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Summary
Summary
Executives, engineering managers, project managers, engineers, and process improvement experts within engineering organizations need a resource that systematically translates the requirements of ISO 9001:2000 into a usable specification for engineers. Understanding ISO 9001:2000 from an engineer's perspective ensures that software, hardware, and systems engineering organizations will continue to develop, maintain and evolve their engineering practices long after the consultants are gone. ISO 9001:2000 for Software and Systems Providers: An Engineering Approach provides proven strategies for using ISO 9001 to implement and revitalize systematic process improvements within software, hardware, and systems engineering organizations.
Written by engineers for engineers, the authors incorporate more than a decade of experience implementing ISO 9001 in engineering organizations of all types. They present a well-defined roadmap that any engineering organization can follow to secure the maximum benefits from the standard. Their roadmap has proven effective in small and large organizations, from Silicon-Valley-based startups to established defense contractors.
This volume dissects and analyzes each paragraph of ISO 9001 from an engineering perspective, clarifying the relationship to engineering practices and the potential benefits to the organization. This volume also stresses the relationships among the paragraphs, which can have a critical impact on the efficiency of the ISO implementation.
Table of Contents
Section I A Brief Orientation | p. 1 |
Chapter 1 An Implementation Roadmap | p. 3 |
Paragraph 4.1 a Identify the Processes | p. 3 |
Paragraph 4.1 b Determine the Interactions | p. 3 |
Paragraph 4.1 b Determine the Sequence of Processes | p. 3 |
Paragraph 4.1 c Map the Organization's Processes against the Standard | p. 5 |
Paragraph 4.1 d Planning and Communication | p. 6 |
Paragraph 4.1 e Monitor and Measure | p. 6 |
Paragraph 4.1 f Execution | p. 7 |
Representing the Implementation Process | p. 7 |
Charting an Alternate Path through the Paragraphs | p. 8 |
Recommendations for Implementers: Establishing ISO 9001 as a Framework | p. 8 |
Principle 1 ISO 9001:2000 Is a Requirements Specification | p. 9 |
About Registrars and Their Auditors | p. 10 |
Principle 2 It Is Easier To Achieve Compliance Than To Maintain Compliance | p. 11 |
Principle 3 Manage the Implementation as if It Were Product Development | p. 11 |
Recommendations for Maintainers: Addressing the Changes in ISO 9001:2000 | p. 12 |
Points To Focus on for Maintainers | p. 12 |
Selecting a Scope | p. 13 |
To Register or Not To Register? | p. 13 |
Selecting a Registrar | p. 16 |
About Accreditation | p. 16 |
Selection Criteria | p. 18 |
Chapter 2 Terminology and Definitions | p. 21 |
What Is in a Name: ISO 9000 and Standard | p. 21 |
Quality and Quality Management System | p. 23 |
Shall, Should, and Other Formalities | p. 24 |
Requirements versus Design: How Flexible Is the Standard? | p. 25 |
Effective | p. 26 |
Ensure | p. 28 |
The Purpose of ISO 9001 | p. 29 |
Registrars and Registration Revisited | p. 30 |
Section II ISO 9001: A Paragraph-by-Paragraph Analysis | p. 31 |
Chapter 3 The Structure of ISO 9001 | p. 33 |
Chapter 4 Paragraph 4 Quality Management System | p. 37 |
Paragraph 4.1 General Requirements | p. 37 |
Implementation Considerations | p. 37 |
Paragraph 4.2 Documentation Requirements | p. 44 |
