ISO 9001:2015 improves on the world's most widely used Quality Management Standard (QMS), reflecting current trends in economics, innovation, technology, business, and customer requirements. Using ISO 9001:2015, organizations can prevent and quickly address quality problems, deliver better customer experiences, and improve both profitability and sustainability.
This guide combines a complete critical explanation of ISO 9001:2015's contents, as well as indispensable expert guidance for effective implementation. Two members of the Technical Committee that developed ISO 9001:2015 and ISO 9000:2015 show exactly how it affects your organization, so you can efficiently pass audits and gain or maintain registration.
In modular, building-block format, Alka Jarvis and Paul Palmes clearly present each requirement and the value it delivers. They also offer a logical, structured process for applying ISO 9001:2015 to improve product or service quality.
If you have already implemented ISO 9001:2008, the authors identify each key change, so you can locate gaps and plan an efficient migration. Practical appendixes include reusable templates and audit meeting agendas, plus essential information on documentation. Coverage includes
ISO 9001:2015's business relevance and role in operational excellence
Why revisions were necessary, and how they impact and benefit you
Deepening your understanding of customer/stakeholder needs and expectations
Scoping your QMS in the context of ISO 9001:2015
Understanding leadership's key role
Identifying risks, opportunities, objectives, resources, and competencies
Performing operational activities related to planning, control, requirements, design, and development
Measuring QMS performance
Addressing non-conformities and analyzing their root causes
Promoting ongoing improvement
This guidewill be indispensable to every leader and professional concerned with quality, throughout any organization that holds or seeks ISO 9001 certification.
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ISBN-13
978-0-13-355250-8 (9780133552508)
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Schweitzer Klassifikation
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 http://www.pdcauditing.com. 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.
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
