Whats the difference, ISO vs EN ISO Std's

[RG Ohidy]

I need to purchase a couple of standards as EN 46002 is going away and I have to be recertified as my certs are expiring. I have the choice of purchasing an ISO 13488 or EN ISO 13488 standard. Whats the difference? Will I have a problem with my auditor if I reference EN ISO and have the ISO standard? Also, with regards to ISO 13488, this standard was issued in 1996, but from what I am told and have read there is a 2000 version and that it is identical to the 1996 version. So, in looking at standards to purchase, it appears I can only purchase a 1996 version and not the 2000 version. Again, would I run into troulbe with an auditor if I referenced 13488:2000 in my documents and my standard is 13488:1996?
Rich

[Claes Gefvenberg]

Hullo Rich,

Nothing to worry about. EN stands for European Norm, and the contents are exactly the same. The standard in question is simply approved as both international and European norm.

You can also find standards beginning with a third letter combination, like SS-EN ISO.... The example stands for: Swedish Standard, European norm (standard) and International Standard.

/Claes

[howste]

ISO 13485:2003 issued in July replaces both 13485:1996 and 13488:1996. 13488 will be "retired" after the three-year transition period for the new standard. You will probably be better off by going for ISO 13485:2003 instead.

I think that most of your questions can be answered by this pdf document issued by AAMI and ISO/TC 210:
http://www.aami.org/applications/com...ts/210n218.pdf

[Jimmy Olson]

I would agree that you will probably want to look at ISO 13485:2003. There will no longer be an ISO 13488. This version is also designed to be a standalone standard, insteas of requireing 9001 (like the old version did). There have been several discussions here regarding 13485:2003 with some good information and there are some people her that have a pretty good knowledge of it. As always, feel free to ask any questions.

[RG Ohidy]

Thank you all for the comments.
I do have ISO 13485-2003, which I have implemented into my quality system. I was planning on upgrading to this standard during recertification this month, however I can't. According to my registar, as this standard has just been released they have no one that can audit it yet, nor does anybody else. The problem I have now is that I have to back track, as my cert's expire at the end of this month, so I am forced to pursue ISO 13488-1996. Hence the need for these standards. I would blame this problem on myself for not watching this closer, however (isn't there always?), I was focused on the implementation of ISO TS 16949, which I am half way through with our auditors. Fun is. So far so good.

[RG Ohidy]

no comment

[Jimmy Olson]

Originally Posted by Claes Gefvenberg

You can also find standards beginning with a third letter combination, like SS-EN ISO.... The example stands for: Swedish Standard, European norm (standard) and International Standard.

Why does a 'Standard' have multiple designations. Isn't that self-contradicting?

RG Ohidy
Gee no further replies, is pricing a taboo subject?

It's not necessarily a taboo subject, but something that I think some people don't like to talk about. 15k sounds a bit high, but I don't know all the details (is this annual, one time, how many day, what all is included, etc..). Plus all my info is based on 9001, which I know is less expensive than medical. Give it a couple days and I'm sure you will get some responses. It just takes a while sometimes.