must be described in the quality manual with reference to applicable internal
and external instructions, standards, regulations etc.
The documentation covers:
-
Names of responsible individuals
Implementation process for all activities affecting quality in the
company.
The manual must display the approval of the company management, the
validity date and the revision status. Responsibility for its updating, revision
service and the distribution list must be defined. The main purpose of a
quality manual is to define the structure of the quality system and, at the
same time, to serve as a permanent reference for the implementation and
maintenance of this system.
In addition, special processes can be separately defined in documented procedures, quality assurance plans etc. This also include instructions on project management (see Question 02.4).
48
02.2
Does the quality system encompass all areas, levels and

employees of the company?
Definition:
Quality system/(Quality management system) (according to DIN EN
ISO 8402/3.6):
The organizational structure, responsibilities, procedures, processes and resources needed to implement quality management.
The quality system extends to all phases of the life cycle of a product
(DIN EN ISO 9004-1 Paragraph 5.1) and all value-adding processes involved. Its interacting functions are a precondition for the continuous compliance with the requirements of customers, legislators and society.
A universal understanding of quality and quality assurance should extend as
a leading theme throughout the entire company. The understanding of
quality management as a task of all employees can be demonstrated by, for
example:
-
actions including various departments

appropriate training, presentations, publications
department-related objectives for quality improvement
responsibilities matrices.
Job descriptions and organization charts serve, among other things, to

endorse employees, clarify relationships at interfaces and provide evidence
of relevant duties. They make the organization transparent, simplify personnel qualification and assignment and promote motivation and enthusiasm
for decision-making.
49
02.3*
Are there documented procedures defining duties, responsibilities and authority levels for quality activities?
Activities affecting quality relate both preventatively and reactively to the
entire life history of a product.
"Quality documented procedures" are special stipulations which are
necessary for the fulfillment of the defined quality-related activity. They
come into effect when signed.
Duties, responsibilities and authorities are to be unambiguously and clearly
defined for those departments and employees which influence product and
process quality. Thereby, coordination and interfaces between various departments and activities must be observed.
These definitions are best made, for example, in:
-
Quality documented procedures

Responsibility matrices
Job descriptions,
which come into effect when signed. Hereby, it must be ensured that duties
are clearly defined with the necessary independence to fulfill stipulated
requirements. This requires a definition as to who, for example:
-
50
can stop faulty products or processes

is responsible for suggesting and monitoring problem solutions
monitors conformity with quality requirements, particularly after
changes
is responsible for quality-relevant documentation.
02.4*
Is there a cross-functional project management established

which includes the quality planning process?
Project management is defined as the management of activities across
several departments within a company, aimed at the realization of a particular project (e.g. introduction of a new product [see Question 08.1], a new
process, start of a series [see Element 14]). This task begins as early as
possible and encompasses the concept/design phase, the manufacturing
process, through to product utilization and disposal. It includes, among other
things, quality planning (see Question 02.5) and the quality plan (see
Question 02.6).
Project flow charts with the main details, among other things for the management of a project, must be raised and developed at a very early stage.
Here, the joint activities include:
-
raising the specification

concept / design,
development
production
utilization
disposal
which must be outlined and explained in the context of simultaneous engineering taking interface issues into account. Quality methods (such as QFD,
DFMEA, PFMEA, DOE,...) must be applied on a project-specific basis.
Depending on the task, the project team should include staff from Development, Production Planning, Quality and Production departments etc.
The Purchasing department and suppliers must be included when necessary.
The duties and responsibilities must, for example, be defined in project
plans or respectively, in product and process development plans. The
appointment of a project representative (project manager) is advantageous
for all projects. In the case of new projects, it must be ensured that
confidentiality, protection and security of data is guaranteed through appropriate procedures for those involved in the project. Suppliers, if necessary,
are also be included.
Note:
The requirement for a "Configuration management" in the standard DIN EN ISO 9004-1, Section 5.2.6 and 8.10, is interpreted as "Project management " in
this questionnaire (also see DIN 69905[12.90] - Project implementation).
51
02.5*
Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements?
Definition:
Quality planning (acc. to DIN EN ISO 8402/3.3): activities that establish the
objectives and quality requirements, as well as the requirements for the
application of the elements of the quality system.
Note:
Quality planning covers:

a) product planning: identifying, classifying and weighting the characteristics for
quality, as well as establishing the objectives, quality requirements and constraints;
b) planning managerial and operational activities: preparing the application of
the quality system including operational and time schedules;
c) the preparation of quality plans and the making of provisions for quality
improvement.
Quality planning (also known as advanced quality planning) must be
regarded as an interdisciplinary task which defines how the quality requirements should be fulfilled. It must be compatible with the quality elements of
the company and match the size, structure and working methods used (e.g.
through reference to appropriate procedures/already existing planning schedules or descriptions).
Quality planning must take into account the tasks and deadlines stipulated
by the customer and must contain specially defined methods.
Interdisciplinary teams must be used for the activities to be carried out (e.g.
Product Development, Process Planning, Quality, Marketing).
52
The quality planning phases for new products are:

Planning and definition
- Determining the customer's requirements and expectations
- All activities must be carried out from the view of the customer
(end user, consumer).
- Input data and results can vary
- The stated input data and results represent recommendations.
Product design and product development, including verification
- The quality planning team responsible for the product must
consider all development aspects in the planning process in
order to ensure that the end product meets the customer's
expectations.
- If the design responsibility lies with the customer, design
aspects must also be considered.
Process design and process development, including verification
- Development of a process system with the quality plans to be
used
- The process system must ensure that the requirements, needs
and expectations of the customer are met.
Process and product validation
- The production process must be validated by evaluating a trial
series.
- The quality planning team responsible for the product should
verify that the quality plan and the process plan are fulfilled and
that the products meet the customer's requirements.
Feedback, evaluation and corrective measures
- The results of the trial series have to be evaluated to ensure
that the products meet the customer's requirements.
- The effectiveness of the product quality planning process must
be newly evaluated
53
Activities include, for example,:

02.6*
Definition and identification of significant characteristics

(tailored to the customer's stipulations)
Development and review of risk analyses (e.g. FMEAs) and the
resulting measures.
Development and review of quality plans (see Question 02.6)
Determining the required resources (e.g. personnel, production
equipment, measuring systems)
Clarification of acceptance criteria
Examination of the realization of the process
Determining manufacturing feasibility/practicality
(see Question 07.2)
Are there quality plans resulting form the quality planning

process?
Definition:
Quality plan (according to DIN EN ISO 8402/3.13):
A document in which the specific-related work instructions and aids, as well
as the sequence of activities with regard to an individual product, an individual project or an individual contract, are outlined.
Note 1:
A quality plan normally refers to those parts of the quality manual which apply in
a specific case.
Note 2:
An alternative description, e.g. "quality assurance plan" can be used, depending

on the area of application of the plan.
Depending on the customers requirements and company practice, a quality

plan can be an independent document or the relevant stipulations are incorporated into a different document, such as, for example, in a project plan.
Quality plans must include components, modules, subassemblies, parts and
materials and the production processes associated with the marketable
product.
54
The quality plan must normally be drawn up for the following 3 phases:
Prototype phase
A description of the dimensional, material and functional inspections
and tests which must be carried out during prototype construction
(when required by the customer).
Pre-series phase
A description of the dimensional, material and functional inspections
and tests which must be carried out after prototype construction and
before series production.
Series phase
Comprehensive documentation of the product and process characteristics, the process control measures, the inspections and tests and
measuring systems which must be observed during series production.
When quality plans are drawn up, a distinction is made between various
versions. These are related to tangible products in
a) plans for a part manufacturing process with, for example, the following
content:
Part name
Process plan (manufacture / inspection / storage)
Process stages (working steps)
Work instructions
Identification of the quality-relevant characteristics which have to be
monitored during production.
Process monitoring
- Process description
- Monitoring methods (quality control charts, automatic recordings etc.)
- Responsibilities (operator inspection, quality inspection etc.)
- Inspection instructions
Inspection
- Parameters
- Geometric/material/functional characteristics
Documentation,
55
b) plans for a finished product with, for example, the following content:
Responsibilities (organizational units)

Review of the customer requirements
Contract review
Design review
Production
Product inspection and testing
including
Associated management plan

Design and development plan
Product quality plan for purchased products
Manufacturing plan (provision of machines, tools, equipment, testing
and inspection equipment)
Control plan (see Question 15.1)
Service plan
If required, the quality plan must be agreed upon with the customer.
Quality plans are living documents and must be reviewed and updated if:
-
56
the product has been modified

the processes have been changed
the processes are no longer stable or capable
03

DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.17
Section 5
No organizational measure, or quality system procedure, works

automatically when it is put into place. It requires constant development and monitoring.
Internal quality audits carried out by trained and qualified staff
serve the purpose of systematic and continuous review as to
whether the activities defined in the quality system and their results:
- actually meet the requirements
- are suitable for achieving the objectives and
- demonstrate improvement possibilities
(CIP continual improvement process)
All the elements, aspects and components of a quality system
should be regularly subjected to internal reviews (internal quality
audits). The audit results shall be presented to management for
their review in documented form and, if necessary, should lead to
corrective actions being implemented.
Audit reports are quality records.
An internal audit encompasses all quality elements and thereby
provides the objective evidence about the necessity for the reduction, elimination and, most importantly, the prevention of nonconformities.
Note:
VDA Volume 6.3 and 6.5 are also applicable for this element.
Reference
DIN EN ISO
9001
9004-1
03.1
*
Are the personnel (auditors) who perform internal quality

audits qualified and independent of the areas being
audited?
4.17
5.5
03.2
*
Are all elements of the quality system regularly subjected

to internal audits and evaluated according to an audit
plan?
4.17
5.4
5.5
03.3
*
Do deviations lead to corrective actions and are these

documented?
4.17
5.4.5
03.4
*
Are the demands placed on products and processes

audited and evaluated internally on the basis of an audit
plan?
5.4.3
57
03.1 *
Are the personnel (auditors) who perform internal quality

audits qualified and independent of the areas being audited?
Definition:
Quality auditor (according to DIN EN ISO 8402/4.11):
Person qualified to perform quality audits.
"Quality auditors" (see DIN ISO 10011, Part 2) must be impartial and free
from any influences which might affect their objectivity.
Personnel tasked with carrying out audits must be independent of the areas
on which they are reporting. They must not come from the organizational
unit to be audited.
Auditors must be qualified to manage and perform internal quality audits.
The required qualification profile must be defined. Depending on the type of
audit and size of the company , the following aspects are particularly
relevant:
Qualification in accordance with DIN ISO 10011-2 and training in
accordance with EOQ or equivalent guidelines. Evidence of training
can also be supplied through internal training courses.
Knowledge and understanding of the standards which might form the
basis for audits of quality systems (DIN EN ISO 9000 - 9004, VDA
Volume 6, Part 1)
Evidence about the methods of grading through investigation,
interview, evaluation and reporting (e.g. auditor training in accordance
with VDA 6.1)
Skills that are essential for the management of a quality audit, such
as planning, organization, communication and leadership
Experience in quality management and quality techniques
Personal characteristics, such as, e.g. integrity, good judgement,
analytical ability, open-mindedness
Upholding of relevant qualifications with certificates.
The qualification profile must be appropriately demonstrated.
Note:
58
For further information, see VDA 6, Chapter 6.
03.2*
Are all elements of the quality system regularly subjected to

internal audits and evaluated according to an audit plan?
The different types of audits with scheduled dates and the areas to be
audited have to be defined in an audit plan (according to DIN ISO 100111). This auditing is the systematic review of all quality elements with regard
to their effectiveness, compliance with the requirements and their topicality.
System audits must be planned and carried out.
Audit plans tailored to the quality elements to be audited must be available
in the organizational units.
An audit plan must contain the following information:
-
Reference documents (standards, quality manual, procedures,

etc.)
Areas and quality elements to be audited
Audit sequence
Questionnaire / checklist
Scheduled dates
Auditors / audit team
After completion of an audit, an audit report with the nonconformances

found and suggested corrective actions is to be raised. It is to be distributed
to the organizational units involved in the audit and the company management. The effectiveness of the corrective actions is to be evaluated within
an appropriate period of time (see also Question 01.6).
Individual quality elements or parts thereof can also be inspected and evaluated at different times. All quality elements, in all areas, and at all company sites must be audited within 3 years.
59
03.3*
Do deviations lead to corrective actions and are these documented?
Definition:
Corrective action (in accordance with DIN EN ISO 8402/ 4.14)
An activity carried out to eliminate the causes of an existing nonconformity,
defect or other undesirable situation in order to prevent its recurrence.
Requirements/Explanation
Detected deviations must lead to immediate corrective actions, i.e. remedying the cause of one or more nonconformances.
A plan of action must be presented within an agreed time regarding the
deviations and proposed corrective actions. The action plan contains, for
example:
a) Deviations
- Non-compliance with a requirement of a standard
- Instructions are not suitable to achieve the objective
- Activity does not correspond to the instructions
- Instructions not actually implemented
b) Evaluating / weighting deviations with respect to
- Image
- Risk/product safety
- Economy
c) Remedial measures
d) Responsibilities/deadlines
e) Effectiveness check
f) Reporting
g) Adapting the documentation (including the quality system)
60
03.4*
Are the demands placed on products and processes audited

and evaluated internally on the basis of an audit plan?
A "product audit" serves to assess the compliance of the workmanship with
the defined quality requirements on the product after the final inspection.
A "process audit" serves to check whether the product complies with the
quality requirements and that the process is mastered and capable.
Product and process audits must be planned and carried out
Audit plans must be defined for products and processes and must include
the following information:
-
Audit aim
Reference documents
Products/processes to be audited
Audit sequence
Questionnaire/checklist
Deadlines
Auditors
Reporting with distribution list
Pursuit of corrective measures
After completion of an audit, an audit report with the nonconformances

found and suggested corrective actions is to be raised and issued to the
involved parties. The effectiveness of the corrective actions is to be evaluated within an appropriate period of time (see also Question 01.6).
The appropriateness of the working and ambient conditions should also be
examined during these audits (see Question 14.6).
61
62
04
Training
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.18
Section 18
The employees utilized in a company are an essential factor contributing to the quality capability of that company. In order to
achieve this, measures to train, qualify and motivate employees
should be planned and implemented for employees in all areas
and at all levels of the company.
Reference
DIN EN ISO
9001
9004-1
04.1
Are training requirements regularly determined 4.18

on an individual and function-related basis and
is a differentiated training program for all
levels of the company derived from this?
18.1.1
04.2
Does the training program also include actions 4.18

for further training in quality techniques?
18.1.1
04.3
Are top management and other management

staff included in the vocational training
program?
04.4
*
Are there introduction and instruction pro4.18

grams for new and transferred employees and
for the introduction of new or modified processes, business procedures etc.?
18.1.3
04.5
*
Do employees possess the formal qualification 4.18

for their activities?
18.2
04.6
Are there measures for the motivation and

promotion of quality awareness?
18.3.1
04.7
*
Do clear and understandable representations

of the achieved quality compared to the set
objectives exist in the company?
18.3.4
4.18
18.1.2
4.1.2.2
63
04.1
Are training requirements regularly determined on an individual and function-related basis and is a differentiated training
program for all levels of the company derived from this?
"Training program" means the determination of the entire training needs and
the derived measures in all areas of the company.
All employees at all levels who carry out activities which affect quality must
be included. Requirement profiles must be defined on a function-related
basis. The training and further training activities must be summarized on an
individual basis. The summary should clearly show completed and still-open
training measures, and the qualification status must be clearly recognizable.
Evidence of training performed can be in the form of grades, certificates or
confirmations of participation.
One person is to be made responsible for the overall training program.
The further training of employees and maintenance of their qualifications is
the responsibility of the direct supervisor.
The training program encompasses all internal and external training
activities and its effectiveness should be examined periodically.
64
04.2
Does the training program also include actions for further

training in quality techniques?
The following topics are relevant, for example:
-
risk analyses
design of experiments
test and measurement technology
capability studies
statistical process control
quality control chart system
system, process and product audit
supplier evaluation
problem solving techniques
evaluation procedures.
The training program must be open to all employees.
65
04.3
Are top management and other management staff included in

the vocational training program?
Training sessions must be held regularly to define and increase understanding of the elements of the quality system.
These elements in particular include, for example:
-
Quality objectives
Quality management / TQM
Quality development
Quality related costs
Quality information
Tools and methods of quality assurance
Product safety
The company management and other managers, for example from:

-
Marketing and Sales

Design
Purchasing and Logistics
Production scheduling and tooling
Production
Quality
Customer Services
Personnel
represent the circle of participants to be addressed.

Sufficient management understanding of the potential of quality techniques
forms the basis for their targeted application in a company.
66
04.4*
Are there introduction and instruction programs for new and

transferred employees and for the introduction of new or
modified processes, business procedures etc.?
"Introductions and instructions" are individual training measures which
enable employees to understand technical and commercial documents and
operational procedures, as well as the necessary techniques/methods
required for their duties, and to use production equipment correctly.
The supervisor (foreman, superintendent, group leader) must instruct his
employees on the appropriate use and operation of production tools and
equipment and regarding the correct interpretation of internal instructions.
The supervisor must satisfy himself as to the effectiveness of the instruction. Evidence of the instruction is shown by signature. These requirements
should sensibly be applied to all organizational areas of the company.
Introduction and instruction programs have to be developed and defined.
When selecting suitable employees, their personal characteristics and their
specialist knowledge / capabilities must be considered.
Special attention should be paid to the selection and training of new personnel, workers on temporary contracts, workers on loan and personnel
entrusted with new duties.
Training and instruction involves employees in the responsibility for equipment and production results. This inevitably leads to the strengthening of
the relationship between employee and supervisor.
Prior to the introduction of operators performing their own inspections, all
affected employees in production must be trained regarding their quality
management duties.
67
04.5*
Do employees possess the formal qualification for their

activities?
The "formal qualification" is the professional status given an employee when
he has demonstrated that he is suitable to perform the defined activities.
Records of formal qualification are necessary when legal and/or contractual
issues must be taken into account. The following, for example, can be
classed as qualification records:
-
materials inspector certificate

welder certificate
certificate for non-destructive materials testing (e.g.
radiographic testing)
Regular internal instruction (first and subsequent instruction) of employees

is also required, as well as a check as to whether the employees are
suitable for their specific duties and that substitution of employees is controlled.
For auditors who carry out external quality audits, records for the following
are to be provided:
-
68
Qualification in accordance with DIN ISO 10011-2 and training

in accordance with EOQ guidelines or equivalent training with
certificate.
Knowledge and understanding of the standards which might
form the basis for audits of quality systems (DIN EN ISO 9000 9004, VDA Volume 6, Parts 1 to 6)
Evidence about the methods of grading through investigation,
interview, evaluation and reporting (e.g. auditor training in
accordance with VDA 6.1)
Skills that are essential for the management of a quality audit,
such as planning, organization, communication and leadership
Experience in quality management and quality techniques
Personal characteristics, such as, e.g. integrity, good judgement, analytical ability, open-mindedness
Upholding of relevant qualifications with certificates.
Evidence must be provided for development and testing activities, for

example:
04.6
Quality Function Deployment (QFD)

FMEA
Design of Experiments (DOE)
CAD/CAM
Value analysis
Simulation techniques
Are there measures for the motivation and promotion of

quality awareness?
Motivationmeans the readiness of employees to perform well.
Quality awareness is shown by the attitude of individual employees to
quality issues.
The continuous improvement of quality awareness in all organizational units
may be achieved, for example, through:
-
Improvement suggestions
Quality circles
Zero defect programs
Poster campaigns, competitions
Training, information meetings
Awards
Workshops.
The quality and performance capabilities of a company are not only dependent on the technical and organizational capabilities and the business resources, but far more so, on the qualification and readiness of employees to
perform well.
69
04.7*
Do clear and understandable representations of the achieved

quality compared to the set objectives exist in the company?
This is related to the named objectives, defined in Question 01.2 Quality
objectives".
The current achieved quality levels is to be represented, for example, by
quality indices.
Periodic quality reports and general information with "specified/actual" comparisons, graphical representations and other methods of communication at
all levels, for example:
-
Representation of quality related costs

Representation of rework (amount/costs)
Presentation of audit results
Comparison of development objectives and development
status
Representation of the satisfaction of internal and external
customers
are documents which give information about this.

