WELMEC 8.

7
Issue 1

WELMEC
European cooperation in legal metrology

Measuring Instruments Directive 2004/22/EC

Assessment of Notified Bodies Designated for Module F
based on EN ISO/IEC 17020

May 2008

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 WELMEC
European cooperation in legal metrology

WELMEC is a co-operation between the legal metrology services

of the Member States of the European Union and EFTA. This
document is the introduction to WELMEC.

WELMEC is publishing a number of Guides to provide guidance to

manufacturers of measuring instruments and to notified bodies
responsible for conformity assessment of their products. The
Guides are purely advisory and do not themselves impose any
restrictions or additional technical requirements beyond those
contained in relevant EC Directives. Alternative approaches may
be acceptable, but the guidance provided in these documents are
representing the considered view of WELMEC as to the best
practice to be followed.

Published by:
WELMEC Secretariat
BEV – Bundesamt für Eich- und Vermessungswesen
Schiffamtsgasse 1-3
A-1025 Vienna

e-mail : [email protected]
website: www.welmec.org

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FOREWORD

This guide is one of those who complete the general guide on the assessment and operation
of notified Bodies performing conformity assessment in application of MID. Several guides
have been established for the detailed application of some modules of MID. These guides
should not be read without taking into consideration all relevant aspects in all the guides related
to a module. In order to facilitate the understanding of the whole set of guides, a table has been
put at the end of each one of this series (annex B).

The Guide is purely advisory and does not impose any restrictions or additional technical
requirements beyond those contained in the MID. Alternative approaches may be acceptable
(in particular see Blue-Guide-2001), but the guidance provided in this document represents
the considered view of WELMEC as being the best practice to be followed. This Guide shall
be followed entirely when reference is made to it.

INTRODUCTION

This document is intended to provide guidance in order to facilitate harmonised assessment

of notified bodies (NB) in charge of declaration of conformity to type based on product
verification, that is module F of MID. As the conformity to EN ISO/IEC 17020 appears to be
one of the two most appropriate generic standards in order to give presumption of conformity
for this activity, this document is built according to the structure of this standard.

In addition, accreditation bodies should be invited to use the provisions in this document for
specific accreditation of bodies in charge of module F in application of MID. It could be used
also for accreditation of bodies in charge of similar conformity assessment procedures with
appropriate adaptations, for instance initial verifications.

However the right column in this document provides guidance that should be used also in
the cases where the Member State or the NB have chosen other ways to prove the
conformity. Provisions in this column are in fact based :
1 On the specific application to MID, that is, it concerns some requirements that are not
applicable in general for similar application in legal metrology.
2 On the metrological culture (legal or general) that any good assessor in legal metrology
should have, based on the standards, OIML documents or the state of the art. As it is not
probable that each NB or each assessor would think to all these aspects, it has
appeared necessary to establish this document in order to ensure an harmonised
approach concerning assessment of NBs.

In all the cases, where a provision exists in the right column, it shall correspond to a
provision in the quality system of the NB, demonstrating that he takes the appropriate
provisions in order to meet the requirements. This is the case for instance where this guide
makes reference to requirements made to the manufacturer, in which case the NB will
demonstrate how it ensures these requirements are met or how it informs the manufacturer
of its obligations.

Where it is written "Applicable such as described" in the right column, this means that the
standard applies as such and does not need additional specific guidance.

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Whether the NB does not claim conformity to the standard, whatever it is written "applicable
such as described" or specific guidance is provided in the right column, he has to implement
appropriate general provisions corresponding to the paragraph of the standard in his quality
system when they are critical for the correct evaluation of the measuring instruments.

This guide is not intended to substitute any other guidance available on the New approach,
in particular the Blue Guide (e.g. on sub-contracting). Discrepancies between this guide and
guides other than those developed by WELMEC could result in particular of the fact that this
guide is more specific for MID and legal metrology.

The expression "national Authority” is used in this document. According to the case this may
mean "notifying authority", "authority responsible for assessment and surveillance of notified
bodies", "market surveillance authority" or "authority responsible for metrological supervision
of instruments in use". This may also cover a single authority or two or more authorities (for
example a central authority and a local authority). The appropriate authority depends on the
organisation of the State and of the type of responsibility of course.