Paragraph 4.2.1 General [Requirements for Documentation] | p. 44 |
Paragraph 4.2.2 The Quality Manual | p. 49 |
Paragraph 4.2.3 Control of Documents | p. 53 |
Paragraph 4.2.4 Control of Records | p. 56 |
Paragraph 4--Summary | p. 59 |
Chapter 5 Paragraph 5 Management Responsibility | p. 61 |
Paragraph 5.1 Management Commitment | p. 63 |
Paragraph 5.2 Customer Focus | p. 65 |
Paragraph 5.3 Quality Policy | p. 66 |
Implementation Considerations: Beyond ISO 9001 | p. 67 |
Paragraph 5.4 Planning | p. 68 |
Paragraph 5.4.1 Quality Objectives | p. 68 |
Paragraph 5.4.2 Quality Management System Planning | p. 75 |
Paragraph 5.5 Responsibility, Authority, and Communication | p. 77 |
Paragraph 5.5.1 Responsibility and Authority | p. 78 |
Paragraph 5.5.2 Management Representative | p. 79 |
Paragraph 5.5.3 Internal Communication | p. 81 |
Paragraph 5.6 Management Review | p. 83 |
Chapter 6 Paragraph 6 Resource Management | p. 87 |
Paragraph 6.1 Provision of Resources | p. 87 |
Paragraph 6.2 Human Resources | p. 87 |
Paragraph 6.2.2 a Implementation Considerations for Determining Necessary Competence | p. 89 |
Paragraph 6.2.2 b Implementation Considerations for Satisfying Needs | p. 89 |
Paragraph 6.2.2 c Implementation Considerations for Evaluating Effectiveness | p. 91 |
Paragraph 6.2.2 d Implementation Considerations for Awareness of Quality Objectives | p. 92 |
Paragraph 6.2.2 e Implementation Considerations for Training Records | p. 92 |
Paragraph 6.3 Infrastructure | p. 93 |
Paragraph 6.4 Work Environment | p. 95 |
Chapter 7 Paragraph 7 Product Realization | p. 97 |
Paragraph 7.1 Planning of Product Realization | p. 98 |
Related Paragraphs | p. 98 |
Implementation Considerations | p. 99 |
Paragraph 7.2 Customer-Related Processes | p. 99 |
Paragraph 7.2.1 Determination of Requirements Related to the Product | p. 100 |
Paragraph 7.2.2 Review of Requirements Related to the Product | p. 105 |
Paragraph 7.2.3 Customer Communication | p. 108 |
Paragraph 7.3 Design and Development | p. 110 |
Paragraph 7.3.1 Design and Development Planning | p. 110 |
Paragraph 7.3.2 Design and Development Inputs | p. 117 |
Paragraph 7.3.3 Design and Development Outputs | p. 120 |
Paragraph 7.3.4 Design and Development Review | p. 120 |
Paragraph 7.3.5 Design and Development Verification | p. 123 |
Paragraph 7.3.6 Design and Development Validation | p. 126 |
Paragraph 7.3.7 Control of Design and Development Changes | p. 127 |
Paragraph 7.4 Purchasing--A Brief Note | p. 130 |
Paragraph 7.5 Production and Service Provision | p. 131 |
Paragraph 7.5.1 Control of Production and Service Provision | p. 132 |
Paragraph 7.5.2 Validation of Processes for Production and Service Provision | p. 142 |
Paragraph 7.5.3 Identification and Traceability | p. 150 |
Paragraph 7.5.4 Customer Property | p. 153 |
Paragraph 7.5.5 Preservation of Product | p. 155 |
Paragraph 7.4 Purchasing | p. 156 |
Paragraph 7.4.1 Purchasing Process | p. 157 |
Paragraph 7.4.2 Purchasing Information | p. 161 |
Paragraph 7.4.3 Verification of Purchased Product | p. 164 |
Paragraph 7.6 Control of Monitoring and Measuring Devices | p. 166 |
Implementation Considerations | p. 169 |
When Equipment Is Found not to Conform to Requirements | p. 170 |
For Software | p. 170 |
Establishing a Calibration Program | p. 171 |
Find Service Providers | p. 172 |
Implement, Monitor, Follow Up | p. 173 |
Paragraph 7 Conclusions | p. 173 |
Chapter 8 Paragraph 8 Measurement, Analysis, and Improvement | p. 177 |
