Quality System Checklist RP-2

UL’s ISO 9000 Registration Program –
ISO 9001:2000
Quality System Checklist
RP-2
Accredited by
RP-2:2000 Issued: 11/27/00 Revised: 3/12/01 Raad voor
Accreditatie
Table of Contents
Section Page
Introduction ................................................................................................... 2
Assessment Summary Sheet - Sample .............................................................. 4
Assessment Summary Sheet............................................................................ 5
Quality System Requirements

Quality Management Systems……………………………….……….…………..6
Management Responsibility ....................................................................... ….8
Resource Management.................................................................................. 11
Product Realization....................................................................................... 13
Measurement, Analysis and Improvement ...................................................... 23
RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

The Quality System Checklist is intended to help organize and streamline
your effort in determining compliance with the ISO 9001:2000 standard.
You can gain a better understanding of ISO 9001:2000 standard as it

applies to your company by reviewing these questions. You may wish to
discuss them with your colleagues to enhance everyone’s understanding of
the ISO 9001:2000 requirements and the assessment process.
You should be aware that although the following questions include all the
requirements of the ISO 9001:2000 standard, they do not necessarily cover
all aspects of the Standard. So, the use of this checklist will give you only a
sample of your organization’s compliance to the ISO 9001:2000 standard.

Assessment Summary Sheet
The Assessment Summary Sheet may be used for visualizing the big picture: what areas
were checked and where discrepancies were found. You’ll see from the sample
Assessment Summary Sheet that assessment of the Purchasing Department uncovered
discrepancies for clauses 4.1, 4.2, 5.5 and 7.4. This may be a sign of problems in that
department or its processes, which warrant planning and close monitoring of corrective
actions. The Areas/Functions Assessed column reveals that for clause 4.2 Documentation
Requirements, discrepancies were uncovered in all applicable areas. This may give
evidence of a system breakdown.
On the sample Assessment Summary Sheet, the circled numbers correspond to the
following:
• The ISO 9001:2000 Assessment Standard correspond to the ISO:9001:2000

International Standard which your company has selected for assessment.
‚ The column Areas/Function Assessed lists the areas (i.e. process functions,
departments, sections, offices, etc.) where compliance to given clauses will be evaluated.
ƒ These columns contain the list of clauses for the applicable ISO Standard to which
compliance is being sought. NOTE: All clauses of the ISO 9001 Standard must be
addressed. See section 1.2. “Application”, for further information.
„ Use this grid to indicate where discrepancies are found by entering a “D” into the
corresponding boxes. Where no discrepancies are uncovered, enter an “X” in the
appropriate boxes.

Assessment Summary Sheet - SAMPLE
Areas/ Functions Assessed* ‚

ISO 9001:2000
•
Quality Management
Management
Stock & Ship

Purchasing
Production
Planning
Systems: Discrepancy
Design
Sales
Test
Requirements
Reference
Number
Clause Clause
Number Description ƒ
4.1 Quality management system X X X X D X X X X
4.2 Documentation requirements D D D D D D D D D
5.1 Management commitment X
5.2 Customer focus X
5.3 Quality policy X
5.4 Planning X
5.5 Responsibility, authority and X X X X D X X X X

communication
5.6 Management Review X
Provision of resource X
6.1
6.2 Human resources D X
„
6.3 Infrastructure X
6.4 Work environment X
Planning of product realization X

7.1
7.2 Customer-related processes X
7.3 Design and development X
7.4 Purchasing D
Production and service provision X X X

7.5
7.6 Control of monitoring and measuring X X
devices
8.1 Measurement, analysis and X

improvement
8.2 Monitoring and measurement X X
8.3 Control of nonconforming product X X D
8.4 Analysis of data X
8.5 Improvement X
* Use an “X” to indicate that the clause was assessed in the area described. Use a “D” to indicate
that a discrepancy was found.

