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

Author: Itay Abuhav
Publisher: Boca Raton : CRC Press, Taylor & Francis, [2018] ©2018
Edition/Format:   eBook : Document : English : Second editionView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
(DLC) 2017060008
(OCoLC)1019842573
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Itay Abuhav
ISBN: 9781351000772 1351000772 9781351000796 1351000799 9781351000789 1351000780 9781523118106 1523118105
OCLC Number: 1036204470
Notes: Includes index.
Description: 1 online resource (xiii, 877 pages)
Contents: Scope --
Normative references --
Terms and definitions --
Quality management system --
Management responsibility --
Resource management --
Product realization --
Measurement, analysis and improvement.
Other Titles: I.S.O 13485:2016
Complete guide to quality management in the medical device industry
Responsibility: Itay Abuhav.

Abstract:

"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."--

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