This makes a comparison between set objectives and achievements
possible. The representations must be easily comprehensible and interpretable for the employees and must allow the comparison between the set objectives and achievements to be easily recognized.
70
05

DIN EN ISO 9004-1,
Section 6
Financial considerations to quality systems are necessary because:
-
quality, or respectively, non-qualityhas considerable effect on

the profit and loss situation of a company and its
organizational units.
by improving effectiveness and efficiency of work, losses are

reduced and customer satisfaction raised.
It is therefore important that the effectiveness of the quality

system is measured in economic terms.
The collection of quality costs can be performed parallel to, or in

connection with, the classical industrial cost accounting system. It
must be clearly defined and enable long term comparisons/trends
to be identified.
Note:
Characteristic figures and trends, but not absolute values/

amounts must be demonstrated to the external auditor.
Reference
DIN EN ISO
9001
9004-1
05.1
Is there a procedure for financial reporting of

the effectiveness of the quality system?
6.1
05.2
*
Does regular financial reporting and evaluation (4.1.3)

by the persons responsible take place?
6.3
05.3
*
Is there evidence about internal losses as a

result of unacceptable quality (nonconformity)?
6.2.2
05.4
*
Is there evidence of external losses as a

results of unacceptable quality (nonconformity)?
6.2.2
71
05.1
Is there a procedure for financial reporting of the effectiveness of the quality system?
There are various methods for collecting, analyzing and displaying financial
data about the quality elements.
The financial reporting methods used depend on the individual structure of
each company and its organizational units, its activities and the maturity of
the quality system.
Traditional methods do not exclude the use of others, or their adaptation
and/or combination.
The appropriate procedure, method and cost structure (see Questions 05.2
to 05.4) must be defined (e.g. with instructions, distribution list, cost center
and cost plan and a summary of all financial outlays for the company
management).
Methods of financial reporting on activities in the quality system include, for
example:
Quality-related costs
- Fault prevention
- Inspection and testing
- Internal and external faults
or process-related costs (profit/cost ratio calculation) with
- conformity costs
- nonconformity costs
or quality-related losses (calculating the quality loss) with
- internal and external material losses (non-fulfillment of quality
requirements).
Reports to management must be prepared concerning the extent, trend and
analysis of costs related to nonconformances and their causes.
Note:
Detailed information is only the subject of internal audits. Only the existence of
the procedure must be proven to an external auditor.
The company has the task of recording, analyzing and outlining on a causerelated and time-related basis the financial figures which illustrate the
effectiveness of the quality system. It must also introduce and monitor the
effectiveness of improvement and preventive measures.
72
05.2*
Does regular financial reporting and evaluation by the

persons responsible take place?
Financial reports on quality-related activities should be compiled and evaluated regularly by the persons responsible. Improvements and objectives
can be derived from this.
The reports must relate clearly to business parameters, such as sales,
turnover or value-added figures, in order to provide a realistic view the
company. Characteristic parameters and measured values must be in line
with target values. Trends and potential areas for improvement must be
identifiable. Quality and cost targets and improvement measures must be
defined for the subsequent period.
05.3*
Is there evidence about internal losses as a result of unacceptable quality (nonconformity)?
Internal losses are losses before delivery as a result of unacceptable quality. They may arise from reduced work efficiency caused by rework, poor
ergonomics etc. They also include nonconformity costs resulting from the
non-fulfillment of quality requirements by a product prior to delivery (e.g.
repeated performance of a service, renewed production, rework, re-inspection and testing, rejects).
These costs/expenditures include, for example:
-
Rejects
Rework
Quantity deviation
Value reduction
Unplanned sorting action
Re-inspection and testing
Investigation of the problem
Down-time caused by failures
Development targets not achieved.
Key cost items must be shown with their causes, in a time-, production- and
product-related manner.
73
05.4*
Is there evidence about external losses as a result of unacceptable quality (nonconformity)?
External losses are tangible and intangible losses which are identified as
resulting from unacceptable quality.
Tangible losses are nonconformity costs which result from the nonfulfillment of quality requirements by a product after delivery (e.g. sorting,
rework and repair, warranty performances and return shipments, direct
costs and compensation, costs of product recalls, product liability costs).
Typical intangible losses include, for example, lost future sales as a result of
customer dissatisfaction.
These costs include, for example:
-
Warranty (on delivery/"0 km" and after use by the customer)

Goodwill cases
Investigation of the problem
Recall action
Product liability
also possible costs from

-
Loss of image
Loss of customers due to dissatisfaction.
Key cost items must be shown with their causes, in a time-, production- and
product-related manner.
74
06
Product Safety
DIN EN ISO 9004-1
Section 19
The safety aspects of a product should be identified, with the aim

of enhancing product safety.
The quality system must always be directed towards the reliable
prevention of nonconformities.
The employees of a company, particularly executive/ management
personnel, must, in accordance with their activities, be appropriately informed of the effects of product nonconformities and the
consequences for the company arising from product liability.
Note:
VDA Volume 1 is also applicable for this element.
Reference
DIN EN ISO
9001
9004-1
06.1
Are the principles of product liability known

throughout the company?
06.2
Is there a procedure to define and identify

(4.2.3 19
products and special characteristics, for which
a,g)
special documented evidence of the quality is
required?
06.3
*
Have procedures for identifying product risks

been defined?
19a, b
06.4
Do emergency plans and procedures for

containing nonconforming products exist?
(4.8)
19d, e
75
06.1
Are the principles of product liability known throughout the

company?
Definition:
Product liability (according to DIN EN ISO 8402/2.12):
A generic term used to describe the onus on a producer or others to make
restitution for loss related to personal injury, property damage or other harm
caused by a product.
Note:
The legal and financial implications of product liability may vary from one
jurisdiction to another.
Indications concerning the knowledge of the principles of product liability
can be, amongst others, evidence of:
-
Instruction and qualification of responsible individuals

Legal services (internal / external)
Product liability insurance
Observation of science and technology
Product safety deficiencies can lead to liability claims against the company.
Therefore, the company employees, particularly the management personnel, in accordance with their activities, must have appropriate knowledge
of the principles of product liability.
Principles of product liability are (amongst others):
-
76
Liability dependent on blame (characterized by the reversal of

the burden of proof. i.e. the burden of proof lies with the
defendant)
Liability independent of blame (new product liability law), liability
for direct damages and consequential damages caused by a
defect
It must be demonstrated that the manufacturing process
(design, manufacturing and testing) is "state of the art" - simply
complying with the applicable standards is not sufficient
Responsibilities must be defined in writing
Inspection and testing documentation with archiving
Traceability must be ensured (limitation of damages)
Warning of possible risks when the product is put into action by
the user.
06 .2
Is there a procedure to define and identify products and special characteristics, for which special documented evidence
of the quality is required?
Products and characteristics, which require the corresponding documentation to be specially archived, have either special significance for functional
safety (operation and use) or are directly subject to requirements derived
from official specifications (see VDA, Volume 1). All products with at least
one such characteristic require documentation with special archiving.
Their special treatment is based on general and specific safety standards
related to the state of the art and customer requirements.
The system should take into consideration, for example:
-
Recognition of product risks (see question 06.3)

Definition of the characteristics concerned
Identification of these characteristics on all relevant documents
Identification and handling of these products
Documentation system with rules for retention periods and
responsibilities.
The documentation includes, for example:

-
Test results, test decisions, process parameters

Records of the calibration of test equipment
Records of the instruction, knowledge, competence and
suitability of personnel (e.g. medical examinations, such, as
eye tests)
Special processes for products with characteristics subject to
documentation.
All documents which relate to such a characteristic must be specially identified. Departments involved must be informed about the need for special
handling of these documents.
77
A retention period of 15 years (differences specified by the customer must

be taken into account) is also valid after discontinuation of production (for
further instructions, see VDA Volume 1).
Proper documentation can contribute towards exoneration in warranty and
product liability cases.
The company obligates itself with the order confirmation to follow the
appropriate procedure, if agreed.
06.3*
Have procedures for identifying product risks been defined?
"Product Risks" are safety risks that are involved in the product fulfilling its
own function. Furthermore, this also refers to the risks that a component
brings to a complete assembly.
Product risks are identifiable through, for example:
-
Risk analyses (FMEA, amongst others)

Load-bearing tests
Service life tests
Crash tests
Material testing
Installation trials
Environmental simulation tests
Investigations of environmental compatibility and disposal
and the derived measures resulting from these.

The safety aspects are of predominant importance during these examinations.
The applicable procedures serve to identify and estimate the potential
dangers, which arise from an incorrectly developed, manufactured and/or
described product. If necessary, they must lead to decisions regarding
actions to be taken.
This applies equally to product descriptions (e.g. manuals).
78
06.4
Do emergency plans and procedures for containing nonconforming products exist?
"Procedures to contain nonconforming items" serve damage limitation.
They facilitate the traceability of products in a manufacturing operation back
to the material and processes used.
Emergency plans for product recalls must be defined commensurate with
the product risks, which are derived from the safety relevance of a product
and possible risks in the entire process chain.
Procedures to contain nonconforming products (see also Questions 11.7
and 13.6), for example, can be:
-
Identification on the part/product

Lot/batch identification
Product verification, documentation
Product identification during transport and storage
Following the "first-in/first-out" principle
Stating and observing use-by dates
Recognized nonconformities which are relevant to safety can thereby be

limited (damage limitation) in the field (during use) and possibly remedied by
improvement or recall actions.
79
80
Z1
Corporate Strategy
Improved and constant quality, delivery reliability in the agreed
time frame and cost reductions on the one hand, plus more intensive confidence-building customer/supplier relationships on the
other hand, in addition to stronger international business relationships, today force many companies to adapt their strategy to these
requirements. Company management, including immediately subordinate executive level, must therefore concern itself with the
following subjects, e.g.:
-
Business plan
Business results
Customer satisfaction
Note:
Comparison of internal and

external performance data
Employee satisfaction
Characteristic figures and trends, but not absolute values/amounts,

must be proven to the external auditor.
Reference
DIN EN ISO
9001
9004-1
Z1.1
Is there a strategic business plan in the

company which contains aspects relating to
costs, sales, quality etc.?
Z1.2
Are there methods to measure business

results and are they used regularly in order to
introduce improvements?
Z1.3
Is company-wide performance data compared with results from benchmarking or similar

methods and are improvement measures
derived from this, if necessary?
Z1.4
*
Is there a procedure which enables customer

satisfaction to be measured and changes to
be detected?
Z1.5
Is employee satisfaction in the company one

of the principles of management and is it
maintained on a continuous basis?
81
Z1.1
Is there a strategic business plan in the company which

contains aspects relating to costs, sales, quality etc.?
Definition of terms:
A "business plan" is a document with company-specific strategic projects
and targets which must be fulfilled or achieved in a defined period.
Requirements / explanation:
A business plan normally includes the following:
a) Cost aspects
- Finance and cost planning (investments, personnel and
material costs)
- Cost targets
b) Salevda-0s and marketing aspects
- Market data
- Turnover/sales targets
- Customer satisfaction criteria (see Question Z1.4)
c) Overall corporate aspects
- Growth projects
- Plant structure plans
- Personnel planning
- Comparison with other companies (benchmarking)
d) Development aspects
- Development and trial projects
- Product analyses of competition results
e) Process and quality aspects
- Important characteristic data of process performances
- Important quality related figures (see Question 01.2)
82
All aspects should:

-
have time details

be based on project-related knowledge
take into account present and future customer expectations
be understandable and monitored, and adapted to any
changes
serve the purpose of process and quality improvement
Business planning activities must be carried out on an interdisciplinary basis

Note:
External auditors are to be provided with evidence of : characteristic figures,

time frame, tendencies, trend analyses but not absolute values/amounts and
also not for all aspects. Attention must be paid to company-specific matters.
Z1.2
Are there methods to measure business results and are they

used regularly in order to introduce improvements?
The "business result" expresses what the company achieves with respect to
its planned performance.
Starting points for financial variables can be, for example:
-
Profit
Cash flow
Turnover
Value added shareholders
Capital
Liquidity
Dividends
Long-term value for
(shareholder value)
In practice, these values are shown partly as absolute values and partly as
ratios per capital unit or per employee.
Starting points for non-financial variables can be, for example:
-
Market share
Rejects achieved
Variability of products
Customer service level
83
Cycle times such as:

-
Innovation time
Time until the profit threshold is reached
Stock turnover frequency
The measured variables are orientated towards the company strategy and
to the corporate aims and plans. They contain measured variables which
enable the internal economy and effectiveness to be recognized and which
are decisive for continued corporate success.
Note:
Only the existing system must be evaluated, not the absolute values /
amounts themselves.
Z1.3
Is company-wide performance data compared with results

from benchmarking or similar methods and are improvement
measures derived from this, if necessary?
The evaluation, analysis and use of company-wide performance data in
comparison with the data of competitors or other companies through
benchmarking must give information on, for example:
-
Productivity
Economy
Quality situation
Efficiency
Trends in the data and information should be compared with the progress
made towards the company's overall targets and converted into useable
information for the purpose of:
-
Note:
development of priorities for the rapid solving of customerrelated problems

determining the important customer-related trends and interrelationships in order to make a review of the company's
situation, decision-making policies and long-term planning
possible.
1. Only the existing system must be evaluated, not the absolute
values/ amounts themselves.
2. This question can be omitted for companies (particularly small
companies) which do not operate on international markets.
84
Z1.4*
Is there a procedure which enables customer satisfaction to

be measured and changes to be detected?
The procedure must consider the following criteria, e.g.:
-
Method application
Recognition frequency
Data evaluation and representation
Interpretation of trends
Responsibility
Distribution list
Measurable variables can be, amongst others:

-
Flexibility regarding inquiries to new/changed products/

processes
Achievement of targets
Product quality at delivery
Delivery reliability (see Question 19.6)
Speed of reactions when quality problems occur
Comparisons with competitors and benchmarking methods are helpful. As

far as possible, not only the direct customer but also the end consumer
should be involved.
Measures which lead to greater customer satisfaction should be derived
from the knowledge gained.
Note:
Only the existing system must be evaluated, not the absolute values/ amounts
themselves.
85
Z1.5
Is employee satisfaction in the company one of the principles

of management and is it maintained on a continuous basis?
"Employee satisfaction" is measured by the way the employees perceive
their company. The needs and expectations of employees must be satisfied
by a comprehensive quality approach, in order to advance the employees
readiness to work well.
Points which effect employee satisfaction are, e.g.:
-
Working conditions, work location, environment, equipment

Health and safety measures
Communication on an individual and company-wide level
Employee performance evaluation, agreed goals, career
planning
Knowledge of work requirements
Knowledge of quality policy and corporate strategy
Involvement in quality matters
System for recognizing and rewarding performance
Management style
Job security
Further indicators for employee satisfaction can be, for example:

Note:
86
Results of employee surveys (questionnaire)

Absenteeism and sickness quota
Personnel turnover
Ease in hiring recruits/trainees
Use of company facilities
Only the existing system must be evaluated, not the absolute values/
amounts/results themselves.
Part P:
Product and Process
07

DIN EN ISO 9001,
Section 4.3
DIN EN ISO 9004-1,
Section 7
This quality element deals with the contract review, a marketing
duty.
Marketing includes market research, marketing and sales.
The marketing function should take priority when defining the quality requirements of the product. They determine the requirements
for a product, the market demand and the customer requirements.
Before a quotation is submitted or a contract or order is accepted,
the requirements contained therein are to be checked for completeness, feasibility, ability to fulfill etc. (Contract Review). This
applies equally to contract changes.
The requirements of the customer should be documented in a
performance specification and should be clearly communicated.
Reference
DIN EN ISO
9001
9004-1
07.1
Has a function marketingbeen incorporated

into the process organization?
7.1a-c
07.2
*
Are inquiries, quotations, contracts/orders

checked for completeness and feasibility and
approved?
4.3.1
4.3.2
7.1a
07.3
Are technical and commercial costs ascertained when preparing a quotation?
07.4
Are the customer's quality requirements on the 4.2.3

product and the quality system available?
4.3.2a
7.1d
07.5
Is a procedure available that ensures the early 4.3.2c

and clear notification of all product specifications to all areas involved?
7.2
87
07.1
Has a function marketing been incorporated into the operational organization?
Definition:
The process organization determines the sequence of actions (control
mechanism) for dealing with a very specific process, for example, from the
market analysis through product development to the payment of invoices.
Requirements/Explanations:
The function marketingand its tasks must be described.
Marketing must determine, define and document the quality requirements
and expectations for a product. To do this, a process organization has to be
established in which all involved functional or organizational units are included and their tasks defined. This can be part of the project management
(see Question 02.4).
Tasks are, for example:
-
88
Projection of production numbers

Providing information on prices and utilization deadlines
Informing about specific customer requirements/expectations
and evaluating feasibility
Guaranteeing internal acceptance for the manufacture of a
product with defined requirements
Taking into account logistical concerns
Providing for disposal.
07.2 *
Are inquiries, quotations, contracts/orders checked for completeness and feasibility and approved?
Definition:
Contract Review (according to DIN EN ISO 8402/3.10):
Systematic activities carried out by the supplier prior to signing the contract
to ensure that the quality requirements are adequately defined, free from
ambiguities, documented and can be realized by the supplier.
Prior to the submittal of a quotation or the acceptance of a contract/order
the contract documents (specifications, drawings, requirement specifications, standards, quality agreements, logistical stipulations etc.) must be
checked for completeness.
Hereby it must be ensured that, e.g.:
-
requirements are complete, appropriate and documented

agreement exist for verbally placed orders prior to acceptance
ambiguities and deviations are clarified early.
For this a system must be in place in which all responsible functions of the
company and its organizational units (e.g. sales, development, production,
production preparation, quality department and material management) confirm that they are able to fulfill customer requirements. The interfaces to the
customer are to be defined.
The contract review includes, for example:
-
a defined sequence of events in the quality manual/procedures (flow

chart)
Approval ruling prior to submittal of quotation to the customer (form
with approval by the responsible organizational units)
Review of contract documents, among others, for:
clarity of the individual requirements
inconsistency of individual requirements
missing of individual requirements
given deadlines.
When contradictions are detected and requirements are not able to be

maintained the customer (normally the responsible developer, purchaser)
must immediately be informed, i.e. even prior to the submittal of a quotation.
The same sequence of events also applies for contract changes.
89
07.3
Are technical and commercial costs ascertained when preparing a quotation?
Definition:
In a quotation a customer (the market) is offered a product for purchase or it
is provided to him as property or for use.
Products can be tangible or non-tangible.
For a quotation, all decisive cost elements must be established and taken
into consideration. The costs are compiled by the responsible divisions and
are incorporated into the overall calculation.
The individual cost elements contain, for example:
-
development costs
material costs
investments (including hardware/software)
costs for quality measures
transportation costs
packaging costs
value-added portions/calculated profit
overheads (administration and marketing cost)
Note:
The procedures in practice must be proven to the auditor, rather than the
absolute values.
07.4
Are the customers quality requirements on the product and

the quality system available?
Definition:
Quality requirement (see Para. 4.2/#.2.3)
The quality requirements for a product must be documented, defined and
thereby the customers requirements completely taken into account. All
relevant functional/organizational units are to be included in these
sequences.
90
The quality requirements (of the customer) are described, for example, in:
-
Specifications
Quality agreements
Drawings
Performance specifications
Standards
Purchasing conditions
Order documents.
The definitions also include requirements based on, for example:

-
Delivery call offs

Delivery dates
Prices
Packaging/Identification
Disposal.
Special requirements with regard to type, scope and structure of the quality
system are to be agreed separately.
07.5
Is a procedure available that ensures the early and clear notification of all product specifications to all areas involved?
Definition:
Requirements Specification (according to DIN 69905):
The entirety of the customer requirements concerning the supplies and services of the supplier.
According to VDI/VDE 3694:
In the requirements specification, all requirements from the users perspective, including all boundary conditions, are to be described. These should be
quantifiable and able to be verified
It is defined in the requirements specification what sort of task lies before
and why it is to be solved.
91
Performance Specification (according to DIN 69905):

All the realization requirements worked out by the supplier based on the
implementation of the requirements specification.
According to VDI/VDE 3694:
The performance specification contains the requirements specification. The
user requirements are detailed in the performance specification and described in an expansion of the realization requirements under consideration
of concrete solutions.
How and with what the requirements are to be realized is defined in the
performance specification.
Evidence must be provided for a procedure which ensures the maintenance
and distribution of all relevant documents to the responsible organizational
units. Thereby, it must be ensured that the requirements are generally comprehensible, i.e. if necessary:
are translated (e.g. translations of foreign language customer standards, quality agreements, requirements specification etc.),
are explained and clarified (e.g. explanation of customer-specific
abbreviations),
the customer contacts for specific topics (development, purchasing,
quality assurance etc.) are known to those responsible
product function and assembly status are known.
The entirety of the customer requirements on a product is to be regarded as
the product specifications. They are defined, for example, in the requirements specification and as realization requirements drawn up by the contractor, for example in the performance specification. Apart from the performance characteristics, they also contain assembly instructions, applicable
standards, quality assurance methods, packaging etc.
92
08
Design Control, (Product Design and Development)

