Explains the ISO 9001 standard, ensuring that you develop the understanding necessary to maintain and improve effective and efficient processes for your engineering organization?

Communicates the requirements of ISO 9001 in a framework useful to a variety of readers, regardless of their level of experience or the size of their organizations?

Offers unique insights into the precedents which formed the latest version of the standard, preventing unproductive speculation and analysis?

Proves its effectiveness in delivering bottom-line business benefits to diverse organizations?

Discusses the acronyms, specialized terms, and concepts inherent in an analysis of ISO 9001?

Includes a number of appendices, referenced throughout the volume, that provide background, examples, samples, and reference material

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.

A BRIEF ORIENTATION

An Implementation Roadmap
Paragraph 4.1 a: Identify the Processes
Paragraph 4.1 b: Determine the Interactions
Paragraph 4.1 b: Determine the Sequence of Processes
Paragraph 4.1 c: Map the Organization's Processes against the Standard
Paragraph 4.1 d: Planning and Communication
Paragraph 4.1 e: Monitor and Measure
Paragraph 4.1 f: Execution
Representing the Implementation Process
Charting an Alternate Path through the Paragraphs
Recommendations for Implementers: Establishing ISO 9001 as a
Framework
Recommendations for Maintainers in Software Organizations:
Addressing the Changes
Selecting a Scope
To Register or Not To Register?
Selecting a Registrar

Terminology and Definitions
What Is in a Name: ISO 9000 and Standard
Quality and Quality Management System
Shall, Should, and Other Formalities
Requirements versus Design: How Flexible Is the Standard?
Effective
Ensure
The Purpose of ISO 9001
Registrars and Registration

SECTION II ISO 9001: A PARAGRAPH-BY-PARAGRAPH ANALYSIS

The Structure of ISO 9001
Paragraph 4: Quality Management System
Paragraph 4.1: General Requirements
Paragraph 4.2: Documentation Requirements
Paragraph 4-Summary

Paragraph 5 Management Responsibility
Paragraph 5.1 Management Commitment
Paragraph 5.2 Customer Focus
Paragraph 5.3 Quality Policy
Paragraph 5.4 Planning
Paragraph 5.5 Responsibility, Authority, and Communication
Paragraph 5.6 Management Review

Paragraph 6 Resource Management
Paragraph 6.1 Provision of Resources
Paragraph 6.2 Human Resources
Paragraph 6.3 Infrastructure
Implementation Considerations
Paragraph 6.4 Work Environment

Paragraph 7: Product Realization
Paragraph 7.1 Planning of Product Realization
Paragraph 7.2 Customer-Related Processes
Paragraph 7.3: Design and Development
Paragraph 7.4 Purchasing-A Brief Note
Paragraph 7.5 Production and Service
Paragraph 7.5.2: Validation of Processes for Production and
Service Provision
Paragraph 7.4 Purchasing
Paragraph 7.6: Control of Monitoring and Measuring Devices
Paragraph 7 Conclusions

Paragraph 8: Measurement, Analysis, and Improvement
PARAGRAPH 8.1 GENERAL
Paragraph 8.2 Monitoring and Measurement
Paragraph 8.3 Control of Nonconforming Product
Paragraph 8.4 Analysis of Data Implementation Considerations
Paragraph 8.5 Improvement
Paragraph 8.5.3 Preventive Action

SECTION III THE APPENDICES
Appendix A A Brief History of ISO 9001 from 1987 to 2000
About ISO 9000-3
Rules for Claiming Conformity under ISO 9001:1987 and ISO 9001:1994

Appendix B Rules for Claiming Conformity under ISO 9001:2000
A Problem: Organization or Company?
Implications for Software

Appendix C Achieving Compliance with Paragraph 4.1

Appendix D A Template for Procedures

Appendix E A Case Study: One Approach to Life Cycles
About the Company: ABC Systems
The Product Life Cycle as a Text-Based Procedure
The Product Life Cycle as a Process Map
The Product Life Cycle as a Table of Responsibilities and Deliverables

Appendix F Implementation as a Managed Process
Introduction to the Elements of a System
The Implementation Process
Implementation Planning
The Implementation Plan and Project File
Supporting the Implementation
Corrective Action
Profile of an Implementation Manager
Samples
The Implementation Model
Development Processes and Procedures

Appendix G Mapping the Standard to Core Competencies
Core Processes and ISO 9001
Functional Priorities

Appendix H A Sample Questionnaire for Registrar
Selection
Comments and Questions
About the Authors

Editorial Reviews

"The book is an excellent resource for both implementers and auditors. … A commentary like this book is essential to properly understand the intent of the ISO standard and to implement it as part of a continuous improvement for software and systems engineers. It would be very valuable for an organization that is just beginning to look at the standard. It is also valuable for auditors who have worked with other types of organizations but not engineers. It can be used both as a text for understanding the standard and as a handbook for reference during an audit. [It] should be in the library of everyone using IS 9001:2000 for engineering projects."
- Software Quality Professional