Implementing an ISO 13485 Quality Management System for Medical Devices - Couverture souple

Goodall, Ann

Couverture souple

ISBN 10 : 0580685950 ISBN 13 : 9780580685958

Editeur : BSI British Standards Institution, 2014

A propos du livre

Présentation de l'éditeur

This book provides you with the appropriate background information and all the practically-based guidance you need to confidently tackle an implementation of ISO 13485. It also reviews projects against the requirements of the medical device quality management system requirements. The book is written by Ann Goodall, IVD Product Specialist who gives you her considerable experience of assessing hundreds of medical device manufacturer processes. Reasons to buy your copy: Identify how to specifically address all the challenges in implementing ISO 13485 e.g. whether to outsource, documenting environmental conditions or controlling change Be introduced to the core processes and the enhancements that are required in order to successfully implement ISO 13485 to the degree whereby a notified body, regulator or customer are satisfied that the system fulfils requirements Use the examples to keep up with best practice

Biographie de l'auteur

Ann Goodall is currently working for BSI Healthcare as an IVD Technical Specialist in the IVD team as well as a Lead Assessor for ISO 9001/13485. She also delivers training on ISO 13485 Quality Management Systems. Before joining BSI, she worked for over 30 years in the In Vitro Diagnostic industry after completing her Ph.D at St Mary's Hospital, London. This has included a variety of roles in small and large diagnostic companies including R&D, Quality Assurance and more recently 5 years in Supplier Quality Management working with international suppliers of finished products, to ensure appropriate product quality and quality system interface. Ann was a member of the EDMA Member of Standardisation Quality and Risk Management Working Party for more than 15 years.

Détails de l'édition

• Éditeur: BSI British Standards Institution
• Date d'édition: 2014
• Langue: anglais
• ISBN 10: 0580685950
• ISBN 13: 9780580685958
• Reliure: Broché
• Nombre de pages: 240
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible