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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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Boca Raton :
CRC Press, Taylor & Francis,
[2018]
|
| Edición: | Second edition. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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|---|---|---|---|
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| 003 | OCoLC | ||
| 005 | 20231027140348.0 | ||
| 006 | m o d | ||
| 007 | cr |n||||||||| | ||
| 008 | 180522s2018 flu ob 001 0 eng d | ||
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| 020 | |a 1523118105 |q (electronic bk.) | ||
| 020 | |z 9781138039179 |q (hardcover) | ||
| 020 | |z 1138039179 |q (print) | ||
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| 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 | ||
| 037 | |a 9781351000772 |b Ingram Content Group | ||
| 050 | 4 | |a HD9994.A2 | |
| 060 | 4 | |a W 26 | |
| 072 | 7 | |a BUS |x 070000 |2 bisacsh | |
| 082 | 0 | 4 | |a 338.476817610218 |2 23 |
| 049 | |a UAMI | ||
| 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 | ||
| 347 | |a data file | ||
| 588 | |a Online resource; title from PDF title page (EBSCO, viewed May 23, 2018). | ||
| 500 | |a Includes index. | ||
| 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 ACADEMIC - Biochemistry, Biology & Biotechnology | ||
| 650 | 0 | |a Medical instruments and apparatus industry |x Standards. | |
| 650 | 0 | |a Quality control. | |
| 650 | 0 | |a Quality control |v Handbooks, manuals, etc. | |
| 650 | 2 | |a Quality Control | |
| 650 | 6 | |a Qualité |x Contrôle |v Guides, manuels, etc. | |
| 650 | 6 | |a Médecine |x Appareils et instruments |x Industrie |x Normes. | |
| 650 | 6 | |a Qualité |x Contrôle. | |
| 650 | 7 | |a quality control. |2 aat | |
| 650 | 7 | |a BUSINESS & ECONOMICS |x Industries |x General. |2 bisacsh | |
| 650 | 7 | |a Medical instruments and apparatus industry |x Standards. |2 fast |0 (OCoLC)fst01014256 | |
| 650 | 7 | |a Quality control. |2 fast |0 (OCoLC)fst01084966 | |
| 655 | 7 | |a Handbooks and manuals. |2 fast |0 (OCoLC)fst01423877 | |
| 776 | 0 | 8 | |i Print version: |z 9781138039179 |z 1138039179 |w (DLC) 2017060008 |w (OCoLC)1019842573 |
| 856 | 4 | 0 | |u https://appknovel.uam.elogim.com/kn/resources/kpISOACGQ2/toc |z Texto completo |
| 938 | |a EBSCOhost |b EBSC |n 1810314 | ||
| 938 | |a Taylor & Francis |b TAFR |n 9781351000796 | ||
| 938 | |a YBP Library Services |b YANK |n 15365644 | ||
| 938 | |a YBP Library Services |b YANK |n 15501298 | ||
| 994 | |a 92 |b IZTAP | ||