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 REQUIREMENTS FOR NOTIFIED BODIES IN
CHARGE OF MODULE F
.
1- SCOPE AND NORMATIVE DEFINITIONS
CHAPTERS OF
N° SCOPE EN ISO/IECIEC 17020 STANDARD APPLICATION GUIDE
(provisional column)
1.1 This European standard specifies This document provides specific guidance on the
general criteria for the competence of application of EN ISO/IEC 17020 in order to give
impartial bodies performing inspection confidence in the capability of a notified body
irrespective of the sector involved. It (NB) to implement the conformity assessment
also specifies independence criteria module “Declaration of conformity to type based
on product verification” (module F) for application
of MID.
Except specific aspects it is not intended to recall
obligations made to manufacturers.
1.2 This standard is intended for the These requirements are established for the
use of inspection bodies and their bodies to be notified and government services in
accreditation bodies as well as other charge of designation, notification, and
bodies surveillance of these bodies.
concerned with recognizing the
competence of inspection bodies. It is also expected that provisions in line with this
document will be used by accreditation bodies
for accreditation of bodies in charge of module F.
1.3 This set of criteria may have to be Declaration of conformity to type based on
interpreted when applied to particular product verification, similar to operations called
sectors, or to in-service inspection initial verification for application of some
regulations, is a legal metrology certification of
product. However it shall be considered in the
exact sense of MID, with all its specificity, in
particular concerning aspects such as marking
affixed by the manufacturer.
In the following guidance, examinations, tests
and judgement performed by a NB in the
framework of declaration of conformity to type
based on product verification are simply called
“verification”.
1.4 This standard does not cover These requirements do not cover aspects on
testing laboratories, certification testing, that are specified in EN ISO 17025.
bodies or the suppliers' declaration of
conformity, the criteria for which are
contained in other European
Standards of the EN 45000 series
The following documents shall also be
considered as far as relevant:
Directive 2004/22/CE on measuring instruments
Relevant harmonised standards
Relevant normative documents
Relevant OIML RECOMMANDATIONS (testing
requirements)
Guide to the expression of uncertainty in
measurement (GUM), 1995
OIML D 14: Training of legal metrology personnel

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 All relevant WELMEC guides and in particular:
WELMEC guide 4.2 Elements for deciding the
appropriate level of confidence in regulated
measurements
WELMEC guide 8.1 Vocabulary
WELMEC guides referred to in the table provided
in the annex to this guide and in particular guide
8.0 Generalities on the assessment and
operation of notified Bodies performing
conformity assessment

2- DEFINITIONS

CHAPTERS OF
Pt n° SCOPE APPLICATION GUIDE
EN ISO/IECIEC 17020 STANDARD
2.1 Inspection Declaration of conformity to type based on
Examination of a product design, product verification (module F) is considered as
product, service, process or plant, and inspection as far as the notified body is
determination of their conformity with concerned.
specific requirements or, on the basis
of professional judgement, general
requirements.
NOTE 1 Inspection of processes includes
personnel, facilities, technology and
methodology.
NOTE 2 The results of inspection may be
used to support certification
2.2 Inspection body
Body, that performs inspection.
NOTE A body can be an organization, or A body in charge of module F is an inspection
part of an organization. body
For other definitions those given in EN
45020:1993 are applicable

3- ADMINISTRATIVE REQUIREMENTS

CHAPTERS OF
Pt n° APPLICATION GUIDE
EN ISO/IEC 17020 STANDARD
3.1 The inspection body, or the Applicable such as described
Juridical
1 structure
organization of which it forms a part,
shall be legally identifiable
3.2 An inspection body that is part of
an organization involved in functions
2 Identification Applicable such as described
other than inspection shall be
identifiable within that organization.
3.3 The inspection body shall have Declaration of conformity to type based on
documentation which describes its product verification (module F) is defined in MID.
functions and the technical scope of Any contract shall conform to MID.
Description
3 of activities
activity for which it is competent.
The precise scope of an inspection
will be determined by the terms of the
individual contract or work order.
In particular the contract or the procedure shall
Definition of clearly indicate if the verification will be based on
4 the service examinations and testing of each instrument or
application of statistical methods.
3.4 The inspection body shall have
5 Liability Refer also to § 7 of article 12 in MID.
adequate liability insurance unless its

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 liability is assumed by the State in
accordance with national laws or by
the organization of which it forms a
part
3.5 The inspection body shall have The documentation shall be conforming to the
documentation describing the scope of the designation and shall indicate in
Commercial conditions on which it does business particular the nature of the work for which the
6 conditions unless it is part of an organization and body is designated as well as the references to
provides inspection services only to his designation.
that organization.
3.6 The inspection body, or the Applicable such as described
Auditable
organization of which it forms a part,
7 accountabilit
y shall have independently audited
accounts

4- INDEPENDANCE, IMPARTIALITY AND INTEGRITY

CHAPTERS OF
Pt n° SCOPE APPLICATION GUIDE
EN ISO/IEC 17020 STANDARD
Absence of 4.1 The personnel of the inspection
commercial body shall be free from any
9
or financial commercial, financial and other
pressure
pressures which might
affect their judgement. Procedures Refer to article 12 in MID, in particular § 1, 2 and
shall be implemented to ensure that 6.
persons or organizations external to
Absence of
external the
10
pressure inspection body, cannot influence the
results of inspections carried out.

