Internal Audit Checklist Example

Form F103.
[Your Company] ISO 9001:2008 Internal Audit & Gap Analysis Checklist Version 1
Page 4 of 61
Audit Date:
Audit Description:
Lead Auditor:
Audit Team Members:
Instructions for Completing the Checklist 4.1 4.2.1 4.2.2 4.2.3 4.2.4
ISO 9001:2008 Auditable Clauses: (Tick those to be evaluated during this audit) 5.1 5.2 5.3 5.4.1 5.4.2
Each auditor should complete the section of the checklist they have been assigned 5.5.1 5.5.2 5.5.3 5.6.1 5.6.2
by the Quality Manager* or Lead Auditor* [* delete as appropriate]. The auditor may
5.6.3 6.1 6.2.1 6.2.2 6.3
provide additional notes and questions regarding the audit trail for each element in
the blank space on the checklist. 6.4 7.1 7.2.1 7.2.2 7.2.3
The Quality Manager* or Lead Auditor* [* delete as appropriate] is responsible for 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
reviewing completed sections of the checklist and to organize all individual sections
into one sequential checklist at the conclusion of the audit. 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3
7.5.1 7.5.2 7.5.3 7.5.4 7.5.5
7.6 8.1 8.2.1 8.2.2 8.2.3
8.2.4 8.3 8.4 8.5.1 8.5.2
8.5.3
PRODUCT REALIZATION PROCESS EXCLUSIONS
ISO 9001:2008 Permissible Exclusions: (Tick those applicable, if any) 7.1 7.2.1 7.2.2 7.2.3 7.3.1
7.3.2 7.3.3 7.3.4 7.3.5 7.3.6
7.3.7 7.4.1 7.4.2 7.4.3 7.5.1
7.5.2 7.5.3 7.5.4 7.5.5 7.6
Legend
A = Minor Non-conformance B = Major Non-conformance C = Critical Non-conformance SQ = Supplementary Question
Auditor Name (print): Initials: Date:
www.iso-9001-checklist.co.uk
Form F103.3
Page 5 of 61
4 Quality Management System
4.1 General Requirements

Clause Ref.
Finding
Question
Audit Evidence
No.
Audit Question NO
YES
A B C N.B. Provide references to documentation where necessary
Has the organization established, documented, implemented and

1 4.1
maintained a QMS and continually improved its effectiveness?
Has the organization identified the processes needed for the QMS and
2 4.1a
their application throughout the organization?
Has the organization determined the sequence and interaction of QMS

3 4.1b
processes?
What are the criteria and methods the organization uses to ensure that
4 4.1c
the operation and control of QMS processes are effective?
Form F103.3
Page 6 of 61
Clause Ref. Finding

Question
Audit Evidence
No.
Audit Question NO
YES
Has the organization provided resources and information needed to

5 4.1d
support the operation and monitoring of QMS processes?
6 4.1e Does the organization monitor, measure and analyze QMS processes?
Has the organization implemented actions necessary to achieve planned

7 4.1f
results and continual improvement of processes needed for the QMS?
Are processes needed for the QMS managed by the organization in

8 4.1
accordance with the requirements of ISO 9001:2008?
9 4.1 How does the organization maintain control over outsourced processes?
Form F103.3
Page 7 of 61
Clause Ref. Finding

Question
Audit Evidence
No.
Audit Question NO
YES
Are the necessary controls for outsourced processes that affect product
10 4.1
conformity with requirements identified within the QMS?
Does organization have adequate control over outsourced processes to

11 4.1
ensure conformity to all customer requirements?
4.2 Documentation requirements
4.2.1 General
Clause Ref.
Finding
Question
Audit Evidence
No.
Audit Question NO
YES
1 4.2.1a Does the organization have a documented quality policy?
2 4.2.1a Does the organization have a set of documented quality objectives?
Form F103.3
Page 8 of 61
Clause Ref. Finding

Question
Audit Evidence
No.
Audit Question NO
YES
3 4.2.1b Does the organization have a quality manual?
4 4.2.1c Does the organization operate a set of documented procedures?
Are adequate documents in place to ensure the effective planning,

5 4.2.1d
operation and control of organization’s processes?
6 4.2.1d Does documentation include the records required by ISO 9001:2008?
4.2.2 Quality Manual

Clause Ref.
Finding
Question
Audit Evidence
No.
Audit Question NO
YES
Where in the quality manual is the scope of the QMS identified, including
1 4.2.2a
details of and justification for exclusions?
Form F103.3
Page 9 of 61
Clause Ref. Finding

Question
Audit Evidence
No.
Audit Question NO
YES
Where does the quality manual contain or reference the documented

2 4.2.2b procedures established for the QMS?
Where does the quality manual include a description of the interaction

3 4.2.2c
between the processes of the QMS?
4.2.3 Control of Documents
Finding
Question
Clause
Audit Evidence
Ref.
No.
Audit Question NO
YES
Does the organization operate an establish document control

1 4.2.3
procedure? (If yes, proceed with questions 22 to 28)
Does the document control procedure define the controls needed

2 4.2.3a
to approve documents for adequacy prior to issue?
Form F103.3
Page 10 of 61
Finding
Question
Clause
Ref.
Audit Evidence
No.
Audit Question NO
YES

3 4.2.3b
to review and update as necessary and re-approve documents?

4 4.2.3c to ensure that changes and the current revision status of
documents are identified?

5 4.2.3d to ensure that relevant versions of applicable documents are
available at points of use?

6 4.2.3e
to ensure that documents remain legible and readily identifiable?

7 4.2.3f to ensure that documents of external origin are identified and
their distribution controlled?

to prevent the unintended use of obsolete documents, and to
8 4.2.3g
apply suitable identification to them if they are retained for any
purpose?

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Form F103.

Audit Team Members:

Auditor Name (print): Initials: Date:

4 Quality Management System

4.1 General Requirements

Has the organization established, documented, implemented and

Has the organization determined the sequence and interaction of QMS

Auditor Name (print): Initials: Date:

Clause Ref. Finding

Has the organization provided resources and information needed to

Has the organization implemented actions necessary to achieve planned

Are processes needed for the QMS managed by the organization in

Auditor Name (print): Initials: Date:

Clause Ref. Finding

Does organization have adequate control over outsourced processes to

4.2 Documentation requirements

1 4.2.1a Does the organization have a documented quality policy?

2 4.2.1a Does the organization have a set of documented quality objectives?

Auditor Name (print): Initials: Date:

Clause Ref. Finding

3 4.2.1b Does the organization have a quality manual?

4 4.2.1c Does the organization operate a set of documented procedures?

Are adequate documents in place to ensure the effective planning,

6 4.2.1d Does documentation include the records required by ISO 9001:2008?

4.2.2 Quality Manual

Auditor Name (print): Initials: Date:

Clause Ref. Finding

Where does the quality manual contain or reference the documented

Where does the quality manual include a description of the interaction

4.2.3 Control of Documents

Does the organization operate an establish document control

Does the document control procedure define the controls needed

Auditor Name (print): Initials: Date:

Does the document control procedure define the controls needed

Does the document control procedure define the controls needed

Does the document control procedure define the controls needed

Does the document control procedure define the controls needed

Does the document control procedure define the controls needed

Does the document control procedure define the controls needed

Auditor Name (print): Initials: Date:

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