DIN EN ISO 9001,
Section 4.4
DIN EN ISO 9004-1,
Section 8
The quality element design control also called the quality at interpretation and design describes the quality-ensuring tasks in the
area of product design and development. These should take care
of the transferal of the customer needs from the requirements specification into a performance specification and technical specifications for products and prepare for a timely realization in conformance with customer requirements. The provision of resources
for, e.g.: personnel, equipment, trials is a precondition for product
development.
Note:
1. This element is to be evaluated except when design responsibilities

are contractually defined. It is not applicable when a completed
product design is adopted.
2. VDA Volume 3, Volume 4 Part 1, 2 and 3 are also applicable to this
element.
Bezug
DIN EN ISO
9001
9004-1
08.1
*
Does an appropriate product development

plan for a new product exist?
4.4.1, 8.1,
.2,.4,.5 8.2
8.10
08.2
Is it ensured that all product requirements can

be realized?
4.4.4
8.2.4
8.4.2a
und b
08.3
Are product trials planned during the development and pre-series phase?
4.4.7
4.4.8
8.3,
8.5
08.4
*
Are procedures and methods available to

carry out a quality evaluation of designs,
design models and pre-series products in
accordance with the particular project phase?
4.4.6
8.2.3
8.3
8.4.2
08.5
Are all responsible functions involved in the re- 4.4.8,

lease of the product design and its realization? .3, .5
8.6,
8.7
08.6
Is the result of the product design and

development documented in specifications?
4.4.5
8.6,
8.8
08.7
Are the experiences of product design and

development experiences of products documented and are they available to other areas?
4.4.3
4.4.5
8.9
93
08.1*
Does an appropriate product development plan for a new

product exist?
For the product development plan current milestone plans, network plans
etc. with detailed plans must be produced which show all activities from
placement (design and development) through to start of series. The systematic processing of the planned tasks (project planning) must be guaranteed. A person responsible for the project and all involved areas with their
tasks must be name (see Question 02.4). Central monitoring of the projects
progress must be guaranteed (specified/actual comparison). Monitoring
must cover the compliance with all given targets such as, e.g.:
-
deadlines
product qualifications
costs.
Evidence must be furnished on the basis of examples whereby depending

on the company and product not every steps stated below must occur.
The plan for the development of a new product is normally characterized by
the following steps:
-
Checking design requirements with regard to appropriateness

Documenting design result
Checking the design results with other competent organizational units
Verifying design (checking) as to whether the requirements of
the design tasks are fulfilled
Validating the design (approving/enforcing) to determine
whether the customers requirements are met
Identifying, documenting, checking and approving design changes and modification according to Question 08.4 and 08.5
Up-dating product development plan.
To limit costs it is appropriate to design inspection and testing tools and

equipment (including software) so that most of it can be reused for series
production.
94
08.2
Is it ensured that all product requirements can be realized?
Definition:
"Quality Requirements" (see also definition in Para. 4.2/ #.2.3) are described, e.g. in:
-
laws, ordinances, etc.

general standards, guidelines, specifications
special standards or requirements specifications (these may
contain special inspection and test instructions also for hardware and software).
The quality requirements as, for example, described in the requirements
specification (compare Questions 07.4 and 07.5) must be checked for
feasibility within the scope of a design review (compare DIN EN ISO 9004,
Part 1/8.5.2).
The design requirements must consider the bases and results of the
contract review (compare Questions 07.2 to 07.4).
Points to be considered are, e.g.:
-
producibility, testability, precision

inspection and test set-up, inspection and test equipment,
computer support
release criteria
experience from production and use (compare Question 21.3)
external or internal standards/specifications or instructions
legal requirements (safety, environmental compatibility,
disposal).
Suppliers tasks are also to be included in the review. Overall responsibility

remains with the company. In cases where fulfillment is not possible, comprehensible measures are to be taken to fulfill the requirements. Unclear,
contradictory requirements must be clarified with the person responsible.
If the development responsibility for a particular product lies, as agreed, with
the company, then it should use computer-supported design and engineering (CAD, CAM, CAQ), e.g., for FMEA, QFD and quality plans. Thereby it
has to be ensured that a problem-free data exchange with the customer is
guaranteed.
95
08.3
Are product trials planned during the development and preseries phase?
Product trials must be considered in the project plan.
The trial conditions for the product are to be determined and agreed with the
customer.
The results of the product trials must be compared to the requirements.
When the requirements are not met the corrective actions must be comprehensible.
The product trials may also be performed by an external body (e.g. independent inspection agencies, customers). The competence of external bodies
must be proven; if required, accredited bodies are to be used.
Product trials are, e.g.:
-
assembly trials
functional testing
durability testing
environmental simulation testing.
They may be documented in, e.g.:

-
96
product life cycles

test reports
trial plans
08.4 *
Are procedures and methods available to carry out a quality

evaluation of designs, design models and pre-series products in accordance with the particular project phase?
The quality evaluations should include:
a) assessment of function, safety, reliability, maintainability under the anticipated storage and usage conditions.
b) qualification tests to confirm that all individual requirements on the quality
characteristics of the design are fulfilled and that all approved design
modifications are implemented and recorded.
c) timely identification of problem areas and shortcomings, as well as introduction of corrective actions (compare Question 06.03 and VDA Volume 4, Part 1, 2 and 3).
d) the result of the product design must be tailored to the possible processes (operating means, equipment) (process capability).
e) practical preliminary planning for the quality of the series and purchasing
f) consideration of test results and field experiences.
A quality evaluation may be performed using various methods. In the appropriate project phases (development progress) for products and processes
these are, e.g.:
"Design" Phase
-
Risk analyses (e.g. Failure Mode and Effects Analysis, Fault

Tree Analysis) (compare VDA Volume 4, Part 1 and 2)
Design of Experiments (statistical test methodology, e.g.
according to Taguchi, Shainin).
"Development sample/Prototype" phase:

-
Risk analysis (e.g. Failure Mode and Effects Analysis, Fault

Tree Analysis)
Functional tests and release
Reliability testing/durability testing
QFD.
97
"Production prior to series startphase (see also Quality Element 09):

-
Process analyses
Process optimization
Process review
Compliance with specification limits.
Note:
Procedure for release of series production see Question 14.2 (Product) and
Question 09.5 (Process).
08.5
Are all responsible functions involved in the release of the

product design and its realization?
A procedure for the release to realization including responsibilities is to be
established.
The following, among others, must be defined for realization:
-
Number, state, delivery date, packaging, delivery location of

development samples (prototypes) and first samples
Form and contents of the inspection reports in agreement with
the customer
Release of samples
Qualification and monitoring of product and cost trends, also at
suppliers involved. (List of approved suppliers compare Question 11.2).
Release is based on the evaluation of the feasibility of the design by, among
others, development, sales, purchasing, production, quality assurance, together with the customer (Project launch meeting). It represents the approval that the design may be realized.
98
08.6
Is the result of the product design and development documented in specifications?
Definition:
Specification (according to DIN EN ISO 8402/3.14):
A document stating requirements.
The results of design and development must be appropriately documented
in the specifications (see Quality Element 10). These documents for the
realization of the quality requirements must be complete and unambiguous.
For products that are not clearly specified in the customer's drawings ("as
delivered", "as per manufacturer's choice", without information on inspection and test instructions etc.), the corresponding information in the companys detailed drawings and the finished part drawings must be completed.
Furthermore, the narrowing of tolerances on the customer's drawings might
be necessary. Company specifications must cover the requirements specified by the customer.
99
08.7
Are the experiences of product design and development

experiences of products documented and are they available
to other areas?
The experiences/results gained during development and trials which are,
e.g., applicable to other development plans must be evaluated, documented
in writing or stored on a computer system.
This may be done, e.g., in:
-
design manuals
data bases for design FMEA
product life cycles with, for example, product optimization/
improvements, adaptation through modified/improved production procedures
documentation of test results
corresponding reports on materials and procedures.
It is an objective to have the development experiences in the company

readily available independent of persons thereby avoiding repeated nonconformities in design.
This information is to be made available to all relevant areas.
100
09

DIN EN ISO 9001,
Sections 4.4, 4.9
DIN EN ISO 9004-1,
Section 8
The planning and development of processes and procedures for
manufacturing products are an essential part of all activities prior
to the start of new/modified processes. They incorporate the
planning of all necessary resources such as, e.g., equipment,
plants, technology, method, personnel and transports.
Within the scope of production preparation, it also includes the
production organization, the planning of material and production
flow, the special structure as well as measures for safeguarding
production, including tool management.
Process planning is performed at the earliest possible time parallel
to product development (design control), or is performed additionally after completion of product development timely prior to serial
production in order to realize production processes and process
sequences.
(Activities prior to the initial start of series production are discussed in the Quality Element 14 "Process Control").
Note:
VDA Volume 4, Part 1, 2 and 3 also applies to this element.
Reference
DIN EN ISO
9001
9004-1
09.1
*
09.2
09.3
09.4
*
09.5
09.6
09.7
Does an appropriate process development plan for

new/modified products exist?
Are production, assembly and maintenance processes and the material flow planned according to
quality aspects and are process control requirements defined?
Is it ensured that all product requirements are met
by the process?
Are procedures and methods available to carry out
a quality evaluation of processes and procedures in
accordance with the respective project phases?
Are all responsible functions involved in the release
of processes and procedures?
Is the result of process planning/development documented in process specifications/ procedures?
Are the experiences from process planning and
development documented and are they available to
all relevant areas?
(4.4.1,
.2, .4, .5)
(4.9
Abs.1
4.9a)
(8.1, 8.2
8.10)
(10.1.1)
(4.3.2c)
(8.2.4
8.4.2a /b)
(8.2.3 8.3
8.4.2)
(4.4.6)
(4.4.8,
.3, .5)
(4.4.5)
(8.6, 8.7)
(4.4.3
4.4.5)
(8.9)
(8.6, 8.8)
101
09.1 *
Does an appropriate process development plan for new/

modified products exist?
For the process development plan, current milestone plans, network plans
etc. with detailed plans must be produced which show all activities from
placement (development) to series start. The personnel and finance resources are also to be considered in the development plan. The systematic
processing of the planned tasks (project planning) must be guaranteed. A
project manager and all involved areas with their tasks must be named.
Central monitoring of the projects progress must be ensured (specified/
actual comparison). Monitoring must cover compliance with all stated
targets such as, e.g.:
-
Deadlines
Process Qualifications
Costs.
Evidence must be furnished on the basis of examples, whereby depending

on the company and product, not every steps outlined below must occur.
The following (amongst others) applies to the development of processes for
manufacturing the new product:
-
Production planning
Equipment/tool design and construction
Procurement (of products, materials, components) from
suppliers
Operating equipment construction
External developments
Purchasing and the procurement of production and manufacturing equipment
Updating the process development plan.
For this, suitable technical resources are to be used. To limit costs it is

appropriate to design testing tools and equipment (including software) so
that most of it can be reused for series production.
102
09.2
Are production, assembly and maintenance processes and

the material flow planned according to quality aspects and
are process control requirements defined?
Definition:
Process control
Process control is a quality control where the observed unit (tangible or nontangible object of an observation) is a process.
Processes such as production, assembly and maintenance, as well as the
material flow which have a direct influence on the quality of the products to
be manufactured, are to be defined. It must be ensured that controlled conditions are available. The conditions to be controlled include, for example,
the definition of:
-
process sequences, process parameters

machines, equipment, facilities, inspection, measuring and test
equipment (including identification)
recording of process nonconformities and corrective measures
working conditions (work plans, tooling plans)
monitoring the compliance with given requirements
approval procedures to be introduced
standards and guidelines to be observed.
The documents (procedures/quality plan) to be produced by the supplier

must include not only individual work steps but also inspection and test
steps or references to inspection and test instructions. When an operator
inspection is carried out references must be available in the work instruction
to a defined inspection and test responsibility.
These documents must be available at site, continuously updated and provided with a revision status. The relation to the revision status must be comprehenisble.
103
To achieve and maintain controlled processes, it is also necessary to carry

out a systematic planning for, e.g.:
-
material control
release of equipment for production, assembly and
maintenance
approval of procedures and work instructions
quality plans
computer software
documentation requirements
as well as to describe and verify the requirements placed on the execution

of work, for example, through:
-
examination, comparison and limit patterns

photographs
quality guidelines
packing instructions.
They make the decision-making easier when carrying out activities in

production, especially where special visual requirements and damage risks
exists.
Note:
09.3
Packaging and storage, see Quality Element 19.
Is it ensured that all product requirements are met by the process?
Definition:
"Quality Requirements" (see also definitions in Para. 4.2/#.2.3) are described in:
-
104
Laws, ordinances, etc.

General standards, guidelines, specifications
Special standards or requirements specifications (these may
contain special inspection and test instructions).
The quality requirements (compare Question 07.4) as described in, for
example, the requirements specification must be checked for their ability to
be complied with within the scope of a process review (compare
DIN EN ISO 9004, Part 1/8.5.2).
Points to be considered are, e.g.:
-
customer-specific requirements (including performance-related

and visual items)
producibility, test capability, precision
inspection and test arrangements, inspection and test equipment, computer support
release criteria
experience from production and use (compare Question 21.3)
external or internal standards/specifications or instructions
legal requirements (safety, environmental compatibility, disposal).
The compliance with legal requirements must be guaranteed in the process.

The inspections are based on the relevant national requirements.
A quality plan must be drawn up.
Tasks for suppliers are also to be included in the review. Overall responsibility remains with the company. In cases of noncompliance, comprehensive
measures are to be taken.
The company should use computer-supported design and engineering
(CAD, CAM, CAQ), e.g., for FMEA, QFD, quality plans to guarantee problem-free data exchange with the customer.
The process requirements must take into account the bases and results of
the contract review (compare Questions 07.2 to 07.4).
105
09.4 *
Are procedures and methods available to carry out a quality

evaluation of processes and procedures in accordance with
the respective project phases?
The method of quality evaluation for processes is applied to ensure that all
quality-relevant findings from the various phases of product development
can be realized.
In detail, the process shall :
ensure that the best possible and most comprehensive picture of the
desired quality of the new product is produced by involving and systematically questionning all affected functional areas,
identify potential weak spots early through the appropriately timed application corresponding to each project phase and initiate the introduce of
corrective actions
guarantee and clarify the implementation of corrective actions (e.g.
results from FMEA, fatigue test, field trial and assembly test)
document all important results of the quality assurance activities during
the development of a new process/procedure
include the practical preliminary planning for the quality of the series and
purchasing.
A quality evaluation may be performed using various methods. In the
relevant project phases (development progress) these are, for example:
DesignPhase:
- Risk analyses (e.g. Failure Mode and Effects Analysis, Fault Tree
Analysis) (compare VDA Volume 4, Part 1 and 2)
- Design of Experiments (statistical test methodology, e.g. according to
Taguchi, Shainin)
106
Production prior to series startPhase:

- Process analyses
Causes of dispersions
Appropriate inspection and test methods, e.g. fault tree
analysis, test methodology, cause/effects diagram
- process optimization
- process review
- compliance with specification limits
Note:
09.5
Procedure for release of series production, see Question 14.2.
Are all responsible functions involved in the release of processes and procedures?
A procedure with responsibilities (of the individual organizational units) is to
be established for the release to realization.
To be considered are, e.g.:
-
number, state, delivery date, packaging, delivery location of development samples (prototypes) and first samples
the form and contents of the inspection reports, in agreement
with the customer
release of samples
production and provision of production and inspection and test
equipment
qualification and monitoring of process and cost trends at suppliers involved.
The release is based on the evaluation of the producibility of the design and,
beside others, through development, sales, purchasing, production, quality
assurance, together with the customer. It represents the approval that the
design may be realized.
Note:
Procedure for release of serial production see Question 14.2.
107
09.6
Is the result of process planning/development documented in

process specifications/ procedures?
Definition:
Specification (according to DIN EN ISO 8402/3.14):
A document stating requirements.
The results of the design work must be appropriately documented in
specifications or process descriptions/procedures (see Quality Element 10).
This includes, among others:
-
description of process
process parameters
important product and process characteristics
inspection and test plans and work plans/instructions
These documents for the realization of the quality requirements must be

complete and unambiguous.
108
09.7
Are the experiences from process planning and development

documented and are they available to all relevant areas?
The experiences/results gained during the development and trial of new
processes which are, e.g., applicable to other requirements or production
processes are to be evaluated, put down in writing or stored in a computer
system.
This can be done, for example, in:
-
processes, process data, feasibility studies

data bases for process FMEA
documentation of test results and process problems
capability studies of machines, plants and processes
plant life cycles with, for example, process optimization/
improvements, adaptation through modified/improved production procedures.
It is an objective to have the development experiences in the company

readily available independent of persons thereby avoiding repeated nonconformities in design.
This information is to be made available to all relevant areas, especially
inspection and test and production planning.
109
110
10

DIN EN ISO 9001,
Section 4.5
DIN EN ISO 9004-1,
Section 17
Quality management requires documents and data which describe
the structure and processes of the quality elements, as well as
the products to be manufactures.
Thereby, the identification, order, distribution, distribution, storage
and maintenance must be taken into account.
Documents and data may be available on media such as paper,
magnetic tapes or visual data carriers. The legibility is to be
ensure within the scope of the archiving period.
Note:
VDA Volume 1 also applies to this element.
Reference
DIN EN ISO
9001
9004-1
10.1
*
Are the responsibilities and procedures for

the identification, maintenance, review and
approval of the documents defined?
4.5.1
4.5.2
17.1
10.2
Is there a distribution and maintenance system with revision service available for the
documents?
4.5.2
4.5.3
17.1
10.3
Is it defined, where, how and for how long the

documents are to be archived?
4.3.4
17.3
10.4
Is the timely introduction and control of external documents ensured?
4.5.2
17.3
10.5
Is it ensured that invalid documents are not

used?
4.5.3
17.1
111
10.1*
Are the responsibilities and procedures for the identification,

maintenance, review and approval of the documents defined?
Definition:
Identification" serves the clear relation to events, processes or products.
"Maintenance" encompasses the revision service and archiving whereby the
ability to retrieve records must be guaranteed.
"Review" includes, beside others, the comparison and translation between
internal and customer specifications, as well as the formal and contextual
review of documents.
"Release" is the approval given by the responsible departments.
The processes are to be comprehensively laid out from the customer to the
company integrating all relevant internal departments. For the following
documents, procedures and responsibilities are to be defined:
Affected are, for example:
-
documents for contract review

specifications
drawings
formulations
standards, regulations, internal standards
inspection and test instructions
inspection and test plans, control plans, inspection and test
instructions
work instructions
work procedures, measuring programs
quality plans
quality procedures
quality manual
procedures for quality verification
reference samples
trial procedures.
Documents must be available with the valid revision status to all involved
organizational units. Special identification instructions from customers are to
be followed
A clear presentation of all types of documents is useful.
112
10.2
Is there a distribution and maintenance system with revision

service available for the documents?
Processes and responsibilities must be defined, e.g., for:
-
distribution, availability
completeness (reference documents)
safeguarding the latest revision status (current revision status)
approval of changes
method of identifying changes in the document
invalidation.
The introduction and realization of changes must be documented, i.e. must

be provable and traceable (e.g. in the product life cycle). This includes:
withdrawal, invalidation, destruction of invalid documents, signature and
countersignature or similar).
Summary sheets are to be established for a complete presentation of all
changes. The responsibilities for this must be defined.
The system must exclude misuse.
The regulations relating to the approval and distribution system must describe a process which ensures that the correct documents are available at
the correct time, in the correct place and that a confusion with invalid
documents is excluded.
Aprocedure must be available which monitors the validity of the documents
at regular intervals.
Note:
Listing of quality relevant documents, see Question 10.1
113
10.3
Is it defined, where, how and for how long the documents are
to be archived?
This requires stipulations on e.g.:
-
retention period
filing system
filing location.
Thereby, the following must be considered, e.g.:

-
protection against fire, water etc.

storage media (files, microfilm, DP storage)
if necessary, additional back-up files (e.g. double archiving,
back-up copy etc.).
The retention of documents - including outdated ones - has to be controlled,

in order to be able to prove also at a later stage that the quality system,
process and the product fulfilled the quality requirements in a particular time
period.
The retention time (archiving) must also be in line with, amongst other
things, requirements of laws, general guidelines, customers and product
liability aspects (see VDA Volume 1).
Note:
114
Listing of quality-relevant documents, see Question 10.1
10.4
Is the timely introduction and control of external documents

ensured?
The company must set up a procedure which ensures that all external
documents such as, e.g., standards, specifications, documented procedures and their revisions are reviewed, distributed or introduced at the appropriate time. Records of this must be kept in the same way as for internal
documents. Summary of the external documents at a central location is
possible.
10.5
Is it ensured that invalid documents are not used?
The exchange of documents at site must be regulated so that invalid
documents can no longer be used.
Immediately after new documents are received, the invalid documents must
be recalled and destroyed by the person responsible.
Evidence of this must be provided for particularly important and identified
documents.
115
116
11
Purchasing
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.6
Section 9
The quality element describes the quality assurance measures

which must be implemented by the company when purchasing
products from his suppliers.
These products purchased by suppliers (materials, components,
subassemblies, parts and services) form part of the customers
end product and thereby directly influence the quality of this
product.
Note:
1. VDA Volume 2, 6 Part 1, 6 Part 3 and 6 Part 4 are also applicable.