4.2 The inspection body shall be

independent to the extent that is
required with regard to the conditions
under which it performs its services. Refer to article 12 in MID, in particular § 1, 2 and
Depending on these conditions it shall 6.
meet the minimum criteria stipulated
in one of the normative annexes A, B
or C.

4.2.1 Type A inspection body

The inspection body providing “third
party” services shall meet the criteria Only Type A inspection bodies may be
of annex A (normative). designated for application of MID.
4.2.2 Type B inspection body
Independenc The inspection body which forms a
11
e separate and identifiable part of an
organization involved in the design,
manufacture, supply, installation, use
or maintenance of the items it
inspects and has been established to
supply
inspection services to its parent
organization shall meet the criteria of
annex B (normative).

4.2.3 Type C inspection body

The inspection body which is involved
in the design, manufacture, supply,
installation, use or maintenance of the
items it inspects or of similar

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 competitive items and may supply
inspection services to other parties
not being its
parent organization shall meet the
criteria of annex C (normative).

5- CONFIDENTIALITY

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
The inspection body shall ensure Refer also to § 8 of article 12 in MID.
confidentiality of information obtained
12 Confidentiality in the course of its inspection
activities.
Proprietary rights shall be protected.

6- ORGANISATION AND MANAGEMENT

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
Organisation 6.1 The inspection body shall have an
enabling to organization that enables it to
13 Applicable such as described
maintain maintain the capability to perform its
capability technical functions satisfactorily.
Description of 6.2The inspection body shall define Applicable such as described
the and document the responsibilities and
14
responsibilitie reporting structure of the organization.
s Where the inspection body also
supplies certification and/or testing
Relationships services, the relationship between its
15 between functions
functions shall be clearly defined
6.3 The inspection body shall have a The technical manager is responsible for :
technical manager however named,
- the definition and qualification of testing and
who is qualified and experienced in
verification means;
the operation of the inspection body
and who has overall responsibility that - the verification procedures and their
Designation of implementation ;
16 the technical the inspection activities are carried out
manager in accordance with this standard. He - Any other relevant technical document of the
shall be a permanent employee. notified body.
NOTE Where an inspection body consists
of several divisions with different scopes
of activity, there may be one technical
manager per division.
6.4 The inspection body shall provide
effective supervision by persons
familiar with the inspection methods Applicable such as described
17 Supervision
and procedures, the objectives of the Supervisions are recorded.
inspection and the assessment of the
examination results Supervision applies to subcontractors if any.
6.5 The inspection body shall have
named persons who will deputize in
Nomination of
18 the absence of any manager, however Applicable such as described
deputies
named, responsible for inspection
services
19 Description of 6.6 Each position category affecting Applicable such as described
positions the quality of the inspection services
shall be described. These job
20 Training and descriptions shall include the

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 experience requirements for education, training,
technical knowledge and experience

7 - QUALITY SYSTEM

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
7.1 The inspection body's The quality policy declaration shall contain
management shall define and commitment on:
document its policy and objectives for,
- Respect of this standard;
and commitment to
quality, and shall ensure that this - respect of the statutory requirements and in
Definition of
policy is understood, implemented particular:
21 the quality
policy and maintained at all levels in the - accepting only instruments that conform to
organization. the applicable requirements;
- accepting only instruments that conform to
the approved type as described in the type
examination certificate.
7.2 The inspection body shall operate
Implementing an effective quality system
22 an effective appropriate to the type, range and Applicable such as described
quality system volume of
work performed
Documented 7.3 The quality system shall be fully The quality system shall contain the necessary
23 quality system documented. There shall be a Quality
information for each category of instruments for
Manual, which shall contain the which the body is designated.
24 Quality information required by this standard
manual
and as listed in annex D (informative)
25 Content of the
quality manual
26 Designation 7.4The management of the inspection
of a body shall designate a person who,
responsible irrespective of other duties, shall have
person for defined authority and responsibility for Applicable such as described
quality
assurance quality assurance within the
inspection body. This person shall
27 have direct
access to top management

Maintaining 7.5 The quality system shall be

27 the quality maintained relevant and current under Applicable such as described
system the responsibility of the same person
7.6 The inspection body shall maintain The system of control shall include information of
a system for control of all the notifying authority.
documentation relating to its activities.
It shall
ensure that:
a) the current issues of the
appropriate documentation are
Maintaining available at all relevant locations and
the to all relevant
28 documentatio staff;
n b) all changes of documents or
amendments to documents are
covered by the correct authorization
and
processed in a manner which will
ensure timely availability at the
appropriate location;
c) superseded documents are

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 removed from use throughout the
organization, but one copy is filed for
a determined period;
d) other parties, as necessary, are
notified of changes.
7.7 The inspection body shall carry The maximum periodicity for internal audits is
out a system of planned and one year. In the case of teams operating
documented internal quality audits to independently (for instance from different
verify geographical locations) each team shall be
compliance with the criteria of this audited at least every two years.
standard and the effectiveness of the
29 Internal audits All applicable statutory provisions and this
quality system. The personnel
performing guidance shall be in the scope of the internal
the audits shall be suitably qualified audits.
and independent from the functions
being audited.

