QUALITY SYSTEM PROCEDURE
QP3
INTERNAL AUDIT
[Your Company]
Signature Position Date
Prepared ByReviewed ByApproved By
COMPANY PROPRIETARY INFORMATION
This document is an uncontrolled copy of a controlled document held by the Quality
Management System. Prior to use, ensure this document is the most recent revision
by checking the Master Document List. To request changes, submit a Document
Change Request to the Document Control Representative.
[Link]
Quality System Procedure
QP3Version 1
[
Your Company]
INTERNAL AUDIT
Page 2 of [Link]
Table of Contents
1. INTRODUCTION &
PURPOSE .............................................................................................3
2.
TERMS &
DEFINITIONS
...3
................................................................................................
APPLICATION
&
SCOPE
.......................................................................................................3
4.
R
EQUIREMENTS
.................................................................................................................3
4.1
Internal Auditor Qualification...................................................................................3
5.
P
ROCESS
..........................................................................................................................4
5.1
Audit Preparation....................................................................................................4
5.2
Audi Initiation ..........................................................................................................4
5.3
Audit Completion.....................................................................................................5
5.4
Audit Documentation & Records.............................................................................5
6.
R
EFERENCES
.....................................................................................................................5
7.
R
EVISION
H
ISTORY
............................................................................................................5
Quality System Procedure
QP3Version 1
[
Your Company]
INTERNAL AUDIT
Page 3 of [Link]
1. Introduction & Purpose
The purpose of this procedure is to define
[
Your Companys]process for undertakinginternal audits in order to assess the
effectiveness of the application of ISO 9001:2008.
2. Terms & Definitions
Internal Audit
is taken to mean a managerial tool which evaluates effectiveness of the quality
management system.
Internal Auditor
is taken to mean any competent person(s) with responsibility of undertaking
internal audits.
Non-conformance
is taken to mean an observation that indicates a policy or practiceis contrary to the
requirements of the standard or documented [Link] following terms and
definitions are taken from ISO [Link]
Term Clause Definition
Document 3.7.2 Information and its supporting mediumProcedure 3.4.5 Specified
way to carry out an activity or a process Quality Manual 3.7.4 Document specifying
the QMS of an organizationRecord 3.7.6 Document stating results or evidence of
activities performedSpecification 3.7.3 Document stating requirements
3. Application & Scope
The scope of this procedure is focused on assessing the effectiveness of
[
YourCompanys]quality management system. Where such processes are found to
bedeficient, the audit will lead to improvement in those [Link] applying the
principles of auditing
[
Your Company]ensures that all audits areconducted with due professional care,
integrity and independence. All conclusionsderived from the audit are based upon
objective, traceable evidence.
4. Requirements
4.1 Internal Auditor Qualification
Internal Auditor candidates are selected from permanent staff members
Internal Auditor candidates must successfully complete an auditor training course
Internal Auditor qualifications must be maintained in the employee training records
Quality System Procedure
QP3Version 1
[
Your Company]
INTERNAL AUDIT
Page 4 of [Link]
5. Process
5.1 Audit Preparation
ISO 9000 procedures are audited a minimum of twice a year. The maximum
intervalbetween audits is six months
[
amend as applicable]. Audits may be completed with agreater frequency if
determined by the Quality Management [Link] Management
Representative
is required to:
Establish and implement audit programme
Evaluate and select competent Internal Auditors
Define the audit criteria, scope and method
Assign audit duties to the Internal Auditors
Maintain records of briefingsTop Management
is required to:
Provide authority to the audit programme
Communicate audit mandateInternal Auditor
is required to:
Review relevant requirements of ISO 9001:2008
Conduct document review
Review and prepare audit checklist
5.2 Audit Initiation
Internal Auditor
is required to:
Arrange audit appointment and conduct opening meeting
Conduct audit using audit method described by the QMR
Sample and observe necessary process inputs/outputs to establish audit trail
Record objective evidence to verify compliance or non-conformance
Initiate non-conformance process where required, update log
Initiate corrective/preventive action processes where required, update log
Conduct follow-up audit to verify close out of non-conformances
Follow-up audit to verify effectiveness of corrective/preventive actions
Conduct close out meeting
Report audit findings to the Quality Management Representative
Quality System Procedure
QP3Version 1
[
Your Company]
INTERNAL AUDIT
Page 5 of [Link]
5.3 Audit Completion
Quality Management Representative
is required to:
Review and approve audit report
Communicate audit report findings
Make recommendations for improvement
Update the audit programme and audit schedule
Obtain feedback on the audit process
Improve audit processTop Management
is required to:
Use audit evidence to drive improvement
Use audit evidence to promote best practice
5.4 Audit Documentation & Records
All documentation and records generated by the internal audit process will be
managedin accordance with ISO 9001:2008 Clauses 4.2.3 & 4.2.4.
6. References
Quality Management Systems Manual Section 8.2.2Internal Audit Schedule Form
F103.1Internal Audit Assignment Form F103.2Internal Audit Checklist Form
F103.3Internal Audit Report Form F103.4Internal Audit Feedback Form F103.5Non
Conformance Report Form F104.1Non Conformance Report Log Form
F104.2Corrective Action Request Form F105.1Corrective Action Request Log Form
F105.2
7. Revision History
Revision Date Name Change Ref.
Internal Audit Procedure Example
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Description: An internal audit procedure must define: Criteria Scope Program
frequency Method Report results Keep records (see 4.2.4)
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An internal audit procedure must define: Criteria Scope Program frequency Method
Report results Keep records (see 4.2.4)
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