The ISO 9001:2015 Handbook

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ISO 9001:2015 is here. A lot has changed. There's an entirely new structure. New requirements have been added. Old requirements have been updated and moved. Some requirements have been removed. To remain compliant, you've got to transition to the new standard.

Fortunately, you've got access to inside information in this new handbook from Lorri Hunt, Jose Dominguez, and Craig William. All three have spent years in leadership positions on the ISO committee that helped to write the new standard. No one is more qualified to write on ISO 9001:2015 than these three technical experts.

Whether you’re a experienced practitioner or just starting out, this handbook will give you the tools you need to successfully implement, maintain, and effectively manage your ISO 9001:2015-based quality management system.

This in-depth, comprehensive handbook will:

  • Help you understand why and how the standard was updated
  • Give you an in-depth clause-by-clause analysis, telling you how to interpret the requirements
  • Show you what you need to do to transition to the new standard
  • Explain how to implement ISO 9001:2015
  • Provide a methodology to successfully integrate ISO 9001:2015 into your existing quality management and other management system standards such as ISO 14001.
  • Detail ISO 9001:2015's new documented information requirements, incluiding how policies and procedures are treated
  • Show you how to not only engage but also excite leadership about ISO 9001:2015
  • Help you add value to your quality management system through conducting effective internal audits, managing costs, and conducting management reviews

You'll also learn about:

  • The standards development process
  • ISO 9000:2015
  • ISO 9001:2015's relationship to other excellence models, such as the Baldrige Award
  • Annex SL

The book is divided into five parts:

Part I: Overview of ISO 9001:2015

  • Understanding ISO 9001:2015
  • The Seven Quality Management Principles

Part II: Clause-by-Clause Analysis

  • Introduction
  • Process Approach
  • Clause 4
  • Clause 5
  • Clause 6
  • Clause 7
  • Clause 8
  • Clause 9
  • Clause 10

Part III: Transition

  • Transition from ISO 9001:2008 to ISO 9001:2015
  • ISO 9001:2015 to ISO 9001:2008 Correlation Matrix

Part IV: Implementation and Integration

  • Implementation
    • Certification vs. Declaration of Conformity
    • Accreditation and Certification
    • Implementation Plan – Explanation of Actions
    • Benefits of Implementation
    • Establishing Leadership Commitment
    • Third-Party Audits
  • Integrating Multiple Management System Standards (e.g., ISO 9001, ISO 14001)
    • Leveraging Annex SL to Help Implementing Multiple Management Systems
  • Documented Information/Procedure Writing
  • Engaging Leadership
    • Update on Quality Management Principles
    • How to Engage Management in the QMS
  • Adding Value to the QMS
    • Internal Audits
    • Managing Costs
    • Conducting a Management Review that Adds Value

Part V: Appendices

  • Integrated Management System Standards
  • The Relationship Between ISO 9001 and ISO 14001
  • Compliance Standards vs. Excellence Models
  • ISO 9000 Family of Standards
  • Quality Management System Checklist

About the Authors

Lorri Hunt is an active member of the U.S. Technical Advisory Group to ISO Technical Committee 176. She is co-convener for the working group responsible for the ISO 9001:2015 revision, ISO/TS 9002, and the ISO 9001 for Small Business handbook. This international participation provides insight on the meaning of ISO 9001 requirements based upon discussions held during the drafting of ISO 9001.

José Domínguez currently serves as director of Plexus Mexico and as a board member of the Latin American Institute of Quality (INLAC). He has served as an expert for ISO/TC 176, Quality Management since 1998. He is co-convener of the working group responsible for the revision of ISO 9001, ISO/TS 9002, and the ISO 9001 for Small Business handbook.

Craig Williams is currently global total quality principal leader for Johnson Controls. He is currently the convener for ISO/TC176/SC1/WG1. Within this role he led the revision process for ISO 9000:2015. He is an active member and has served as chair of the Automotive Industry Action Group (AIAG) Quality Steering Committee.

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