7.8 The inspection body shall have It shall be foreseen that:

documented procedures for dealing
- corrective actions are documented and
with feedback and corrective action
placed at the disposal for the national
whenever discrepancies are detected
Authority,
in the quality system and/or in the
- circumstances necessitating report to the
Feedback and performance of inspections
notifying Authority are defined,
30 corrective
actions - the notifying Authority is informed as quickly
as possible of any discrepancy which has
affected the conformity of measuring
instruments, with reference to articles 19 and
20 of MID.

7.9 The management of the The maximum periodicity for these reviews is one
inspection body shall review the year.
Quality quality system at appropriate intervals
31 system to ensure its All applicable statutory provisions shall be the
reviews continuing suitability and object of the reviews.
effectiveness. The results of such
reviews shall be recorded

8- PERSONNEL

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
32 Personnel 8.1 The inspection body shall have a
available sufficient number of permanent
personnel with the range of expertise
to carry
out its normal functions.

33 Qualification 8.2 The staff responsible for Refer to article 12 in MID, in particular § 3, 4 and
of the inspection shall have appropriate 5.
personnel qualifications, training, experience and
a satisfactory
knowledge of the requirements of the
inspections to be carried out. They
shall have the ability to make
34 Ability to professional
judgement judgements as to conformity with
general requirements using
examination results and to report
there on.

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 They shall also have relevant
35 knowledge of the technology used for
Technological the manufacturing of the products
knowledge of inspected, of
the personnel
the way in which products or
processes submitted to their
inspections are used or are intended
to be used, and of
36 the defects which may occur during
Understanding use or in service.
the They shall understand the significance
significance of of deviations found with regard to the
deviations normal use of the products or
processes concerned.
37 Up-to-date 8.3 The inspection body shall Refer to article 12 in MID, in particular § 5.
training establish a documented training
system to ensure that the training of
its personnel,
in the technical and administrative
aspects of the work in which they will In addition, all the personnel of the body likely to
be involved, is kept up-to-date in have contacts with the national Authority
Adapted accordance with its policy. (reception, telephone…) shall be aware of the
38 training The training required shall depend verification activities and of the names of the
upon the ability, qualifications and responsible persons.
experience of persons involved. The
inspection body shall establish the
necessary stages of training for each
of its personnel. These may include:
a) an induction period;
b) a supervised working period with
experienced inspectors;
c) continuation training, throughout
employment, to keep pace
with developing technology
39 Recording of 8.4 Records of academic or other
qualifications qualifications, training and experience
of each member of its personnel shall Applicable such as described
be
maintained by the inspection body
40 Conducting 8.5 The inspection body shall provide
the staff Applicable such as described
guidance for the conduct of its staff
41 Remuneration 8.6 The remuneration of persons Refer also to § 6 of article 12 in MID.
of the engaged in inspection activities shall
personnel not directly depend on the number of
inspections carried out and in no case
on the results of such inspections

9- FACILITIES AND EQUIPMENTS

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
9.11 The inspection body shall have Refer also to § 4 of article 12 in MID.
available to it suitable and adequate
facilities and equipment to permit all If the notified body uses manufacturer’s facilities
Necessary activities associated with the and equipments , this shall be documented and
42 facilities and inspection services to be carried out. recorded in the contract as defined in § 3.3 of EN
equipments IS/IEC 17020. In this case, it remains the
responsibility of the notified body to ensure that
test means are suitable and traceable to
standards.

