ISO 9001: 2015: Understand, Implement, Succeed!

ISO 9001: 2015: Understand, Implement, Succeed!

by Alka Jarvis, Paul Palmes

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Product Details

ISBN-13: 9780133552508
Publisher: Pearson Education
Publication date: 12/22/2015
Sold by: Barnes & Noble
Format: NOOK Book
Pages: 195
File size: 3 MB

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 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.


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


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