Assessment Summary Sheet
Areas / Functions Assessed
ISO 9001:2000
Quality Management
Systems: Discrepancy
Requirements
Reference
Number
Clause Clause
Number Description
4.1 Quality management system
4.2 Documentation requirements
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and

communication
5.6 Management Review
Provision of resource
6.1
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
Product realization
7.1
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
Production and service provision

7.5
7.6 Control of monitoring and measuring
devices
8.1 Measurement, analysis and

improvement
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement

QUALITY SYSTEM CHECKLIST
Quality System Requirements Document Explanatory Notes and
ISO 9001:2000 References Comments
Quality Management System

4.0
General Requirements
4.1.
Has a quality management system been
4.1 established, documented, maintained and
Continually improved in accordance with the
requirements ISO 9001:2000 ?
How will it be demonstrated that the following
4.1. activities have been accomplished in
accordance with the requirements of ISO
9001:2000 ?
• Processes needed for the quality management
system and their application identified?
• Sequence and interaction of quality
management system processes determined?
• Criteria and methods needed to ensure the
effective operation and control of quality
management system processes determined?
• Information and resources made available to
support the operation and monitoring of quality
management processes?
• Measuring, monitoring and analysis of quality
management system process implemented?
• Has action necessary to achieve planned results
and continual improvement of the quality
management system been implemented?
Is evidence available confirming that all
4.1 outsourced processes affecting product
conformance with requirements have been
identified and controlled within the quality
management system?
4.2 Documentation requirements
Does the quality management system
4.2.1 documentation include:
• Documented quality policy and objectives?
• A quality manual?
• Documented procedures required by ISO
9001:2000 ?
• Documents needed to ensure effective
planning, operation and control of
processes?
• Quality records required by ISO
9001:2000 ? (see 4.2.4)

4.2.2 Quality Manual

4.2.2 Has a quality manual been established and
maintained that includes the following?
• The scope of the quality management
system, including details of, and justification
for, any exclusions? ( see Clause 1.2,
“Application”of ISO 9001:2000 )
• Documented procedures for the quality
management system or reference to them?
• A description of the interaction between
the processes of the quality management
system?
Control of Documents
4.2.3
Have all documents required for the quality
4.2.3 management system been placed under
control?
Are records controlled in accordance with the
4.2.3 requirements of 4.2.4?
4.2.3 Is there a documented procedure for control of
documents, which addresses all requirements of
4.2.3?
4.2.3 Are documents approved for adequacy prior to
use?
4.2.3 Are documents reviewed, updated and
reapproved as necessary?
4.2.3 Are changes and the current revision status of
documents identified?
4.2.3 Are the relevant versions of applicable
documents available at points of use?
4.2.3 Are the documents legible and readily
identifiable?
4.2.3 Are documents of external origin identified and
their distribution controlled?
Are controls in place to prevent the unintended
4.2.3 use of obsolete documents, and to apply
suitable identification to them if they are
retained for any purpose?

Control of quality records

4.2.4
Do quality records provide evidence of
4.2.4 conformance to requirements and the effective
operation of the quality management system?
Has a documented procedure been established
4.2.4 for the identification, storage, retrieval,
protection, retention time and disposition of
quality records?
4.2.4 Are quality records legible, readily identifiable
and retrievable?
Management Responsibility
5.0
Management commitment
5.1
Can top management demonstrate evidence of
5.1 commitment to the development,
implementation and improvement of the
effectiveness of the quality management
system by:
• Communicating to the organization the
importance of meeting customer
requirements?
• Establishing the quality policy?
• Ensuring that quality objectives are
established?
• Conducting management reviews?
• Ensuring the availability of resources?
Customer focus
5.2
5.2 How does top management ensure that
customer requirements are determined and
fulfilled with the aim of enhancing customer
satisfaction?
5.3 Quality Policy
5.3 Is top management able to demonstrate how
they ensure that the quality policy is:
• Appropriate to the organization?
• Includes a commitment to comply with
requirements and continually improve the
system?
• Provides a framework for establishing and
reviewing quality objectives?
• Is communicated and understood
throughout the organization?
• Is reviewed for continuing suitability?

