QUALITY SYSTEM

PROCEDURE
QP3
INTERNAL AUDIT

[Your Company]


Signature Position Date
Prepared By
Reviewed By
Approved 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
QP3
Version 1 [Your Company]
INTERNAL AUDIT
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Table of Contents

1. INTRODUCTION & PURPOSE................................................................................................ 3
2. TERMS & DEFINITIONS ....................................................................................................... 3
3. APPLICATION & SCOPE....................................................................................................... 3
4. REQUIREMENTS ................................................................................................................. 3
4.1 Internal Auditor Qualification................................................................................... 3
5. PROCESS .......................................................................................................................... 4
5.1 Audit Preparation .................................................................................................... 4
5.2 Audi Initiation .......................................................................................................... 4
5.3 Audit Completion..................................................................................................... 5
5.4 Audit Documentation & Records............................................................................. 5
6. REFERENCES..................................................................................................................... 5
7. REVISION HISTORY ............................................................................................................ 5



























Quality System Procedure
QP3
Version 1 [Your Company]
INTERNAL AUDIT
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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.
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 practice
is 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 medium
Procedure 3.4.5 Specified way to carry out an activity or a process
Quality Manual 3.7.4 Document specifying the QMS of an organization
Record 3.7.6 Document stating results or evidence of activities performed
Specification 3.7.3 Document stating requirements
3. Application & Scope

The scope of this procedure is focused on assessing the effectiveness of [Your
Companys] quality management system. Where such processes are found to be
deficient, the audit will lead to improvement in those processes.

By applying the principles of auditing [Your Company] ensures that all audits are
conducted with due professional care, integrity and independence. All conclusions
derived 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
QP3
Version 1 [Your Company]
INTERNAL AUDIT
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5. Process
5.1 Audit Preparation

ISO 9000 procedures are audited a minimum of twice a year. The maximum interval
between audits is six months [amend as applicable]. Audits may be completed with a
greater 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 briefings

Top Management is required to:

Provide authority to the audit programme
Communicate audit mandate

Internal 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
QP3
Version 1 [Your Company]
INTERNAL AUDIT
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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 process

Top 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 managed
in accordance with ISO 9001:2008 Clauses 4.2.3 & 4.2.4.
6. References

Quality Management Systems Manual Section 8.2.2
Internal Audit Schedule Form F103.1
Internal Audit Assignment Form F103.2
Internal Audit Checklist Form F103.3
Internal Audit Report Form F103.4
Internal Audit Feedback Form F103.5
Non Conformance Report Form F104.1
Non Conformance Report Log Form F104.2
Corrective Action Request Form F105.1
Corrective Action Request Log Form F105.2
7. Revision History

Revision Date Name Change Ref.