Handbook of Lean ISO 9001 Adding Spark to Your ISO 9001 QMS

ISO Adding Spark to Your ISO 9001 QMS and Sustainability to Your Lean Efforts

Numerous research have confirmed that ISO 9001-registered businesses perform better than non-registered businesses, however a key result in many of these studies revealed that registered businesses do as well regardless of their ISO 9001 registration. Even though it is required for many businesses to hold an ISO 9001 certification, they are not getting the benefits they would expect. Tens of thousands of businesses worldwide are currently engaged in a Lean initiative to cut waste from their processes, which is based on the Toyota Production System. Sustaining the gains made by organizations throughout the deployment of Lean is one of the major issues. Implementing Lean and ISO 9001, according to author Mike Micklewright, are two complementary forces that, when combined, may be a potent force in generating higher profits for any ISO 9001 certified firm. Use this book to streamline your Quality Management System procedures and inject some energy into your sluggish system.

 

Table of Contents

List of Figures and Tables

A Few Things About the Format of This Book

Preface

Acknowledgments

 

Chapter 1 Lean and ISO 9001: Two Complementary Forces

 The Bookends of Lean: The ISO 9001 Quality Management System

• But ISO Is So Boring and Old, and Lean Is So Exciting and New
• The Principles behind ISO 9001 and Lean
• Standardized Tasks Are the Foundation for Continuous Improvement and Employee Empowerment
• ISO 9004 and Lean
• How ISO 9001 and Lean Make Up for Each Other’s Weaknesses
• If They Are So Complementary, Why Are They Not Integrated?

Chapter 2 Leaning Out the Documentation System

• Entropy
• Why Do Documentation Systems Get Fat?
• The Dangers of a Fat QMS
• Origin of Leaning Out the QMS Documentation
• Using 5S to Lean Out Your Quality Management System
• Sorting the QMS Documentation
• Sorting within Procedures
• Internal Auditors Can Help Sort
• Setting the QMS Documentation in Order
• Shining the QMS Documentation
• Standardizing the QMS Documentation
• Lean Procedure and Work Instruction Format
• Sustaining a Lean QMS

Chapter 3 Integrating Lean Practices with the QMS 87

• Work Instructions Addressing Lean Practices
• Auditing for Lean and Gemba Walks
• Lean and Preventive Actions
• Integrating Lean with Quality Planning
• Where Does A3 Fit In?
• Integrating Lean with Management Review
• Integrating Targets with Quality Objectives
• Integrating TWI with Job Competency Requirements

Chapter 4 Leaning Out the QMS Processes

• Waste in Continual Improvement Processes
• Document Control: Speeding Up the Modification and Approval Process
• 5S’ing Files and Folders (A Lean Order Entry Case Study)
• Minimizing the Waste in Record Control
• Minimizing the Waste in Management Review
• Minimizing the Waste in Corrective and Preventive Actions
• Minimizing the Waste in Internal Quality Auditing

Chapter 5 Lean ISO 9001 Maturity Assessment Model 189

Appendix A

Lean and Quality Terms

Appendix B

Abolish the ISO 9001 Registration System,

As It Is, Before It’s Too Late 203

Appendix C

Turtle Diagrams, Registrar Auditors, and

More Waste 211

Appendix D

The Two-Page Quality Manual 219

Appendix E

Ten Signs Your CEO Still Has No Idea About

ISO 9001 (and Maybe Lean) 221

Appendix F

Why Did TWI Die in the United States in the

Late ’40s, and Will It Happen Again?

Endnotes

Index

About Quality Quest, Inc

 

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