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43 Rules for 9.2 The inspection body shall have
access to and clear rules for the access to and the
use of use of specified facilities and Applicable such as described
facilities and equipment
equipments
9.3 The inspection body shall ensure The verification is carried out in suitable locations
the continued suitability of the facilities and conditions as MID does not provide
and the equipment mentioned in 9.1 information on this. As far as available or
for their intended use relevant, the NB shall apply the applicable
provisions in the most suitable standards or
WELMEC guides or normative documents or
OIML recommendations and documents. In any
case the verification will be performed in a
location and conditions ensuring that the MI in
Continued use will meet the applicable requirements were
suitability of properly installed.
44 facilities and
equipments The notified body shall ensure that all
environmental conditions applicable to the
instrument are adapted, especially regarding the
statutory regulations, and if applicable, regarding
the type examination certificate. This applies
whether the verification is carried out on the
location of installation of the instrument or not.
If the environmental conditions are not suitable,
in particular when the MI is tested on site, the
body shall refuse to carry out the verification.
9.4 All such equipment shall be The identification shall be comprehensive, clear,
Identification properly identified
45 of equipments
without ambiguity and shall be recorded (See
also § 9.15 of EN IS/IEC 17020)
9.5 The inspection body shall ensure
Maintaining that all such equipment is properly
46 equipments maintained, in accordance with Applicable such as described
procedures documented procedures and
instructions
9.6 The inspection body shall ensure Requirements concerning traceability should be
that, where appropriate, equipment is in line with standard ISO 17025 and/or ISO
calibrated before being put into 10012, and especially :
service
- the testing facilities shall be initially
and thereafter according to an
qualified,
established programme.
- the testing facilities shall be comprehensively
identified.
- the testing facilities shall (in all the cases) be
calibrated or verified before being put into
Calibration service or back into service.
47 program
- the frequency of verification and/or
calibration of the testing facilities shall
conform to applicable standards or WELMEC
guides.
- the testing facilities shall clearly carry the limit
of validity of the previous verification and/or
calibration.
- the responsibilities of the metrological
management person (as defined in the ISO
10012) shall be clearly defined and ensured.
9.7The overall programme of The test facilities used for verification shall be
Traceability of calibration of equipment shall be identified distinguishing those that are critical for
48 the working designed and operated so as to the conformity of MIs (in particular those used for
standards ensure that calibration of the intended measurand).
wherever applicable measurements

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 made by the inspection body are The test facilities that are critical for the
traceable to national and International conformity shall be traceable to standards
Standards of measurement where according to ILAC-P 10:2002 “ILAC Policy on
available. Where traceability to Traceability of Measurement Results”.
national or International Standards
measurement is not applicable, the
inspection body shall provide Those that are not critical (for instance a
satisfactory evidence of correlation or chronometer used to determine the duration of a
accuracy of test) may be qualified and verified according to
inspection results internal rules ensuring appropriate results. This
shall be recorded.
In all the cases the calibration uncertainties shall
be compatible with the applicable metrological
requirements ( WELMEC guide 4.2, Elements for
deciding the appropriate level of confidence in
regulated measurements, may be considered).
49 Use of 9.8 Reference standards of The list of standards shall allow clear
reference measurement held by the inspection identification of reference and working standards.
standards body shall be used for calibration only
and for no other purpose. Reference
50 Traceability of
standards of measurement shall be Guidance on § 9.7 of EN ISO/IEC 17020 is
reference calibrated by a competent body that applicable
standards can provide
traceability to a national or
International Standard of
measurement.
In-service 9.9 Where relevant, equipment shall Applicable such as described
checks be subjected to in-service checks
51 between between regular recalibrations
recalibrations
9.10 Reference materials shall where
Traceability of
possible be traceable to national or
52 reference Applicable such as described when applicable
materials International Standard reference
materials
9.11 Where relevant to the quality of This applies in particular to purchasing of
inspection services, the inspection metrological equipment, as well as testing,
body shall have procedures for: calibration and verification of this equipment.
a) selection of qualified suppliers;
Purchasing b) issuing appropriate purchasing
53 procedures documents;
c) inspection of received materials;
d) ensuring appropriate storage
facilities.
9.12 Where applicable the condition of
Assessment
stored items shall be assessed at
54 of stored Applicable such as described
items appropriate intervals to detect
deterioration
9.13 If the inspection body uses Applicable to testing equipment as well as to
computers or automated equipment in technical procedures
connection with inspections, it shall
ensure
that: The provisions shall ensure in any case that the
a) computer software is tested in previous data will be still available during the
Hardware and
order to confirm that it is adequate for period of validity of the calibration or verification
55 software
equipment use; of the test facilities and/or the period defined in §
b) procedures are established and 12.3 of EN ISO/IEC 17020, even if the hardware
implemented for protecting the or the operating system has been replaced.
integrity of data;
c) computer and automated If the documents are computerised, the specific
equipment is maintained in order to and critical software shall be initially, then
ensure proper functioning; and periodically qualified under the body’s

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 responsibility. When a specific application in
d) procedures are established and made from a general commercial software (e.g.
implemented for maintenance of Excel), this applies only to the specific application
security of data. of the general commercial software.

9.14The inspection body shall have Applicable such as described

documented procedures for dealing
Procedures with defective equipment. Defective
for dealing equipment shall be removed from NOTE: the mentioned equipment is the one
56 with defective service by segregation, prominent used by the body and not the instruments to be
equipment labelling or marking. The inspection verified.
body shall examine the effect of
defects on previous inspections
9.15 Relevant information on the
Recording equipment shall be recorded. This will Applicable such as described
57 relevant normally include identification,
information calibration Apply standards when available
and maintenance

