#Iso 13485:2012 iso#
market, which is in 21 CFR part 820, so manufacturers following the ISO should have an easier time expanding.
Here is a comparison of the latest revision to the 2012 version: In this new version, ISO 13485 better covers the requirements needed to export to the U.S. ISO 13485 Presentation for BSI China Event May 2013 Updated 150513_22.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_01.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_02.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_03.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_04.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_05.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_06.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_07.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_08.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_09.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_10.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_11.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_12.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_13.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_14.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_15.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_16.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_17.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_18.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_19.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_20.jpgISO 13485 Presentation for BSI China Event May 2013 Updated 150513_21. This standard will soon be the harmonised standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC (Medical Devices) and 98/79/EC (In. Since the official publication of ISO 13485:2016 on March 1, 2016, the transition of accredited certifications to the new ISO 13485:2016 can now be effected within the scope of a regular surveillance or recertification audit. The most current ISO 13485 version that is used is from 2016.
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