ISO 9001:2008 Internal Audit & Gap Analysis Checklist

Quality Management System

4.1 General Requirements

4.1

Has the organization established, documented, implemented

and maintained a QMS and continually improved its
effectiveness?

4.1a

Has the organization identified the processes needed for the

QMS and their application throughout the organization?

4.1b

Has the organization determined the sequence and

interaction of QMS processes?

4.1c

4.1d

MAJOR N/C

MINOR N/C

OFI

Audit Question

COMPLIANT

CLAUSE No.

Finding (Tick)
Audit Evidence

Opportunities for
Improvement (OFI)

Provide reference to documentation or

records that justify the finding

Provide suggestions for process

improvement

Initials:

Date:

What are the criteria and methods the organization uses to

ensure that the operation and control of QMS processes are
effective?
Has the organization provided resources and information
needed to support the operation and monitoring of QMS
processes?

4.1e

Does the organization monitor, measure and analyze QMS

processes?

4.1f

Has the organization implemented actions necessary to

achieve planned results and continual improvement of
processes needed for the QMS?

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ISO 9001:2008 Internal Audit & Gap Analysis Checklist

Management Responsibility

5.1 Management Commitment

5.1a

Does the organization communicate the importance of

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?

5.1e

Does top management ensure the availability of resources to

support and continually improve the QMS?

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MAJOR N/C

MINOR N/C

OFI

Audit Question

COMPLIANT

CLAUSE No.

Finding (Tick)
Audit Evidence

Opportunities for
Improvement (OFI)

Provide reference to documentation or

records that justify the finding

Provide suggestions for process

improvement

Initials:

Date:

ISO 9001:2008 Internal Audit & Gap Analysis Checklist

Resource Management

6.1 Provision of Resources

MAJOR N/C

MINOR N/C

OFI

Audit Question

COMPLIANT

CLAUSE No.

Finding (Tick)
Audit Evidence

Opportunities for
Improvement (OFI)

Provide reference to documentation or

records that justify the finding

Provide suggestions for process

improvement

Audit Evidence

Opportunities for
Improvement (OFI)

Provide reference to documentation or

records that justify the finding

Provide suggestions for process

improvement

Initials:

Date:

Has the organization provided the necessary resources to

6.1.1a implement and maintain the QMS and continually improve its
effectiveness?
6.1.1b

Has the organization provided the necessary resources to

ensure that customer requirements are met?

6.2 Human Resources

6.2.1

SQ

MAJOR N/C

MINOR N/C

OFI

Audit Question

COMPLIANT

CLAUSE No.

Finding (Tick)

Does the organization ensure that personnel have the

necessary competence to ensure product conformity?
Does the organization use job descriptions to define the roles
of personnel?

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ISO 9001:2008 Internal Audit & Gap Analysis Checklist

Findings Summary
Non-conformance
No.

ISO/Specification Ref.

Summary

Root Cause

NCR No.

Rectification Date

Summary

Root Cause

CAR No.

Rectification Date

Root Cause

PAR No.

Implementation Date

Corrective Action
No.

ISO/Specification Ref.

Preventive Action & OFI

No.

ISO/Specification Ref.

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Summary

Initials:

Date:

ISO 9001:2008 Internal Audit & Gap Analysis Checklist

Observations, Comments & Notes

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Initials:

Date: