ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach

ISO-9001:2000 for Software and Systems Providers: An Engineering Approach......Page 1
INTRODUCTION......Page 5
Contents......Page 9
Section I. A Brief Orientation......Page 14
Paragraph 4.1 b: Determine the Sequence of Processes......Page 16
Paragraph 4.1 c: Map the Organization’s Processes against the Standard......Page 18
Paragraph 4.1 e: Monitor and Measure......Page 19
Representing the Implementation Process......Page 20
Recommendations for Implementers: Establishing ISO 9001 as a Framework......Page 21
Principle 1: ISO 9001:2000 Is a Requirements Specification......Page 22
About Registrars and Their Auditors......Page 23
Principle 3: Manage the Implementation as if It Were Product Development......Page 24
Points To Focus on for Maintainers......Page 25
To Register or Not To Register?......Page 26
Selecting a Registrar......Page 27
About Accreditation......Page 28
About Preassessments.......Page 29
References......Page 32
What Is in a Name: ISO 9000 and Standard......Page 33
Quality and Quality Management System......Page 35
Shall, Should, and Other Formalities......Page 36
Requirements versus Design: How Flexible Is the Standard?......Page 37
Effective......Page 38
Ensure......Page 40
The Purpose of ISO 9001......Page 41
References......Page 42
Section II. ISO 9001: A Paragraph-by-Paragraph Analysis......Page 43
3: The Structure of ISO 9001......Page 45
Eliminate Duplication.......Page 49
The Requirements Unique to Paragraph 4.1......Page 50
About Establish......Page 52
About Outsource.......Page 53
The Required Documents......Page 56
Scope and Exclusions......Page 61
Interactions......Page 62
Implementation Considerations......Page 63
A Suggested Outline and Approach......Page 64
Implementation Considerations......Page 65
Implementation Considerations......Page 66
Retrieval......Page 69
The Documented Procedure......Page 70
References......Page 71
5: Paragraph 5 Management Responsibility......Page 72
Paragraph 5.1 Management Commitment......Page 74
Paragraph 5.2 Customer Focus......Page 76
Paragraph 5.3 Quality Policy......Page 77
More from Dr. Deming.......Page 78
Paragraph 5.4.1 Quality Objectives......Page 79
Implementation Considerations.......Page 80
Policies and Standards for Objectives.......Page 81
Identify Current Objectives......Page 82
Recommend Additions and Modifications.......Page 83
Some Thoughts about Objectives.......Page 84
Paragraph 5.4.2 Quality Management System Planning......Page 86
Maintaining the Integrity of the Quality Management System.......Page 87
Paragraph 5.5 Responsibility, Authority, and Communication......Page 88
Implementation Considerations......Page 89
Implementation Considerations.......Page 90
Implementation Considerations......Page 92
Provide Broad Visibility.......Page 93
Paragraph 5.6 Management Review......Page 94
Implementation Considerations......Page 95
References......Page 97
Paragraph 6.2 Human Resources......Page 98
Paragraph 6.2.2 b: Implementation Considerations for Satisfying Needs......Page 100
Paragraph 6.2.2 c: Implementation Considerations for Evaluating Effectiveness......Page 102
Paragraph 6.2.2 e: Implementation Considerations for Training Records......Page 103
Paragraph 6.3 Infrastructure......Page 104
Implementation Considerations.......Page 105
Implementation Considerations......Page 106
References......Page 107
7: Paragraph 7 Product Realization......Page 108
Related Paragraphs......Page 109
Paragraph 7.2 Customer-Related Processes......Page 110
Types of Requirements.......Page 111
Requirements and Solutions.......Page 112
The Five Activities of Requirements Engineering.......Page 113
Paragraph 7.2.2 Review of Requirements Related to the Product......Page 116
Implementation Considerations.......Page 118
Paragraph 7.2.3 Customer Communication......Page 119
Level of Detail.......Page 121
Implementation Considerations.......Page 122
Plans within Plans.......Page 123
Defining Life Cycle.......Page 124
Describing Life Cycles.......Page 125
Stages of Design and Development.......Page 126
The Plan.......Page 127
Paragraph 7.3.2 Design and Development Inputs......Page 128
Implementation Considerations.......Page 129
Conflicting Requirements and the Ability to Meet Defined Requirements.......Page 130
Implementation Considerations......Page 131
Paragraph 7.3.5 Design and Development Verification......Page 134
Related Paragraphs.......Page 135
Implementation Considerations.......Page 136
Wherever Practicable… .......Page 137
Paragraph 7.3.7 Control of Design and Development Changes......Page 138
Implementation Considerations.......Page 139
Paragraph 7.4 Purchasing—A Brief Note......Page 141
Paragraph 7.5 Production and Service Provision......Page 142
Paragraph 7.5.1 a: Information about Product Characteristics.......Page 143
Paragraph 7.5.1 b: Work Instructions.......Page 144
Paragraph 7.5.1 c: Use Suitable Equipment.......Page 145
When Engineering Produces Product.......Page 146
Paragraph 7.5.1 e: Implement Monitoring and Measurement.......Page 147
Release: Implementation considerations.......Page 148
Release: When Engineering Produces Product.......Page 149
Delivery: Implementation Considerations.......Page 150
Delivery: When Engineering Delivers Product.......Page 151
Postdelivery Activities: Implementation Considerations.......Page 152
Paragraph 7.5.2 Validation of Processes for Production and Service Provision......Page 153
Implementation Considerations.......Page 154
Validation.......Page 155
Paragraph 7.5.2 b: Approval of Equipment......Page 156
Paragraph 7.5.2 c: Use of Specific Methods and Procedures.......Page 157
Paragraph 7.5.2 d: Requirements for Records.......Page 158
Conclusions and Comments about the Selection Criteria and Selection.......Page 159
Paragraph 7.5.3 Identification and Traceability......Page 161
Related Paragraphs.......Page 162
Implementation Considerations for Software and Systems Providers.......Page 163
Paragraph 7.5.4 Customer Property......Page 164
Implementation Considerations.......Page 165
Implementation Considerations.......Page 166
Paragraph 7.4 Purchasing......Page 167
Paragraph 7.4.1 Purchasing Process......Page 168
Implementation Considerations.......Page 169
Partner or Supplier?......Page 171
Paragraph 7.4.2 Purchasing Information......Page 172
Paragraph 7.4.2 a: Requirements for the Approval of Supplied Product.......Page 173
Paragraph 7.4.2 a: Requirements for the Approval of Procedures, Processes, and Equipment.......Page 174
Paragraph 7.4.3 Verification of Purchased Product......Page 175
Supplier Corrective Action and Change Management.......Page 176
Paragraph 7.6 Control of Monitoring and Measuring Devices......Page 177
Implementation Considerations......Page 180
For Software......Page 181
Survey the Equipment, Build and Maintain an Inventory.......Page 182
Find Service Providers......Page 183
References......Page 184
Paragraph 8.1 General......Page 187
Paragraph 8.2.1 Customer Satisfaction......Page 189
Paragraph 8.2.2 Internal Audit......Page 190
Auditor Selection and Qualification.......Page 192
Achieving Independence.......Page 194
Selecting Strategies and Methods.......Page 195
Paragraph 8.2.3 Monitoring and Measurement of Processes......Page 197
Paragraph 8.2.4 Monitoring and Measurement of Product......Page 198
Approval and Configuration Management.......Page 199
Implementation Considerations.......Page 203
Paragraph 8.4 Analysis of Data......Page 204
Implementation Considerations.......Page 205
Paragraph 8.5.1 Continual Improvement......Page 206
Related Paragraphs.......Page 207
Paragraph 8.5.2 Corrective Action......Page 208
Implementation Considerations.......Page 209
Review the Nonconformities.......Page 210
Record the Results of the Action.......Page 211
Corrective Action for Product Problems.......Page 213
Corrective Action for Process Problems.......Page 214
Implementation Consideration.......Page 215
References......Page 216
Appendix A: A Brief History of ISO 9001 from 1987 to 2000......Page 219
About ISO 9000-3......Page 220
Rules for Claiming Conformity under ISO 9001:1987 and ISO 9001:1994......Page 221
References......Page 222
A Problem: Organization or Company?......Page 224
Implications for Software......Page 225
Reference......Page 226
Appendix C: Achieving Compliance with Paragraph 4.1......Page 227
Appendix D: A Template for Procedures......Page 239
About the Company: ABC Systems......Page 245
The Product Life Cycle as a Process Map......Page 246
The Product Life Cycle as a Table of Responsibilities and Deliverables......Page 250
Appendix F: Implementation as a Managed Process......Page 0
Introduction to the Elements of a System......Page 254
Phase 1: Define Requirements......Page 256
Phase 5: Implementation Review......Page 260
Implementation Planning......Page 261
Forward Planning......Page 262
Effort, Method, and Resources......Page 263
The Implementation Plan and Project File......Page 265
The Project File......Page 266
Corrective Action......Page 270
Responsibilities......Page 273
Knowledge, Skills, and Abilities......Page 274
The Implementation Model......Page 275
List of Suggested Procedures To Support a Software Engineering Life Cycle......Page 276
Areas To Consider for Supporting Procedures and Standards......Page 281
References......Page 282
Project Management......Page 283
Quality Control: Verification and Validation......Page 285
Manufacturing and Logistics......Page 286
Business Acquisition......Page 287
Service and Support......Page 289
Appendix H: A Sample Questionnaire for Registrar Selection......Page 299
Exhibit H-1.Registrar questionnaire.......Page 300
Comments and Questions......Page 309
About the Authors......Page 310