ISO 9001: 2000 quality management system design

Title:

Personal Author:

Schlickman, Jay

Publication Information:

Boston : Artech House, 2003

ISBN:

9781580535267

Subject Term:

ISO 9000 Series Standards

Available:*

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010018028	TS156.6 S35 2003	Open Access Book	Book	Searching... Unknown

Customers are demanding it, industry regulations are requiring it, and competitive pressures are making it a must for doing business in the high-tech marketplace. It is ISO 9000 certification and nearly half a million companies worldwide have implemented quality management systems to gain this sought after certification. This guide shows the ins and outs of designing a quality management system that is fully compliant with ISO 9001:2000. It unravels the complexities of the ISO standards so that quality professionals can make the upgrade quickly and effectively. Based on the author's experience of working in ISO certification, the volume can also be used as a tool for quality professionals who must design from scratch quality management systems.

Author Notes

Jay J. Schlickman received his B.S. and M.S. in physics from Northeastern University.

Schlickman is an RAB certified quality management systems lead auditor; an RAB qualified ISO 9001:2000 auditor; a certified Canadian medical devices conformity assessment system auditor; and quality management systems consultant based in Lexington MA. He is a Life Member of the Institute of Electrical & Electronics Engineers (IEEE), a member of the American Physical Society (APS), and a member of the American Society for Quality (ASQ).