2. This element may also be applied to internal customer/supplier
relationships.
Reference
DIN EN ISO
9001
9004-1
11.1
Are the quality requirements on the products

and services clearly and completely specified
in the order documents for suppliers?
4.6.2
4.6.3
4.6.4.2a
9.2
11.2
*
Are the evaluation and selection of suppliers

defined?
4.6.1
4.6.2a
9.3
11.3
Are sample tests for purchased products

defined?
4.6.1
4.6.2b
9.3b
11.4
Does the company provide procedures for the

regular evaluation of its suppliers?
4.6.1
4.6.2c
9.4,
9.8
11.5
Do agreements with the suppliers regarding

the method and responsibilities for quality
inspections exist?
4.6.2b
(4.6.4)
9.5
11.6
*
Is the quality of delivered products and services ensured?
4.6.1
4.6.4
4.10.1
9.7
11.7
*
Is the traceability of delivered products to the

suppliers ensured?
4.8
9.8
117
11.1
Are the quality requirements on the products and services

clearly and completely specified in the order documents for
suppliers?
Specifications which are clearly defined and easily understood by the
suppliers must be an integral part of orders (drawings, standards, requirements of test certificates, quality agreements, work and inspection and test
instructions, packaging and dispatch instructions, etc.).
The company must agree these specifications with the supplier. Prior to release of the order documents, these must be checked for clarity and completeness. Specifications passed on to suppliers may exceed the quality
requirements of the companies customers, but must at least contain all
these requirements on which the supplier has an influence or which affect
him.
This also includes visits of the companiescustomers at his suppliers, if this
is contractually agreed.
Processes and responsibilities must be defined.
Only an order or order confirmation which is completed with all details
contributes to the complete fulfillment of the purchasing and quality
requirements. Hereby, a defined and continually updated revision status is
important.
When purchasing tools and capital goods the following must be considered
and defined, beside others:
-
118
interdisciplinary cooperation on placement and acceptance

through, for example: development, production, quality
assurance
supervision during the design phase with progress reports
computer-supported design and data processing.
11.2*
Are the evaluation and selection of suppliers defined?
Suppliers must be evaluated by the company prior to their acceptance.
Therefore the requirements and assessment criteria, as well as the
selection mode must be defined.
The suitability of a supplier may be demonstrated by means of:
a) Assessment of his quality system through
-
systems and process audits of the company

system audit results of other customers of the supplier
certifications through accredited certification bodies.
(Such system audits also serve as a support for the supplier in setting up
his quality system. They also serve the purpose of system consultancy.)
b) Assessment of the product quality of all obtained product through
-
product audits
first sample testing (compare Question 11.3)
quality assessments of capital goods (compare Question 14.2)
A list of approved suppliers is to be maintained and to be taken into account

by the involved parties.
Special care is to be paid to the selection of suppliers for products with special characteristics, the documentation of which requires special archiving.
An evaluation should be repeated in case of, e.g.:
-
re-location of production at the supplier

new products/ product group
repeated occurrence of quality deficiencies.
119
11.3
Are sample tests for purchased products defined?
Definition:
Sample (according to DGQ 11-04/95):
Material unit which is subjected to a quality inspection for a particular reason
or which is required within the scope of a quality inspection.
First sample (according to VDA Volume 2):
First samples are products and materials which have been completely
manufactured with standard equipment under series conditions.
For all products of a supplier a production process and product approval
(PPA) must be carried out (internal or external) for new or modified products/processes prior to serial use. The results of the first sample inspection
are to be documented in writing in the first sample report with specified and
actual values (VDA form). It must contain statements on:
-
geometry
material (special attention to hazardous material)
function
reliability.
For important characteristics, proof of capability is to be produced.

The scope and documentation of the first sample inspection is to be coordinated between the company and the supplier based on existing experience.
First sampling provides evidence that the supplier is able to fulfil the required specifications with the applied procedures and equipment. The first
120
samples give the company important evidence on the quality of the series to
be expected. A release of the first samples by the inspector does not relieve
the supplier of the responsibility for the series of these products.
For the release procedure of series products see VDA Volume 2.
Note:
Depending on the application purpose, there are various types of samples. In

many branches other designations are used instead of "first sample" such as,
for example, "First lot", "First delivery". The above requirements apply in
corresponding form to all sample types.
11.4
Does the company provide procedures for the regular

evaluation of its suppliers?
Definition:
A "regular evaluation" includes the periodic evaluation of the quality of the
delivered products and services and the assessment of the supplier's
quality system.
The performance of a supplier should be reviewed with a frequency that is
suited to the complexity and technical requirements on the product and the
previous performance of the supplier and must be recorded in a list.
A quality history of the products delivered is to be provided, for example,
through:
Note:
results of material receiving inspection (compare Question 15.3)

reject results
delivery fulfillment (deadline/quantity)
complaints
warrant.
1. The assessment of the suppliers quality system is performed by audits
(compare Question 11.2) and forms part of the overall assessment.
2. The suppliers should be informed about their evaluation on a regular basis.
121
11.5
Do agreements with the suppliers regarding the method and

responsibilities for quality inspections exist?
Where necessary, the company has to set up clear agreements with its
suppliers, regarding e.g.:
-
inspection and test procedures

inspection and test equipment
the scope of inspection and testing.
An agreement on the methods of quality inspections serves the

comparability of test results and is prerequisite for their acceptance, when
they are provided by the supplier.
11.6 *
Is the quality of delivered products and services ensured?
Appropriate measures must be taken to ensure that the received deliveries
are sufficiently monitored. A material receiving inspection must be performed according to the inspection and test plan and may be carried out as an
identification, random sample or 100% inspection (compare Question 22.3).
When the supplier provides quality records (e.g. test certificates according
to DIN EN 10204/3.1b), then control tests are to be performed periodically.
The characteristics to be shown on the quality records are to be agreed.
The certificate must be based on tests carried out on goods ready for
delivery.
If it has been agreed with the supplier that product inspections are only
carried out at his premises, then the company has to satisfy itself as to the
proper execution at the supplier. The visits shall be carried out depending
on the quality capability of the supplier and on the importance of the
product. The company must demonstrate this by means of visit reports.
122
A clear identification of the identity of the delivery lots and a differentiation of

released and non-released lots is to be carried out. The material receiving
system must bar goods that have not been released. In the event of use of
the delivered product prior to the completion of inspection, a procedure
(special concession) must be implemented (traceability).
A consequent management of suppliers contributes to the minimization of
complaints or to ensure a consistent quality level of the final product and
may eventually lead to the reduction of the material receiving inspection.
Note:
1. The first sample status must be known at material receiving.

2. Acceptance conditions for services (non-tangible products) must also be
defined.
11.7 *
Is the traceability of delivered products to the suppliers

ensured?
Definition:
Traceability (according to DIN ISO 8402/3.16)
Ability to trace the development, application or location of a unit by means of
recorded identifications.
Corresponding to a risk assessment, a system for traceability must be
established. Traceability may be realized, e.g., via delivery number, batch
number or order number.
Ensuring traceability serves the localization of nonconforming products and
the limitation of damages in case of nonconformities.
This applies particularly to products and related characteristics where a
special archiving of the corresponding documents is to be provided (compare VDA Volume 1).
123
124
12
Control of Customer-Supplied Product

DIN EN ISO 9001,
Section 4.7
"Customer-supplied products" are products which are the property
of the customer and are provided to the company in fulfillment of
the contract requirements. This also includes, beside others, tools
and packaging.
The customer has full quality responsibility for the products
provided.
Products sold by the customer to the company are not the subject
of this quality element as the normal customer/supplier relationship applies.
The contractual aspects are to be considered in the Quality Element 07 Contract Review.
Note:
This element does not apply when no customer-supplied products, as

defined above, are present.
Reference
DIN EN ISO
9001
9004-1
12.1
Do agreements with the customer on quality

measures for customer-supplied products
exist?
4.7
12.2
*
Is a definition available for the control, verification, storage and receipt of customersupplied products?
4.7
12.3
Is a procedure defined for reporting nonconformities or losses of customer-supplied

products to the customer?
4.7
12.4
Does a documentation on the quality of

customer-supplied products exist?
4.7
125
12.1
Do agreements with the customer on quality measures for

customer-supplied products exist?
Definition:
"Customer-supplied products" are those provided to the customer, generally
at no cost, for further processing.
At contract finalization the required quality assurance activities on the customer-supplied products to be carried out by the company should be agreed
with the customer. These agreements control, for example:
-
test certificates (documentation)

inspections and tests (type and scope of material receiving
inspection, identification check)
identification
traceability
warranty.
Where no agreements exist, the company can only take quality responsibility for his value- added activities (compare Question 12.2).
12.2 *
Is a definition available for the control, verification, storage

and receipt of customer-supplied products?
In the event that no special agreements with the customer have been made,
a documented procedure must define responsibilities for at least the
following measures:
-
126
Establishing the identity and quantity, according to delivery

papers
Establishing the external condition and integrity (transport
damage)
Correct identification
Appropriate storage and maintenance of value (special attention on products with limited storage life).
12.3
Is a procedure defined for reporting nonconformities or

losses of customer-supplied products to the customer?
When nonconforming products are delivered or when products are lost the
customer must be informed of the following, for example:
-
Delivery condition/damage
Incorrect delivery
Quantity deviation/lost goods
malfunction
Deterioration of quality during processing
Rework.
Process and responsibility are to be controlled.

12.4
Does a documentation on the quality of customer-supplied

products exist?
Definition:
The documentation describes the quality history of customer-supplied products. It provides a summary of the quality situation during a particular
period.
The delivery quality of customer-supplied products can have a significant
influence on further processing. Deviations from defined quality characteristics are, for example, to be:
-
documented upon receipt

recorded within the area of the production process
recorded in the case of a product ready for dispatch
assigned to the delivery lot
stored for a defined period.
The recordings showing the type of deviation may be carried out, for
example, in:
-
nonconformity tally cards

quality control charts
Statistics.
127
128
13
Product Identification and Traceability (Process Control,

Inspection and Test Status)
DIN EN ISO 9001,
Section 4.9, (4.8, 4.11, 4.12)
DIN EN ISO 9004-1
Section 11
This quality element covers all activities which are necessary to
ensure the required production quality in series production. It includes the monitoring of processes, identification of materials and
products, traceability, inspection and test status and documentation of results and measures.
Note:
To complete this element, Sections 11.2 and 11.7 from DIN EN

ISO 9004-1 are additionally discussed here.
Reference
DIN EN ISO
9001
9004-1
13.1
Is the identification of products for internal pro- 4.8

cesses defined?
4.12
11.2
13.2
Is the fulfillment of the quality requirements on 4.9d

the product ensured through process control
measures?
11.4
13.3
Are process parameters recorded and

deviations including corrective actions
reported?
4.9
11.4
(Abs. 4) 11.5
4.16
13.4
Are production as well as inspection, measuring and test equipment appropriately

stored and protected during interruptions in
use?
4.11.2
h
11.3
13.5
*
Is it guaranteed that only products which fulfill

the quality requirements reach the next process/process phase and dispatch?
4.12
11.7
13.6
Is the known product data traceable from dispatch to material receiving?
4.8
11.2
(Abs.2)
13.7
*
Is there a procedure available for the rerelease to serial production?
4.9e
11.1
129
13.1
Is the identification of products for internal processes

defined?
Definition:
"Identification of products" means the clear and traceable identification
through subject number, part number or comparable and of the revision
status.
The system shall ensure that products are unambiguously identified in every
stage of the material flow, also with regard to their operational state,
inspection and testing and modification status in order to avoid mix-ups. For
products with a limited storage life, the storage limitation must also be
identified.
The identification of products must be effective in all production areas from
entry until its departure. This may be achieved by means of, e.g.:
-
accompanying product documents

tags
markings, numberings
bar codes
stampings
labels
inspection and test reports.
The relation to the lot or batch must be traceable. The corresponding work
instructions must be available at site.
Products missing identification may lead to mix-ups and incorrect deliveries
and are to be regarded as barred until their identity is cleared.
Note:
1. The identification system used by the company must allow the clear relation
to the customers drawing with revision index at the interface to the
customer (dispatch).
2. Identification for traceability, see Question 13.6
130
13.2
Is the fulfillment of the quality requirements on the product

ensured through process control measures?
Definition:
Process control measures include, among others, all inspections and tests
accompanying the process in the complete production sequence used for
controlling.
The inspection during production is a comparison between the requirement
(specification) and the actual result of each work sequence on the product.
It is carried out according to the stipulations of the inspection and test
instruction.
Inspections and tests accompanying the process must be carried out so that
timely detection of deviations is guaranteed. This allows the timely introduction of corrective actions and prevents further processing of defective
materials.
The results of all planned inspections and tests are to be documented so
that trends can be identified and targeted corrective actions can be introduced. Independent of the selected storage medium, the traceability of the
inspection and test results to the inspector is sensible.
The documentation must also contain the results from manual and/or automatic 100 % inspections. In the case of an automated 100 % inspection, a
recording of inspected and rejected products must be carried out.
Processes, notes concerning measures and responsibilities must be
defined.
131
13.3
Are process parameters recorded and deviations including

corrective actions reported?
Definition:
"Process parameters" are process-influencing quantities that serve to control and regulate the process.
Typical process parameters are, for example:
-
Pressure
Temperature
Time
Torque
Distance
Electric current
Voltage
Frequency
Humidity
Velocity.
Monitoring of the process parameters may be performed either automatically or manually. For manual inspections and tests the results are to be
documented. In the case of automatic monitoring of the process parameter
the review by means of a process audit is sufficient.
Process parameters must always be specified with tolerances.
When deviations are found corrective actions must be recorded.
The monitoring or control elements are to be treated as inspection and test
equipment and must be monitored regularly.
Note:
132
The control elements for process-influencing should be protected from

unauthorized interference.
13.4
Are production as well as inspection, measuring and test

equipment appropriately stored and protected during interruptions in use?
Production and inspection and test equipment must be appropriately stored
and protected from damage and dirt so that the performance capability is
not affected. This also applies to computers and data storage media.
Tools specifically linked to parts and inspection and test equipment must be
related to a defined release or revision status of the related product. The
revision status must be securely attached to the production mean or, e.g.,
must be included in the file for production means.
In the production means store, the tool crib etc. the difference between tools
ready for production and those still to be inspected and reconditioned must
be identifiable (release status).
Mix-ups lead to nonconforming production, complaints, rework costs,
additional set-up costs etc. This can only be excluded through a clear
process organization.
13.5*
Is it guaranteed that only products which fulfill the quality

requirements reach the next process/process phase and
dispatch?
Products must be given an inspection status after each process step
(except for interlacing) which shows whether the products have been
inspected, which quality inspections have been carried out and whether or
not they meet the quality requirements (see Question 13.1). Hereby
customer requirements must be considered.
The sequence organization, with responsibilities, must be defined. This
applies particularly where operator inspection is practiced.
This is intended to ensure that only those products which have been
released in accordance with the work instructions and which are usable
reach the next operational stage or dispatch.
Where the identification of products is not possible or economically
justifiable the type of identification must be agreed and proven.
133
13.6
Is the known product data traceable from dispatch to material

receiving?
Definition:
"Traceability of products" relates to
-
the origin of the material and components (identification, date

of inspection)
the processing history
the distribution and positioning of the product following its
delivery.
Corresponding to a risk analysis a traceability system must be developed
and described. Exceptions are to be agreed with the customer and demonstrated.
"First in First out" (FIFO) and/or consequent separation of lots and
batches serve as supporting systems in order to prevent mixing of various
manufacturing periods. The FIFO principle shall prevent products with
various production dates or revision status being mixed.
Clearly separated production lots/batches facilitate the traceability when
probems occur. A transparent material flow is guaranteed and thus the
material disposition more accurate. The mixing of products with differing
revision status is prevented.
Traceability is guaranteed through the connection of the known data of the
processed materials and products with the delivery goods.
Known product data is (among others):
-
134
se data (parts number, revision status)

t/batch number
oduction date
oduction facility
ift.
The FIFO principle must be followed in all production areas (material

receiving, in-process, delivery and external stores) (for example through
transient or electronically controlled stores with storage date as a sorting
criteria, etc.). Instructions must be available at the individual work stations.
A clear date identification on the material traveler cards is required,
especially for reserved and fixed storage areas and products with a
expiration date.
The individual production lots and batches are to be identified and kept
sepaate. The identification applies to all areas of the company (material
receiving, production, stores, etc.) up to the point of use. Identification is
placed directly on the parts and/or on the containers/ packaging (compare
Question 13.1).
135
13.7 *
Is there a procedure available for the re-release to serial

production?
Definition:
"Re-release for serial production" is the order-related release for the
renewed start of production. The release is required for product and
process.
The renewed release of the production start shall be carried out by an
authorized employee who performs quality assurance functions in a responsible position. If a release cannot be given directly for time reasons, then
the products must definitely be clearly identified and barred until their
release is granted. The particular proceedings are to be collated in a procedure.
The performed release inspection is to be documented with its result.
The re-release of serial production (see definition, Para. 4.5.3) includes,
beside others:
Note:
136
Documentation of the last series order (quality records, corrective actions etc.)
Documentation of the data of the last series order (quality
records, corrective actions etc.)
Completeness of equipment and documents for production and
inspection and testing
Determination of responsibilities for release after set-up
Determination of the treatment of lead products and set-up
scrap
Proof of release at site
Setting of process parameters
The release of the serial production for products manufactured for the first
time is evaluated in Question 14.2.
14
Process Control
DIN EN ISO 9001,
DIN EN ISO 9004-1,
Section 4.9
Section 10
This quality element covers the planning and implementation of all

necessary activities as an interdisciplinary task of preparing production, assembly and maintenance processes for the initial start
of series production.
Within the scope of production preparation it also covers production organization, the planning of material and production flow, the
spatial structuring, as well as measures for ensuring production,
including tool management.
Note:
VDA Volume 2 and Volume 4, Part 1, 2 and 3 also apply.
Remark:
Activities which are necessary for restart of series production are

treated under Question 13.7
Reference
DIN EN ISO
14.1
14.2
*
14.3
14.4
14.5
14.6
14.7
Are capability studies carried out on new/overhauled machines (plants) and also on new/
modified products?
Are the conditions for a release to series production for new and modified products/processes regulated and are they agreed with the
customer)?
Is the monitoring and control (regulation) of
the relevant process parameters and product
characteristics ensured?
Does a tool management and a planned
maintenance/servicing for equipment and
tools exist?
Are the requirements on special processes
defined?
Are the environmental conditions which influence product and process controlled?
Is the effectiveness of production processes
evaluated with suitable methods?
9001
9004-1
4.9b
10.1.1
4.9
c, d, e
10.1.1
4.9d
10.1.2
10.2
4.9g
11.3
4.9
Abs.2,3
4.9b
4.11.2g
-
11.4
Abs.3
10.3
-
137
14.1
Are capability studies carried out on new/overhauled

machines (plants) and also on new/modified products?
Definition:
Machine Capability
"Machine capability" is given by the relationship between tolerance and production distribution of a production facility. Determination and evidence is
normally established through mathematical-statistical methods whereby only
the short term distribution is considered largely excluding the processinfluencing but machine-independent factors (compare VDA Volume 4,
Part 1).
Process Capability
However, when looking at the long term distribution under consideration of
the process-influencing parameters then one uses the term Process Capability. A process is capable when the statistical parameters for distribution
and position in relation to the specified value and tolerance value meet the
requirements (at least Cpk = 1.33). If this is not the case, the process
capability must be reached through process analysis and optimization.
The characteristics and method for performing the capability study are to be
defined.
Machine Capability
The capability of newly aquired machinery including tools is to be demonstrated either by the machine and tool manufacturer or recipient prior to
application.
138
Under specific conditions, capability studies must be repeated in coordination with the customer, e.g., for:
-
new parts orders

new tools/equipment
narrowing of tolerances
modification of production processes/original state
following repair (with influence on the product)
following relocation of machine
following longer production stops.
Evidence of machine capability should be available for the assessment of

the process capability.
In capability studies the machine with tools and, if applicable, integrated test
and control equipment is to be treated as a unit. The short term distribution
must have a capability characteristic number of at least cmk 1.67. If deviations occur corrective actions must be determined and a new capability
study is to be carried out after these actions have been implemented.
Process capability
Process capability is to be demonstrated for product characteristics and process parameters which have a crucial influence on product quality (compare
VDA Volume 4, Part 1).
All characteristic values must generally lie within the tolerance range. The
characteristics important to product quality must be defined and agreed with
the customer. If process capability cannot be proven for important
characteristics measures must be defined. These can be, for example:
-
100% inspections of a production lot

Constructive measures with, if necessary, tolerance modifications.
The results of a 100% inspection must be recorded.
139
For cost and risk reasons, a 100% inspection requires process optimization.
In the case of non-capable processes, the 100% inspection is the only
procedure for sorting out defective products and introducing fault analysis
and corrective actions. Thereby, all actions should have the aim to continually improve the processes within the scope of a zero-failure strategy.
The capability characteristic number for the long-term distribution must be at
least Cpk = 1.33. When deviations occur corrective actions must be defined.
A new capability study must be carried out after these actions have been
implemented.
14.2 *
Are the conditions for a release to series production for new

and modified products/processes regulated and are they
agreed with the customer)?
For release to series production (see Definition, Section 4.5.3) all production
factors must be available. Only the consideration of all production factors
ensures the problem-free start of series. When determining capacities all
production factors must be considered. Bottlenecks lead to quality
impairments and additionally to exceeding of costs and deadlines.
Production factors are, e.g.:
-
140
Specifications, drawings, formulations, standards with latest revision

status
Quality plan (compare Question 02.6)
Qualified personnel
Site determination
Defined production sequences, production plan, production environment
Released machines, equipment, operating material
Maintenance instructions (compare Question 14.4)
Required inspection and test equipment including capability evidence
(compare Question 16.4)
Approved suppliers (compare Question 11.2)
Approved materials/supplied products
Inspection and work instructions
Process capability (compare Question 14.1).
provisional
final
Product qualification review

