ISO 9001:2008
Clause 8.2.2
P018 Internal Audit Procedure
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P018 Internal Audit Procedure
Contents
P018 Internal Audit Procedure ..................................................................................................................................... 4
1. Introduction & Purpose ............................................................................................................................................... 4
2. References ................................................................................................................................................................... 4
3. Terms & Definitions ..................................................................................................................................................... 4
4. Application & Scope ..................................................................................................................................................... 4
5. Requirements ............................................................................................................................................................... 4
6. Process ......................................................................................................................................................................... 4
6.1 Audit Planning ........................................................................................................................................................ 5
6.2 Audit Preparation................................................................................................................................................... 5
6.3 On-site Audit .......................................................................................................................................................... 6
6.4 Wrap-up Meeting................................................................................................................................................... 6
6.5 Follow-up ............................................................................................................................................................... 6
6.6 Reporting ............................................................................................................................................................... 6
6.7 Review .................................................................................................................................................................... 6
6.8 Records .................................................................................................................................................................. 6
6.9 Audit Process Matrix .............................................................................................................................................. 7
6.10 Internal Audit Process Map.................................................................................................................................. 9
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P018 Internal Audit Procedure
P018 Internal Audit Procedure
1. Introduction & Purpose
The purpose of this procedure is to define Your Companys process for undertaking internal audits in order to assess
the effectiveness of the application of ISO 9001:2008 and also to define the responsibilities for planning and
conducting audits, reporting results and retaining associated records.
2. References
Reference
Title & Description
8.2.2
Quality System Manual
F018-1
Internal Audit Schedule
F018-2
Internal Audit Plan
F018-3
Internal Audit Assignment
F018-4
Internal Audit & Gap Analysis Checklist
F018-5
Internal Audit Report
F018-6
Internal Audit Feedback
3. Terms & Definitions
Term
ISO Clause
Definition
Non-conformity
3.6.2
Non-fulfilment of a requirement
Preventive Action
3.6.4
Action taken to eliminate a potential non-conformity
Corrective Action
3.6.5
Action taken to eliminate the cause of a non-conformity
Audit
3.9.1
A systematic, independent documented process for obtaining and evaluating audit
evidence objectively to determine the extent to which audit criteria are fulfilled
4. Application & Scope
The scope of this procedure is focused on assessing the effectiveness of Your Companys QMS. Where such processes
are found to be deficient, the audit will lead to improvement in those processes.
By applying the principles of auditing, outlined by ISO 19011:2002, Your Company ensures that all internal audits are
conducted with due professional care, integrity and independence. All conclusions derived from the audit are based
upon objective and traceable evidence.
5. Requirements
An audit of the QMS is conducted at planned intervals to:
Determine whether the QMS conforms to planned arrangements
Determine whether the QMS is properly implemented and maintained
Provide information on the results of audits to Top Management
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P018 Internal Audit Procedure
6.10 Internal Audit Process Map
Quality Management
Representative
Audit Team
Responsible Manager
Top Management
Audit Considerations
ISO 9001 requirements
Customer complaint
QMS requirements
Quality objectives/policy
Corrective actions
Statutory/legal requirements
Management decisions
3rd party concerns
Results of 3rd party audits
Employee concerns
Management Review
Additional Considerations
Status
Importance
Frequency
Document review
Prepare audit schedule
F018-1
Prepare audit checklist
F018-4
Devise audit plan
F018-2
Provide feedback on
audit F018-6
Conduct audit
Assign audit duties
F018-3
Noncompliance
found?
YES
Initiate corrective
actions
NO
Review audit findings
Prepare audit report
F018-5
Close-out corrective
actions
UPDATE
Recommendations for
improvement
Verify close-out at
follow-up meeting
Management review
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