ISO 9001

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

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 5.1fj    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,...