Cover image for Quality audits for ISO 9001:2000 : making compliance value-added
Quality audits for ISO 9001:2000 : making compliance value-added
O'Hanlon, Tim, 1958-
Personal Author:
Publication Information:
Milwaukee, Wis. : ASQ Quality Press, [2002]

Physical Description:
xix, 220 pages : illustrations ; 24 cm
Format :


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TS156.6 .O34 2002 Adult Non-Fiction Non-Fiction Area

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This book takes a brand new look at the entire audit process for both auditors and auditees. No longer will auditees need to feel like they must comply with an auditores checklist without understanding why compliance is helpful to, or necessary for, the organization. Likewise, auditors will learn a fresh approach for developing feedback and reports that are more than lists of failings, but are value-added assessments of an organizationes strengths and areas for improvement. By educating them as customers of the audit, this guide teaches auditees how to get the most value from their audit. Auditors will receive guidance about how to make their job something organizations will appreciate as a tool they can use to improve their company. This complete how-to guide will help auditors and organizations plan for their internal or external audit. OeHanlon himself is a registered IRCA Lead Auditor and Lead Auditor trainer who teaches you the previously undiscussed areas of the audit process. Additionally, this book will show both auditors and auditees how to make your audit a process that creates value for the organization, not just a tool to ensure compliance. Internal, second- and third-party auditors and auditees can use the numerous frequently asked questions to prepare for the situations they will encounter during an actual audit.

