Contents
Preface. . . . . . . . . . . . . xvii
Acknowledgments . . . . . . . . . xxiii
Part I: QMS Design Fundamentals. . . . . 1
1 QMS Foundations . . . . . . . . . . 3
1.1 The Relevance of Standards 3
1.2 Core Competencies 4
1.2.1 Core Processes 5
1.2.2 Strategy To Transform Documentation into an Operational System 6
1.3 Selection of a QMS Baseline 7
Endnotes 8
2 The ISO 9001:2000 QMS . . . . . . . . 11
2.1 The ISO 9000 QMS Design Context 11
2.2 Effective QMS Processes 12
2.3 The ISO 9000 QMS Process Model 14
2.3.1 Quality Management System Defined 14
2.3.2 Operational Model for ISO 9001:2000 14
Endnotes 16
3 QMS Continual Improvement Framework . . 17
3.1 Continuous/Continual Improvement Is Inherent 17
3.1.1 Continuous Versus Continual Improvement Concept 17
3.1.2 Quality As a Philosophy 18
3.1.3 Quality As a Scientific Measurement 19
3.1.4 Continual Improvement Is Intrinsic Within the Standard 19
3.1.5 Customer-Driven Orientation 19
3.1.6 Shewhart Cycle 20
3.2 Continuous Improvement Cycle Within Elements 23
3.2.1 Other C/I 23
3.2.2 Further Demonstration 23
3.2.3 Continuous Improvement Cycle 24
3.2.4 Continual Improvement Imperative 24
3.3 Mandatory Documentation Requirements 24
3.3.1 Accreditation Impact on Guidelines 25
3.3.2 QMS Design Methods To Be Presented 28
Endnotes 30
Part II: QMS Documentation Design. . . . 33
4 Recommended QMS Documentation . . . . 35
4.1 Overview of Documentation Requirements 35
4.1.1 Introduction 35
4.1.2 Recommended Documentation Taxonomy 36
4.2 The Four-Tier Pyramid Concept 37
4.2.1 Matrix Format 38
4.2.2 Operational Tiers 38
4.2.3 Guidelines 38
4.2.4 Four Tiers 38
4.2.5 Navigation Is Key 40
4.2.6 Clearly Link Lower Tiers from the Manual 40
4.2.7 Waterfall Effect 40
4.2.8 ISO 9000 Hierarchal Drivers 40
4.3 The ISO 9001:2000 QMS Is To Be Documented 42
4.3.1 Information Channel Management 44
4.3.2 Mandatory Tier II Linkage Requirements 45
Endnotes 47
5 Quality Manual Design . . . . . . . . 49
5.1 A Quality Manual Is a Mandatory Document 49
5.1.1 The Manual Should Be User Friendly 50
5.1.2 A Quality Policy Statement Is a Mandatory Document 51
5.1.3 Statements of Quality Objectives Are Mandatory Documents 51
5.1.4 Example 51
5.1.5 Performance Rate 54
5.2 The Quality Manual Controversy 54
5.2.1 An Issue of Content 54
5.2.2 Manual’s Value 55
5.2.3 Major Gate 56
5.2.4 Competitive Advantage 57
5.2.5 Rationale for an Ineffective Manual 58
5.2.6 Conclusion 58
5.2.7 Observed Root Causes 59
5.3 Strategic Framework for the Manual 60
5.3.1 Unified Approach—Integration of Enterprise Strategy
with Quality Management 60
5.3.2 Unified Business and Quality Policy 60
5.3.3 Proprietary Information 63
5.3.4 The Design of Quality Policy Statements 64
5.3.5 Manual’s Value Within the QMS 65
5.3.6 Prescriptive Versus Paraphrased Methods 65
5.4 Cross-Functional Manual Action Teams 66
5.4.1 Section Experts 66
5.4.2 Ineffectiveness 66
5.5 SHALL Analysis 67
5.5.1 Definition of SHALL 67
5.5.2 Appropriate Response to the SHALLS 67
5.5.3 Scope of Effort 69
5.5.4 Effective Number of SHALLS 69
5.5.5 Method to Count SHALLS 71
5.6 Manual Section Length 73
5.7 Concomitance 73
5.7.1 Requirement 74
5.7.2 Training Example of Concomitance 74
5.7.3 Application 80
5.8 Nonapplicability of Specific SHALLS 81
5.9 Appropriate Detail Level 82
5.9.1 An ISO 9000–Certified Vendor 82
5.9.2 Example #1—On Work Environment 82
5.9.3 Example #2—On Control of Monitoring
and Measuring Devices (Clause 7.6) 83
5.9.4 Example #3—On Internal Audits (Clause 8.2.2) 83
5.9.5 Suggested Rule 84
5.10 Level of Detail in Practice 85
5.10.1 Summary of Quality Policy Statement Attributes 85
5.10.2 Electronic Media Solutions 86
5.11 Pyramid for a Manual 87
5.11.1 Quality Policy 88