10 - INSPECTION METHODS AND PROCEDURES

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
10.1 The inspection body shall use The verification methods and procedures shall be
the methods and procedures for described with an appropriate level of details and
inspection which are defined in the shall conform to most suitable standards or
requirements, against which WELMEC guides or normative documents or
conformity is to be determined OIML recommendations and documents where
available.
They shall contain information on:
Defined - examinations and tests to be performed on
58 methods and the instruments,
procedures
- conditions in which the identification mark of
the NB is affixed,
- conditions in which the authorisation of
affixing marking during the manufacturing
process is delivered,
- conditions in which a verification report and a
certificate of conformity are established (see
§ 13.1 of EN ISO/IEC 17020 for more detail).
10.2 The inspection body shall have
and use adequate documented
instructions on inspection planning
and on
standard sampling and inspection
techniques, where the absence of
Adequate such instructions could jeopardize the
inspection efficiency of the inspection process.
59 planning Where applicable, this requires
documents sufficient knowledge of statistical In the case of verifications based on statistical
techniques to methods it shall be established that the criteria
ensure statistically sound sampling laid down in the point 5.3 of Annex F of MID are
procedures and the correct met.
processing and interpretation of
results.

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 10.33 When the inspection body has There shall be a procedure how to deal with
to use inspection methods or cases where the standard procedures cannot be
procedures which are non-standard, used.
such
methods and procedures shall be
appropriate and fully documented Deviation from standard procedures shall be
described in the verification report.
The reasons for these procedures shall be
justified, as well as their relevance and the
Non-standard
estimation of the measurement uncertainties.
60 methods or
procedures Depending on the level of flexibility accepted by
the notifying authority, information of this
authority about the new procedures developed
shall be made in advance or the information shall
be available afterwards
Non-standard procedures for permanent
application are to be reported to the national
authority.

10.4 All instructions, standards or

written procedures, worksheets, check
Availability of lists and reference data relevant to the
61 Applicable such as described
documents work of the inspection body shall be
maintained up-to-date and be readily
available to the staff.
10.5 The inspection body shall have a Applicable such as described
contract or work order control system
which ensures that:
a) work to be undertaken is within its
expertise and that the organization
has adequate resources to meet the
requirements;
b) the requirements of those seeking
the inspection body's services are
adequately defined and that special
conditions are understood so that
Contract unambiguous instructions can be
62 control issued to staff performing the duties to
system
be
required;
c) work being undertaken is controlled
by regular review and corrective
action;
d) completed work is reviewed to
confirm that requirements have been
met.

10.6 Observations and/or data The recording procedures shall apply to each
obtained in the course of inspections verified instrument (or group of instruments as
shall be recorded in a timely manner foreseen in MID).
to
prevent loss of relevant information. They shall allow to determine retrospectively, for
On time
63 recording
each instrument (or group):
- its identification (including the reference to
the type examination certificate)
- the examinations and tests performed,
- the results and conclusions of these

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 examinations and tests,
- where applicable, conditions in which an
evaluation of parts have been taken into
consideration,
- where applicable, conditions in which
examinations and/or tests have been
performed by an other body.
Calculations 10.7 All calculations and data
64 and transfer of transfers shall be subject to Applicable such as described
data appropriate checks
10.8 The inspection body shall have
Safety documented instructions for carrying
65 instructions
Applicable such as described
out inspection safely.

11 - HANDLING INSPECTION SAMPLES AND ITEMS

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
11.1 The inspection body shall ensure Applicable such as described
that samples and items to be
Identification
inspected are uniquely identified to
66 of inspected
items avoid
confusion regarding the identity of
such items at any time.
67 Recording of 11.2 Any apparent abnormalities Applicable such as described
apparent notified to, or noticed by, the inspector
abnormalities shall be recorded before
commencement
Consulting the
of the inspection. Where there is any
68 client in case doubt as to the item’s suitability for the
of doubt inspection to be carried out, or where
the item does not conform to the
description provided, the inspection
body shall consult the client before
proceeding.

11.3 The inspection body shall In particular, conditions in which an evaluation of

establish whether the item has parts performed by an other body is taken into
received all necessary preparation, or consideration shall be documented.
Necessary
69 preparation
whether the
client requires preparation to be
undertaken or arranged by the
inspection body.
11.4 The inspection body shall have Applicable such as described
documented procedures and
appropriate facilities to avoid
Avoiding
70 deterioration
deterioration or
damage to inspection items while
under its responsibility.

12 - RECORDS

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
12.1 The inspection body shall
Record
71 maintain a record system to suit its Applicable such as described
system
particular circumstances and to

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 comply with
applicable regulations.

12.2 The records shall include The recordings include the results of the
sufficient information to permit examination and testing of the instruments but
satisfactory evaluation of the also on the conclusion on the conformity of the
inspection instrument to the type examination certificate.
If applicable, the body shall keep a record of the
authorisations he gives to manufacturers
Recordings concerning apposition of his identification number
72 content on the instruments and on the possibility to apply
marking during the process of manufacturing.
The NB should keep records for statistical data
(for instance, number of verified instruments,
refusal rate, average error and variance of these
errors) in order to be capable to cooperate with
the national Authority.
73 Records 12.3 All records shall be safely stored
storage All ercords shall be kept at the disposal of the
for a specified period, held secure and
national Authority for a duration identical to the
in confidence to the client, unless
one applicable to the certificate of conformity (at
otherwise required by law.
least ten years).

