Medical Devices - ISO 13485 and ISO 9001

Description

This book is for those who are responsible for seeking compliance with the requirements of the quality management systems standard ISO 13485 on medical devices. There are many aspects of this standard that are identical to ISO 9001, meaning that accredited certification to both standards can be achieved at the same time, relatively easily. In addition the continual improvement aspect of ISO 9001 can offer real gains and competitive advantage to those who manufacture and service medical devices. The book takes the reader through the clauses of both standards, providing essential information on ISO 13485, ISO 9001 and quality management system auditing. Content: Front Matter • Preface • Table of Contents 1. Brief Historical Background to Quality Assurance 2. Quality Standards 3. ISO 13485 Medical Devices and ISO 9001 4. Quality Management Systems (Clause 4) 5. Management Responsibility (Clause 5) 6. Resource Management (Clause 6) 7. Product Realization (Clause 7) 8. Measurement, Analysis and Improvement (Clause 8) 9. Justification for Exclusion of Design and Development 10. Guideline Audit Questions Appendices Figures and Forms