Acceptance criteria
Functional performance
First sample with first sample inspection report (VDA Volume 2)
geometric
material
functional
visual
Production release
provisional
final
The selection and training of personnel, as well as the capability studies,

quality analysis (quality evaluation, FMEA, system optimization etc.), review
and correction of technical documents and specifications must be completed prior to start of series.
The conditions for a release and the type of documentation (e.g. checklist)
must be defined. It is useful and in certain cases (e.g. modified/relocated
processes) it is necessary to agree the release conditions (series and
modifications) with the customer in advance. This includes, among other
things, the production process and product approval procedure (PPA)
(compare VDA Volume 2) and the procedures/methods prior to start of
series (compare VDA Volume 4, Part 1, 2 and 3).
When changed or relocated processes are concerned the customer must
be informed and, if necessary, the PPA procedure has to be applied. In any
case, an internal new sampling is required.
141
14.3
Is the monitoring and control (regulation) of the relevant

process parameters and product characteristics ensured?
The monitoring of the relevant process parameters and characteristics are
to be defined in the quality plan. The necessary activities in the event of
deviations from the requirements must also be stated herein. Changed
requirements and agreements with the customer must be included in the
quality plan (compare Question 02.6).
As the compliance with the product characteristics (special customer
requirements are also to be considered) depends on various process
parameters, their influence on product quality must be investigated prior to
series start.
The parameters and monitoring frequency must be defined. In the event of
deviations from the specified value they must be (manually or automatically)
regulated again (e.g. SPC). The results of the monitoring must be
documented and cross-referenced to the product. Instructions and sequences must be available at the work stations as instructions (documented
procedures).
Documentation must also contain and justify every change to the defined
production parameters. A change to the production parameter may require
a new process capability study.
142
14.4
Does a tool management and a planned maintenance/servicing for equipment
Explanation of term:
Tool management is a system in which tools, appliances, accessory
instruments etc. are documented, monitored and controlled. Suppliers of
tools must also be included therein.
Definition:
Planned maintenance (according to VDI Guideline 2890):
A maintenance is scheduled when the servicing and inspection of a
machine/plant is carried out to a defined scope and time interval. This also
includes that necessary maintenance actions are planned ahead or, if
necessary, are performed on a preventive basis.
Note:
This serves to ensure the continuing quality capability of the process and may
also include computer and software.
Tool management includes, among other things:
-
autonomous maintenance and repairs

storage and overhauling of tools
tool change program for wearing tools.
Scheduled/preventive maintenance refers to all servicing, inspection and

maintenance work performed on the production equipment in order to avoid
any unforeseen machine failure or a process deviation. The maintenance
plan covers all necessary activities relating to preventive actions in a timedependent or number-dependent definition and must be performed for all
machinery (including computers and software).
Maintenance is to be presented in a clear form with time structure (e.g.
blackboard, book, data file). All production equipment, including appliances
and tools, must be included. The completion of the work performed is to be
documented and work to be done must be sorted according to due date.
Maintenance work can be carried out by the machine operator or by maintenance personnel.
143
Based on a risk analysis a minimum amount of spare parts must be kept in

stock for bottleneck machines and equipment.
A history on the production equipment is to be kept to identify weak points.
Recording of wear are useful to prevent failures at an early stage.
Special attention must be given to the maintenance of equipment for
"special processes(compare Question 14.5)
Note:
14.5
The evaluation results of measurements on product and process characteristics have a significant influence on preventive maintenance.
Are the requirements on special processes defined?
Definition:
Special processes are processes the results of which can only be verified
(checked) on the product at a later time or not at all.
These processes must be qualified. To do this, qualification criteria must be
defined, such as, e.g.:
-
Characteristics
Parameters
Sequences
Targets.
The control and monitoring of the processes must correspond to the process situation. Personnel assigned for these processes must be appropriately qualified and trained. The unambiguous allocation of the documentation
for processes, equipment and personnel must be given.
144
14.6
Are the environmental conditions which influence product

and process controlled?
The environmental conditions must be tailored to the work contents and
products in order to prevent contamination, damage and mix-ups. Products
with "special visual requirements" have to fulfill special requirements.
Criteria are, e.g.:
-
definition of the responsibilities for order and cleanliness

clean, intact transport and operating equipment
clean, well-illuminated workplaces and inspection places
clear identification systems (e.g. escape routes)
clear, ordered, if possible synchronous material flow
appropriate disposal containers
appropriate room and storage conditions.
Order and cleanliness have a significant influence on the work result. Where
possible, descriptions of the standards should be available.
14.7
Is the effectiveness of production processes evaluated with

suitable methods?
The production process must be continually monitored for deviations from
requirements and possible improvement potential.
Personnel active in the process must be involved in the evaluation so that
their experiences are taken into account. Recognized improvement possibilities must be implemented without delay according to a plan to be defined.
Potential methods are, e.g:
-
process audit (compare Question 03.4)

CIP (compare Question 01.3)
Quality circle (compare Question 04.6)
The following must be evaluated, beside other:

-
production/work plan
adapted automization
ergonomic and human factors
value-adding work
sinventory management system.
145
146
15

DIN EN ISO 9001,
Section 4.10
DIN EN ISO 9004-1,
Section 12
Quality inspections serve to ensure quality requirements are met
and provide evidence through records. Recording of evidence
should be carried out in all phases of production.
This evidence can be provided both through internal records which
directly or indirectly prove the quality of the product (product or
process data, as well as through certification about this for the
client (the customer).
Prevention of nonconformances has priority over detection of
nonconformances.
Reference
DIN EN ISO
9001
9004-1
15.1
Are all inspection activities covered by control

plans with inspection instructions?
4.2.3
b bis e
10.1.3
15.2
Are the quality inspections in the process and 4.10.1

the appropriate methods/techniques defined in
inspection instructions?
10.1.4
15.3
Are the defined quality records maintained for

all incoming products?
4.10.1
4.10.2
12.1
15.4
Are the defined quality records maintained

during the processes/working stages?
4.10.1
-3,
4.12
12.2
15.5
*
Are the defined quality records maintained on

the end product?
4.10.1
4.10.4
12.3a
15.6
Are there records about periodic inspections

and tests?
(4.10.1) 12.3b
147
15.1
Are all inspection activities covered in control plans with

inspection instructions?
Explanation of Terms:
The "control plan" is a product-related representation of all quality inspections, with reference to inspection instructions, from incoming goods through
to delivery.
All inspections (including destructive testing) during the construction process of a product must be recorded in control plans and these plans must
be kept available on site. The control plans must include, among other
things:
-
specific parts data (part number, designation)

quality characteristics at the relevant process stage
reference to supplementary process descriptions
reference to supplementary inspection descriptions/inspection
instructions
references to decision possibilities (release, place on hold,
rework).
If inspections are carried out externally, the same regulations apply. The
company must regularly satisfy itself of the correctness of the operations
performed. When required by the customer, accredited laboratory facilities
are to be used.
A single inspection control plan can apply to a group or family of parts which
are manufactured using the same process and the same equipment.
When drawing up control plans, different information is used and obtained
from, e.g. :
-
Process plan
System-/Product-/Process-FMEA
Special characteristics which were agreed upon
Knowledge obtained from similar parts / processes
Knowledge obtained from the development phases
Other analytical techniques (optimization methods, QFD,
DOE).
The inspection control plan must be in line with the quality management
plan. It can also be included within the quality management plan.
148
15.2
Are the quality inspections in the process and the appropriate

methods/techniques defined in inspection instructions?
The way in which a product is to be inspected and tested must be defined in
inspection instructions for every relevant inspection characteristic in the
production process, right through to delivery.
This includes, for example:
-
inspection and test methods

inspection and test equipment
random sampling method
(acceptance number C=0/"0" defects)
evaluation methods
documentation types.
Inspection instructions are necessary for complex inspections. All quality

evidence which must be furnished is defined in them (see Questions 15.3 to
15.5). They represent a constantly available reference in the workplace and
support management when familiarizing/instructing new employees.
Inspection instructions are also necessary for repeat inspections (e.g.
inspections following rework), or as a result of particular knowledge
obtained (e.g. from series production).
For visual inspection characteristics, limit patterns have to be defined and if
necessary agreed with the customer.
149
15.3
Are the defined quality records maintained for all incoming

products?
The inspection results from material receiving inspections are to be
comprehensively documented; the documentation, related to the subject
number, must contain, for example:
-
type and scope of inspections and tests

information about when the goods were received
quantity of received and inspected units/products
scope of inspection
inspection results and decisions for geometry, materials, function and reliability with the date and name of the inspector.
When material receiving inspections are reduced on the basis of previous

positive inspection results, then the lots not inspected must be documented
with date of receipt and quantity of delivered parts.
It has to be ensured, that only released products are submitted for further
processing.
Inspection documentation from suppliers (results from inspections on the
delivery or on the relevant units by the manufacturer) with details of the
values determined for the specially required quality characteristics can also
serve as evidence. (see Question 11.6).
In order to fulfill the obligation to show due care and attention, periodic
cross-checks and repeated inspections and tests must be performed.
If rework has to be carried out on delivered products, it must be checked
and documented (repeat inspections).
150
15.4
Are the defined quality records maintained during the processes/working stages?
In all production areas, inspections must be carried out in accordance with
the inspection control plan/quality management plan and inspection instructions. The following, for example, must be documented here:
-
Inspection scope (number of tested products and

characteristics)
Inspection results (actually measured values, reject quantities,
types and numbers of nonconformances)
Inspection decisions (release, concession, rework, reject,
return shipment,
construction deviation, special treatment)
Results of repeat inspections, e.g. after rework
Inspection results showing unacceptable quality must also be documented

and evaluated; in this case the implementation of corrective actions must be
evident. (see Question 14.1).
Possible records are, among others;
-
nonconformity tally charts

dimensional reports
records of original values.
Quality evidence also includes, for example, results from

-
series production/set-up inspection releases

automatic inspection/process control
process monitoring
running tests
batch inspections.
151
15.5*
Are the defined quality records maintained on the end product?
The inspections must be carried out in accordance with the inspection
control plan and inspection instructions. Refer to Question 15.4 for further
requirements/explanation.
The defined evidence must be provided for repeat inspections (rework).
Quality evidence also includes, for example, results from
Note:
15.6
final inspections and tests

functional inspections (under conditions of use)
acceptance tests
product audits
reliability testing.
It must be guaranteed that all inspections and tests are carried out before the
goods are dispatched to the customer. Special agreements must be made, if
this does not apply.
Are there records about periodic inspections and tests?
Periodic inspections and tests should also be defined in the control plan or
quality management plan; the results are to be documented.
These periodic inspections and tests should prove that all quality requirements of the product are fulfilled. The type and scope of these inspections
go beyond the normal inspections and tests during production.
They can be performed at different times for differing requirements.
"Periodic inspections" are inspections, for example, such as:
-
long term tests (weathering, ozone, corrosion testing)

re-qualification tests
durability tests
Records about verification checks on products which are delivered with

quality evidence conforming to DIN EN 10204 are included in the periodic
inspections.
Repeated inspections, performed as and when required, can also become
necessary and be carried out for a limited period as a result of special
findings, e.g. from serial inspections.
152
16

DIN EN ISO 9001,
Section 4.11
DIN EN ISO 9004-1,
Section 13
Prior to the use of inspection and test equipment (measuring and testing equipment, including software and gauges), it has to be ensured
that the equipment is suitable for the foreseen purpose, for example,
through equipment capability evidence and comparison measurements.
The control of the inspection and test equipment in all areas is a basic
requirement to ensure the necessary confidence in the accuracy of
measuring results and subsequent decisions made based on those
results.
Through control of the inspection, measuring and test equipment, the
regular calibration of the equipment and thereby the traceability of
measured results to national standards is guaranteed. This procedure
corresponds with recognized rules of technology", as defined and
required in relevant national and international regulations, standards,
official specifications and contractual agreements.
The accuracy of the results from a piece of equipment, evidenced in
its documentation, is of particular importance as inaccurate
measurements could lead not only to nonconformance of an "assured
characteristic", but could also present a risk when testing quality and
safety-relevant characteristics.
Reference
DIN EN ISO
9001
9004-1
16.1
*
16.2
16.3
16.4
16.5
Is there a procedure for the approval, identification, calibration, control and maintenance of
inspection and test equipment?
Is the adherence (traceability) of inspection and
test equipment to the requirements of national
and international standards regulated?
Are only pieces of inspection and test equipment
used that have a sufficiently low measurement
uncertainty?
Is there a procedure defined to record the
inspection and test equipment capability?
Are corrective actions defined following the
detection of defective and damaged inspection
and test equipment?
4.11.1 13.1
4.11.2 13.2
b - e, -i
4.11.2b 13.2b
4.11.2a 13.2b
(4.11.2a) 13.1
4.11.2 f 13.4
153
16.1*
Is there a procedure for the approval, identification, calibration.

control and maintenance of inspection and test equipment?
The control of all inspection and test equipment in all areas, e.g. in development, tool making, maintenance, production, assembly, quality and customer services, must be guaranteed in order to provide confidence in decisions and actions based on the measured results of tests and inspections.
Inspection and test equipment must be approved for use and calibrated
regularly in order to guarantee its accuracy throughout its entire service life.
The control must cover, among other things:
-
standard inspection and test equipment of all kinds

gauges
measuring instruments
sensors
measurement recorders
special test equipment and the corresponding software.
In addition, devices, inspection and test records, comparison references

and process monitoring instruments which might influence the quality of a
product or a process must be controlled in the same way.
The system for controlling equipment must be described in a documented
procedure or similar, including the following, for example:
-
154
initial inspection and approval for use of new test equipment

identification system
recording of the equipment in a supply source record/approval list
inspection instructions for the testing/calibration of inspection
and test equipment with defined inspection intervals and
documentation (see VDI / VDE / DGQ Guideline 2618 for
Inspection instructions for the control of inspection and test
equipment")
internal/external control body
reference standards, master gauges
control of test equipment used by customer services
control of supplied inspection and test equipment with clear
regulation in the contract permitting its use
definition of the testing/calibration intervals dependent on the
wear and tear and frequency of use
examination of the equipment following changes, damage, and
suspicion of false indications
maintenance of inspection, measuring and test equipment.
Gauges linked to specific parts must be able to be clearly cross-referenced

to the subject numbers of the parts, as well as their current revision status in
order to prevent confusion.
Appropriate equipping of the calibration room, the calibration processes and
the skills of the operating personnel must be guaranteed.
The test and calibration intervals depend on the frequency of use and must
be evident from the files or directly on the equipment itself. Actual calibration
and measurement values are to be documented (including initial calibration
values prior to first use). The results provide additional information about
wear and tear and the likely time the inspection and test equipment will
become obsolete.
Access to technical data and records about inspection, measuring and test
equipment has to be provided, when required by the customer.
16.2
Is the adherence (traceability) of inspection and test equipment to the requirements of national and international standards regulated?
Definition:
Calibration (according to DIN EN ISO 10012 Part 1):
The set of operations which establish, under specified conditions, the
relationship between values indicated by a measuring device or system, or
values represented by a material measure or a reference material on the
one hand, and the corresponding values of a quantity realized by a
reference standard on the other.
(Measurement) standard (according to DIN EN ISO 10012 Part 1):
A material measure, measuring instrument, reference material or system
intended to define, realize, conserve or reproduce a unit or one or more
values of a quantity in order to transmit them to other measuring instruments by comparison. Examples: a) 1 kg mass standard; b) standard gauge
block; c) 100 standard resistor; d) Weston standard cell; e) cesium
atomic frequency standard; solution of cortisol in human serum as a standard of concentration.
155
Traceability according to DIN EN ISO 10012 Part 1:

The property of a result of a measurement whereby it can be related to
appropriate measurement standards, generally international or national
standards, through an unbroken chain of comparisons.
Complete evidence of the traceability to the next highest level of adherence
(e.g. Deutscher Kalibrierdienst [DKD], Physikalisch-Technische Bundesanstalt [PTB], equivalent national organization, research facilities or manufacturers standard) with validity certificates must be furnished.
Traceability forms part of ensuring the correctness and precision of measurements and is legally regulated. In the case of measuring devices and
material measures, calibration is necessary. Calibration takes place against
a standard.
The uninterrupted chain goes in rising form (calibration hierarchy) from the
used standard, to the reference standard, via the national standard through
to the primary standard.
16.3
Are only pieces of inspection and test equipment used that

have a sufficiently low measurement uncertainty.
Definition:
Uncertainty of measurement (according to DIN EN ISO 10012 Part 1/3.b):
Result of the evaluation aimed at characterizing the range within which the
true value of a measure is estimated to lie, generally with a given likelihood.
Note:
The measurement uncertainty is frequently incorrectly described, contrary to

the standard, as accuracy.
Testing equipment must be selected so that the characteristics to be tested
can be measured with an acceptable level of uncertainty, which must be
known.
The highest permissible measuring uncertainty is dependent on the
process/product specification and the inspection instructions of the
customer. These factors and the corresponding surrounding conditions (e.g.
temperature, humidity) must be taken into account when selecting the
necessary inspection and test equipment.
156
16.4
Is there a procedure defined to record the inspection and test

equipment capability?
The "capability of inspection and test equipment" is determined from the
measurement uncertainty of the inspection and test equipment in relation to
the tolerance of the characteristic to be measured.
The capability study of inspection and test equipment is to be proven on the
basis of the statistical evaluation of ranges of measurements. This may be
done by calculation or graphically (correlation diagram). Special customer
requirements must also be considered here, as far as possible and other
procedures are to be agreed, if necessary.
The inspection and test equipment capability is determined using the
repeatability or comparability of measurements, with the help of the range
method or the mean value and range method under consideration of the
chance variance (95/97, 5/99%).
The result of the study is not only determined by the test equipment itself,
but also through other influences, for example:
-
composition of the tested products

operator
measurement records
holding devices
surrounding conditions.
The necessity for evidence of the capability of inspection and test equipment is dependent on:
-
the measurement uncertainty of the inspection and test equipment

the complexity of the inspection and test equipment
the use of interlocking inspection and test equipment/methods.
This applies especially to complex inspection and test equipment such as:
Note:
measuring machines
multi-point measuring devices
measuring equipment for statistical recording
test equipment for electrical quantities.
When technical modifications are made to products, the inspection and test
equipment capability must, if necessary, be reassessed.
157
16.5
Are corrective actions defined following the detection of

defective and damaged inspection and test equipment?
When it is determined that inspection and test processes are no longer controlled or the inspection and test equipment can no longer maintain its
highest permissible level of measurement uncertainty or is damaged,
corrective actions are required .
An evaluation is to be carried out to determine the effects on finished products, calculate the deviations and to initiate suitable measures, such as,
e.g.:
-
rework,
re-testing
complete rejection
informing the customer.
In order to prevent reoccurrence, an investigation of the cause is to be

carried out.
The responsibilities and procedures are to be defined for:
-
reporting of nonconformities and/or damage

actions on inspection and test equipment
actions on products, if necessary, with notification to the
customer
detection and elimination of cause(s)
These must also form part of the content of employee instructions.
158
17
Control of Nonconforming Product

DIN EN ISO 9001,
Section 4.13
DIN EN ISO 9004-1
Section 14
A nonconformity according to DIN ISO 8402 / 2.10: "The failure to
comply with a defined requirement"
Should, despite continuous efforts to improve quality and to prevent nonconformities, product nonconformities not be completely
avoidable, then procedures must be put into place which ensure
that nonconforming products at any phase of production are
quickly and accurately identified and excluded from further
processing, delivery or use.
The quality control systems must initiate cause analyses and
corrective actions and prevent, on a long term basis, the recurrence of identified nonconformities.
Reference
DIN EN ISO
9001
9004-1
17.1
*
Are there procedures for the handling of

nonconforming units?
4.13.1
4.13.2
14.2
17.2
Is the agreement of the customer obtained,

prior to shipment of products which deviate
from the specification?
4.13.2
14.5
17.3
Is rework executed according to a plan and

documented?
4.13.2
14.6
17.4
Is there a procedure for the identification of

recurrent nonconformities?
4.14.2
a
14.7
159
17.1*
Are there procedures for the handling of nonconforming

units?
There must be a procedure that guarantees an unambiguous separation of
good and nonconforming products. The identification can be in the form of
tags, special containers or markings on the product, whereby tags and
markings must be protected from unintended removal.
The procedure must contain instructions for identification, segregation,
corrective actions and evidence of effectiveness, as well as responsibilities,
and must be known to all involved employees.
Decisions about the disposition of nonconforming products must be made
by competent persons on the basis of understandable criteria. They must be
documented. These decisions can be, for example:
-
rework
acceptance with or without repair, on the basis of a concession
downgrade for another use
rejection
scrap.
Nonconformities may be detected or suspected in retrospect, if, for example, an inspection or work stage is left out, or deviations are subsequently
detected at calibration of inspection and test equipment or a corrective
production step has been forgotten. Nonconformities detected in retrospect,
for example, following prolonged functional or life testing or as a result of
late evaluation of control charts, must be communicated to the customer.
Should nonconformities be suspected on products already shipped, then the
customer must be informed immediately. Considerations about safety, product liability and customer satisfaction can lead to a finished product being
recalled.
The processes addressed here must describe all activities which are carried
out in conjunction with the control of nonconforming products in order to
remedy faults. This must also include units which are suspected of being
nonconforming. This can necessitate an inspection of other products which
have been developed and manufactured using the same process and/or of
preceding lots of the same product.
160
17.2
Is the agreement of the customer obtained, prior to shipment

of products which deviate from the specification?
Definition:
Concession (in accordance with DIN EN ISO 8402/4.17):
Written authorization to use or release a product which does not conform to
the specified requirements.
The internal and external concession procedure until the agreed delivery to
the customer (internal/external) must be defined.
The deviation from the specification must be presented in detail to the customer and documented. If necessary, the products must be identified and
the approved, as well as the dispatched quantity is to be recorded.
Products deviating from the specification - even where the deviation does
not appear critical to the company - may only be shipped if the customer
has given his agreement. This procedure, if necessary including the validity
period of the concession, must be documented.
17.3
Is rework executed according to a plan and documented?
For any required rework, the working and inspection steps, together with the
associated production and testing equipment, must be defined. Qualified
staff must be used. The performance of the orderly work is to be monitored
and documented.
Documentation should include, for example:
Note:
Rework inspection reports

Product designations (e.g. rejections, scrapping)
Concessions
Construction deviations
The responsibilities for the initiation and monitoring of corrective actions are
evaluated in Question 18.1.
161
17.4
Is there a procedure for the identification of recurrent nonconformities?
Recurrent nonconformities mean nonconformities which reoccur because
their actual cause was not correctly identified and remedied during previous
corrective actions.
The procedure must describe the activities regarding further analyses and
corrective actions. The evaluation should consider internally and externally
encountered nonconformities, for example, by means of:
-
continuous, systematic nonconformity evaluation

evaluation of complaints
rework evaluation.
To do this, it is helpful, for example, to create a nonconformities file.