Paragraph 8.1 General | p. 177 |
Paragraph 8.2 Monitoring and Measurement | p. 179 |
Paragraph 8.2.1 Customer Satisfaction | p. 179 |
Paragraph 8.2.2 Internal Audit | p. 180 |
Paragraph 8.2.3 Monitoring and Measurement of Processes | p. 187 |
Paragraph 8.2.4 Monitoring and Measurement of Product | p. 188 |
Paragraph 8.3 Control of Nonconforming Product | p. 193 |
Paragraph 8.4 Analysis of Data | p. 194 |
Paragraph 8.5 Improvement | p. 196 |
Paragraph 8.5.1 Continual Improvement | p. 196 |
Paragraph 8.5.2 Corrective Action | p. 198 |
Paragraph 8.5.3 Preventive Action | p. 205 |
Section III The Appendices | p. 207 |
Appendix A A Brief History of ISO 9001 from 1987 to 2000 | p. 209 |
About ISO 9000-3 | p. 210 |
Rules for Claiming Conformity under ISO 9001:1987 and ISO 9001:1994 | p. 211 |
Appendix B Rules for Claiming Conformity under ISO 9001:2000 | p. 215 |
A Problem: Organization or Company? | p. 215 |
Implications for Software | p. 216 |
Appendix C Achieving Compliance with Paragraph 4.1 | p. 219 |
Appendix D A Template for Procedures | p. 231 |
Appendix E A Case Study: One Approach to Life Cycles | p. 237 |
About the Company: ABC Systems | p. 237 |
The Product Life Cycle as a Text-Based Procedure | p. 238 |
The Product Life Cycle as a Process Map | p. 238 |
The Product Life Cycle as a Table of Responsibilities and Deliverables | p. 242 |
Appendix F Implementation as a Managed Process | p. 245 |
Introduction to the Elements of a System | p. 246 |
The Implementation Process | p. 248 |
Phase 1 Define Requirements | p. 248 |
Phase 2 Design and Develop | p. 252 |
Phase 3 Test | p. 252 |
Phase 4 General Implementation | p. 252 |
Phase 5 Implementation Review | p. 252 |
Implementation Planning | p. 253 |
Forward Planning | p. 254 |
Quality, Cost, Schedule, and Content | p. 255 |
Effort, Method, and Resources | p. 255 |
Benefits of a Standard Methodology | p. 257 |
The Implementation Plan and Project File | p. 257 |
The Implementation Plan | p. 258 |
Reporting Progress | p. 258 |
The Project File | p. 258 |
Supporting the Implementation | p. 262 |
Corrective Action | p. 262 |
Management Responsibility and Authority | p. 265 |
Profile of an Implementation Manager | p. 265 |
Responsibilities | p. 265 |
Knowledge, Skills, and Abilities | p. 266 |
Personal Attributes | p. 267 |
Samples | p. 267 |
The Implementation Model | p. 267 |
Development Processes and Procedures | p. 268 |
List of Suggested Procedures To Support a Software Engineering Life Cycle | p. 268 |
Areas To Consider for Supporting Procedures and Standards | p. 273 |
Procedure Definition and Construction: The Seven Key Elements | p. 274 |
Appendix G Mapping the Standard to Core Competencies | p. 275 |
Core Processes and ISO 9001 | p. 275 |
Requirements Engineering | p. 275 |
Project Management | p. 275 |
Integrated, Interdisciplinary Teams | p. 277 |
Product Engineering | p. 277 |
Third-Party Development | p. 277 |
Quality Assurance | p. 277 |
Quality Control: Verification and Validation | p. 277 |
Configuration Management and Document Control | p. 278 |
Manufacturing and Logistics | p. 278 |
Service and Support | p. 279 |
Organizational Change | p. 279 |
Functional Priorities | p. 279 |
Business Acquisition | p. 279 |
Product Development | p. 281 |
Manufacturing | p. 281 |
Service and Support | p. 281 |
Appendix H A Sample Questionnaire for Registrar Selection | p. 291 |
Comments and Questions | p. 301 |
About the Authors | p. 303 |
Index | p. 305 |