ISO 9001:2000 for software and systems providers: an engineering approach

Select an Action

Place Hold(s)
Add to My Lists
Email
Print

Title:

Personal Author:

Bamford, Robert

Publication Information:

Boca Raton, Fla. : CRC Press, 2004

ISBN:

9780849320637

Subject Term:

ISO 9000 Series Standards

Added Author:

Deibler, William J.

Available:*

Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010064558	TS156.6 B35 2004	Open Access Book	Book	Searching... Unknown

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.

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

Available:*

On Order

Summary

Summary

Table of Contents