13 - INSPECTION REPORTS AND INSPECTION CERTIFICATES

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
13.1 The work carried out by the A distinction is made between :
inspection body shall be covered by a
retrievable inspection report and/or - the document recording the results of
inspection certificate examinations and tests performed in the course
of verifications, let at the disposal of the national
Authority for surveillance purposes, and called in
this guide the « verification report », and
- the certificate of conformity in respect of the
examinations and tests carried out by the NB,
delivered to the manufacturer (see 4.2 of Annex
Report and F in MID), and called in this guide the « certificate
74 certificate of conformity ».
The verification report and the certificate of
conformity are two different documents in the
sense of this guide, even if they may use
common elements.
However this does not prevent having one
combined document bearing all the information
and with one copy delivered to the manufacturer
and another one kept by the NB at the disposal of
the National Authority
13.2 The inspection report and/or The verification report and the certificate of
inspection certificate shall include all conformity shall conform to provisions in annex
the results of examinations and the A.
determination of conformity made
Content of the
from these results as well as all
75 report or
certificate information needed to understand and The verification reports shall be kept at the
interpret disposal of the national Authority for at least ten
them. All this information shall be years
reported correctly, accurately, and
clearly. Where the inspection report or The copy of the certificates of conformity shall be

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 inspection certificate contains kept at the disposal of the national Authority for at
results supplied by subcontractors, least ten years (4.2 and 5.4 of Annex F in MID).
these results shall be clearly
identified.
13.3 Inspection reports and inspection Applicable such as described
Approval and certificates shall be signed or
signature of otherwise approved by authorized
76 reports and staff
certificates members only.

13.4 Corrections or additions to an

Correction inspection report or inspection Amended certificates are uniquely identified and
and additions certificate after issue shall be include a statement referring to the original
77 to reports and certificate (serial number).
recorded and
certificates justified in accordance with the
relevant requirements of this section.

14 - SUBCONTRACTING

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
14.1 The inspection body shall itself The NB may delegate only part of examinations
normally perform the inspections and tests for which he has established clear
which it contracts to undertake procedures and formats of reports, and which do
not result in delegating his capacity of judgement
even partially.
General policy Conditions in which this delegation is possible
for shall be clearly established.
78 subcontractin
g In any case the NB shall have the competence to
perform himself the subcontracted activities (see
point 4 of article 12 in MID). If parts of the
procedures established by the NB are based on
procedures established by a subcontractor, these
parts shall be the object of a careful review by the
NB prior he may accept them.
Competence 14.2 When an inspection body
79 of subcontracts any part of the
subcontractor inspection, it shall ensure and be able See article 12 points 3 and 4 of MID
s to demonstrate
80 that its subcontractor is competent to
Acceptance of perform the service in question and
subcontractin where applicable complies with the
g by the client criteria
stipulated in the relevant standard of
the EN 45000 series. The inspection
body shall advise the client of its
intention
to subcontract any part of the
inspection. The subcontractor shall be
acceptable to the client.

14.3 The inspection body shall record

and retain details of its investigation of
Recording all
the competence and compliance of
81 subcontractin Applicable such as described
g its subcontractors. The inspection
body shall maintain a register of all
subcontracting.
14.4 Where the inspection body Applicable such as described
Assessment subcontracts certain specialized
82 of activities, it shall have access to a

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 subcontractor qualified and See also 14.1 of EN ISO/IEC 17020
s experienced person who is able to
form an independent assessment of
the results of these subcontracted
activities.
The responsibility for the
determination of conformity with the
requirements rests with the inspection
body itself.

15 - COMPLAINTS AND APPEALS

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
15.1 The inspection body shall have This procedure shall be part of the designation
documented procedures for dealing request. Its existence shall be mentioned in the
Procedure for with complaints received from clients contract specified in § 3.3 of EN ISO/IEC 17020.
83 dealing with or
complaints other parties about the inspection This procedure concerns also the demands,
body's activities warnings or complaints issued by the Authorities
from other member States.
15.2The inspection body shall have
documented procedures for the
consideration and resolution of
Procedure for
84 appeals appeals Applicable such as described
against the results of its inspections,
where these are carried out under
legally delegated authority
15.3 A record shall be maintained of
Records of
all complaints and appeals and of the
85 complaints Applicable such as described
and appeals actions taken by the inspection body.

