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Revision 1
ISO 9001:2008 Internal Audit & Gap Analysis Checklist
Page 1 of 28
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
The Quality Manager* or Lead Auditor* [* delete as appropriate] is responsible for reviewing 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5
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
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
6.3 Infrastructure
6.3q1a Are the buildings, workspace, and utilities
provided appropriate to achieve conformity to
product requirements? How are they
maintained?
6.3q1b What kind of process equipment (both hardware
and software) is necessary to conform to product
requirements? How is the equipment maintained?
6.3q1c What supporting services (such as transport or
communication) are needed to ensure that
product meets requirements? How are they
maintained?
6.4 Work environment
QF-008
Revision 1
ISO 9001:2008 Internal Audit & Gap Analysis Checklist
Page 10 of 28
Finding
Q# Audit Question YES NO Objective Evidence
A B C
6.4q1 What kind of work environment is required to
achieve conformity to product requirements?
How is this environment managed and
maintained?
7 Product realization
7.1 Planning of product realization
7.1q1 Where are the processes needed for product
realization identified?
7.4 Purchasing
7.4.1 Purchasing process