Table of Contents

List of Illustrationsp. xiii
Forewordp. xv
Prefacep. xvii
Acknowledgmentsp. xviii
Introductionp. xix
Chapter 1 Backgroundp. 1
Understanding Qualityp. 1
Quality Assurance Is a Preventive Way of Thinkingp. 1
The Accreditation and Certification Processesp. 2
Chapter 2 Understanding the Requirements of ISO 9001:2000p. 7
Background on the Standardp. 7
Purpose of the Standardp. 7
The Logic of Quality Management Systemsp. 8
Understanding the Requirementsp. 8
Frequently Asked Questionsp. 17
The Eight Quality Management Principlesp. 36
Chapter 3 Quality System Documentationp. 39
Documenting a Quality Management Systemp. 39
The Quality Manualp. 41
The Documented Proceduresp. 42
Document Controlp. 42
Control of Recordsp. 43
Chapter 4 Background on Auditingp. 45
Understanding the Audit Processp. 45
The Three Types of Auditp. 45
Traditional Criteria-Based Auditingp. 46
Integrated Systems Auditingp. 47
Moving Away from a Focus on Paperp. 47
Auditing Standardsp. 48
Generalp. 48
Reasons for Initiating an Auditp. 48
Understanding the Audit Scopep. 48
Understanding the Audit Objectivesp. 49
Understanding the Audit Planp. 49
Understanding the Lead Auditor's Responsibilitiesp. 51
Understanding the Auditor's Responsibilitiesp. 51
Understanding the Responsibilities of the Auditee's Management Teamp. 53
Finalizing the Audit Team Selectionp. 53
Aborting an Auditp. 54
Chapter 5 Initial Preparationp. 55
The Pertinent Documentationp. 55
Scope and Exclusionsp. 55
Initial Contact and Gathering Informationp. 56
The Preaudit Visitp. 57
The Adequacy Auditp. 58
Summary of Initial Preparationp. 66
Chapter 6 Detailed Planningp. 67
The Selection of Guides (Escorts)p. 67
Briefing the Audit Teamp. 67
Understanding the Benefits of Detailed Planningp. 67
Final Considerations of Detailed Planningp. 68
Understanding the Various Methodsp. 68
Forward Trace and Backward Tracep. 68
Horizontal and Vertical Methodsp. 69
The Process Inputs Methodp. 70
Planning the Resources Required for the Auditp. 71
The Audit Programp. 71
Audit Checklistsp. 71
Criteria-Based Checklist for ISO 9001:2000p. 72
Other Forms of Checklistsp. 88
Summary of Checklistsp. 88
Chapter 7 The Human Side of Auditingp. 95
Why This Chapter Is Necessaryp. 95
Getting to the Real Issuesp. 95
The Modern Approachp. 96
Getting to the Right Peoplep. 96
Overenthusiastic Escortsp. 97
Sampling Evidencep. 98
What Makes a Good Auditor?p. 99
What Makes a Bad Auditor?p. 100
A Question of Ethicsp. 100
Things That Can Go Wrong, Ethically Speakingp. 101
Chapter 8 The Opening Meetingp. 103
Why the Opening Meeting Is Necessaryp. 103
Preparing for the Opening Meetingp. 103
Arriving for the Meetingp. 104
The Introductionsp. 104
The Purposep. 105
Working through the Program and Confirming Administrative Arrangementsp. 105
The Feedback of Resultsp. 105
Fixing the Time and Attendees for the Closing Meetingp. 106
Handling Questionsp. 106
Things That Can Go Wrongp. 107
Chapter 9 The Audit Processp. 109
Remember Why You Are Therep. 109
Questioning Stylep. 109
Personal Demeanourp. 110
Elephants Have Good Memories; Auditors Make Notesp. 111
Objective Evidencep. 112
Auditor Tacticsp. 113
Auditee Tacticsp. 114
Things That Can Go Wrongp. 115
Chapter 10 Reporting Findings and Nonconformitiesp. 117
How and When to Report Audit Findingsp. 117
Classification of Nonconformitiesp. 118
Wording of Potential Nonconformitiesp. 126
Chapter 11 The Closing Meetingp. 143
This Is Not Like the Opening Meetingp. 143
The Agenda of the Closing Meetingp. 143
The Introductionp. 144
Complimentsp. 144
The Disclaimerp. 144
The Overviewp. 144
The Detailed Findingsp. 145
Agreement on the Need for Corrective Actionp. 146
Recommendationp. 147
The Report Processp. 147
Dealing with Questionsp. 148
Things That Can Go Wrongp. 149
Chapter 12 Corrective Actionp. 151
What Is Corrective Action?p. 151
The Corrective Action Process: Agreeing on the Need for Corrective Action (Step 1)p. 152
The Auditee's Responsibility (Step 2)p. 154
Agreeing on Corrective Action Time Frames (Step 3)p. 155
Self-Verification of the Effectiveness and Sustainability of the Corrective Action (Step 4)p. 156
Notifying the Auditor (Step 5)p. 156
Verifying the Implementation, Effectiveness, and Sustainability of the Solution (Step 6)p. 156
Formal Closure of the Nonconformity (Step 7)p. 157
Chapter 13 Follow-up and Surveillance Visitsp. 159
The Purpose of the Follow-Up Visitp. 159
Agreeing on the Logistics of the Follow-Up Visitp. 159
Equity of the Follow-Up Visitp. 160
Reporting the Findings of the Follow-Up Visitp. 160
The Purpose of Surveillance Visitsp. 164
To Announce or Not to Announcep. 164
The Dos and Don'ts of Surveillance Visitsp. 165
Chapter 14 The Future of Auditingp. 167
The Paradigm Shift: Setting a New Examplep. 167
Self-Assessmentp. 167
Improving the Value-Adding Contribution of Audit Reportsp. 180
The Impact on the Internal Auditorp. 183
Appendix A Case Study One: The Business Advantages of Effective Auditingp. 189
Appendix B Lessons Learned (Based on Feedback during Auditor/Lead Auditor Courses)p. 197
Appendix C Case Study Two: One Approach to Developing Policy and Objectives and How They May Be Deployedp. 201
Appendix D Typical Action Plan for Implementing ISO 9001:2000p. 207
Appendix E Job Description for an Internal Auditorp. 211
Bibliographyp. 214
Further Readingp. 214
Indexp. 215