History of ISO 13485

gunnyshore

Starting to get Involved
#1
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

thanks
Jim
 

Wolf.K

Quite Involved in Discussions
#2
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
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#3
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.
 

yodon

Forum Moderator
Staff member
Moderator
#4
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.
 

Candi1024

Quite Involved in Discussions
#5
For History of the standard, I would think people would be more interested the reason for it's creation, and incidents resulting in changes.
 

yodon

Forum Moderator
Staff member
Moderator
#7
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).
 
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