1st Edition

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

    324 Pages 32 B/W Illustrations
    by CRC Press

    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

    Biography

    Robert Bamford, William J. Deibler II

    "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