ISO 9001: 2015: Understand, Implement, Succeed!

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.

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  

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 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.