About the Book
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, organisations 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 analysing their root causes
Promoting ongoing improvement
This guide will be indispensable to every leader and professional concerned with quality, throughout any organization that holds or seeks ISO 9001 certification.
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Table of Contents:
Chapter 1: Quality Management Systems: Adding Business Value
Chapter 2: Executive Overview of Changes Within ISO 9001:2015
Chapter 3: Opportunities to Reevaluate Your Quality Management System
Chapter 4: Making a Compelling Case for Leadership and Governance
Chapter 5: Clause 4: Context of the Organization
Chapter 6: Clause 5: Leadership
Chapter 7: Clause 6: Planning for the Quality Management System
Chapter 8: Clause 7: Support
Chapter 9: Clause 8: Operation
Chapter 10: Clause 9: Performance Evaluation
Chapter 11: Clause 10: Improvement
Chapter 12: Restating the Value Added and Enablement Perspective
Appendix A: The Quality Management Principles
Appendix B: Other Standards
Appendix C: Documentation
Appendix D: Templates
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.