Medical Devices: ISO 13485 & ISO 9001

Description

Are you responsible for compliance with ISO 13485 on medical devices? Then this is the book you need.

The book takes an in-depth look at the key standards for quality management relating to medical devices:

    * BS EN ISO 13485:2003 Medical devices. Quality management systems. Requirements for regulatory purposes

    * BS EN ISO 9001:2000 Quality management systems. Requirements

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.

CONTENTS:

* Background to quality and quality assurance

    * Quality systems standards

    * Quality management system

    * Management responsibility

    * Resource management

    * Product realization

    * Measurement, analysis and improvement

    * Design and development

    * Sample forms and documents

    * Guideline audit questions.