Planning
5.4.
5.4.1 Quality objectives
5.4.1 Is top management able to demonstrate how
they ensure that quality objectives, including
those needed to meet requirements for product
(see 7.1) are established at relevant functions
and levels within the organization?
Are the quality objectives measurable and
5.4.1 consistent with the quality policy?
Quality management system planning
5.4.2
Is top management able to demonstrate how

5.4.2 they ensure:
• Quality management system planning is
carried out in order to meet the requirements
given in 4.1 and the quality objectives?
• The integrity of the quality management
system is maintained when changes to the
quality management system are planned and
implemented?
Responsibility, authority and communication
5.5
Responsibility and authority

5.5.1

they ensure that the responsibilities, authorities
and their interrelation are defined and
communicated within the organization?

Management Representative
5.5.2
Has top management appointed one or more
5.5.2 members of management to serve as the
management representative?
Does the management representative’s
5.5.2 authority and responsibility, irrespective of
other responsibilities include:
• Ensuring that processes for the quality
management system are established,
implemented and maintained?
• Reporting to top management the
performance of the quality management
system including needs for improvement?
• Promoting awareness of customer
requirements throughout the organization?
5.5.3 Internal Communication
they ensure that appropriate communication
processes are established within the
organization, and that communication takes
place regarding the effectiveness of the quality
management system?
Management Review
5.6
General
5.6.1
5.6.1 Does top management review the quality
management system at planned intervals to
ensure its continuing suitability, adequacy and
effectiveness?
5.6.1 Does management review evaluate the need for
changes to the quality management system,
including the quality policy and quality
objectives?
Are the results of management review
5.6.1 recorded? (see 4.2.4)

ISO 9001:2000 Quality System Requirements Document Explanatory Notes and
References Comments
5.6.2 Review Input
Do the inputs to management review include
5.6.2 information on the following:
• Results of audits?
• Customer feedback?
• Process performance and product
conformance?
• Status of preventative and corrective
actions?
• Follow-up actions from earlier
management reviews?
• Planned changes that could affect the
quality management system?
• Recommendations for improvement?
Review Output
5.6.3
Do the outputs from management review
5.6.3 include decisions and actions related to:
• Improvement of the effectiveness of the
quality management system and its
processes?
• Improvement of product related to
customer requirements?
• Resource needs?
6.0 Resource Management
6.1 Provision of resources
6.1 How will it be demonstrated that the
organization determines and provides the
resources needed to:
• Implement, and maintain and continually
improve the quality management system?
• Enhance customer satisfaction by meeting
requirements?
6.2 Human resources
6.2.1 General
6.2.1 Is evidence available that personnel performing

work affecting product quality are competent
on the basis of appropriate education, training,
skills and experience?

6.2.2 Competence, awareness and training
6.2.2 Has the necessary competence for personnel

performing work affecting product quality been
determined?
• Appropriate records of education, training,
skills and experience are maintained?
6.2.2 Has Training been provided or other actions

taken to satisfy competency needs?
6.2.2 Is the Training provided or other actions taken

evaluated for effectiveness in meeting the
competency needs?
6.2.2 Are Personnel aware of the relevance and
importance of their activities and how they
contribute to the achievement of the quality
objectives?
6.2.2 Are appropriate records of education, training,

skills and experience maintained? (See 4.2.4)
6.3 Infrastructure
How will it be demonstrated that the

6.3 organization determines, provides and
maintains the infrastructure needed to achieve
conformity to product requirements?
Does infrastructure include, as applicable:
6.3 • Buildings, workspace and associated
utilities?
• Process equipment including hardware and
software?
• Supporting services such as transport or
communication?

