AUDIT CHECK LIST RC & Q Management System

ISO 9001 / 14001/ Manual Section 8.3: Design and Development

ISO 45001 Elements

Date:
Auditor Auditee:
Clause No.

Audit Evidence
Audit Question

Provide reference to documented

information to justify the finding
Does the organization establish, implement and maintain
a design and development process that is appropriate to
8.3.1
ensure the subsequent provision of products and
services?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
nature, duration and complexity of the design and
development activities?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
required process stages, including applicable
design and development reviews?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
required design and development verification and
validation activities?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
responsibilities and authorities involved in the
design and development process?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
internal and external resource needs for the design
and development of products and services?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
need to control interfaces between persons involved
in the design and development process?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2
need for involvement of customers and users in the
design and development process?
When determining the stages and controls for design
and development, does the organization consider the
8.3.2 level of control expected for the design and development
process by customers and other relevant interested
parties?

Page 1 of 4 Issue Date : June 2018 Issue : 1.1

AUDIT CHECK LIST RC & Q Management System

ISO 9001 / 14001/ Manual Section 8.3: Design and Development

ISO 45001 Elements

Date:
Auditor Auditee:
Clause No.

Audit Evidence
Audit Question

Provide reference to documented

information to justify the finding
When determining the stages and controls for design
and development, does the organization consider the
8.3.2 documented information needed to demonstrate that
design and development requirements have been met?
(See 7.5.1a & b)
Does the organization determine the requirements
8.3.3 essential for the specific types of products to be
designed and developed?
Does the organization consider functional and
8.3.3
performance requirements?
Does the organization consider information derived from
8.3.3
previous similar design and development activities?
Does the organization consider statutory and regulatory
8.3.3
requirements?
Does the organization consider standards or codes of
8.3.3
practice that it has committed to implement?
Does the organization consider potential consequences
8.3.3
of failure due to the nature of the products ?
Are the inputs adequate for design and development
8.3.3
purposes, complete and unambiguous?

8.3.3 Are conflicting design and development inputs resolved?

Does the organization retain documented information on

8.3.3
design and development inputs? (See 7.5.1b)
Does the organization apply controls to the design and
8.3.3 development process to ensure that the results to be
achieved are defined?

Does the organization apply controls to the design and

development process to ensure that reviews are
8.3.3
conducted to evaluate the ability of the results of design
and development to meet requirements?

Does the organization apply controls to the design and

development process to ensure that verification activities
8.3.3
are conducted to ensure that the design and
development outputs meet the input requirements?

Page 2 of 4 Issue Date : June 2018 Issue : 1.1

AUDIT CHECK LIST RC & Q Management System

ISO 9001 / 14001/ Manual Section 8.3: Design and Development

ISO 45001 Elements

Date:
Auditor Auditee:
Clause No.

Audit Evidence
Audit Question

Provide reference to documented

information to justify the finding
Does the organization apply controls to the design and
development process to ensure that validation activities
8.3.3 are conducted to ensure that the resulting products and
services meet the requirements for the specified
application or intended use?

Does the organization apply controls to the design and

development process to ensure that any necessary
8.3.3
actions are taken on problems determined during the
reviews, or verification and validation activities?
Does the organization apply controls to the design and
8.3.4 development process to ensure that documented
information of these activities is retained? (See 7.5.1b)

Does the organization ensure that design and

8.3.5
development outputs meet the input requirements?

Does the organization ensure that design and

8.3.5 development outputs are adequate for the subsequent
processes for the provision of products ?

Does the organization ensure that design and

development outputs include or reference monitoring
8.3.5
and measuring requirements, as appropriate, and
acceptance criteria?

Does the organization ensure that design and

development outputs specify the characteristics of the
8.3.5
products and services that are essential for their
intended purpose and their safe and proper provision?

Does the organization retain documented information on

8.3.5
design and development outputs? (See 7.5.1b)

Does the organization identify, review and control

changes made during, or subsequent to, the design and
8.3.6 development of products, to the extent necessary to
ensure that there is no adverse impact on conformity to
requirements?
Does the organization retain documented information on
8.3.6
design and development changes? (See 7.5.1b)

Page 3 of 4 Issue Date : June 2018 Issue : 1.1

AUDIT CHECK LIST RC & Q Management System

ISO 9001 / 14001/ Manual Section 8.3: Design and Development

ISO 45001 Elements

Date:
Auditor Auditee:
Clause No.

Audit Evidence
Audit Question

Provide reference to documented

information to justify the finding
Does the organization retain documented information on
8.3.6
the results of reviews?
Does the organization retain documented information on
8.3.6
the authorization of the changes? (See 7.5.1b)
Does the organization retain documented information on
8.3.6 the actions taken to prevent adverse impacts? (See
7.5.1b)

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Page 4 of 4 Issue Date : June 2018 Issue : 1.1