History and Current Status of ISO 13485?

A

Alf Gulford

#21
ISO GUY-

I think we pretty well agree on everything here, including a point that you brought up previously: If you can say that you're registered to both - why not do it?

One of the issues we're still struggling with is the ISO 9001 name recognition. Even though we can say that ISO 13485 does everything we need, hardly anyone knows what it is. There's still a possibility that our marketing folks around the world will object to losing that sales tool. That's why we haven't made the absolutely final decision yet.

Alf
 
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G

Greg Maggard

#22
Let me see if I get this understanding of IOS 13485. This is all new to me.
The place I work is a rubber MFG for medical and Automotive.
I want to set our goals and systems for TS16949, ok Now I hear I need ISO 13485 to be compliant with Medical????????:confused: :smokin:
Is this for internal use medical products or extrnal products.
Here is my site with most of our products www.kokokuintech.com
:truce: :truce: Help me understand if I am going to be required.
 
A

Alf Gulford

#23
Hi, Greg-

I'm buggin' out early today but I just saw your post and wanted to give at least a quick answer.

Not necessarily (how's that?)

A lot depends on where you sell your medical device products. If you're selling in Canada you need to have ISO 13485 included in your ISO 9001 registration scope by January, 2003. If you conform to EN 46001 you're about 90% there already.

If you're selling in Europe you need to conform to the Medical Device Directive (MDD) that requires that you, in turn, conform to a recognized quality system (my wording may not be precise, I'm in a hurry). Currently, ISO 9001/2 is about the only one that's really recognized.

In a year or so, you'll have the option of using either ISO 9001 or ISO 13485 to meet the MDD requirements (ISO 13485 doesn't have the infamous Customer Satisfaction and Continual Improvement additions). BUT - you'll still have to have ISO 13485 for Canada. That's why a lot of us are turning away from ISO 9001 in favor of ISO 13485.

If you like, we can pick this up again in a few days. The grandkids are coming over and I haven't even started decorating the tree.

Merry Christmas!

Alf


Hey, Greg-

What about the FDA? I was halfway out the door when I realized we hadn't mentioned the FDA. They use ISO 13485 as a medical device add-on so your company should already be familiar with, and conforming to, the additional requirements. Just add my above statements to this.

Alf
 
Last edited by a moderator:
A

Alf Gulford

#24
An FYI for anyone this affects.

There now appears to be a newly updated version of ISO 13485 available (ISO DIS 13485). Global Engineering Documents shows it as a 02/21/02 dated document so it must be the one I've been waiting for. I haven't seen or heard anything about it yet so have no idea what kind of changes might there. What concerns me is that the usual ISO pattern is to follow-up the DIS version with an FDIS and then the 'approved' version (i.e.; more changes to come?).

Anyone - please let me know if you have any info on this.

Thanks.

Alf
 
A

Aaron Lupo

#25
AG,
Yes that is the same copy I have 02/21/02, the previous one was 06/15/01. I have compared the two documents and they are 99.99% the same not much has really changed since the June release. What they did was not "require" as many procedures the last release 06/15/02 "required 21". I don't see very many changes happening before the final release.
 
A

Alf Gulford

#26
Thanks, ISO GUY-

That's exactly the answer I was hoping for. I heard from the beginning that the final version wasn't expected to change much from the CD version. Maybe that prediction will hold up.

Alf
 
A

Alf Gulford

#27
ISO GUY-

I just got a chance to look through the ISO/DIS 13485 and, for the record, I agree with your opinion of it. The few changes there are (doesn't require a procedure for identifying training needs, does require procedures for design control, etc.) are really moot for us since the FDA requires both anyway.

Hopefully it will be smooth sailing to the final version now.

Alf
 
A

Aaron Lupo

#28
Yes it will be interesting to see what the FDA does. they are supposed to try and follow 13485 but we will see what happens when the FDA does thier revision.

We had an FDA audit yesterday and I am not very happy with the auditor they sent at this point. The auditor didn’t ask question and was very accusatory. But what do you expect from Government, they don't usually hire competent people.
 
A

Alf Gulford

#29
An FDA audit? Verrrry Interesting.

They're so understaffed and over-extended that I don't expect to see them for awhile (but then we're Class 1. It would probably take a serious complaint to bring them in). Presumably you're making Class 2/3 product.

I do have to say that the last investigator I dealt with was pretty reasonable. He was definately digging to get to the bottom of an issue but I never felt like there was a bulls-eye painted on my back.

I have noticed that many of the better [connected] ones get sucked into Industry at several times the government salary (or so the story goes).

Hope your next experience is a better one (and far, far in the future).

Alf
 
G

Greg Maggard

#30
Howdy boys and girls,
I have decided to go for the TS16949 certification. As well as the ISO14001 here at the KU. This will get me started and well on the way to covering all that we manufacture here in the world of rubber. I have recieved an early copy of the second edition for TS and will plan to be certified by December 2002 (both programs)
:smokin: Thanks for the input. I will still try to verify the other.
 
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