Written by an implementer, auditor, and expert with decades of experience with ISO 9001, The ISO 9001:2015 Implementation Handbook is the practical guide organizations need.
This book will:
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Provide guidance to organizations, both manufacturing and service, seeking certification to ISO 9001:2015
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Assist currently certified ISO 9001 organizations in upgrading to ISO 9001:2015, while improving their present quality management system (QMS)
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Provide guidance for internal auditors, with audit questions provided for every clause of ISO 9001
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Provide guidance on interpreting ISO 9001:2015 requirements
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Suggest improvements on the formatting of the ISO 9001 standard
The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.
All clauses of the standard are explained in both the context of their difference from the 2008 version and also what they mean for organizations.
Included on an accompanying CD-ROM are extensive and complete internal audit checksheets for ISO 9001:2015 (74 pages in length); check lists to assist the reader in determining the possible external issues, internal issues, and interested parties related to the context of their organization; an ISO 9001:2015 gap analysis vs ISO 9001:2008, and examples of ISO clauses and processes where risk analysis can be applied; and more.
List of Figures and Tables
CD Contents
Preface
Chapter 1 : ISO 9000 History and Chronology
Chapter 2 : The QMS as a Process
Chapter 3 : ISO 9001:2015 Requirements
Chapter 4 : Clause 4 : Context of the Organization
Chapter 5 : Clause 5 : Leadership
Chapter 6 : Clause 6 : Planning
Chapter 7 : Clause 7 : Support
Chapter 8 : Clause 8 : Operation
Chapter 9 : Clause 9 : Performance Evaluation
Chapter 10 : Clause 10 : Improvement
Chapter 11 : Interpretation Guidance : ISO 9001:2015 Standard
Appendix A : ISO 9001:2015 Gap Analysis
Appendix B : Failure Modes and Effects Analysis (FMEA)
Appendix C : Stage-Gate Idea-to-Launch Model
Appendix D : Quality in Healthcare : Five Whys and Five Hows
Appendix E : What is Six Sigma?
Appendix F : What if Lean?
Appendix G : Context of the Organization : Checklists for External and Internal Issues and Interested Parties
References
Index
About the Author
