History and Current Status of ISO 13485?

A

Aaron Lupo

#1
Does anyone know the current status of ISO 13485, I know it was in the process of being revised, but I would like to know if it is a DIS or FDIS?
 
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A

Alf Gulford

#2
I didn’t even know it was being revised until I listened to the April FDA Teleconference yesterday on their website, and now I’m really curious what the future’s going to look like.

According to the current(?) BSI E-Magazine ‘Business Standards,’ ISO 13485 is a draft. A panelist on the FDA broadcast says they hope for an approved version in late 2002 or early 2003, at which time it will fully replace EN 46001.

According to the broadcast, and echoed in the BSI E-magazine article, medical device manufacturers (and maybe all regulated organizations) should start thinking about being certified to the new ISO 13485 instead of ISO 9001:2000. The reasoning seems to be that:

1) We have to stay compliant with all ISO 13485 requirements to sell in Europe, Canada and Australia (and maybe others soon). This includes some documentation requirements that have been dropped from ISO 9001:2000.

2) We do not have to be compliant with such ISO 9001:2000 requirements as:
a) Customer Satisfaction
b) Continual Improvement, etc.


3) Not all regulatory agencies (foreign and FDA) accept ISO 9001:2000 as meeting their requirements.

I’ve never thought about becoming registered to ISO 13485. Presumably it would fulfill the requirement for a quality system as described in Annex II (1) of the European Medical Device Directive.

My big concern is that there is a trend towards integration of ISO 9001 and ISO 14001, demonstrated both by the new 9001 revision and by combining the auditing requirements for both in the upcoming (about 2005) ISO 14969. I even anticipate registration to both management systems being a European CE requirement in about 5 years. If this happens, we’ll have to maintain certification to everything anyway so why not stay with 9001 and just keep 13485 in the scope?

The bottom line is that I’m looking for opinions from medical device futurists:

1) Will it be better to forget ISO 9001:2000 and register to ISO 13485?

2) Will it be better to stay with ISO 9001 (plus 13485) because it will incorporate ISO 14001, or because of the greater name recognition?

3) Other?

I know interest in this subject will be limited and I’ll appreciate any opinions.

Alf
 
A

Aaron Lupo

#3
Did you know that ISO 13485 superseded EN 46001 and ISO 13488 superseded EN 46002. I have also heard that ISO 13485 will not be adopting some of the changes to ISO 9K2K, such as Customer Satisfaction and Continual Improvement.
 
#4
At the recommendation of our registrar (TUV Rheinland), we added ISO 13485 12/96 to the scope of our certificate along with ISO 9001 8/94 and EN-46001 9/96. Our current certificate was issued in March 2001.
 
A

Alf Gulford

#5
Just to stir the pot a little and keep this subject alive, we're now about 80% certain that we'll be registering to ISO 13485:200x instead of 9001 on the next go-round. I don't know yet how it's going to work but it seems reasonable since, as a medical device manufacturer, we have to comply with 13485. And even though Customer Satisfaction, Continual Improvement, etc. are critical in a business sense, we don't want to be audited to those requirements.

I've always disliked seeing the ISO 9000 effort fragmented (if that's the right word) by parallel standards like QS, AS, TL, FS, etc., but I suspect that's going to continue to happen.

By the way, I haven't heard anything about SA 8000 for a year or two. Anybody know if that's picking up any steam or just fading away?

Alf
 
A

Aaron Lupo

#6
Alf,
Just out of curosity who is your notified body/registrar.

It looks like as if 13485/13488 will be released the 1st quarter of 2003 as a stand alone document.
 
A

Alf Gulford

#7
Hi, ISO GUY

We're with BSI and they're recommending that medical device people go 13485. Check their e-magazine article at:

http://www.businessstandards.com/

This is also pretty much what I was hearing in the FDA webcast from last spring (although not as strongly worded).

Alf
 
A

Aaron Lupo

#8
Alf,
That's what I have been hearing and from the looks of thats the way we are going. This after I was being proactive and re-writting or QM for 9K2K when the draft was out LOL.

Also did you know that TUV PS is the only notified body/registrar that can issue an acredited certificate for 13485.
 
A

Alf Gulford

#9
I've spent quite a few hours on a new Quality Manual myself. Fortunately, much of the new 13485 is the same as 9001:2000 so not all of those hours were wasted.

Thanks for the information about TUV. I've been wondering when the registrars would get themselves qualified for this. I'll bet BSI isn't far behind, but probably not all registrars will bother with it.

Alf
 
Last edited by a moderator:
A

Alf Gulford

#10
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
:ko:
 
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