ISO 9001

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.

Autorentext

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.

Inhalt

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: Resourc…