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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.
REVISION HISTORY ........................................................................ ............................................................................................................ .................................... 5
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Quality System Procedure [Your Company]
1.
INTERNAL AUDIT
QP3 Version 1 Page 3 of 5
Introduction & Purpose The purpose of this procedure is to define [Your Company’s] 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
3.
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
Application & Scope The scope of this procedure is focused on assessing the effectiveness of [Your Company’s] 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
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Quality System Procedure [Your Company]
5.
Process
5.1
Audit Preparation
INTERNAL AUDIT
QP3 Version 1 Page 4 of 5
ISO 9000 procedures are audited a minimum of twice a year. The maximum interval between audits is six months [amend as applicable]. 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:
5.2
Review relevant requirements of ISO 9001:2008
Conduct document review
Review and prepare audit checklist
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
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Quality System Procedure [Your Company]
5.3
QP3 Version 1
INTERNAL AUDIT
Page 5 of 5
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:
5.4
Use audit evidence to drive improvement
Use audit evidence to promote best practice
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.
