ISO 9001:2008 Internal Audit & Gap Analysis Checklist

4 Quality Management System

4.1 General Requirements
Finding (Tick)
Opportunities for
Audit Evidence
CLAUSE No.

Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Audit Question

OFI
Provide reference to documentation or Provide suggestions for process
records that justify the finding improvement
Has the organization established, documented, implemented
4.1 and maintained a QMS and continually improved its
effectiveness?
Has the organization identified the processes needed for the
4.1a
QMS and their application throughout the organization?

Has the organization determined the sequence and

4.1b
interaction of QMS processes?
What are the criteria and methods the organization uses to
4.1c ensure that the operation and control of QMS processes are
effective?
Has the organization provided resources and information
4.1d needed to support the operation and monitoring of QMS
processes?
Does the organization monitor, measure and analyze QMS
4.1e
processes?
Has the organization implemented actions necessary to
4.1f achieve planned results and continual improvement of
processes needed for the QMS?

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5 Management Responsibility
5.1 Management Commitment
Finding (Tick)
Opportunities for
Audit Evidence
CLAUSE No.

Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Audit Question

OFI
Provide reference to documentation or Provide suggestions for process
records that justify the finding improvement

Does the organization communicate the importance of

5.1a
meeting customer, statutory and regulatory requirements?

5.1b Does the organization have an established quality policy?

5.1c Are the quality objectives established by top management?

5.1d Does top management conduct management reviews?

Does top management ensure the availability of resources to

5.1e
support and continually improve the QMS?

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6 Resource Management
6.1 Provision of Resources
Finding (Tick)
Opportunities for
Audit Evidence
CLAUSE No.

Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Audit Question

OFI
Provide reference to documentation or Provide suggestions for process
records that justify the finding improvement
Has the organization provided the necessary resources to
6.1.1a implement and maintain the QMS and continually improve its
effectiveness?
Has the organization provided the necessary resources to
6.1.1b
ensure that customer requirements are met?

6.2 Human Resources

Finding (Tick)
Opportunities for
Audit Evidence
CLAUSE No.

Improvement (OFI)
COMPLIANT

MAJOR N/C
MINOR N/C
Audit Question

OFI
Provide reference to documentation or Provide suggestions for process
records that justify the finding improvement

Does the organization ensure that personnel have the

6.2.1
necessary competence to ensure product conformity?

Does the organization use job descriptions to define the roles

SQ
of personnel?

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Findings Summary
Non-conformance
No. ISO/Specification Ref. Summary Root Cause NCR No. Rectification Date

Corrective Action
No. ISO/Specification Ref. Summary Root Cause CAR No. Rectification Date

Preventive Action & OFI

No. ISO/Specification Ref. Summary Root Cause PAR No. Implementation Date

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 ISO 9001:2008 Internal Audit & Gap Analysis Checklist

Observations, Comments & Notes

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