5.11.2 Total Quality Policy 88
5.11.3 Elemental Policies and Specific ISO 9001:2000 Requirements 88
5.11.4 Quality Policy Statement Examples 88
5.12 Quality Manual Sequences 89
5.12.1 Four Possible Quality Manual Sequences 89
5.12.2 Direct Sequences 90
5.12.3 Shewhart Sequence 112
5.12.4 Operational Sequence 114
5.12.5 According to Another Standard’s Sequence 117
5.12.6 Comparison of Sequences 121
5.13 Manual Configurations 123
5.13.1 Two Unique Configurations 123
5.13.2 The Stand-Alone Configuration—Model I 123
5.13.3 The Integrated Manual Configuration—Model II 126
5.14 Multidivisional Manuals 129
5.14.1 ISO Management Review—Example of Labels 130
5.14.2 Summary and Conclusion 131
5.15 Sector-Specific Manuals 132
5.15.1 The Accreditation Board Requirements 132
5.15.2 Sector-Specific Quality Policy Statements 133
5.15.3 Current Good Manufacturing Practices Example 134
5.15.4 EN46001/ISO 13485 Example 136
5.16 Potential Manual Readership 138
5.17 Manual Objectives 140
Endnotes 142
6 Process Document Design . . . . . . . 147
6.1 The Process Document 147
6.1.1 The Critical Development of Processes 147
6.1.2 Process Document Application 148
6.2 The Trouble with Tier II 151
6.3 ISO 9000 Quality Plans—Optional 156
6.3.1 Sounds Like a Process 156
6.3.2 Device Master Record Technique 158
6.4 Process Flow Charts 160
Endnotes 162
7 Procedure Design . . . . . . . . . 163
7.1 Some Procedures Are Mandatory Documents 163
7.2 The Special Case of Work Instructions—Optional 164
Endnote 165
8 Forms and the Control of Records . . . . 167
8.1 Forms Versus Records 167
8.1.1 Formats 167
8.1.2 Analytical Linkage 167
8.1.3 Bypasses for Forms 168
8.2 Records Are Mandatory Documents 170
8.2.1 Records As Historical Documents 174
8.2.2 Records As Objective Evidence 174
8.3 The Records Master List 175
8.3.1 Specific Records 175
8.3.2 Records Quantity 177
Endnotes 177
9 Other Mandatory Documents . . . . . . 179
9.1 SHALL Analysis of Other Mandatory Documents 179
9.2 The Special Case of Product Characteristics 180
9.3 Mandatory Organizational Requirements 181
9.3.1 Mandatory Requirements from the Registrar 181
9.3.2 Responsibility and Authority Required by the Standard 182
9.3.3 Job Descriptions 184
9.3.4 Registrar Mandatory Interface Issues 184
9.4 Mandatory Effective Implementation Requirement 185
9.5 Nonmandatory Sensible Requirements 186
9.6 Special Mandatory Requirements 187
9.6.1 Customer Complaints As a Mandatory Requirement 187
9.6.2 Registrar-Mandated Factored-Items Requirement 187
9.7 Mandated Standards and Codes Requirement 188
Endnotes 189
Part III: QMS Implementation . . . . . 191
10 The Quality Manual Scope of Effort . . . . 193
10.1 Estimates 193
10.2 Discussion 194
11 Hub Documents . . . . . . . . . . 197
11.1 Definition 197
11.2 Hub Template 197
12 Quality Manual Issues . . . . . . . . 201
12.1 Hard-Copy Manual Issues 201
12.1.1 Manual Control 201
12.1.2 Manual Revisions 201
12.1.3 Manual Distribution 202
12.2 Online Manual Issues 202
12.2.1 Impact of the Online Manual 202
12.2.2 Key Factors 202
Endnotes 204
13 Leadership. . . . . . . . . . . . 205
13.1 ISO 9000 Stewardship 205
13.2 The Stewards Take Our Temperature 207
13.3 Team Leaders 211
13.3.1 Cross-Functional Team Organization 212
13.3.2 Organizations Without Explicit Design or Quality-Assurance Functions 215
13.3.3 Team Effectiveness 217
13.3.4 Typical Real-Time Action Team Plan 219
13.4 Certification Audits 220
13.4.1 You Cannot Fail 220
13.4.2 Audit Focus 221
13.4.3 Assessor Role 222
13.4.4 Structure of the Audit 223
13.4.5 Audit Plan for Sector-Specific Requirements 225
13.4.6 Tip of the Iceberg 229
13.4.7 Dynamics of the Initial Assessment 229
Endnotes 230
Part IV: QMS Effectiveness . . . . . . 233