16 - COOPERATION

Pt CHAPTERS OF
SCOPE APPLICATION GUIDE
n° EN ISO/IEC 17020 STANDARD
The inspection body is expected to The body shall have implemented provisions in
participate in an exchange of order to recall with appropriate efficiency the
experience with other inspection obligations made to manufacturers in application
bodies and in the of module F.
Standardization processes as
Co-operation appropriate
86 and Co-operation with the national Authority shall be
exchanges
provided for purposes of surveillance and audits
of the body. This includes means and information
necessary for the statutory surveillance.
If applicable co-operation shall be also provided
to accreditation bodies.

The NB shall commit himself in participating into

intercomparisons organised at the European
technical level.
87 co-operation

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 ANNEX A
Content of the verification report
A verification report (whether it is established on a paper sheet or an electronic file) shall
bear at least the following information:
- title « Verification report » in respect of the examinations and tests carried out »
- specific identification of the report
- name and address of the notified body
- name and address of the manufacturer
- address of the verification location (if different)
- date of the verification and if relevant issue date
- identification of the instrument(s) subject to verification
- reference to the type examination certificate
- main statutory identification elements of the instrument
- any other useful information on the verification (verification of every instrument or
statistical verification…)
- reference to the verification procedure
- any other useful information on the test conditions (method ,conditions, means…)
together with either uncertainties of measurements or reference to documents
establishing these uncertainties
- detailed results of the examinations ant tests performed
- conclusion versus conformity to the type examination certificate
- conclusion versus conformity to essential requirements
- clear identification of the person who has performed the verification and (when
applicable) identification and signature of the authorized person to issue the document

The document shall be paginated (number of the page/total number of pages) and shall
bear on each page an unambiguous identification of the report .

Content of the certificate of conformity

A certificate of conformity shall bear at least the following information:
- title « certificate of conformity in respect of the examinations and tests carried out »
- specific identification of the certificate
- name and address of the notified body
- name and address of the manufacturer
- address of the verification location (if different)
- date of the verification and if relevant issue date
- identification of the instrument(s) subject to verification including identification of main
elements
- reference to the type examination certificate
- list of examination and tests performed, reference to the verification procedure,
identification of the batch if statistical verification, reference of the associated test
report
- conclusion versus conformity to the type examination certificate
- conclusion versus conformity to appropriate essential requirements
- identification and signature of the authorized person to issue the document and
optionally identification of the person who has performed the verification

The document shall be paginated (number of the page/total number of pages) and shall
bear on each page an unambiguous identification of certificate.

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 ANNEX B

Overview of documents useful for the application of MID

(This document is indicated as white in between shaded areas)

Specific guide for Specific guide QS of Specific guide for

General guide QS of NB for manufacturer
assessment of QS of
according to application of according to
bodies manufacturers
the module

A No NB Not applicable No Not applicable Not applicable

EN ISO/IEC 17020
A1 ? ? Not applicable Not applicable
or EN 45011 *
Assessment of
notified bodies in Application of
B EN 45011 ** Not applicable Not applicable
charge of type module B
examination **

C No NB Not applicable No Not applicable Not applicable

EN ISO/IEC 17020
C1 ? ? Not applicable Not applicable
or EN 45011 *
Presumption of
EN ISO 9001 +
Application of conformity of the
D ISO/IEC 17021 No EN ISO/IEC
module D quality system of
17025 for tests
manufacturers
Generalities EN ISO 9001+
D1 on the ISO/IEC 17021 No ? EN ISO/IEC ?
assessment 17025 for tests
and operation
of notified EN ISO 9001+
E bodies ISO/IEC 17021 No ? EN ISO/IEC ?
performing 17025 for tests
conformity EN ISO 9001+
E1 assessment ** ISO/IEC 17021 No ? EN ISO/IEC ?
17025 for tests
Assessment of
EN ISO/IEC 17020 notified bodies in
F ? Not applicable Not applicable
or EN 45011 * charge of module
F
EN ISO/IEC 17020
F1 ? ? Not applicable Not applicable
or EN 45011 *
EN 45011 or
G ? ? Not applicable Not applicable
EN ISO/IEC 17020 *
EN ISO 9001+
H ISO/IEC 17021 No ? EN ISO/IEC ?
17025 for tests
Presumption of
DEC: EN 45011 ? EN ISO 9001+
Application of conformity of the
H1 EN ISO/IEC
module H1 quality system of
QS: ISO/IEC 17021 No 17025 for tests
manufacturers
* The following can be said concerning the alternative for A1, C1, F, F1 and G. In general the choice of one of these two standards is
depending on whether the NB practices most of its activities on design certification of products (EN 45011) or product verification (EN ISO/IEC
17020 ; only type A inspection bodies). But in practice a specific consideration should be paid on the complexity of the instrument’s category: in
the case where the study of the design is complex for application of module G, preference should be given to EN 45011.
** See foreword of Guide 8.0
For testing refer to 3.3 of Guide 8.0
A question mark indicates that until now no need was identified or no decision was taken.

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