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...

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Bibliographic Details
Main Author: Abuhav, Itay, (Author)
Format: eBook
Language: English
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.
elektronické knihy
electronic books
ISBN: 9781351000772
1351000772
9781351000796
1351000799
9781351000789
1351000780
9781523118106
1523118105
9781138039179
1138039179
Physical Description: 1 online resource (xiii, 877 pages)

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Table of contents

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008 180522s2018 flu ob 001 0 eng d
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020 |a 9781351000772  |q (electronic bk.) 
020 |a 1351000772  |q (electronic bk.) 
020 |a 9781351000796 
020 |a 1351000799 
020 |a 9781351000789 
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020 |a 9781523118106  |q (electronic bk.) 
020 |a 1523118105  |q (electronic bk.) 
020 |z 9781138039179  |q (hardcover) 
020 |z 1138039179  |q (print) 
024 7 |a 10.1201/9781351000796  |2 doi 
035 |a (OCoLC)1036204470  |z (OCoLC)1035845363  |z (OCoLC)1048766141  |z (OCoLC)1051420646  |z (OCoLC)1285798961  |z (OCoLC)1287273701  |z (OCoLC)1287868130  |z (OCoLC)1303520521 
100 1 |a Abuhav, Itay,  |e author. 
245 1 0 |a ISO 13485:2016 :  |b a complete guide to quality management in the medical device industry /  |c Itay Abuhav. 
246 3 |a I.S.O 13485:2016 
246 3 |a Complete guide to quality management in the medical device industry 
250 |a Second edition. 
264 1 |a Boca Raton :  |b CRC Press, Taylor & Francis,  |c [2018] 
264 4 |c ©2018 
300 |a 1 online resource (xiii, 877 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
500 |a Includes index. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a "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."--  |c Provided by publisher 
505 0 |a Scope -- Normative references -- Terms and definitions -- Quality management system -- Management responsibility -- Resource management -- Product realization -- Measurement, analysis and improvement. 
504 |a Includes bibliographical references and index. 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Medical instruments and apparatus industry  |x Standards. 
650 0 |a Quality control. 
650 0 |a Quality control  |v Handbooks, manuals, etc. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
776 0 8 |i Print version:  |z 9781138039179  |z 1138039179  |w (DLC) 2017060008  |w (OCoLC)1019842573 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpISOACGQ2/iso-134852016-a?kpromoter=marc  |y Full text 

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