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ISO 9001: 2015


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Table of Contents

Preface xi

Acknowledgments xvii

About the Authors xix

Chapter 1: Quality Management Systems: Adding Business Value 1

ISO 9001 and Innovation 3

The Business Call for ISO 9001 4

Chapter 2: Executive Overview of Changes Within ISO 9001:2015 7

Revision Process and Rationale for Structural Changes 10

Understanding Changes: Variance Between ISO 9001:2008 and ISO 9001:2015 13

Impact of Changes on Implementation 15

Constraints of the Revised Structure 19

Benefits of the Revised Structure 19

Transition to ISO 9001:2015 20

Chapter 3: Opportunities to Reevaluate Your Quality Management System 21

Value-Added Restructuring of Your Quality Management System 21

Focus on Competence versus Paperwork 25

Customer Expectations and Quality Certifications 28

Operational Excellence: The Process Approach 30

Operational Excellence: Enabling Business and Innovation 32

Developing a Restructuring Plan: Who, How, and Focusing on "Output Matters!" 34

Self-Assessment Form 36

Chapter 4: Making a Compelling Case for Leadership and Governance 39

The Compliance Model 39

Cost Avoidance 42

Key Performance Indicators 43

A Last Word on Cost 44

Return on Investment 45

Tools, Techniques, and Strategies for Obtaining Management Buy-In 46

Cost of (Poor) Quality 48

Corrective Action and Nonconformance Costs 50

Balanced Scorecard 51

Chapter 5: Clause 4: Context of the Organization 55

Clause 4.1: Understanding the Organization and Its Context 55

Clause 4.2: Understanding the Needs and Expectations of Interested Parties 58

Clause 4.3: Determining the Scope of the Quality Management System 60

Clause 4.4: The Quality Management System and Its Processes 62

Chapter 6: Clause 5: Leadership 69

Clause 5.1: Leadership and Commitment 69

Clause 5.1a: Accountable for Effectiveness 71

Clause 5.1b: Develop and Maintain the Quality Policy and Objectives to Be Compatible with Context (4.1) and Strategic Direction 72

Clause 5.1c: Ensuring the Integration of QMS Requirements into Your Business Processes 72

Clause 5.1d: The Process Approach and Risk-Based Thinking 73

Clause 5.1e: Availability of Resources for the QMS 75

Clauses 5.1f-j 75

Clause 5.2: Quality Policy 76

Clause 5.2.1: Policy 78

Clause 5.2.2: Communicating the Quality Policy 80

Clause 5.3: Organizational Roles, Responsibilities, and Authorities 81

Clauses 5.3a-e 81

Chapter 7: Clause 6: Planning for the Quality Management System 83

Clause 6.1: Actions to Address Risks and Opportunities 84

Clause 6.2: Quality Objectives and Planning to Achieve Them 86

Clause 6.3: Planning of Changes 88

Chapter 8: Clause 7: Support 91

Clause 7.1: Resources 91

Clause 7.2: Competence 95

Clause 7.3: Awareness 96

Clause 7.4: Communication 97

Clause 7.5: Documented Information 98

Chapter 9: Clause 8: Operation 101

Clause 8.1: Operation Planning and Control 101

Clause 8.2: Requirements for Products and Services 104

Clause 8.2.1: Customer Communication 104

Clause 8.3: Design and Development of Products and Services 108

Clause 8.4: Control of Externally Provided Processes, Products, and Services 112

Clause 8.5: Production and Service Provision 114

Clause 8.6: Release of Products and Services 115

Clause 8.7: Control of Nonconforming Outputs 116

Chapter 10: Clause 9: Performance Evaluation 119

Clause 9.1: Monitoring, Measurement, Analysis, and Evaluation 120

Clause 9.2: Internal Audit 124

Clause 9.3: Management Review 127

Chapter 11: Clause 10: Improvement 131

Clause 10.1: General 131

Clause 10.2: Nonconformity and Corrective Action 132

Clause 10.3: Continual Improvement 136

Chapter 12: Restating the Value Added and Enablement Perspective 137

Managing the Quality System 139

Further Improvement Opportunities for Implementers: Business Excellence Methodologies 141

ISO 9001 as a Foundation and Enabler 152

Appendix A: The Quality Management Principles 155

Appendix B: Other Standards 159

Appendix C: Documentation 163

Appendix D: Templates 167

Quality Policy 167

Nonconformance Report 168

Internal Audit Report 169

Opening Meeting of an Audit 172

Audit Interviews 173

Daily Discussion Meetings 173

Closing Meeting 174

Index 175

About the Author

Alka Jarvis has 30 years of experience in software engineering, including 19 spent in total quality management. Her background encompasses management of large scale systems/solutions development, product and process quality assurance, IT security, industry standards and regulations, and corporate training.

She has frequently been an invited speaker on quality assurance topics at international as well as domestic events and has worked in a variety of capacities for Fortune 500 companies such as Cisco Systems, Apple, Bank of America, AT&T, and others.

Alka is an adjunct lecturer in computer engineering at Santa Clara University. She is also an instructor for the software quality courses at U.C. Santa Cruz and U.C. Berkeley Extensions. She won Silicon Valley's "Corporate Woman Advocate of The Year" award for her accomplishments in the software quality field. ASQ in Milwaukee, Wisconsin, recognized Alka by publishing her accomplishments in their "Who's Who in Quality" article.

Ms. Jarvis was named as an expert on Industry 4.0/Smart Manufacturing and represents American National Standard's Institute (ANSI)/US, in the strategic advisory group at the international level, to the ISO's Technical Management Board.

In her role as the chair for the past nine years, representing the United States to the Technical Committee 176 for the International Standards Organization (ISO), Alka has been instrumental in the development of ISO 2000, 2004, and 2008 versions of ISO 9001 and 9004 Standards. She was in the drafting committee of the latest 9001-2015 version and is an ISO Lead Auditor, certified by Exemplar Global of United States.

Ms. Jarvis is currently a member of ASQ's Learning Institute Advisory Board; served as the president of the Bay Area Quality Assurance Association (BAQAA); has been an Applied Total Quality Advisory Board member for UC Berkeley Extension; an advisory board member to the Certificate Program in Continuous Improvement and Quality Management at U.C. Santa Cruz Extension; board member for Quality Assurance Institute; an advisory member for ASQ's 2015 and 2016 International Conference on Quality Standards;, and vice president of the Indian Business and Professional Women.

Paul Palmes is principal consultant with Business Systems Architects, Inc., of Fargo, North Dakota, and Prescott, Wisconsin. Working as a specialist in quality management and world-class quality systems over the past 27 years, he has enabled many organizations to attain ISO 9001 registration and many others to improve profitability and culture. He is a Certified Quality Manager and a BSI Certified Lead Auditor. He is an active podcaster who educates worldwide listeners through his "Quality 101" program series at His many publications include two books, Process-Driven Comprehensive Auditing and The Magic of Self-Directed Work Teams, published by ASQ Quality Press, as well as articles written for ASQ's Quality Progress magazine and the Auditor Newsletter, published by Paton Press. He is currently chairman of ISO TC 176 SC 1, responsible for the revision of ISO 9000.

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