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ISO 9001: 2015

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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 Index 175

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.

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