Checklist ISO 9001:2000 annex 7.

3
Audit scheme: IS0-9001:2000 (supplement to design activities)
Auditor:
Auditee: Date:
Quest- Stand- Question Doc Impl Findings/Comments Consequence
ion no. ard
Sanction
element

23 7.3 If there are design and/or development processes, these requirements

should be included in the audit; see ISO 9001:2000 and ISO 10007.
23a 7.3.1 The organisation must plan and control the design and development of
the product. During the design and the development planning, the
organisation must determine the following:
a. the design and development stages;
b. the review, verification and validation that are appropriate for each
design and development stage, and
c. the responsibilities and authorities for design and development
The organisation must manage interfaces between different groups
involved with design and development to ensure effective
communication and a clear assignment of responsibilities.
Planning output must be updated, as appropriate, as the design and
development progresses.
23b 7.3.2 Input relating to product requirements must be determined and records
must be maintained (see 4.2.4). These inputs must include:
a. Functional and performance requirements;
b. Applicable statutory and regulatory requirements;
c. Where applicable, information derived from previous similar
designs, and
d. Other requirements essential for design and development.
These inputs must be reviewed for adequacy. Requirements must be
complete, unambiguous and not in conflict with each other.
23c 7.3.3 The outputs of design and development must be provided in a form that
enables verification against the design and development input. This
output must be approved prior to release.
Design and development outputs must:
a. Meet the input requirements for design and development;
b. Provide appropriate information for purchasing, production and
service provision;
c. Contain or reference product acceptance criteria, and

EN Checklist ISO aanvulling ontwerp 7.3 260303.doc 1/3

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 Checklist ISO 9001:2000 annex 7.3
Audit scheme: IS0-9001:2000 (supplement to design activities)
Auditor:
Auditee: Date:
Quest- Stand- Question Doc Impl Findings/Comments Consequence
ion no. ard
Sanction
element

d. Specify the characteristics of the product that are essential for safe
and proper use.
23d 7.3.4 At suitable stages, systematic reviews of design and development must
be performed in accordance with planned arrangements (see 7.3.1):
a. To evaluate the ability of the results of design and development to
meet requirements;
b. To identify any problems and propose necessary actions.
Participants in such reviews must include representatives of functions
concerned with the design and development stage/steps being
reviewed. Records of the results of the reviews and any necessary
actions must be maintained (see 4.2.4)
23e 7.3.5 Verification must be performed in accordance with planned
arrangements (see 7.3.1) to ensure that the design and development
outputs have met the design and the development input requirements.
Records of the results of the verification and any necessary actions
must be maintained (see 4.2.4).
23f 7.3.6 Design and development validation must be performed in accordance
with planned arrangements (see 7.3.1) to ensure that the resulting
product is capable of meeting the requirements for the specified
application or intended use, where known. Wherever practicable,
validation must be completed prior to the delivery or implementation
of the product. Records of the results of the validation and any
necessary actions must be maintained (see 4.2.4).
23g 7.3.7 Design and development changes must be identified and records of
these must be maintained. The changes must be reviewed, verified and
validated, as appropriate, and approved before implementation. The
review of design and development changes must include the evaluation
of the effect of the changes on the constituent parts and the products
already delivered.
Records of the results of the review of changes and any necessary
actions must be maintained (see 4.2.4)

EN Checklist ISO aanvulling ontwerp 7.3 260303.doc 2/3

© 2003 MPS. All rights reserved

 Checklist ISO 9001:2000 annex 7.3
Audit scheme: IS0-9001:2000 (supplement to design activities)
Auditor:
Auditee: Date:
Quest- Stand- Question Doc Impl Findings/Comments Consequence
ion no. ard
Sanction
element

EN Checklist ISO aanvulling ontwerp 7.3 260303.doc 3/3

© 2003 MPS. All rights reserved