MARC Record from Library of Congress

LEADER: 01837nam a22003378a 4500
001 2011022826
003 DLC
005 20110707142809.0
008 110527s2012 flu bf 001 0 eng
010 $a 2011022826
020 $a9781439866115 (hardback : alk. paper)
035 $a(DNLM)101561593
040 $aDNLM/DLC$cDLC
042 $apcc
050 00 $aR856.15$b.A28 2012
060 10 $aW 26
082 00 $a610.284$223
100 1 $aAbuhav, Itay.
245 10 $aISO 13485 :$ba complete guide to quality management in the medical device industry /$cItay Abuhav.
260 $aBoca Raton :$bTaylor & Francis,$c2012.
263 $a1108
300 $ap. ;$ccm.
504 $aIncludes bibliographical references and index.
505 00 $aScope -- Normative references -- Terms and definitions -- Quality management system -- Management responsibility -- Resource management -- Product realization -- Measurement, analysis, and improvement.
520 $a"The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures"--Provided by publisher.
650 0 $aMedical instruments and apparatus$xStandards$vHandbooks, manuals, etc.
650 0 $aMedical instruments and apparatus industry$xQuality control$xStandards$vHandbooks, manuals, etc.
650 12 $aEquipment and Supplies$xstandards.
650 22 $aEquipment Design$xstandards.
650 22 $aManufactured Materials$xstandards.
650 22 $aQuality Control.