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ISO 9001:2015: Understand, Implement, Succeed!

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ISO 9001:2015: Understand, Implement, Succeed!

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  • Copyright 2016
  • Dimensions: 7" x 9"
  • Edition: 1st
  • eBook (Watermarked)
  • ISBN-10: 0-13-355246-2
  • ISBN-13: 978-0-13-355246-1

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.

Sample Content

Online Sample Chapter

Quality Management Systems: Adding Business Value

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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