Work Environment
6.4
How will it be demonstrated that the
6.4. organization determines and manages the work
environment needed to achieve conformity to
product requirements?
Product Realization
7.0
Planning of product realization
7.1
How will it be demonstrated that:
7.1 • Processes needed for product realization
are planned and developed?
• Planning of product realization is
consistent with the requirements of other
processes of the quality management
system? (see 4.1)
Is the following determined, as appropriate,

7.1 during product realization planning?
• Quality objectives and requirements for the
product?
• The need to establish verification,
validation, monitoring, inspection and test
activities specific to the product and criteria
for product acceptance?
• Records needed to provide evidence that
realization processes and resulting product
fulfill requirements (see 4.2.4)
7.2 Customer related processes
7.2.1 Determination of requirements related to the
product
7.2.1 How will it be demonstrated that the following
is determined:
• Requirements specified by the customer,
including requirements for delivery and
post-delivery activities?
• Requirements not stated by the customer
but necessary for specified use or known and
intended use?
• Statutory and regulatory requirements
related to the product
• Any additional requirements determined
by the organization?

Review of requirements related to the

7.2.2 product
7.2.2. Are Requirements related to the product

reviewed prior to the commitment to supply a
product to the customer?
Does the review activity ensure:
7.2.2 • Product requirements are defined?
• Contract or order requirements differing
from those previously expressed are
resolved?
• The organization’s ability to meet defined
requirements?
Are records of the results of review and actions
7.2.2 arising from review activity maintained? (see
4.2.4)
How will it be demonstrated that
7.2.2 the organization confirms customer
requirements when no documented statement
of requirement is provided by the customer?
7.2.2 Is evidence available that relevant documents

are amended and relevant personnel made
aware of any changed product requirements?
7.2.3 Customer communication
7.2.3 Do effective arrangements exist for customer

communication related to:
• Product information?
• Inquiries, contracts, order handling and
amendments?
• Customer feedback and customer
complaints?

Design and development

7.3
Design and development planning

7.3.1.
7.3.1 Is evidence available that the organization

plans and controls the design and development
of product?
7.3.1 Is the following determined during design and
development planning?
• The design and development stages?
• The review, verification and validation that
are appropriate to each design and
development stage?
• The responsibilities and authorities for
design and development?
7.3.1 Are the interfaces between different groups

involved in design and development managed
to ensure effective communication and clear
assignment of responsibility?
Are planning outputs updated, as appropriate,
7.3.1 as the design and development progresses?
7.3.2 Design and development inputs
7.3.2 Are inputs relating to product requirements

determined and records maintained (see 4.2.4)
relating to:
• Functional and performance requirements?
• Applicable statutory and regulatory
requirements?
Applicable information from previous
similar designs?
• Other requirements essential for design
and development?

7.3.2 Design and development inputs
7.3.2 What evidence is available to indicate:

• Design and development inputs are
reviewed for adequacy?
• Requirements are complete, unambiguous
and not in conflict with each other?
Design and development outputs
7.3.3
Are the outputs of design and development:

7.3.3 • In a form that enables verification against
the design and development inputs?
• Approved prior to release?
Do the design and development outputs:
7.3.3 • Meet input requirements for design and
development?
• Provide appropriate information for
purchasing, production and service
provision?
• Contain or reference product acceptance
criteria?
• Specify the characteristics of the product
that are essential for its safe and proper use?
7.3.4 Design and development review
7.3.4 Are reviews conducted at suitable stages of

design and development to:
• Evaluate the ability of the results of design
and development to fulfill requirements?
• Identify any problems and propose
necessary actions?
Do design and development reviews include
7.3.4 representatives concerned with the design and
development stage (s) being reviewed?

7.3.4 Design and development review
Are records of the results of design and

7.3.4 development reviews and any necessary actions
arising from review activity maintained? (see
4.2.4)
Design and development verification
7.3.5
Is verification performed to ensure that design

7.3.5 and development outputs have satisfied the
design and development input requirements?
Are records of the results of verification and
7.3.5 any necessary actions maintained? (see 4.2.4)
7.3.6 Design and development validation
7.3.6 Is design and development validation

conducted in accordance with planned
arrangements (see 7.3.1), to ensure that the
resulting product is capable of fulfilling the
requirements for the specified or known
intended use or application?
7.3.6 Where practicable, is validation completed
prior to the delivery or implementation of the
product?
Are records of the results of validation and any
7.3.6 necessary actions maintained? (see 4.2.4)
Design and development changes

7.3.7
Are design and development changes:

7.3.7 • Identified?
• Reviewed?
• Verified and validated as appropriate?
• Evaluated for effect on constituent parts
and delivered products?
• Approved before implementation?
• Recorded?