Such a procedure must highlight problems with a similar nonconformity
profile, so that they can be distinguished from those which represent unique
occurrences.
Note:
162
The procedure for the prevention of recurrent nonconformities is evaluated in

Question 18.4.
18

DIN EN ISO 9001,
Section 4.14
DIN EN ISO 9004-1
Section 15
This quality element concerns corrective actions for the elimination
of problem causes and for continuous quality improvement. The
implementation of a corrective action begins with the detection of
a quality-related problem and includes the implementation of
actions to eliminate or minimize the repetition of the problem.
Corrective actions in design documents, in the manufacturing process, on the product itself and on quality system elements are to
be differentiated.
The necessity for a corrective action to remedy a nonconformity
cause can, for example, be recognized through:
- Development evaluations
- Analyses of potential nonconformity possibilities
- Quality inspections and audits
- Reports on process nonconformities
- Feedback from the market
- Service reports
- Customer complaints
- Management reviews (see Question 01.6).
Reference
DIN EN ISO
9001
9004-1
18.1
*
Are the responsibilities for the initiation and

monitoring of corrective actions clearly
defined?
4.14.1
4.14.2
15.2
18.2
Are there procedures to estimate potential

nonconformity risks and to implement corresponding preventive actions?
4.14.3
15.6
18.3
Are there procedures for the analysis of nonconformity causes?
4.14.2
b
15.4
15.5
18.4
*
Are there procedures to prevent recurrent

nonconformities?
4.14.2
d
15.7
15.8
163
18.1*
Are the responsibilities for the initiation and monitoring of

corrective actions clearly defined?
Definition:
Corrective action (in accordance with DIN EN ISO 8402/4.14):
Action taken to eliminate the causes of an existing nonconformity, defect or
other undesirable situation in order to prevent its recurrence.
The correction of internally and externally encountered deviations must be
organized so that a prompt and effective elimination of the problem is
guaranteed, for example, through:
-
root cause analysis and identification

determination of actions and responsibilities
informing the affected and responsible departments
determination of monitoring mechanisms.
The responsibility and authority for the initiation of corrective actions must
be defined. Responsible persons must be also defined for the coordination,
recording and monitoring of corrective actions. The monitoring activity includes both the performance of the remedial action and the check of its
effectiveness.
An appropriate operational organization must be defined in writing and, if
necessary, relevant instructions must be available at the relevant workplaces. The analysis and performance could involve a variety of functional
departments of the business, for example, Development, Procurement, Production, Sales and Quality (see also the quality loop).
Through the management review (see Question 01.6), it must be ensured
that pertinent information concerning preventive and corrective actions (e.g.
changes to procedures and to the quality system) is made known to the
company management.
164
18.2
Are there procedures to estimate potential nonconformity

risks and to implement corresponding preventive actions?
The significance of a quality problem should be evaluated with regard to its
possible effect on:
-
process costs
quality-related costs,
performance, functional capability and safety of the product,
customer satisfaction.
The significance, frequency of occurrence and detectability of the nonconformity must be considered in the procedure for estimating risks. The
following formalized methods, for example, offer assistance:
-
System, Design and/or Process FMEA

Fault tree analysis (FTA)
Failure mode analysis
Design of experiments.
Feedback of findings from nonconformities encountered where risk analyses already exist (e.g. Design/Process FMEA) must take place, in order to
derive preventive measures from it.
With the classical method of eliminating a nonconformity after it has
occurred, technical systems with greater safety and reliability, high level of
quality, lower total costs and with ever shorter innovation times can no
longer be realized. Instead, preventive measures must be used so that
potential nonconformities are identified at an early stage and translated into
corrective actions, even before nonconformities arise.
Risk analyses, for example, form the basis for the optimization of and
changes to:
-
specifications
operations
test and manufacturing equipment
instructions.
165
18.3
Are there procedures for the analysis of nonconformity

causes?
The following quality methods, for example, may be helpful:
-
Fish bone diagrams (Ishikawa diagrams)

Stratification (separating data and dividing it into categories)
Pareto analyses (ABC analysis)
Capability studies
Histograms
Correlation diagrams
Failure mode analyses
Probability charts
Data collection
Recording with corresponding graphic representations
FMEA review.
Within the scope of preventing nonconformities, actions for elimination must

be derived from the results of the root cause analysis and their performance
evidenced.
When a quality problem occurs, the actual root cause must be determined
by analysis before corrective actions are planned. Often the root cause is
not obvious; which necessitates a thorough analysis of, for example,:
-
product specifications (including materials etc.),

all related processes/work stages (equipment, installations,
tools),
quality records,
customer service reports and customer complaints
As far as is appropriate, the supplier and/or customer must be involved in

the analysis of the root causes of the nonconformities.
166
18.4*
Are there procedures to prevent recurrent nonconformities?
"Recurrent nonconformities" are those nonconformities which reoccur because their root cause was not correctly identified and remedied in previous
corrective actions.
In order to prevent a problem reoccurring, special preventive actions must
be implemented. When measures to eliminate nonconformities have been
realized, their effectiveness must be monitored to ensure that the desired
objective is achieved. Changes and the experiences resulting from them
must be documented.
Indications of the effectiveness can also come from customer services/
service department.
Problem solving in teams:
0.
1.
2.
3.
4.
5.
6.
7.
8.
Note:
Clarify the problem for yourself.

Work on the problem in a team.
Describe the problem.
Initiate temporary actions to limit damage and check their
effectiveness.
Determine the root cause(s) and check that it is (they are)
really the root cause(s).
Define measures for the elimination of the problem and check
their effectiveness through experiments/trials.
Implement the measures for elimination and check their
effectiveness.
Define measures that will prevent a recurrence of the problem.
Praise the performance and success of the team.
See also Question 17.4.
167
168
19

DIN EN ISO 9001,
Section 4.15
DIN EN ISO 9004-1
Section 16
Measures to prevent quality shortcomings arising from incorrect
handling, storage, packing, preservation and transport of the products are included in the terms stated in the heading. They
encompass the entire logistical chain of product manufacturing
from beginning to end.
Reference
DIN EN ISO
9001
9004-1
19.1
Are there instructions for the handling of

products?
4.15.1
4.15.2
4.15.3
(10.4)
19.2
Is the packing and identification process prior

to delivery defined and monitored?
4.15.4
16.2
19.3
Is it ensured that damage or deterioration in

quality during storage and transport is
prevented?
4.15.4
4.15.5
4.15.6
16.1
19.4
Is there a procedure to record, rectify and

initiate corrective actions on packaging nonconformities and transport related damage?
4.15.1
4.14.1
16.1
16.2
19.5
Is the identification of products during

transport and storage ensured?
4.15.4
16.1
16.2
19.6
*
Is there a procedure which documents delivery -reliability?
--
169
19.1
Are there instructions for the handling of products?
Handling of products is viewed as all transport and handling methods and
operations in the complete logistical chain.
The instructions must contain orderly planning and control for incoming
materials, their further processing, and for end products up to the point of
use by the final customer. The methods and responsibilities must be defined
for, e.g.:
-
170
handling, storage, internal and external transport

planning and inspection of packaging
storage of only clearly identified products
appropriate storage conditions
first in / first out (stock control system)
monitoring of limited storage-life products
shipping operations
orderliness and cleanliness
implementation of customer instructions
cleaning and preservation
informing the customer about handling
disposal.
19.2
Is the packing and identification process prior to delivery

defined and monitored?
Procedures/work instructions must describe all steps which guarantee
appropriate packing. The packing must ensure that products arrive at their
place of use complete and undamaged. Training and instructions are
necessary for this.
Adherence to requirements can be proven through dispatch audits.
Product packing includes the following:
-
initial packing
final packaging / repackaging for shipment container
identification,
as well as the materials themselves which are necessary for this.

Customer requirements regarding packing must be observed and must be
accessible on site.
171
19.3
Is it ensured that damage or deterioration in quality during

storage and transport is prevented?
In order to avoid damage or deterioration in quality (e.g. through dirt,
corrosion, chemical reaction) written instructions for product handling are to
be raised (see Question 19.1).
Special attention should be paid to, for example:
-
condition of containers
cleaning and preservation
filling of containers
methods of transport (temperature, vibrations, etc.)
protective measures for products and personnel
effects of humidity
padding
secure fixing
collective packaging
instructions for handling (e.g. assembly, delivery).
Conformance to the requirements is to be ensured (e.g. by regular plant

inspections, if necessary, in the context of audits).
19.4
Is there a procedure to record, rectify and initiate corrective

actions on packaging nonconformities and transport related
damage?
Reporting routes and processing of incidents of both internal and external
transport-related damage are to be defined in writing and the responsible
circle of people informed. The responsibilities for corrective actions are to
be determined (if necessary, the customer must be involved).
The measures implemented are to be checked for their effectiveness.
172
19.5
Is the identification of products during transport and storage

ensured?
It must be ensured that products are identifiable at all times during transport
and storage. Customer requirements must be taken into account.
The identification refers to e.g.:
-
Note:
19.6*
identification in accordance with specification requirements

revision status
clear and permanent referencing of identification and/or
accompanying documents to the product (processing stage,
inspection status)
expiry date
removal of invalid identification.
The identification should be sufficient to allow for the identification of an
individual product, if a recall or a special inspection is necessary.
Is there a procedure which documents delivery reliability?
Under delivery reliability one understands the adherence to promised
delivery deadlines and delivery quantities for products within a defined
delivery period. If deviations from the delivery obligations are recognized or
reported, corrective measures are to be introduced.
The information system should continuously serve to:
-
optimize the throughput time

adjust the stock turnover to the needs of the customer
minimize stock levels.
Furthermore, the system should be structured so that:

-
the customer is informed in advance about delivery shipments

an emergency strategy can be operated if a bottleneck in
supply occurs.
173
174
20

DIN EN ISO 9001,
Section 4.16
DIN EN ISO 9004-1,
Section 17
Quality management need records of quality-relevant data in order
to be able to demonstrate compliance with the defined quality
requirements and the effectiveness of the quality system. Their
identification, collection, compilation, distribution, archiving and updating must be ensured. The ability to retrieve records and their
hierarchical order must be guaranteed at all times.
Quality records from suppliers must be taken into account in the
same manner.
All quality records must be legible and stored in facilities under
suitable conditions which avoid damage, deterioration or loss and
must be kept in order so that they are easily retrievable. The same
applies to records on electronic media.
Note:
For this element VDA Volume 1 and 7 are also valid.
Reference
DIN EN ISO
9001
9004-1
20.1
Are procedures and responsibilities defined for 4.16

the identification, review and approval of quality records?
17.1
20.2
Are there procedures and responsibilities

defined for the evaluation and distribution of
quality records?
4.16
17.3
20.3
Is it defined where, how and for how long

quality records are retained?
4.16
4.3.4
17.3
20.4
Is the manner in which quality records are

made accessible to the customer defined, if
this has been contractually agreed?
4.16
175
20.1
Are procedures and responsibilities defined for the identification, review and approval of quality records?
Identification" serves the clear referencing to processes, operations or
products.
"Review" encompasses the plausibility check, as well as the formality and
correctness of the contents of the records.
"Approval" is the approval of the measures noted in the records.
The operations are to be comprehensively structured from the customer
through to the company under inclusion of all relevant departments. A clear
illustration of all types of quality records is advantageous.
Quality relevant records are, for example:
-
176
evidence to contract review

evidence of inspections, tests and experiments
product/process approvals and releases
capability records (quality capability of men and machines,
including tools/organizations)
quality audits (system, process and product audits)
materials tests
calibrations
complaints
evidence of implemented corrective actions
evidence of quality related costs
evidence of process related costs
evidence of quality related losses
documentation of preventive maintenance.
20.2
Are there procedures and responsibilities defined for the evaluation and distribution of quality records?
"Procedures" describe what, when and to what extent evaluations are to be
performed.
"Responsibilities" are those functions within the company which evaluate
and distribute quality records.
To control quality in the various areas of authority, meaningful evaluations of
quality data must be available to the responsible parties. This applies to
individual reports, periodic projections and status reports.
The quality records of the supplier and customer must be incorporated into
this process.
Processes and responsibilities for the evaluation and distribution must be
controlled.
Note:
For a listing of quality records, see Question 20.1
177
20.3
Is it defined where, how and for how long quality records are
retained?
"Retained" refers to the filing and archiving of records, whereby it must be
guaranteed that all documents are retrievable.
This requires instruction about e.g.:
-
retention period
filing system
filing location.
Thereby the following, for example must be considered:

-
protection against fire, water etc.

storage media (files, microfilm, DP storage)
if necessary, additional back-up files (e.g. double archiving,
security copy etc).
Retaining quality records is necessary in order to be able to prove, even at a

later date that the quality system, the process and the product fulfilled all the
quality requirements for that particular period.
The retention (or archiving) period must be defined, among other things, on
the basis of the requirements of legislation, general guidelines, customers
and product liability aspects (see VDA Volume 1).
Minimum requirements for the archiving period are:
-
one year after product discontinuation: Product/ process

releases, Tool inspection reports, Purchase contracts and
supplements to them etc.
two years: Records on quality performance (quality control
charts), Inspection results, ppm lists etc.
three years: Reports for the (top) management, Records to
internal quality audits, management reviews etc.
longer: documents requiring special archiving (DWSpA) (See
VDA Volume 1)
The destruction of quality records after defined archiving period has to be

ruled.
Note:
178
1) For a listing of quality records, see Question 20.1

2) Copies of records concerning discontinued products which are required for
approval of the new products must be archived referenced to these new
products.
3) See Question 06.2
20.4
Is the manner in which quality records are made accessible

to the customer defined, if this has been contractually
agreed?
Quality records must be made accessible to the customer, in so far as this
is contractually agreed. The procedure for this must be defined.
Direct referencing and identification of the relevant records to the defined
products and associated processes must be defined as a procedure.
In many cases, certain product characteristics of the finished product can no
longer be inspected by the customer. Therefore it must be possible to refer
back to the suppliers quality records for this purpose.
Note:
For a listing of quality records, see Question 20.1
179
180
21
Servicing, (After Sales, Post-production Activities)

DIN EN ISO 9001,
Section 4.19
DIN EN ISO 9004-1
Section 16, (7)
This element summarizes all quality-relevant activities which are
necessary for observing a product in the utilization phase. The
knowledge gained from customer service and from maintenance
activities about weaknesses must be used to improve products
and processes.
Note:
If only the Question 21.3 is relevant for the evaluation of this element,
then this question can also be considered and evaluated as an
additional question 18.5 under Element 18. In this case the individual
evaluation of Element 21 is no longer applicable.
Reference
DIN EN ISO
9001
9004-1
21.1
Is the preparation of operation and assambly

instruction defined and are these clear and
understood?
(4.19)
16.4.3
21.2
Is there a procedure for product surveillance

and an early warning system for product
failures in use?
7.3
16.5
16.6
21.3
Is there a procedure to analyze product nonconformities during use, as well as to implement and monitor corrective actions?
7.3
21.4
Is the customer service function included in

the information flow system?
16.4.1
21.5
Is there a procedure for maintenance activities, if these are agreed?
4.19
16.4
181
21.1
Is the preparation of operation and assambly instruction

defined and are these clear and understood?
The preparation of operating and assembly instructions is necessary for
some products.
In this case, the following must be considered:
-
responsibility for the preparation

multilingual
arrangements with respect to the range of users
consideration of foreseeable misuse
warnings concerning incorrect use (also during
commissioning).
It must be noted that the operating and assembly instructions must be

available and, if necessary, agreed with the customer in good time, that is,
prior to the introduction of the product.
Note:
Regarding products within the automotive industry, this question applies

primarily to companies active in the accessory business sector. The necessity
of this question is to be agreed upon in individual cases.
21.2
Is there a procedure for product surveillance and an early

warning system for product failures in use?
The procedure for this must be defined and, if necessary, agreed with
customers that further process delivered products. Thereby, not only the
warranty period but also the entire utilization period should be taken into
account (e.g. also long-term evaluations).
Every company must be aware of how its products behave in use. The
activities undertaken by the company, in order to obtain information about
the quality of its products in use, must be evidenced.
182
This includes for example:

-
regular market observation

evaluation of field returns / warranty cases
customer surveys
customer information/early warning system.
An early warning system must be agreed and built up between the company
and the customer. This should include, e.g.:
-
an observation and information system

an organizational system for actions when necessary
the definition of the responsible person / contact person.
The information must be available to, among others, the following organizational units:
Note:
Development
Work planning
Production
Quality management.
It is especially important that systems suppliers and suppliers of complex
products establish a quick feedback system for the introduction of new
products. See Question 21.3 concerning the analysis and evaluation of
nonconformities.
183
21.3
Is there a procedure to analyze product nonconformities

during use, as well as to implement and monitor corrective
actions?
For product nonconformities during use, or respectively for return shipments
from customers, a procedure must be defined for the analysis, implementation and monitoring of corrective actions.
The following steps must, for example, be understandable and documented:
-
Procurement of the nonconforming product

Analysis of nonconforming production with regard to location,
type and cause of nonconformity
Definition of corrective actions (short, medium and long term)
Implementing corrective actions
Monitoring of corrective actions
Evidence of the effectiveness of actions carried out.
The results of the analysis of the nonconformity and the corrective actions
must be informed to the customer and, if necessary, to the development
department.
The aim is to avoid nonconformities, to exclude the possibility of a
recurrence of the nonconformity and to implement continuous improvements to the process.
Note:
184
The procedure for the above is to be defined with the customer.
21.4
Is the customer service function included in the information

flow system?
Customer service is the care of the products at the customer (including
intangible products - see Section 4.1 #1.4).
Customer service is recognizable through, for example:
-
providing special tools and testing equipment for customer

services
technical advice (liaison engineer, advice on processing and
use)
requests for quality related information
support for own sales offices
information flow to and from the customer
qualification measures in manufacturing plants
timely availability of (modified) replacement parts
recall of obsolete products and evidence about this.
Evidence of customer services can be, for example:

