Medical Devices & Healthcare

Dennis Green

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 proformas and essential information on the standards and auditing.

Contents: Preface Background to quality and quality assurance Quality systems standards and quality management systems standards ISO 13485 and ISO 9001 Quality management system Management responsibility Resource management Product realization Measurement, analysis and improvement

Design and development Justifiable exclusions Guideline audit questions                                             A4 paperback 194 pages 2005 ISBN 0 580 45644 7 BSI order ref BIP 2071 BSI

Dennis Green

Contents: Introduction Home documentation Process diagrams Quality management system Management responsibility Resource management Product realization Measurement, analysis and improvement Mandatory procedures for ISO 9001 Guideline audit questions

A4 paperback 146 pages 2005 ISBN 0 580 45645 5 BSI order ref BIP 2072 BSI

Dennis Green

Contents: Introduction Hospital documentation Process diagrams Quality management system Management responsibility Resource management Product realization Measurement, analysis and improvement Design and development: justifiable exclusion

Mandatory procedures for ISO 9001 Clinical audit: guideline questions                                       A4 paperback c.220 pages 2005 ISBN 0 580 45646 3 BSI order ref BIP 2073 BSI