Design and development changes

7.3.7
Are records of the results of changes and any

7.3.7 necessary actions maintained? (see 4.2.4)
Purchasing
7.4
7.4.1 Purchasing process
7.4.1 What processes exist to ensure that purchased

product conforms to specified purchase
requirements?
Is the type and extent of control applied to
7.4.1 suppliers and purchased products are
determined based upon the effect of purchased
product on subsequent product realization or
final product?
7.4.1 Are suppliers evaluated and selected based

upon their ability to supply product in
accordance with the organization requirements?
7.4.1 Are records of the results of supplier
evaluations and any necessary actions arising
from evaluations maintained? (see 4.3.4)
7.4.1 Has criteria for supplier selection, evaluation
and re-evaluation been determined?
7.4.2 Purchasing Information
7.4.2 Does purchasing information describe the

product to be purchased, including where
appropriate:
• Requirements for approval of product,
procedures, processes and equipment?
• Requirements for qualification of
personnel?
• Quality management system requirements?

7.4.2 Purchasing Information
Is the adequacy of specified purchase

7.4.2 requirements are ensured prior to their
communication to the supplier?
7.4.3 Verification of purchased product
7.4.3 Have inspection or other activities necessary

for ensuring that purchased product meets
specified purchase requirements been
established and implemented?
When the organization or the customer
7.4.3 performs verification at the supplier’s premises,
has the organization stated the intended
verification arrangements and the method of
product release in the purchasing information?
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1 Are production and service operations carried

out under controlled conditions?
What evidence is available to demonstrate that

7.5.1 controlled conditions include the following, as
applicable?
• The availability of information that
describes the characteristics of the product?
• The availability of work instructions?
• The use of suitable equipment?
• The availability and use of monitoring and
measurement devices?
• The implementation of monitoring and
measurement?
• The implementation of release, delivery
and post-delivery activities?

7.5.2 Validation of processes for production and

service provision
7.5.2 Are production and service processes validated

where the resulting output cannot be verified
by subsequent monitoring or measurement
validated?
7.5.2 How do validation activities demonstrate the
ability of these processes to achieve planned
results?
7.5.2 Do validation processes include the following
as applicable?
• Defined criteria for review and approval of
the processes
• Approval of equipment and qualification
of personnel
• Use of specific methods and procedures
• Requirements for records (see 4.2.4)
• Re-validation?
7.5.3 Identification and traceability
7.5.3 Is product identified, as appropriate, by suitable

means throughout product realization?
7.5.3 Is product status identified with respect to

measuring and monitoring requirements?
7.5.3 Is traceability a specified requirement? If so, is

unique identification of the product controlled
and recorded? (see 4.2.4)
7.5.4 Customer Property
7.5.4 Is customer property provided for the use or

incorporation into the product under the control
or use of the organization? If so, does a
process exist which ensures that care is
provided for customer property?

7.5.4 Customer Property
7.5.4 How will it be demonstrated that customer

property is:
Identified?
Verified?
Protected?
Safeguarded?
7.5.4 Is lost, damaged, or unsuitable product reported
to the customer and records maintained? (see
4.2.4)
7.5.5 Preservation of product
7.5.5 How will it be demonstrated that conformity of

product, and constituent parts of the product,
are preserved during internal processing and
delivery to the intended destination?
7.5.5 Are product preservation methods established
for:
Identification?
Handling?
Packaging?
Storage?
Protection?
7.6 Control of monitoring and measuring devices
7.6 Has the organization determined the

monitoring and measurement to be undertaken,
and the monitoring and measurement devices
needed to provide evidence of conformity to
determined requirements? (see 7.2.1)
7.6 Are processes established which ensure
monitoring and measurement is carried out in a
manner consistent with measuring and
monitoring requirements?

