Author(s): D. H. Stamatis
Series: Practical Quality of the Future: What It Takes to Be Best in Class
Publisher: CRC Press
Year: 2021
Language: English
City: Boca Raton
Cover
Half Title
Series Page
Title Page
Copyright Page
Dedication
Table of Contents
List of Figures
List of Tables
Preface
Acknowledgments
Author
Introduction
Chapter 1 Introduction to International Quality Standards
Overview
ISO 9001
General Comments
ISO 9000/9001
Clauses 0–3: Introductory Chapters
Certification
Contents of the ISO 9001:2015 Fifth ed
Clauses 0–3: Introductory Chapters – Non-certifiable
ISO 9001 Documentation Requirements
How to Submit and Maintain Your Required Documentation
Conclusion
ISO 14000
General Comments
Plan–Do–Study (Check)–Act Methodology of EMS
Benefits of ISO 14001
Conformity Assessment
General Structure of ISO 14001:2015
Layout of ISO 14001:2015
Clarification of Concepts
Things That an Auditor Should Be Concerned With
ISO 18001/45001
General Comments
Management Commitment
Worker Involvement
Risk versus Hazard
Structure
ISO 18001
General Comments
ISO 45001
General Comments
Chapter 2 Industrial Standards/Requirements
Overview
Automotive Standard – IATF 16949
Quality Management System + Manufacturing Process + Product Audit = IATF 16949
Customer Satisfaction as a Main Goal
VDA 6
Overview
A Cursory View of the VDA 6.3 Third ed. 2016
AIAG Requirements
Overview
2019 AIAG versus VDA – FMEA
Chapter 3 Customer Specific
Overview
Fiat Chrysler Automotive (FCA)
FCA’s Forever Requirements
FCA’s Specific Requirements
Clause 4: Context of the Organization
Clause 5: Leadership
Clause 6: Planning for the Quality Management System
Clause 7: Support
Clause 8: Operation
Clause 9: Performance Evaluation
Clause 10: Improvement
General Motors Company (GM)
GM’s BIQS System
GM’s Primary Requirements
Ford’s Customer-Specific Requirements
Manufacturing Site Assessment (MSA)
Q1 3 rd ed
Scoring
Specific Requirements on a per Element Basis
Clause 4: Context of the Organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance Evaluation
Clause 10: Improvement
Chapter 4 Documentation
Overview
The Mandatory Documents Required by ISO 9001:2015
A Guide to the Non-mandatory Documentation
What about the Quality Manual?
The Advantages of Creating Quality Manual
How to Submit and Maintain Your Required Documentation
Structure of the Documents
A Computer-Generated Structure Design
Quality System Overview
The Structure of Documentation
The Quality System Manual
Typical Contents of the Quality Manual
Specific Requirements of a Typical Quality Manual
Procedures
Instructions
Contents of Procedures
Formats for Procedure Writing
The Procedure and Instruction Development Process
Effort and Cost
Quality Plans
Procedure for Process Y
Quality Records
Documents for Design Control
Document and Data Control
Production Issues in the Documentation Process
The Body of the Documentation Should Contain the Following Items
Basic Issues of Technical Writing
Production Concerns
Key Items for Auditors to “Watch Far”
Mandatory Documents
Mandatory Records
Chapter 5 Checklists
Overview
Generating a Checklist
A Thematic Approach to a Generic Checklist
General
A Typical Internal Preassessment Survey
A Formal ISO 9001:2015 Checklist
Clause 4: Context of the Organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operations
Clause 9: Performance Evaluation
Clause 10: Improvement
ISO 9001:2015 Mandatory Records
ISO 9001:2015 Mandatory Documents
Checklist for ISO 14000 – Environmental Standards
Overview
The Structure and Content of the Standard
ISO 18001
ISO 45001:2018
Clause 4: Context of the Organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance Evaluation
Clause 10: Improvement
IATF 16949:2016
Clause 4: Context of the Organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operations
Clause 9: Performance Evaluation
Clause 10: Improvement
VDA 6.3
Overview
Individual Evaluation of the Questions and Process Elements
Overall Grade (pp. 53–54, 60 )
Downgrading Rules (p. 61)
References