Where to buy ISO 13485:2012

[parr05]

I checked the ISO store I couldn't find the 2012 version. Any advise. Thanks.

 

[Sam Lazzara]

Interesting/strange.

In any case I highly recommend that you purchase EN ISO 13485:2012 instead of the pure ISO 13485:2012. Much better value since it includes the ISO version and the recently updated informative annexes.

I always check with BSI to get the scoop on EN/ISO/IEC standards but I tend to purchase what I need through AAMI (cannot get EN's from them though) or the Document Center in California, USA. I recently compared pricing between BSI, Document Center, Tech Street and IHS Global for this standard and unless you are a BSI member, the Document Center had the best pricing.

AAMI has the best pricing for medical device standards on planet earth if you become a member and then subscribe to their standards on CD collection.

I do not work for any of these companies, just sharing my experience. I like to check BSI's info since they indicate whether EN ISO standards are identical to an ISO standard. The ANSI/AAMI/ISO or ANSI/AAMI/IEC standards also indicate their equivalency to the pure ISO/IEC standards.

 

[Marcelo]

There's no ISO 13485:2012.

Only the EN version has a new revision this year.

 

[Ajit Basrur]

Re: Where to buy ISO 13485:2012 ?

Current version is ISO 13485:2003 - http://www.iso.org/iso/catalogue_detail?csnumber=36786 with the stage of 90.92 that indicates it is "International Standard to be revised".

There is a Corrigendum - ISO 13485:2003/Cor. 1 :2009 - http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=54724

There is a ISO 13485 under development - ISO/CD 13485 - http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=59752

There is a EN ISO 13485:2012 published in Mar 2012 - http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030268037

Pls note that the text in the EN ISO 13485:2012 version remains unchanged from ISO 13485:2003 with changes only in the foreword and annexes.

 

[parr05]

Many thanks for the information and links.
We are 3 weeks away from a surveillance audit, and the NB asked us to observe the new version of ISO 13485:2003/2012 to incorporate new demands in our QMS.
If the new revision contains no new requirements, what changes can be done to our QMS? besides revision year.
Any comments are appreciated.

 

[Sam Lazzara]

I need to correct the first post I made in this thread. Here is what I should have stated.

There is no ISO 13485:2012 but if you have current CE marked devices you should be interested in EN ISO 13485:2012. The normative requirements have not changed. The 2012 version has updated informative "Z" annexes that point out the sections of the medical device directives that are not covered by ISO 13485:2003.

Since you have presumably already proven conformance with the directive(s) that apply to your devices, you should not have to make any changes to your QMS (except referencing EN ISO 13485:2012) unless you notice that you do not cover all of the requirements of the directive(s). That would also mean that your prior Notified Body audits and your internal audits did not detect those gaps.

 

[MIREGMGR]

I've been told by AAMI that they will issue a 2012 edition of AAMI/ANSI/ISO 13485 at some point in October or November, and that it will have US nationally specific content.

 

[Marcelo]

I've been told by AAMI that they will issue a 2012 edition of AAMI/ANSI/ISO 13485 at some point in October or November, and that it will have US nationally specific content.

I think this is extremely unlikely. The way the FDA deals with ISO 13485 is by influencing the development of the standard, in the same manner they are influencing it's revision right now.

I'm also at the moment in a meeting with an AAMI officer which also thinks that it's unlikely, but we are still to hear a final word from the direct AAMI officer. Anyway, what we've got at the moment is that AAMI/ANSI/ISO 13485 is, as happens from time to time, under revision, but that it's probably going to be reaffirmed in 2012 without modifications.

 

[MIREGMGR]

Maybe I misunderstood? I talked with their sales folks about a month ago.

 

[Marcelo]

Maybe I misunderstood? I talked with their sales folks about a month ago.

May be so.

I was also last week with the convenor of ISO TC 210 WG 1, who is also the convenor of the AAMI group, and he didn't mention anything related to this.

With the high emphasis the FDA is giving to the IMDRF single-audit program, it would be weird to begin creating "problems" with ISO 13485 right now.

When I get info from AAMI I will post an update.