7.6 Control of monitoring and measuring devices
7.6 Is measuring equipment

Calibrated or verified at specified intervals or
prior to use against traceable international or
national measurement standards? (If
international or national measurement
standards are not available, the basis for
calibration or verification shall be recorded)
• Adjusted or re-adjusted as necessary?
• Identified to enable calibration status to be
determined?
• Safeguarded from adjustments that would
invalidate the measurement result?
• Protected from damage and deterioration
during handling, maintenance and storage?
7.6 How will it be demonstrated that:
• The validity of previous measuring results
is assessed by the organization when
equipment is found not to conform to
requirements?
• Appropriate action is taken on the
equipment and any affected product?
7.6 Are records of the results of calibration and
verification maintained (see 4.2.4)?
7.6 Is computer software used in the measuring and

monitoring of specified requirements?
If so, is the ability of computer software to
satisfy the intended application confirmed prior
to initial use and re-confirmed as necessary?

8.0 Measurement, analysis and

improvement
8.1 General
8.1 Are monitoring, measurement, analysis and

improvement processes planned and
implemented as needed to:
• Demonstrate conformity of the product?
• Ensure conformity of the quality
management system?
• Continually improve the effectiveness of
the quality management system?
• Determine applicable methods including
statistical techniques and the extent of their
use?
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.1 Is information relating to customer perceptions

to whether the organization has fulfilled
customer requirements monitored?
8.2.1 What are the methods for obtaining and using
customer satisfaction information?
8.2.2 Internal audit
8.2.2 Have the responsibilities and requirements for

planning and conducting audits, and for
reporting results and maintaining records (see
4.2.4) been defined in a documented
procedure?

8.2.2 Internal audit
8.2.2 Does the internal quality audit activity

determine whether the quality management
system:
• Conforms to planned arrangements? (see
7.1)
• Conforms to ISO 9001:2000 ?
• Conforms to quality management system
requirements established by the
organization?
• Is effectively implemented and
maintained?
8.2.2 Is evidence available to confirm that internal
audits are conducted at planned intervals based
upon:
• The status and importance of the processes
and areas to be audited?
• The results of previous audits?
8.2.2 Have audit criteria, scope, frequency and
methods been defined?
8.2.2 Is evidence available to confirm that internal

auditors are objective and impartial of the audit
process?
8.2.2 Does the management responsible for the area
being audited ensure that actions are taken
without undue delay to eliminate detected
nonconformities and their causes?
8.2.2 Do the nonconformity follow-up activities
include the verification of the actions taken and
the reporting of verification results? (see 8.5.5)
8.2.3 Monitoring and measurement of processes
8.2.3 Can it be demonstrated that suitable methods

for monitoring, and where applicable,
measurement of the quality management
system processes been applied?
8.2.3 Do these methods:
• Confirm the ability of these processes to
achieve planned results?
• Provide for appropriate correction and
corrective action when planned results are
not achieved to ensure product conformity?

8.2.4 Monitoring and measurement of product
8.2.4 Can it be demonstrated that measurement and

monitoring of the product is carried out at
various stages of the product realization
process in accordance with planned
arrangements? (see 7.1)
8.2.4 Is evidence of conformity with the acceptance
criteria maintained, and do records indicate the
person authorizing release of product ? (see
4.2.4)
8.2.4 Are controls in place to ensure that product
release and service delivery do not proceed
until all planned arrangements (see 7.1) are
satisfactorily completed? If not, is release
approval evidence from a relevant authority or
the customer available?
8.3 Is product that does not conform to

requirements identified and controlled to
prevent its unintended use of delivery?
FDIS
8.3 Have the controls and related responsibilities

and authorities for dealing with nonconforming
product been defined in a documented
procedure?