-
identified responsibilities
discussion notes
check lists
meeting reports
travel reports.
The objective is to ensure the feedback of information from the customer to

the corresponding company departments.
185
21.5
Is there a procedure for maintenance activities, if these are

agreed?
Where maintenance on delivered products is a requirement of the recipient,
the company must define:
-
what belongs to the scope of maintenance

how it is to be reported on
how the requirements are to be fulfilled.
The following must also be taken into account, among other things,
-
special tools
inspection measuring and testing equipment
work instructions for commissioning
administration of spare parts
The organizational procedures must be shown.
186
22
Statistical Methods
DIN EN ISO 9001,
DIN EN ISO 9004-1
Section 4.20
Section 20
The use of statistical methods is an important quality element in all

areas of the quality loop. It is dependent on the product and on the
manufacturing processes implemented and encompasses the
planning, the performance, as well as the evaluation of results.
The use of statistical methods and procedures:
- in the design phase leads to the definition of realistic tolerances
and functional values
- in experiments raises the meaningfulness and safety of
statements using low numbers of experiment samples
- in production, allows the evaluation of the quality of a quantity
of (untested) parts based on a sample of products.
Statistical methods are based on the laws of probability calculation. Their implementation allows, with economical expenditure,
correct statements to be made about quality levels and any
changes to these levels. All statistical statements are limited in
that they are only valid with a certain degree of probability. This
must be considered by the users of statistical methods.
Reference
DIN EN ISO
9001
9004-1
22.1
Are the possibilities for using statistical

4.20.1
methods determined and is their use planned?
20.1
22.2
Are statistical methods used for planning and

evaluating experiments and estimating
product risks during development?
20.1b,
h20.2
22.3
Are statistical methods used for the evaluation 4.20

of quality inspections on deliveries?
20.1f
20.2
22.4
Are statistical methods used for process

optimization and for process control?
20.1c/g
20.2
22.5

of quality test at final inspection?
20.1f
20.2
22.6

of product failures during use?
20.1a,
h 20.2
4.20
4.20
187
22.1
Are the possibilities for using statistical methods determined

and is their use planned?
The need for statistical methods to determine, monitor and examine
process and product within the process chain must be defined.
It is to be defined, dependent on the results of the risk analysis (e.g. FMEA),
which processes and characteristics have to be tested and evaluated and
with which methods.
The appropriate method must be defined and used for the particular
application.
Statistical methods allow the user to assess processes taking into account
economic aspects within the process chain.
Statistical methods are planned within the framework of project planning in
the form of a advanced quality plan (quality planning).
The results of the statistical evaluation must be considered within the scope
of quality improvement programs.
Wherever possible and economically viable, the statistical evaluation of process parameters must be given precedence over the evaluation of quality
results on products.
22.2
Are statistical methods used for planning and evaluating

experiments and estimating product risks during development?
Typical methods are e.g.:
-
Design of Experiments / analysis of influencing variables

variance and regression analysis
significance studies
calculation of failure probability
FMEA
failure tree analysis
system optimization.
Statistical methods must be used both for product and process development
in testing, design and model construction.
188
22.3
Are statistical methods used for the evaluation of quality

inspections on deliveries?
Typical methods are, e. g.:
-
Random sampling techniques

Nonconformity tally cards
Pareto analysis.
The evaluation of quality evidence for deliveries also forms part of this.
These evaluations also serve supplier evaluations.
22.4
Are statistical methods used for process optimization and for

process control?
Typical methods for process control and optimization, are e.g.:
-
Quality control cards /SPC

Random sampling techniques
Nonconformity tally cards
Pareto analysis
Capability studies(Cmk, Ppk, Cpk)
Design of Experiments
Analysis of influencing variables
Variance and regression analysis
Significance studies
189
22.5
Are statistical methods used for the evaluation of quality test

at final inspection?
-
random sampling techniques

Pareto analysis.
Random sampling plans are to be defined from a statistical viewpoint. The

Zero-Defect-Strategy is to be considered. (i.e. Acceptance figure c=0).
22.6
Are statistical methods used for the evaluation of product

failures during use?
-

Pareto analysis
probability grids.
Keeping statistics related to a production period is in many cases of great

significance.
It finds application, for example, in customer services and handling of
warranty cases.
190
Forms for the Quality System Audit - tangible products -
The use of forms to correctly carry out the quality system audit is advantageous because they enable the results to be gathered quickly, rationally
and clearly for all parties involved. The forms shown below show examples
of possibilities.
The set of forms: Quality system audit for material products in accordance
with VDA 6.1 consisting of :
Questionnaire (questions only)
DIN A5, block of 10 sets, 12 pages each set.
Assessment documents
Overall assessment of the quality system
Overall grading
Summary of results
Summary of the assessed questions
Corrective actions
Corrective actions - summary
DIN A4, block of 10 sets, 5 pages each set.
Both blocks belong together and are only available as a set in
German/English.
Order No. 1749
Reference sources:
Druckerei Henrich
D-60528 Frankfurt am Main, Schwanheimer Str. 110
(0 69)67 80 06-0
(0 69)67 80 06-30
191
VDA 6, Part 1- Quality System Audit

Overall Evaluation of the Quality System
of the Company
Customer/Certification body
Area/Works Location
Auditor
Report No. of System Audit:
Audit-period:
starting
ending
Audited/Certified Company
Area / Works Location
Audited Products / Product groups
Address
Contact person
Result
Overall Compliance
CTOT
from CM
and
CP
Issuing of Audit Certificate is recommended

yes
no
Comments of the audited / certified company:

........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
Signature of audited/certified
company/Date
Signature Auditor(s) / Date
.................................................
.................................................
The customer/certification body agrees, that the audited/certified company

may communicate the audit results to other parties.
.................................................
Signature/Date
192
VDA 6, Part 1- Quality System Overall Compliance

nd
- Only for Customer / Supplier Audits (2 Party)
Customer:
Supplier:
Date:
Ranking:
Overall Compliance
CTOT
Auditor Ranking
from CM
and
CP
(for downgrading acc. to. Par..3.3.3 Notes 1 and 2)
Comments on Ranking (Auditor):

........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
System evaluation:
Overall Compliance
in percent
Evaluation of
Quality System
Designation of
Evaluation
90 to 100
full compliance
A *)
80 to less than 90
mainly compliant
AB*)
60 to less than 80
conditionally compliant
less than 60
not compliant
*) see notes under Par. 3.3.3
193
VDA 6, Part 1 - Quality System Audit: Summary of Results

Customer/Certification body:
Company:
Report N. of System Audit:
Date:
No. Of
Scoree
Questions
max. Asses max. archieposs. sed poss. ved
VDA Element
No.
Part M: Management
01 Management Responsibility
02
Quality System
03
Internal Audits
04
Training, Personnel
05
Fin. consideration on Q.-System.
06
Z1
CM
Product Safety
Company Strategy
X Compliance level 1 - Z1
Part P: Product and Process

07 Contract Review, Quality in Marketing
08
Design Control (Product design)
09
Process Planning,(Process dev.)
10
11
Purchasing
12
Control of customer supplied Prod.
13
Identification, Traceability, etc..
14
Process Control
15
Inspection + Test (for Products)
16
Control of Insp.+Test Equipment
17
Control of non-conforming Prod.
18
Corrective + Preventive Actions.
19
Handling., Storage, Pack., etc.
20
21
22
Control of Quality records

Servicing (Post-Production Activity)
Statistical Methods
CP
194
X Compliance level 7 - 22
Compl.
level
CE %
Compliance
Profile
%
20 40 60 80
VDA 6, Part 1- Quality System Audit: Summary of Evaluated questions

Customer /
Certification body:
Certificate N.:
Audited/Certified
company:
Date:
DIN EN ISO:
Valid to:
01.1
01.2
01.3
01.4
01.5
01.6
02.1
02.2
02.3
02.4
02.5
02.6
03.1
03.2
03.3
03.4
04.1
04.2
04.3
04.4
04.5
04.6
04.7
05.1
05.2
05.3
05.4
06.1
06.2
06.3
06.4
Z1.1
Z1.2
Z1.3
Z1.4
Z1.5
07.1
07.2
07.3
07.4
07.5
08.1
08.2
08.3
08.4
08.5
08.6
08.7
09.1
09.2
09.3
09.4
09.5
09.6
09.7
10.1
10.2
10.3
10.4
10.5
11.1
11.2
11.3
11.4
11.5
11.6
11.7
12.1
12.2
12.3
12.4
13.1
13.2
13.3
13.4
13.5
13.6
13.7
14.1
14.2
14.3
14.4
14.5
14.6
14.7
15.1
15.2
15.3
15.4
15.5
15.6
16.1
16.2
16.3
16.4
16.5
17.1
17.2
17.3
17.4
18.1
18.2
18.3
18.4
19.1
19.2
19.3
19.4
20.1
20.2
20.3
20.4
21.1
21.2
21.3
21.4
21.5
22.1
22.2
22.3
22.4
22.5
Note:
na
19.5
19.6
22.6
= Question not applicable thus not evaluated, reasons to be

given on a separate sheet.
= *- Questions with particular relevance for product-,
process and Quality system
195
VDA 6, Part 1- Quality System Audit: Remarks on Status

Customer /
Certification body:
Audited/Certified
company:
Date:
Ref. to Quality Element ________ / Question _______/Page N.
196
VDA 6,Part 1- Quality System Audit: Corrective Actions

Customer / Certification body:
Audited/Certified Company:
Date:
Q-Element
seq. No.
Deviations, proposed
corrective actions
Response and actions of the

audited / certified company
deadline
197
VDA 6, Part 1- Quality System Audit: Corrective action - Summary

Customer /
Certification body:
VDA
Element
No.
Part M: Management
01
02
Quality System
03
Internal Audits
04
Training, Personnel
05
Fin. consideration on Q.-System.
06
Z1
Product Safety
Company Strategy
Part P: Product and Process

07
Contract Review, Quality in
Marketing
08
Design Control (Product design)
09
Process Planning,(Process dev.)
10
11
Purchasing
12
Control of custom-supplied Prod.
13
Identification, Traceability, etc..
14
Process Control
15
Inspection + Test (Product testing)
16
Control of Insp.+Test Equipment
17
Control of non-conforming Prod.
18
Corrective + Preventive Actions.
19
20
21
22
Handling., Storage, Pack., etc.

Control of Quality records
Servicing (Post-Production Activity)
Statistical Methods
198
Audited/Certified
Company:
Date:
J F M A M J J A S O
further
Information on
page No.
Literature
9.1
VDA-Series "Quality Management in the Automotive Industry":

Volume 1
Quality Evidence
- Guidelines for Documenting and Archiving Quality
Requirements-
Volume 2
Quality Assurance of Supplies

- Supplier Selection, Quality Agreements, Production
Process and Product Approval, Quality Performance
in the Series-
Volume 3
Ensuring Reliability of Car

Suppliers
Procedures and Examples -
Volume 4
Quality Assurance prior to Serial Application

Part 1: Partnerships, Processes, MethodsPart 2: System FMEA
Part 3: Project Planning
Volume 6
Basics: Quality Audit, Fundamentals

Part 1: Quality System Audit
Part 2: System Audit Services
Part 3: Process Audit
Part 4: Quality System Audit, Production Means
Part 5: Product Audit
Part 6: Product Audit, Services
Volume 7
Basics for Interchange of Quality Data

Electronic Transfer of Quality Data -
Volume 8
Guidelines for Quality Assurance of Trailer,

Superstructure and Container Manufacturers
Volume 9
Quality Assurance
Emissionen and Consumption
Manufacturers
and
199
9.2
Masing, Walter (Hrsg.),

Handbuch des Qualittsmanagement, 3. Auflage, 1994
9.3
DGQ-Schrift 11 - 04 (Stand 1995)

Begriffe zum Qualittsmanagement
9.4

Qualittssicherungs-Handbuch und Verfahrensanweisung,
Leitfaden fr die Erstellung
9.5

Systemaudit
9.6
DIN EN ISO 8402 (1995)

Qualittsmanagement und Qualittssicherung Begriffe
9.7
DIN EN ISO 9000, Teil 1 (08/94)

Qualittsmanagement- und Qualittssicherungsnormen; Leitfaden
zur Auswahl und Anwendung
9.8
DIN EN ISO 9000 Teil 2 (03/92)

Qualittsmanagement- und Qualittssicherungsnormen; Allgemeiner Leitfaden zur Anwend. von ISO 9001, ISO 9002 und ISO 9003
9.9

Qualittsmanagement- und Qualittssicherungsnormen; Leitfaden
fr die Anwendung von ISO 9001 auf die Entwicklung, Lieferung
und Wartung von Software
9.10

Qualittsmanagement- und Qualittssicherungsnormen; Anwendung auf das Zuverlssigkeitsmanagement
9.11
DIN EN ISO 9001 (08/94)

Qualittssicherungssysteme; Modell zur Darlegung der Qualittssicherung in Design/Entwicklung, Produktion, Montage und Kundendienst
9.12
DIN EN ISO 9002 (08/94)

Qualittssicherungssysteme; Modell zur Darlegung der Qualittssicherung in Produktion und Montage
200
9.13
DIN EN ISO 9003 (08/94)

Qualittssicherungssysteme; Modell zur Darlegung der Qualittssicherung bei der Endprfung
9.14
DIN EN ISO 9004, Teil 1 (08/94)

Qualittsmanagement und Elemente eines Qualittssicherungssystems - Leitfaden
9.15
DIN EN ISO 9004, Teil 2 (08/94)

Qualittsmanagement und Elemente eines Qualittssicherungssystems - Leitfaden fr Dienstleistungen
9.16

Qualittsmanagement und Elemente eines Qualittssicherungssystems - Leitfaden fr verfahrenstechnische Produkte
9.17

Qualittsmanagement und Elemente eines Qualittssicherungssystems - Leitfaden fr Qualittsverbesserung
9.18
DIN ISO 10011 Teil 1 (06/92)

Leitfaden fr das Audit von Qualittssicherungssystemen; Auditdurchfhrung
9.19
DIN ISO 10011 Teil 2 (06/92)

- Qualifikationskriterien fr Auditoren
9.20
DIN ISO 10011 Teil 3 (06/92)

- Management von Auditprogrammen
9.21
DIN ISO 10012 Teil 1 (08/92)

Forderung an die Darlegung der Qualittssicherung von Prfmitteln - Management von Prfmitteln
9.22
VDI-Richtlinie 2890 (1986)

Planmige Instandhaltung:
Anleitung zur Erstellung von Wartungs- und Inspektionsplnen
9.23
VDI/VDE/DGQ-Richtlinie 2618 (Teil 1 - 17):

Prfanweisung zur Prfmittelberwachung
201
9.24
VDI/VDE/DGQ-Richtlinie 2619:
Prfplanung
9.25
DGQ-Schrift 14-18 (1995)

Wirtschaftlichkeit durch Qualittsmanagement
References
9.1
Verband der Automobilindustrie e. V. (VDA)

Qualittsmanagement Center (QMC)
Lindenstrae 5, 60325 Frankfurt
9.2
Carl Hanser Verlag, Postfach 86 04 20, 81631 Mnchen
9.3 - 25 Beuth-Verlag, Burggrafenstrae, 10787 Berlin
202
10
Agreement with Industrial Associations
10.1
Introduction
The current publication on the auditing of quality systems according to DIN

EN ISO 9004, Part 1 and DIN EN ISO 9001 has since the publication of the
st
1 Edition in January 1991 received great attention even beyond the sector
of the automotive industry. This was the reason why quality management
working groups from several expert and industrial associations have discussed the content and formulation of this document. Thereby, it was established that the questionnaire could be adapted apart from some questions
not pertinent to this industry sector. These questions not pertinent to this
industry sector should not be used in audits/certification and evaluation. The final determination of the which questions are or are not used in
the audit/certification process is subject to agreement between the company
to be audited and the customer or certification body under consideration of
risk aspects. This may vary when comparing different associations and
suppliers.
10.2
Summary of the National Associations
Deutsche Gesellschaft fr Materialkunde e. V. (DGM)

Oberursel/Ts. German Association for Material Science)
For the committees:
Strangpressen und Walzen von NE-Metallen
(Extrusion Molding and Rolling)
Deutscher Schraubenverband e. V
Hagen (German Association of Fasteners)
Verband der Chemischen Industrie e. V. (VCI)
Frankfurt/Main (Association of the Chemical Industry)
The VCI regards all questions as applicable, however, the production
processes in the chemical industry are partially structured different to
other industrial branches. Therefore, supplementing explanations for
some questions of the VDA questionnaire were established from a
chemistry-specific viewpoint.
The comparison and explanations are contained in a VCI brochure which
is available from the VCI.
Verband der Deutschen Federnindustrie (VDFI)
203
Hagen (Association of the German Spring Industry)

For the member associations:
- VDFI Fahrzeugfedern e.V. - FF (Vehicle Springs)
- VDFI Kaltgeformte Federn - KF (Cold Formed Springs)
- Verein Deutscher Eisenhttenleute e.V. (VDEH)
Dsseldorf (Association of German Iron Foundry Workers)
- Industrieverband Deutscher Schmieden e. V. (IDS)
Hagen (German Forging Industry Association)
Wirtschaftsvereinigung Ziehereien und Kaltwalzwerke e. V.
Dsseldorf (Drawing and Cold Rolling Works Industrial Association)
For the member associations:
- Eisen- und Stahldrahtvereinigung e. V. (Steel Wire Organization)
- Fachvereinigung Kaltwalzwerke e. V. (Cold Rolling Works)
Kaltbund und Kaltprofile (Cold Strip and Cold Profile)
- Fachvereinigung Przisionsrohrwerke e. V.
(Association of Precision Tube Works)
- Stabziehereien-Vereinigung e. V. (Bar Drawing Association)
10.3 International Agreement on Mutual Recognition

In March 1994, the agreement on the mutual recognition of results of quality
system audits between the French and German Automotive Industry was
concluded. This was realized after an intensive comparison of the two
existing questionnaires and after a corresponding alignment of the requirements, as well as after joint audits at German and French suppliers. The
wording of the agreement in the German language is printed on the following page.
204
AGREEMENT
on mutual recognition
PSA Peugeot Citron, Renault, FIEV and Verband der Automobilindustrie (VDA)
The car manufacturers PSA PEUGEOT CITRON and RENAULT
evaluate the quality capability of
their suppliers according to a procedure that is described in the
publication
REFERENTIEL DEVALUATION
DAPTITUDE QUALIT FOURNISSEURS
(Evaluation of the quality capability
of suppliers)
Edition 94, based on the standard
series EN29000.
The French component manufacturers, members of the FIEV
(Fdration des Industries des
Equipements pour Vhicules),
have participated in the develop-
ment of this procedure. It forms the

basis for evaluating the quality
capability of their own suppliers.
The German car and component
manufacturers, members of the
VDA (Verband der Automobilindustrie e.V. Association of the
German Automotive Industry) have
established an audit procedure for
the evaluation of the quality systems of their suppliers that is described in Volume 6 of the series
QUALITTSMANAGEMENT IN
DER AUTOMOBILINDUSTRIE
QUALITSSICHERUNGSSYSTE
MAUDIT
and which is also based on the
standard series EN 29000.
In an effort to raise the efficiency when auditing quality systems and after
establishing the comparability of both evaluation procedures
The car manufacturers PSA
PEUGEOT
CITRON
and
RENAULT, as well as the component manufacturers of the
FIEV on the one side and
The car and component manufacturers of the VDA on the

other side
have decided
TO MUTUALLY RECOGNIZE AUDITS WHICH HAVE BEEN CARRIED
OUT BY ONE OF THE CONTRACT PARTNERS FOLLOWING ONE OF
THE ABOVE PROCEDURES AND THEIR RESULTS.
This requires, that the audited company provides the result and audit report
of a preceding audit. Specific elements of the respective partner may be
subject of a supplementing audit.
nine signatures
- End of the agreement
205
11
Notes on a Certification according to VDA 6.1
Certification bodies, contractually accredited by VDA, may, upon request,

certify the quality system of a company on the basis of VDA Volume 6,
Part 1. This certification is based on a certificate according to DIN EN ISO
9001 or 9002. It is supplemented by VDA 6.1-specific elements and
questions whereby all appropriate questions of the VDA 6.1 questionnaire
must be evaluated.
A certificate supplement VDA 6.1 (for the certificate according to DIN EN
ISO 9001/ 9002) may be issued by the certification body if an overall
compliance of at least 90% has been reached, no element lies below 75%
compliance, no question identified with a * is marked with less then eight
points and no question without marking reaches zero points (compare Para.
3.3.3).
When certifying according to VDA 6.1 an existing certificate according to
DIN EN ISO 9001 or 9002 may be taken into account so that the expenditure for upgrading to VDA 6.1 is limited.
Certification audits must only be carried out by certified VDA 6.1 auditors
with the corresponding branch expertise.
More details are given in VDA Volume 6, Basics.
206
12
Appendix
12.1
Changes of the 4 Edition compared to the 3 Edition
th
rd
Further corrections and updating have been incorporated. The audited

organization is from now on generally referred to as the company.
The factual content of the chapters, elements and questions has widely
remained unchanged. Changes have been made in:
Foreword
"Quality Standards of the German Automotive Industry" updated
3.

st
nd
rd
Scope of application for all 3 audit types (1 -, 2 and 3 -party)

determined.
3.2
Selection of the Quality elements and Relevant Questions

The possibility regarding the omission or addition of elements or
questions have been defined more precisely.
The definition of 41 questions as being of special influence to
product and process quality or the quality system (*-questions) has
been newly introduced.
3.3.1

The definition of mainlyhas been extended.
3.3.3
nd
Rating during Customer/Supplier Audits (2 Party)

nd
The classification for customer/supplier audits (2 party) has

been revised taking into account the questions with special
influence (*-questions).
An additional downgrading from A to AB has been introduced
when questions are marked with 0 points.
3.3.4
rd
Awarding of the VDA 6.1 Certificate Supplement (3 party)

Rules for the issue of certificate, and for follow-up or re-audits
have been newly included.
207
3.7
VDA 6.1 Certificate

The text of the certificate has been changed. The statement of the
level of compliance has been dropped.
Questionnaire
Question 01.6: Management review "with all elements" dropped
Question 03.1: Qualification requirements for internal auditors updated. External auditors now defined under 04.5.
Question 04.5 Qualification requirements for external auditors
newly included.
Question 06
The circle of persons to be informed has been

newly formulated.
Question 06.4 Definition for Emergency Plansrevised.

