ISO 13485:2016 : a complete guide to quality management in the medical device industry /

"This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality managemen...

Full description

Bibliographic Details
Call Number:Libro Electrónico
Main Author: Abuhav, Itay (Author)
Format: Electronic eBook
Language:Inglés
Published: Boca Raton : CRC Press, Taylor & Francis, [2018]
Edition:Second edition.
Subjects:
Medical instruments and apparatus industry > Standards.
Quality control.
Quality control > Handbooks, manuals, etc.
Quality Control
Qualité > Contrôle > Guides, manuels, etc.
Médecine > Appareils et instruments > Industrie > Normes.
Qualité > Contrôle.
quality control.
BUSINESS & ECONOMICS > Industries > General.
Handbooks and manuals.
Online Access:Texto completo
Description
Summary:"This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization. This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available. The Second Edition will clarify, explain and demonstrate the new version."--
Item Description:Includes index.
Physical Description:1 online resource (xiii, 877 pages)
Bibliography:Includes bibliographical references and index.
ISBN:9781351000772
1351000772
9781351000796
1351000799
9781351000789
1351000780
9781523118106
1523118105

Similar Items