Marc-
In another thread you mentioned wanting to know a little bit about ISO 13485. Sometimes I feel like I only know ‘a little bit’ so, without going into irrelevant history, let me start with this (as I understand it):
[Note to Readers – If you’re not medical device people (and maybe if you are) this will be really boring.]
First the UK created EN 46001/46002 to add significant requirements to ISO 9001/9002 for medical devices. Much of EN 46001/46002 reads “[paragraph#] x.xx.x of EN ISO 9001:1994 applies,” and only adds language where needed for the purpose. This cannot be used as a ‘stand-alone’ document since you have to have ISO 9001/9002 to get complete details.
Then ISO created an almost identical document (ISO 13485/13488) for the same purpose. This is the one the FDA chose to recognize and reference as they harmonized with ISO 9001/9002. Again, it’s not a ‘stand-alone’ document (so now I’m carrying around three sets of standards in my head, ISO 9001, ISO 13485 & FDA 21 CFR, part 820 – terrific!).
Now ISO 9001 has been re-written and re-organized AND added requirements such as measuring customer satisfaction and demonstrating continual improvement. This is where the FDA balked. Not only do they feel that it’s not in their province to regulate companies in these areas, they’re also upset that they spent all that time (and our money) harmonizing their regulations, just to have the rug pulled out from under them. What if they re-write their regulations again to harmonize and ISO 9001 changes drastically in 2005 (and I think it will but that’s another discussion)?
So someone, and I don’t know how this part went, re-wrote ISO 13485 as a complete, stand-alone standard. It’s very close to ISO 9001:2000 in form and content, except for eliminating things like customer satisfaction and continual improvement, and it has the medical device requirements built in – no additional documents (i.e. ISO 9001) required. Equally important, the FDA feels that they can depend on ISO 13485 to remain fairly constant and not veer off into left field like ISO 9001 has done and is likely to continue to do.
At this point, since US medical device manufacturers must comply with FDA and therefore must comply with ISO 13485, it doesn’t make much sense to add ISO 9001 to the mix, unless the name recognition is worth something.
One kink is that the new ISO 13485:200x is currently in the Committee Draft (CD) stage and not expected to approved for another year or so. Barely a year before ISO 9001:1994 goes away. We’ll have to do most of our preparation based on the CD version.
And then there’s Canada. They’re requiring registration to ISO 13485/488:1996 by January 1, 2003. As far as registrars go, currently I think only one, TUV is qualified to register to ISO 13485 in Canada, although several others have applied to the Canadian Medical Devices Conformity Assessment System for approval.
That’s about it. In the last few weeks I’ve upped my estimate to put us at about 95% sure to go with ISO 13485.
Interesting times ahead. And if you’ve actually read down to this point, corrections to this yarn are more then welcome.
Alf