Element Z1
Is now generally to be taken into account during

audits/certification.
Question Z1.3 Examples for data have been supplemented.

Question 07.5 Formulation: earlyhas been added.
Question 09.4 Quality evaluation at least three timeshas been
dropped.
Element 10
VDA Volume 1 has been added as being applicable.
Element 11
Supplier is generally used instead of Subsupplier. The note was added that the element is
also applicable for internal customer/supplier relationships.
Question 11.6 inspected and not inspected has been replaced by releasedand not released.
Question 13.2 Inspection and test plan has been replaced by
inspection and test instruction.
Question 13.3 Formulation: Production parameters of the process
has been replaced with process parameters.
Question 13.4 Formulation: Manufacturing means has been replaced by production means.
Question 14.1 Explanation to Process Capabilityadded.
Question 14.2 PPA Process according to VDA Volume 2 and
note on process changes added.
208
Question 14.7 Note on applicable methods added.

Question 15.1 Destructive testingadded.
Question 15.2 Procedure for rework added.
Question 15.6 Durability test added, Product audit dropped
(compare 03.4).
Element 20
Quality-relevant records changed into Quality

records. Note on VDA Volume 1 added.
Question 20.1 Formulation: maintenancehas been dropped.

Question 20.3 Definition for DwSpA added (compare VDA 1).
Element 21
8
Note on procedure when only Question 21.3 is

relevant.
Forms
Generally, the term supplierhas been dropped.

In the form Corrective actionsthe word deviationshas been added.
11
Notes on Certification
This section has been updated. VDA Volume 6, Basics for Quality Audits is
referenced.
12
Appendix
The notes on changes made from 2

dropped.
nd
rd
Edition to the 3 Edition have been
209
12.2
Comparison Tables
In the following, the comparison tables to DIN EN ISO 9001 are shown.
12.2.1
VDA 6
M
01.
01.1
01.2
01.3
01.4
01.5
01.6
02.
02.1
02.2
02.3
02.5
02.4
02.6
03.
03.1
03.2
03.3
03.4
04.
04.1
04.2
04.3
04.4
04.5
04.6
04.7
05.
05.1
05.2
05.3
05.4
06.
06.1
06.2
06.3
06.4
210
Comparison Matrix VDA 6.1 / DIN EN ISO 900194

Subject of the Question
Company Management
Quality policy
Quality objectives
Continual improvement
Quality system, resources for personnel and material costs
Management representative
Management review
Quality System
Quality manual
Scope of quality system
Responsibility and authority
Project management
Quality planning
Quality plans
Internal Audits
Auditor qualification
Internal quality audits
Corrective actions and their documentation
Product and process audits
Training
Training program
Further training in quality techniques
Further training - Executives
New appointments, realization
Qualification
Promotion of quality awareness
Presentation of the quality achieved
Methods of reporting
Regularity of reporting
Nonconformity costs internal
Nonconformity costs external
Product Safety
Product liability - Basics
Products requiring documentation
Identification of product risks
Localization of nonconforming units
DIN EN
ISO 9001
4.1
4.1.1
4.1.1
-4.1.2.2
4.1.2.1, 4.1.2.3
4.1.3
4.2
4.2.1, 4.2.2
4.1.2
4.1.2.1
(4.4.3)
4.2.3
4.2.3
4.17
4.17.2
4.17.1, 4.17.3
--4.18
4.18
4.18
4.18, 4.1.2.2
4.18
4.18
---(4.1.3)
---(4.2.3a, -g)
-(4.8)
VDA 6
Z1.
Z1.1
Z1.2
Z1.3
Z1.4
Z1.5
P
07.
07.1
07.2
07.3
07.4
07.5
08.
08.1
DIN EN
ISO 9001

Corporate Strategy
Business plan on costs, sales, quality etc.
Measuring methods for business results and CIP use
Performance data, company-wide / comparison
Customer satisfaction, measurement and modification
Personnel satisfaction
Product and Process
Contract Review / Quality in Marketing
Marketing function
Contract review
Structure quotation
Quality requirements of the customer
Requirements and performance specification known
Design Control
Product/process development plan
08.2
08.3
08.4
08.5
Quality requirements fully considered

Product/process trial
Management review
Design approval
08.6
08.7
09
09.1
Result of design work

Transfer of development experience
Process development Plan for new/modified products
09.2
Production plans, work instructions
09.3
09.4
09.5
Quality requirements fully considered

Management review of processes and procedures
Approval of processes and procedures
09.6
09.7
10.
10.1
10.2
10.3
10.4
10.5
Result of process planning and development work

Transfer of experiences from process planning
Quality-relevant documents, responsibility, procedures, ..
Approval and revision
Archiving
Appropriately times introduction of customer documents
Non-use of invalid documents
-----4.3
-4.3.1, 4.3.2
-4.2.3, 4.3.2a,
4.3.2c
4.4
4.4.1, 4.4.2,
4.4.4, 4.4.5
4.4.4, 4.3.2c
4.4.7, 4.4.8
4.4.6
4.4.8, 4.4.3,
4.4.5
4.4.5
4.4.3, 4.4.5
4.4, (4.9)
4.4.1, 4.4.2,
4.4.4, 4.4.5
4.9 Abs.1,
4.9a
4.4.4, 4.3.2c
4.4.6
4.4.8, 4.4.3,
4.4.5
4.4.5
4.4.3, 4.4.5
4.5,
4.5.1 to -3
4.5.2, 4.5.3
4.3.4
4.5.2
4.5.3
211
VDA 6
11.
11.1
Purchasing
Order documents
11.2
11.3
11.4
11.5
11.6
11.7
12
12.1
12.2
12.3
12.4
13.
Supplier selection
Sample test
Supplier quality performance
Agreements on quality inspections
Material receiving inspection
Traceability
Control of customer-supplied Products
Agreed quality measures
Minimum scope of inspection and testing
Reporting of nonconformities
Quality history
Process Control/Identification and Traceability/Inspection and Test
Status
13.1
13.2
13.3
Product identification
Process control measures
Records of process parameters
13.4
13.5
13.6
13.7
14.
14.1
14.2
14.3
14.4
14.5
14.6
14.7
15.
15.1
15.2
15.3
Production means Storage

Quality objective/subsequent process, dispatch
Traceability
Release on restart
Process Control
Machine/process capability tests
Production release
Control of relevant process parameters
Maintenance, preventive servicing
Special processes
Environmental conditions specified/complied with
Evaluation of the effectiveness of production processes
Inspection and test plans
Inspection and test plans and instructions
Quality evidence for external purchases
15.4
Quality evidence according to work steps
15.5
15.6
Quality evidence on the final product

Periodic inspections and tests
212
DIN EN
ISO 9001
4.6
4.6.2, 4.6.3,
4.6.4.2
4.6.1, 4.6.2a
4.6.1, 4.6.2b
4.6.1, 4.6.2c
4.6.2b, (4.6.4)
4.6.4, 4.10.1
4.8
4.7
4.7
4.7
4.7
4.7
4.9, (4.8,
4.11, 4.12,
4.196)
4.8, 4.12
4.9d
4.9 (Para.4)
4.16
4.11.2h
4.12
4.8 (Para.2)
4.9e
4.9
4.9b
4.9c, -d, -e
4.9d, 4.9f
4.9g
4.9 Para. 2, 3
4.9b, 4.11.2g
-4.10, (4.2.3)
4.2.3b,-c,-d,-e
4.10.1
4.6.4.1,
4.10.1, 4.10.2
4.10.1,4.10.3,
4.12
4.10.1, 4.10.4
(4.10.1)
VDA 6
16.
16.1

Control and calibration system
16.2
16.3
17.
17.1
17.2
17.3
17.4
18.
18.1
18.2
18.3
18.4
19.
19.1
Connection to national/international standards

Measurement uncertainty of inspection, measuring and test
equipment
Inspection, measuring and test equipment capability
Measures to be taken in case of nonconforming inspection,
measuring and test equipment
Control of Nonconforming Products
Treatment of nonconforming units
Concessions
Carrying out of corrective actions
Identification of reoccurring nonconformities
Corrective and Preventive Actions
Initiation of corrective actions
Estimating the nonconformity risk
Analysis of the cause of nonconformities
Prevention of nonconformity reoccurrence
Product handling
19.2
19.3
Packaging and identification process

Prevention of transport damage
19.4
Correction of packaging errors
19.5
19.6
20.
20.1
20.2
20.3
20.4
21
21.1
21.2
21.3
21.4
21.5
22.
22.1
22.2
22.3
22.4
22.5
22.6
Product identification
Delivery reliability
Quality-relevant documents
Evaluation of quality records
Archiving
Customer access to quality records
Quality in the application phase/Servicing/Customer Service
Users manual and installation instructions
Product observation/Field failure-early warning system
Field failure analysis
Customer service information
Servicing
Statistical Techniques (at)
Method planning
Development/Trial
External sources
Process development and control
Final inspection
Evaluation of field failures
16.4
16.5
DIN EN
ISO 9001
4.11
4.11.1,4.11.2
b,-c,-d,-e,-g,-i
4.11.2b
4.11.2a
(4.11.2a)
4.11.2f
4.13
4.13.1, 4.13.2
4.13.2
4.13.2
4.14.2a
4.14
4.14.1, 4.14.2
4.14.3
4.14.2b
4.14.2d
4.15
4.15.1,4.15.2,
4.15.3
4.15.4
4.15.4,4.15.5,
4.15.6
4.15.1 with
4.14.1
4.15.4
-4.16
4.16
4.16
4.16, 4.3.4
4.16
(4.19)
(4.19)
-(4.14.2b)
-4.19
4.20
4.20.1
4.20
4.20
4.20
4.20
4.20
213
12.2.2 Comparison Matrix DIN EN ISO 900494 / VDA6.1

DIN EN
Element according to DIN EN ISO 9001
ISO 9001
4.1
.1.1
Quality policy
.2.1
Organization, responsibility and authority
.2.2
Organization, resources
.2.3
.3
4.2
.1
.2
.3
Organization, management representative

Management review
Quality System
General
Documented quality procedures
Quality planning
4.3
.1
.2a
.2b
.2c
Contract Review
General
Review, requirements documented and understood
P. nonconformities quotation/order
Capability to meet the requirements
.3
Amendment
.4
4.4
.1
.2
Records
Design Control
General
Design and development plan
.3
Organizational and technical interfaces
.4
Design input
.5
Design result
.6
.7
.8
Design review
Design verification
Design validation
.9
Design modifications
214
VDA6
01
01.1, 01.2
01.5, 02.2,
02.3,
01.4, 02.2,
04.3
01.5, 02.2,
01.6, (05.2)
02
02.1, 02.2
02.1,
02.5, 02.6,
07.4, [06.2, ],
15.1
07
07.2
07.2, 07.4
07.2
07.2, 07.5,
08.2, 09.3
See introductory
comment.
20.3, 09.3
08, 09
08.1, 09.1
(04.5), 08.1,
09.1
(02.4), 08.5,
08.7, 09.5,
09.7
08.1, 08.2,
09.1
08.1, 08.5,
08.6, 08.7,
09.1, 09.5,
09.6, 09.7
08.4, 09.4
08.3
08.3, 08.5,
[09.3], 09.5
[08.1 - 08.7,
09.1 - 09.7]
See introductory
comment.
DIN EN
ISO 9001
4.5
.1
General
.2
Approval and issue of D. & D.
VDA6
10
10.1
10.1, 10.2,
10.4
10.2, [07.2 with
introductory
comment], 10.5
11
11.2, 11.3,
11.4
11.1, 11.2
.3
Amendments to documents and data
4.6
.1
Purchasing
General
.2a
4.7
Evaluation of subcontractors
Suitability: evaluate and select
Monitoring: Capabilities and performance
Record corresponding data
Purchasing information
Inspection of purchased products (Supplier at the subcontractor).
Inspection of purchased products
(Inspection by the customer).
Control of Customer-supplied Products
4.8
Identification and Traceability of Products
(06.3), 11.7,
13.1, 13.6
4.9
Para.1
a
b
Process Control
Planning of quality-influencing assembly and servicing
Documented procedures
Suitable equipment and environmental conditions
c
d
Compliance of standards, quality plans, documented procedure.

Matching process parameters
Approval of processes and equipment
f
g
e
Criteria for work performance

Maintenance
Release
Para.2,3
Para.4
Special processes
Recordings of quality processes, equipment, personnel
9, 13, 14
9.1, 13.2
9.2, 13.2
9.4, 14.1,
14.6
9.3, 9.5, 14.2
9.5, 13.2,
14.2, 14.3,
(13.4)
9.4, 9.5, 13.7,
14.2,
9.2, 14.3
14.4
9.5, 13.7,
14.2
9.4, 14.5
9.6, 9.7, 13.3
.2b
.2c
.3
.4.1
.4.2
11.3, 11.5
11.4
11.1
[11.5], 11.6
[11.1, 11.5],
11.6
12
215
DIN EN
ISO 9001
4.10
.1.1
General
.2.1
.2.1
.2.2
.2.3
.3
.4
.5
Receiving inspection and testing

Application after verification
Scope and type of receiving inspection
Pre-release and concession
In-process inspection and testing
Final inspection and testing
Inspection and test records
4.11
.1
.2a
.2i
4.12

General
Determination of control procedure, inspection and testing and
inspection, measuring and test equipment
Determination and calibration of inspection, measuring and test
equipment
Determination of corresponding procedures
Identification of calibration status
Archiving of records on calibration
Evaluation and recording of previous measurement results for
nonconformities on inspection, measuring and test equipment
Environmental conditions for measurements
Handling, protection and storage of inspection, measuring and test
equipment
Protection of the calibration status
Inspection and Test Status
4.13
.1
.2
Control of Nonconforming Products

General
Evaluation and handling of nonconforming products
4.14
.1
.2a
.2b
.2c
.2d
.3
4.15
.1
.2
.3
.4

General
Corrective actions, effective treatment of nonconformities
Corrective action cause of nonconformity in relation to
production, process, system
Corrective action Determination of...
Corrective action Monitoring of their effectiveness
Preventive actions
General
Handling
Storage
Packaging
.5
.6
Preservation
Delivery
.2b
.2c
.2d
.2e
.2f
.2g
.2h
216
VDA6
15
11.6, 15.2,
15.3, 15.4,
15.5, (15.6)
15.3
15.3
15.3,
15.3
15.4
15.5
(Records
always)
16
16.1
14.2 with
16.3, (16.4)
16.1, 16.2
16.1
16.1, 16.4
16.1, 20.1
16.5
14.6, 16.1
13.4
16.1
13.1, 15.4
17
17.1
17.1, 17.2,
17.3
18
18.1, 19.4
17.4, 18.1
18.1, 18.3,
(21.3)
18.1
18.1, 18.4
18.2
19
19.1, 19.4
19.1
19.1
19.2, 19.3,
19.4
[07.5], 19.3
[07.5], 19.3
DIN EN
ISO 9001
4.16
12.3, 20
4.17
Para.1
Para.2
Para.3
Para.4
4.18

Documented procedure
Planning of audits and auditors
Recording and distribution of results
Follow-up audits corrective actions
Training
03
03.2
03.1
03.2
03.3
04
4.19
Servicing
(21.1 to
21.4),21.5
4.20
.1
Statistical Techniques
Determination of demand
.2
Procedure
22
21.1, 21.2,
21.3, 21.4
21.1, 21.2,
21.3, 21.4
VDA6
217
Other VDA-FORMS
FIRST SAMPLE TEST REPORT new version
Cover page, Order No. 2661
Test results, Order No. 2662
Multipart form set, 5 copies (packed of 50 sets)
Outline form for process capability verification, Order No. 2663
Pad of 50 sheets Minimum order 1 pad
FIRST SAMPLE TEST REPORT present edition
First Sample Test Report Report result, Order No. 5331
Multipart form set, 7 copies (packed of 50 sets)
First Sample Test Report Test result, Order No. 5332
Pad of 100 sheets
SYSTEM - FMEA
- new version Order No. 7422, DIN A3 format, Pad of 50 sheets
FAILURE-POSSIBILITY-AND INFLUENCE-ANALYSIS (FMEA)

- old version Order No. 769, DIN A3 format, Pad of 50 sheets
QUALITY SYSTEM AUDIT (Material products)

Questionnaire (only questions)
DIN A5, Pad of 10 sets 12 sheets
Evaluation documents
Final evaluation of the quality system
Summary of results
Total grading
Summary of evaluated questions
Individual measures
Corrective Actions-Outline
DIN A4, Pad of 10 sets of 5 sheets
The two pads form a unit and are only offered as a set
Order No. 1749
Order:
DRUCKEREI HENRICH GMBH
Schwanheimer Strae 110, D-60528 Frankfurt
Telephone (069) 96766-158, Telefax (069) 96777-159.
218
Quality Management in the Automotive Industry

Volume 1
Quality Evidence
Guidelines for Documenting and Archiving Quality
Requirements
Volume 2
Quality Assurance of Supplies

-Supplier Selection/Sampling/Quality Performance in the
Series-
Volume 3
Ensuring Reliability of Car Manufacturers and Suppliers

-Procedures and examples -
Volume 4 Part 1

-Partnerships, Processes, Methods
Volume 4 Part 2

-System FMEA-
Volume 4 Part 3

-Project Planning-
Volume 6
Basic for Quality Audits, Auditing and Certification
Volume 6 Part 1
Quality System Audit, Basics DIN EN ISO 9001 and

DIN EN ISO 9004
Volume 6 Part 2
System Audit Services
Volume 6 Part 3
Process Audit
Volume 6 Part 5
Product Audit
Volume 7
Basics for Interchange of Quality Data

-Electronic Transfer of Quality Data-
Volume 8
Guidelines for Quality Assurance of Trailer,

Superstructure and Container Manufacturers
Volume 9
Emissions and Consumption
219

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VDA

Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1

4rd Revised Edition 2000

Based on DIN EN ISO 9001

4 Revised Edition 2000

Verband der Automobilindustrie e.V. (VDA)

Non-Obligatory VDA Standard Recommendation.

Foreword to the 4 Edition

The 3 Edition also includes requirements from the guidelines EAQF/94

In the 4 Edition further corrections and up-dates were included. Comments

Quality System Audit

Quality System Audit

Quality System Audit

Audi AG, Ingolstadt

VERBAND DER AUTOMOBILINDUSTRIE E. V. (VDA)

QUALITY SYSTEM ACCORDING TO THE

QUALITY SYSTEM AUDIT

Definitions for Quality Systems according to

CROSS-REFERENCE LIST OF PARAGRAPH NUMBERS

STRUCTURE AND NUMBER OF QUESTIONS

QUALITY SYSTEM AUDIT QUESTIONNAIRE

FORMS FOR THE QUALITY SYSTEM AUDIT

AGREEMENT WITH INDUSTRIAL ASSOCIATIONS

NOTES ON A CERTIFICATION ACCORDING TO VDA 6.1

Quality management is an interdisciplinary key function. The quality of

Definition of the quality policy, agreeing and monitoring quality

Definition and monitoring of quality-related costs

Quality system according to the DIN EN ISO 9000 Series

The DIN EN ISO 9000 series is applied as a standard in the European

Explanations to DIN EN ISO 9004 (Edition 8/94)

This standard is an internationally agreed guideline in which the elements of

Quality Assurance Model

The following alternative models for quality assurance described in three

Model for quality assurance in design , development, production,

Quality System Audit

demand special qualification requirements of the auditors, as they must be

If the quality system of a company, on the occasion of a system audit, has

Selection of the Quality Elements and Relevant Questions

During internal quality audits (1 Party) and customer audits (2 Party)

During certification audits (3 Party) additional requirements can only be

questions with an *. Non compliance with these requirements has

Evaluation and Rating

Individual Rating of Questions and Quality Elements

Is the subject in question defined in writing in the quality

He must then further evaluate:

Is the subject in question proven to be effective in practice?

Defined completely in the

Under "mainly" it is understood that all applicable requirements are

completely defined in the quality system and proven to be

not completely defined in the quality system but proven to

completely defined in the quality system and mainly proven

not completely defined in the quality system but mainly

not proven to be effective regardless of completeness of

When compiling a summarized rating for a quality element, every question

Calculation of element ratings:

total points assessed for relevant questions

total possible points for relevant questions

Overall Rating of Audit Result

sum of levels of compliance of all relevant elements