050

Preface	p. xvii
Acknowledgments	p. xxiii
Part I QMS Design Fundamentals	p. 1
1 QMS Foundations	p. 3
1.1 The Relevance of Standards	p. 3
1.2 Core Competencies	p. 4
1.3 Selection of a QMS Baseline	p. 7
Endnotes	p. 8
2 The ISO 9001:2000 QMS	p. 11
2.1 The ISO 9000 QMS Design Context	p. 11
2.2 Effective QMS Processes	p. 12
2.3 The ISO 9000 QMS Process Model	p. 14
Endnotes	p. 16
3 QMS Continual Improvement Framework	p. 17
3.1 Continuous/Continual Improvement Is Inherent	p. 17
3.2 Continuous Improvement Cycle Within Elements	p. 23
3.3 Mandatory Documentation Requirements	p. 24
Endnotes	p. 30
Part II QMS Documentation Design	p. 33
4 Recommended QMS Documentation	p. 35
4.1 Overview of Documentation Requirements	p. 35
4.2 The Four-Tier Pyramid Concept	p. 37
4.3 The ISO 9001:2000 QMS Is To Be Documented	p. 42
Endnotes	p. 47
5 Quality Manual Design	p. 49
5.1 A Quality Manual Is a Mandatory Document	p. 49
5.2 The Quality Manual Controversy	p. 54
5.3 Strategic Framework for the Manual	p. 60
5.4 Cross-Functional Manual Action Teams	p. 66
5.5 SHALL Analysis	p. 67
5.6 Manual Section Length	p. 73
5.7 Concomitance	p. 73
5.8 Nonapplicability of Specific SHALLS	p. 81
5.9 Appropriate Detail Level	p. 82
5.10 Level of Detail in Practice	p. 85
5.11 Pyramid for a Manual	p. 87
5.12 Quality Manual Sequences	p. 89
5.13 Manual Configurations	p. 123
5.14 Multidivisional Manuals	p. 129
5.15 Sector-Specific Manuals	p. 132
5.16 Potential Manual Readership	p. 138
5.17 Manual Objectives	p. 140
Endnotes	p. 142
6 Process Document Design	p. 147
6.1 The Process Document	p. 147
6.2 The Trouble with Tier II	p. 151
6.3 ISO 9000 Quality Plans--Optional	p. 156
6.4 Process Flow Charts	p. 160
Endnotes	p. 162
7 Procedure Design	p. 163
7.1 Some Procedures Are Mandatory Documents	p. 163
7.2 The Special Case of Work Instructions--Optional	p. 164
Endnote	p. 165
8 Forms and the Control of Records	p. 167
8.1 Forms Versus Records	p. 167
8.2 Records Are Mandatory Documents	p. 170
8.3 The Records Master List	p. 175
Endnotes	p. 177
9 Other Mandatory Documents	p. 179
9.1 Shall Analysis of Other Mandatory Documents	p. 179
9.2 The Special Case of Product Characteristics	p. 180
9.3 Mandatory Organizational Requirements	p. 181
9.4 Mandatory Effective Implementation Requirement	p. 185
9.5 Nonmandatory Sensible Requirements	p. 186
9.6 Special Mandatory Requirements	p. 187
9.7 Mandated Standards and Codes Requirement	p. 188
Endnotes	p. 189
Part III QMS Implementation	p. 191
10 The Quality Manual Scope of Effort	p. 193
10.1 Estimates	p. 193
10.2 Discussion	p. 194
11 Hub Documents	p. 197
11.1 Definition	p. 197
11.2 Hub Template	p. 197
12 Quality Manual Issues	p. 201
12.1 Hard-Copy Manual Issues	p. 201
12.2 Online Manual Issues	p. 202
Endnotes	p. 204
13 Leadership	p. 205
13.1 ISO 9000 Stewardship	p. 205
13.2 The Stewards Take Our Temperature	p. 207
13.3 Team Leaders	p. 211
13.4 Certification Audits	p. 220
Endnotes	p. 230
Part IV QMS Effectiveness	p. 233
14 The Biggest Change in ISO 9001:2000 from ISO 9001:1994	p. 235
15 Quality Objectives	p. 237
15.1 Quality Objectives Issue	p. 237
15.2 The Components of a Quality Objective	p. 238
15.3 The Framework for Quality Objectives	p. 241
15.4 Universal Quality Objectives Process	p. 242
Endnotes	p. 244
Part V QMS Styles	p. 245
16 Readership and Form	p. 247
16.1 Which Comes First? The Manual, the Processes, or the Procedures?	p. 247
16.2 Par. 4.2.1 of the Standard	p. 248
Endnote	p. 250
17 The Adverse Effects of Paraphrasing	p. 251
17.1 The Two Classes of Paraphrasing	p. 251
17.2 Paraphrased Class I Characteristics	p. 252
17.3 Paraphrased Class II Characteristics	p. 253
17.4 Conclusions	p. 255
18 Publication Media	p. 259
18.1 Selection of a Publication Media (Hard-Copy Versus Electronic)	p. 259
18.2 Generic Numbering System	p. 262
Endnotes	p. 263
19 Writing Style	p. 265
19.1 Contain Paragraphs and Sentences That Are Variable in Length, but Short	p. 265
19.2 Use Simple Declarative Sentences	p. 265
19.3 Avoid Redundancy, [i.e., repeated material]	p. 266
19.4 Stress the Active Voice (Subject, Verb, Object)	p. 266
19.5 Clearly Label Section Content	p. 266
19.6 Build a Useful Table of Contents (TOC)	p. 266
19.7 Minimize Organizational Jargon, but Keep the Industry Language	p. 267
19.8 Write To Be Understood, Not to Impress	p. 268
19.9 Clearly Define Terms	p. 268
19.10 Effectively Link the Reader to Referenced Documents	p. 268
19.11 Use Bullets or Equivalent Symbols Wherever Possible	p. 268
19.12 Avoid Words That End in "ing"	p. 269
19.13 Use the Spell Checker, and Then Don't Believe It	p. 269
19.14 Use Graphics Whenever Possible for Tables, Figures, and Flow Charts	p. 269
19.15 Avoid the Future Tense--Stay with the Present Tense	p. 269
Endnotes	p. 270
Part VI QMS Design Rule Summary	p. 271
20 Issue Resolution	p. 273
20.1 Proposal	p. 273
20.2 Benefits	p. 276
Endnote	p. 278
21 QMS Documentation and Implementation Design Rules	p. 279
21.1 Design Rule Tables	p. 279
21.2 Closing Invitation to the Case Studies	p. 283
Endnotes	p. 284
Part VII Two Case Studies	p. 285
22 Case Study #1: The Growth Corporation Upgrades to ISO 9001:2000	p. 287
22.1 Choice Point	p. 287
22.2 Application Notes to the Upgraded Quality Manual	p. 291
22.3 The Upgraded ISO 9001:2000 Quality Manual: Cover Page and Table of Contents	p. 292
22.4 Quality Management System (QMS)	p. 295
22.5 Management Responsibility	p. 306
22.6 Resource Management	p. 317
22.7 Product Realization	p. 320
22.8 Measurement, Analysis, and Improvement	p. 337
23 Case Study #2: Mike's Advice on ISO 9001:2000 from the Ground Floor Up	p. 349
23.1 The Phone Call	p. 349
23.2 The Certification Plan from the Ground Floor Up	p. 350
Appendix A ISO 9000 Stewardship and Team Leader Summary	p. 355
Appendix B Further Examples of Quality Policy Statements	p. 357
Appendix C Checklist for ISO 9001:2000 Element 4.2.3: Control of Documents Quality Manual Requirements	p. 359
Appendix D An Example of Excellent's Process Flow-Charting Protocol	p. 361
About the Author	p. 363
Index	p. 365

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Table of Contents