CSA PLUS 9001MD : 1998

Preface
1 Foreword
  1.1 IS0 9000: Horizon 2000
  1.2 ISO/TC 176 Mission and Vision
  1.3 IS0 9000 Family in the Year 2000
  1.4 Quality Assurance and Quality Management: 2000
  1.5 Key Strategies
2 Conceptual Overview of the IS0 9000 and 13485 Standards
  2.1 Overview
  2.2 IS0 9001
  2.3 From 9001 to 13485
  2.4 From Voluntary to Mandatory - The Canadian Example
  2.5 Quality Assurance as Minimum Requirements
  2.6 Contacts
3 An Implementation Path
4 Quality system requirements
  4.1 Management responsibility
       4.1.1 Quality policy
       4.1.2 Organization
       4.1.3 Management review
  4.2 Quality system
       4.2.1 General
       4.2.2 Quality system procedures
       4.2.3 Quality planning
  4.3 Contract review
       4.3.1 General
       4.3.2 Review
       4.3.3 Amendment to a contract
       4.3.4 Records
  4.4 Design control
       4.4.1 General
       4.4.2 Design and development planning
       4.4.3 Organizational and technical interfaces
       4.4.4 Design input
       4.4.5 Design output
       4.4.6 Design review
       4.4.7 Design verification
       4.4.8 Design validation
       4.4.9 Design changes
  4.5 Document and data control
       4.5.1 General
       4.5.2 Document and data approval and issue
       4.5.3 Document and data changes
  4.6 Purchasing
       4.6.1 General
       4.6.2 Evaluation of subcontractors
       4.6.3 Purchasing data
       4.6.4 Verification of purchased product
  4.7 Control of customer-supplied product
  4.8 Product identification and traceability
  4.9 Process control
  4.10 Inspection and testing
       4.10.1 General
       4.10.2 Receiving inspection and testing
       4.10.3 In-process inspection and testing
       4.10.4 Final inspection and testing
       4.10.5 Inspection and test records
  4.11 Control of inspection, measuring and test equipment
       4.11.1 General
       4.11.2 Control procedure
  4.12 Inspection and test status
  4.13 Control of nonconforming product
       4.13.1 General
       4.13.2 Review and disposition of nonconforming product
  4.14 Corrective and preventive action
       4.14.1 General
       4.14.2 Corrective action
       4.14.3 Preventive action
  4.15 Handling, storage, packaging, preservation and delivery
       4.15.1 General
       4.15.2 Handling
       4.15.3 Storage
       4.15.4 Packaging
       4.15.5 Preservation
       4.15.6 Delivery
  4.16 Control of quality records
  4.17 Internal quality audits
  4.18 Training
  4.19 Servicing
  4.20 Statistical techniques
       4.20.1 Identification of need
       4.20.2 Procedures
Appendices
Appendix A - List of Key Standards
Appendix B - Glossary of Key Terms from IS0 8402 and IS0 13485
Appendix C - Relationships between Standards
Appendix D - Canadian Quality Assurance Mandatory Requirements
             for Medical Devices
Figures
Tables

Provides both novice and experienced quality practitioners with a concise, user-friendly guide for understanding and implementing the requirements of the two standards ISO 13485 and ISO 13488, which are based on ISO 9001 and ISO 9002 respectively.