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

Section I A Brief Orientation Chapter 1 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 Principle 1: ISO 9001:2000 Is a Requirements Specification About Registrars and Their Auditors Principle 2: It Is Easier To Achieve Compliance Than To Maintain Compliance Principle 3: Manage the Implementation as if It Were Product Development Recommendations for Maintainers: Addressing the Changes in ISO 9001:2000 Points To Focus on for Maintainers Selecting a Scope To Register or Not To Register? Selecting a Registrar About Accreditation Selection Criteria Chapter 2 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 Revisited Section II ISO 9001: A Paragraph-by-Paragraph Analysis Chapter 3 The Structure of ISO 9001 Chapter 4 PARAGRAPH 4 Quality Management System PARAGRAPH 4.1 General Requirements Implementation Considerations PARAGRAPH 4.2 Documentation Requirements PARAGRAPH 4.2.1 General [Requirements for Documentation] PARAGRAPH 4.2.2 The Quality Manual PARAGRAPH 4.2.3 Control of Documents PARAGRAPH 4.2.4 Control of Records PARAGRAPH 4—Summary Chapter 5 PARAGRAPH 5 Management Responsibility PARAGRAPH 5.1 Management Commitment PARAGRAPH 5.2 Customer Focus PARAGRAPH 5.3 Quality Policy Implementation Considerations: Beyond ISO 9001 PARAGRAPH 5.4 Planning PARAGRAPH 5.4.1 Quality Objectives PARAGRAPH 5.4.2 Quality Management System Planning PARAGRAPH 5.5 Responsibility, Authority, and Communication PARAGRAPH 5.5.1 Responsibility and Authority PARAGRAPH 5.5.2 Management Representative PARAGRAPH 5.5.3 Internal Communication PARAGRAPH 5.6 Management Review Chapter 6 PARAGRAPH 6 Resource Management PARAGRAPH 6.1 Provision of Resources PARAGRAPH 6.2 Human Resources PARAGRAPH 6.2.2 a: Implementation Considerations for Determining Necessary Competence PARAGRAPH 6.2.2 b: Implementation Considerations for Satisfying Needs PARAGRAPH 6.2.2 c: Implementation Considerations for Evaluating Effectiveness Copyright © 2004 by Taylor & Francis PARAGRAPH 6.2.2 d: Implementation Considerations for Awareness of Quality Objectives PARAGRAPH 6.2.2 e: Implementation Considerations for Training Records PARAGRAPH 6.3 Infrastructure PARAGRAPH 6.4 Work Environment Chapter 7 PARAGRAPH 7 Product Realization PARAGRAPH 7.1 Planning of Product Realization Related Paragraphs Implementation Considerations PARAGRAPH 7.2 Customer-Related Processes PARAGRAPH 7.2.1 Determination of Requirements Related to the Product PARAGRAPH 7.2.2 Review of Requirements Related to the Product PARAGRAPH 7.2.3 Customer Communication PARAGRAPH 7.3 Design and Development PARAGRAPH 7.3.1 Design and Development Planning PARAGRAPH 7.3.2 Design and Development Inputs PARAGRAPH 7.3.3 Design and Development Outputs PARAGRAPH 7.3.4 Design and Development Review PARAGRAPH 7.3.5 Design and Development Verification PARAGRAPH 7.3.6 Design and Development Validation PARAGRAPH 7.3.7 Control of Design and Development Changes PARAGRAPH 7.4 Purchasing—A Brief Note PARAGRAPH 7.5 Production and Service Provision PARAGRAPH 7.5.1 Control of Production and Service Provision PARAGRAPH 7.5.2 Validation of Processes for Production and Service Provision PARAGRAPH 7.5.3 Identification and Traceability PARAGRAPH 7.5.4 Customer Property PARAGRAPH 7.5.5 Preservation of Product PARAGRAPH 7.4 Purchasing PARAGRAPH 7.4.1 Purchasing Process PARAGRAPH 7.4.2 Purchasing Information PARAGRAPH 7.4.3 Verification of Purchased Product PARAGRAPH 7.6 Control of Monitoring and Measuring Devices Implementation Considerations When Equipment Is Found not to Conform to Requirements For Software Establishing a Calibration Program Find Service Providers Implement, Monitor, Follow Up PARAGRAPH 7 Conclusions Chapter 8 PARAGRAPH 8 Measurement, Analysis, and Improvement PARAGRAPH 8.1 General PARAGRAPH 8.2 Monitoring and Measurement PARAGRAPH 8.2.1 Customer Satisfaction PARAGRAPH 8.2.2 Internal Audit PARAGRAPH 8.2.3 Monitoring and Measurement of Processes PARAGRAPH 8.2.4 Monitoring and Measurement of Product PARAGRAPH 8.3 Control of Nonconforming Product PARAGRAPH 8.4 Analysis of Data PARAGRAPH 8.5 Improvement PARAGRAPH 8.5.1 Continual Improvement PARAGRAPH 8.5.2 Corrective Action 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 Phase 1: Define Requirements Phase 2: Design and Develop Phase 3: Test Phase 4: General Implementation Phase 5: Implementation Review Implementation Planning Forward Planning Quality, Cost, Schedule, and Content Copyright © 2004 by Taylor & Francis Effort, Method, and Resources Benefits of a Standard Methodology The Implementation Plan and Project File The Implementation Plan Reporting Progress The Project File Supporting the Implementation Corrective Action Management Responsibility and Authority Profile of an Implementation Manager Responsibilities Knowledge, Skills, and Abilities Personal Attributes Samples The Implementation Model Development Processes and Procedures List of Suggested Procedures To Support a Software Engineering Life Cycle Areas To Consider for Supporting Procedures and Standards Procedure Definition and Construction: The Seven Key Elements Appendix G Mapping the Standard to Core Competencies Core Processes and ISO 9001 Requirements Engineering Project Management Integrated, Interdisciplinary Teams Product Engineering Third-Party Development Quality Assurance Quality Control: Verification and Validation Configuration Management and Document Control Manufacturing and Logistics Service and Support Organizational Change Functional Priorities Business Acquisition Product Development Manufacturing Service and Support Appendix H A Sample Questionnaire for Registrar Selection Comments and Questions