8.3 Is evidence available that nonconforming
product is dealt with by one or more of the
following ways:
• By taking action to eliminate the detected
nonconformity
• By authorizing its use, release or
acceptance under concession by a relevant
authority, and where applicable by the
customer
• By taking action to preclude its original
intended use or application
8.3 Are records of the nature of nonconfomities

and any subsequent actions taken, including
concessions maintained? (see 4.2.4)
8.3 Is evidence available that corrected
nonconforming product is subject to re-
verification to demonstrate conformity to the
requirements?
8.3 Are actions appropriate to the effects, or
potential effects of nonconforming product
taken when nonconforming product is detected
after delivery or use has started?
8.4 Analysis of data
8.4 Is appropriate data collected and analyzed to:

• Demonstrate the suitability and
system ?
• Evaluate where continual improvement of
the quality management system can be
made?
8.4 Is data generated as a result of monitoring and
measurement as well as from other relevant
sources collected for analysis?
8.4 Does the data analysis provides information
relating to:
• Customer satisfaction (see 8.2.1)
• Conformance to product requirements (see
7.2.1)
• Characteristics and trends of processes and
products ?
• Opportunities for preventative action?
• Suppliers?

8.5 Improvement

8.5.1 Continual improvement
8.5.1 How will it be demonstrated that the

system is being continually improved?
8.5.1 Are the following being used to improve the
system?
• Quality policy?
• Quality objectives?
• Audit results?
• Analyze of data?
• Corrective actions?
• Preventative actions?
• Management review?
8.5.2 Corrective action
8.5.2 Is action taken to eliminate the cause of

nonconformities in order to prevent recurrence?
8.5.2 Are the Corrective actions taken appropriate to

the effects of the nonconformities encountered?
8.5.2 Does a documented procedure define

requirements for:
• Reviewing nonconformity?
• Reviewing customer complaints?
• Determining the causes of
nonconformities?
• Evaluating the need for action to ensure
that nonconformites do not recur?
• Determining and implementing action
needed?
• Recording results of the action taken (see
4.2.4)
• Reviewing corrective action taken?

8.5.3 Preventative action
8.5.3 Is action is taken to eliminate the causes of

potential nonconforties in order to prevent their
occurrence?

8.5.3 Are the Preventative actions taken appropriate
to the effects of the potential problems?
8.5.2 Does a documented procedure define

requirements for:
• Determining potential nonconformites and
their causes?
• Evaluating the need for action to prevent
occurrence of nonconformities?
• Determining and implementing action
needed?
• Recording results of the action taken (see
4.2.4)
• Reviewing preventative action taken?

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UL’s ISO 9000 Registration Program –

Quality System Requirements

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

You can gain a better understanding of ISO 9001:2000 standard as it

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

• The ISO 9001:2000 Assessment Standard correspond to the ISO:9001:2000

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

Areas/ Functions Assessed* ‚

Stock & Ship

4.2 Documentation requirements D D D D D D D D D

5.1 Management commitment X

5.2 Customer focus X

5.3 Quality policy X

5.5 Responsibility, authority and X X X X D X X X X

5.6 Management Review X

6.4 Work environment X

Planning of product realization X

7.3 Design and development X

Production and service provision X X X

8.1 Measurement, analysis and X

8.2 Monitoring and measurement X X

8.3 Control of nonconforming product X X D

8.4 Analysis of data X

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

Areas / Functions Assessed

4.2 Documentation requirements

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.5 Responsibility, authority and

5.6 Management Review

6.4 Work environment

7.3 Design and development

Production and service provision

8.1 Measurement, analysis and

8.2 Monitoring and measurement

8.3 Control of nonconforming product

8.4 Analysis of data

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

Quality Management System

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

4.2.2 Quality Manual

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

Control of quality records

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

Is top management able to demonstrate how

Responsibility and authority

5.5.1 Is top management able to demonstrate how

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

6.2.1 Is evidence available that personnel performing

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

6.2.2 Competence, awareness and training

6.2.2 Has the necessary competence for personnel

6.2.2 Has Training been provided or other actions

6.2.2 Is the Training provided or other actions taken

6.2.2 Are appropriate records of education, training,

How will it be demonstrated that the

RP-2:2000 Issued: 11/27/00 Revised: 3/12/01

Is the following determined, as appropriate,