Iso 9001

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