14 The Biggest Change in ISO 9001:2000
from ISO 9001:1994 . . . . . . . . . 235
15 Quality Objectives . . . . . . . . . 237
15.1 Quality Objectives Issue 237
15.2 The Components of a Quality Objective 238
15.3 The Framework for Quality Objectives 241
15.4 Universal Quality Objectives Process 242
Endnotes 244
Part V: QMS Styles. . . . . . . . . 245
16 Readership and Form . . . . . . . . 247
16.1 Which Comes First? The Manual, the Processes,
or the Procedures? 247
16.2 Par. 4.2.1 of the Standard 248
16.2.1 Linear Estimate 249
16.2.2 Conclusion 250
Endnote 250
17 The Adverse Effects of Paraphrasing . . . 251
17.1 The Two Classes of Paraphrasing 251
17.1.1 The Issue 251
17.1.2 Classes 251
17.2 Paraphrased Class I Characteristics 252
17.2.1 ISO 10013:1995 252
17.2.2 Discussion on the Direct Method of Paraphrasing—Class I 252
17.3 Paraphrased Class II Characteristics 253
17.3.1 Discussion of the TOC Approach to Paraphrasing—Class II 254
17.3.2 Comment 255
17.4 Conclusions 255
18 Publication Media . . . . . . . . . 259
18.1 Selection of a Publication Media (Hard-Copy
Versus Electronic) 259
18.1.1 Media Types 259
18.1.2 What Should Be the Exact Form of the Documentation System? 260
18.1.3 Control Issue 260
18.1.4 An Example of How to Choose What Is Best for You 261
18.2 Generic Numbering System 262
Endnotes 263
19 Writing Style . . . . . . . . . . . 265
19.1 Contain Paragraphs and Sentences That Are Variable
in Length, but Short 265
19.2 Use Simple Declarative Sentences 265
19.3 Avoid Redundancy, i.e., repeated material 266
19.4 Stress the Active Voice (Subject, Verb, Object) 266
19.5 Clearly Label Section Content 266
19.6 Build a Useful Table of Contents (TOC) 266
19.7 Minimize Organizational Jargon, but
Keep the Industry Language 267
19.8 Write To Be Understood, Not to Impress 268
19.9 Clearly Define Terms 268
19.10 Effectively Link the Reader to Referenced Documents 268
19.11 Use Bullets or Equivalent Symbols Wherever Possible 268
19.12 Avoid Words That End in “ing” 269
19.13 Use the Spell Checker, and Then Don’t Believe It 269
19.14 Use Graphics Whenever Possible for Tables,
Figures, and Flow Charts 269
19.15 Avoid the Future Tense—Stay with the Present Tense 269
Endnotes 270
Part VI: QMS Design Rule Summary . . . 271
20 Issue Resolution . . . . . . . . . . 273
20.1 Proposal 273
20.2 Benefits 276
Endnote 278
21 QMS Documentation and Implementation
Design Rules . . . . . . . . . . . 279
21.1 Design Rule Tables 279
21.2 Closing Invitation to the Case Studies 283 Endnotes 284
Part VII: Two Case Studies . . . . . . 285
22 Case Study #1: The Growth Corporation
Upgrades to ISO 9001:2000 . . . . . . 287
22.1 Choice Point 287
22.1.1 Author’s Introduction 287
22.1.2 An Upgrade Decision 288
22.1.3 The Staff Meets 289
22.1.4 The Upgrade Assessment 290
22.2 Application Notes to the Upgraded Quality Manual 291
22.3 The Upgraded ISO 9001:2000 Quality Manual: Cover Page and Table of Contents 292
22.4 Quality Management System (QMS) 295
22.5 Management Responsibility 306
22.6 Resource Management 317
22.7 Product Realization 320
22.8 Measurement, Analysis, and Improvement 337
23 Case Study #2: Mike’s Advice on
ISO 9001:2000 from the Ground Floor Up . . 349
23.1 The Phone Call 349
23.2 The Certification Plan from the Ground Floor Up 350
Appendix A: ISO 9000 Stewardship
and Team Leader Summary . . . . . . 355
Appendix B: Further Examples of Quality
Policy Statements . . . . . . . . . 357
Appendix C: Checklist for ISO 9001:2000
Element 4.2.3: Control of Documents
Quality Manual Requirements. . . . . . 359
Appendix D: An Example of Excellent’s
Process Flow-Charting Protocol . . . . . 361
About the Author. . . . . . . . . . 363
Index . . . . . . . . . . . . . 365