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.

www.iso-9001-checklist.co.uk

Quality System Procedure

QP3Version 1
[
Your Company]
INTERNAL AUDIT

Page 2 of 5www.iso-9001-checklist.co.uk

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 5www.iso-9001-checklist.co.uk

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 procedures.The following terms and
definitions are taken from ISO 9000:2005:
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 processes.By 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 5www.iso-9001-checklist.co.uk

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 Representative.Quality 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 5www.iso-9001-checklist.co.uk

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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