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
The medical devices sector is highly regulated with standards, rules and legislation.
To help manufacturers negotiate through the minefield of regulations, a brand new book authored by Dennis Green, Medical Devices: ISO 13485 and ISO 9001, has just been published by BSI Business Information.
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.
Many aspects of this standard 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.
This book takes the reader through the clauses of both standards, providing essential information on ISO 13485, ISO 9001 and quality management systems auditing.
Chapter 1: Brief historical background to quality assurance.
Chapter 2: Quality standards.
Chapter 3: ISO 13485 Medical Devices and ISO 9001.
Chapter 4: Quality management systems.
Chapter 5: Management responsibility.
Chapter 6: Resource management.
Chapter 7: Product realization.
Chapter 8: Measurement, analysis and improvement.
Chapter 9: Justification for exclusion of design and development.
Chapter 10: Guideline audit questions.
Appendix 1: Quality management system mandatory procedures.
Appendix 2: Compliance with European Union Directives: Medical Devices.
Appendix 3: References Figures and Forms.
A4 paperback, 194 pages, £50.
