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History of ISO 13485
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History of ISO 13485
History of ISO 13485
History of ISO 13485
History of ISO 13485
History of ISO 13485
History of ISO 13485
History of ISO 13485
History of ISO 13485
History of ISO 13485
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History of ISO 13485


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history, iso 13485 - medical device qms, iso 13485:2016
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  Post Number #1  
Old 13th February 2018, 11:18 PM
gunnyshore's Avatar
gunnyshore

 
 
Total Posts: 13
Please Help! History of ISO 13485

I was asked to put together a quick introduction to the Standard and need to pull together the history of the standard. Here's what I've found so far, do you have any other information?

1996 - first released with the title “Quality System – Medical Devices – Particular requirements for the application of ISO 9001."
2003 - updated and replaced 1st edition and canceled/replaced ISO 13488:1996.
2012 - works started to update the Standard
2016 - March, the new standard was published

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Jim

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  Post Number #2  
Old 14th February 2018, 04:46 AM
Wolf.K

 
 
Total Posts: 64
Re: History of ISO 13485

I looked at our supplier of standards and just went back in time (for the German DIN and/or European Norm EN):

DIN EN ISO 13485 Berichtigung 1:2017-07

DIN EN ISO 13485:2016-08

DIN EN ISO 13485:2012-11 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN]

DIN EN ISO 13485:2010-01 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN

DIN EN ISO 13485:2007-10 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN]

DIN EN ISO 13485:2003-11 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN]

DIN EN ISO 13485:2001-02 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN]

DIN EN 46001:1996-09 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN]

DIN EN 46001:1993-12 [ACHTUNG: DOKUMENT ZURÜCKGEZOGEN]

Titel (Englisch): Quality systems; medical devices; particular requirements for the application of EN 29001; German version EN 46001:1993

DIN EN 46001 - 1993-12 DIN EN 46001 - Beuth.de
Thanks to Wolf.K for your informative Post and/or Attachment!
  Post Number #3  
Old 14th February 2018, 06:21 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,232
Re: History of ISO 13485

European directives required (still voluntary) use of ISO 9000 (EN 29000 in Europe at the time) to fulfill certain requirements of the directives as a harmonized standard. For the medical device sector, it was understood that ISO 9000 was not enough, so a study was developed to define additional requirements. This lead to the development of ISO 46000, which was the application of ISO 9001 (EN 29000) to medical devices, with aims of harmonization to the directives.

It was understood that EN 46000 was important to other countries, so ISO TC 210 was created and ISO TC 210 WG 1 was tasked with creating an international version of EN 46000, which was published as ISO 13485.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #4  
Old 14th February 2018, 03:43 PM
yodon

 
 
Total Posts: 1,144
Re: History of ISO 13485

You may also want to consider the BS EN ISO 13485:2012 version. BSI noted that just compliance to 13485 was not sufficient to be fully compliant with the MDD (or IVD) and added a list of things that need to be considered for full compliance.
Thanks to yodon for your informative Post and/or Attachment!
  Post Number #5  
Old 15th February 2018, 03:51 PM
Candi1024

 
 
Total Posts: 120
Re: History of ISO 13485

For History of the standard, I would think people would be more interested the reason for it's creation, and incidents resulting in changes.
  Post Number #6  
Old 16th February 2018, 12:47 PM
LCordie

 
 
Total Posts: 2
Re: History of ISO 13485

I use the attached diagram to explain the evolution of ISO 9001 to ISO 13485. You might find it useful, but keep in mind it is a high-level summary only.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Review History of ISO 9001 & ISO 13485.pdf (73.2 KB, 102 views)
Thank You to LCordie for your informative Post and/or Attachment!
  Post Number #7  
Old 17th February 2018, 11:34 AM
yodon

 
 
Total Posts: 1,144
Re: History of ISO 13485

Very nice diagram, LCordie, thanks for sharing.

I think it brings up a couple of fairly interesting (well, to nerds like me) points:
1) The 13485 folks chose to NOT adopt the high level structure established in Annex SL.
2) The alignment with regulations was both with the MDD as well as the US FDA QSR (e.g., design transfer).
Thanks to yodon for your informative Post and/or Attachment!
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