Integrating ISO 13485:1996 with ISO 9001:1994

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MiniP

Guest
#1
ISO 13485:1996 with ISO 9001:1994

Hey, I'm so new to this and sooo confused. Hope you guys can help me out.

We want the 13485:1996 but it is not a stand alone so we are using it with ISO 9001:1994 (which expires soon). We only want to be certified for 13485 not 9001. Is this ok or is there a conflict there which I don't see.
 

howste

Thaumaturge
Forum Moderator
#2
Why not get certified to ISO 13485:2003? It is a standalone certification, and you won't have to worry about transitioning to the new standard later.

But, to answer your original question, I believe that you can be certified to 13485:1996 until July 2006 - without the ISO 9001:1994 certification.

Here's a link to an official guidance document from AAMI and ISO/TC210 that confirms what I said above (See 5.2 co-existence period):
http://www.aami.org/applications/committeecentral-app/documents/210n218.pdf
 

Aaron Lupo

Inactive Registered Visitor
#3
howste said:
Why not get certified to ISO 13485:2003? It is a standalone certification, and you won't have to worry about transitioning to the new standard later.

But, to answer your original question, I believe that you can be certified to 13485:1996 until July 2006 - without the ISO 9001:1994 certification.

Here's a link to an official guidance document from AAMI and ISO/TC210 that confirms what I said above (See 5.2 co-existence period):
http://www.aami.org/applications/committeecentral-app/documents/210n218.pdf
That is correct ISO 13485:96 is now a standalone and you can be certified to the 96 version until 07/15/06. However, if you are not yet certified you may as well implement the 13485:2003 version.
 
M

MiniP

Guest
#4
Thanks for the help guys however canyou clear it up a little bit more for me,

so the ISO 13485:1996 will remain valid after Dec. 15, 2003. What if you don't already have the 13485 certificate, or any other ISO certificate. Can you still get the 13485:1996 certificate after Dec and once again that is without having any other certification to go with it such as the ISO 9001.

Oh, and about 13485:2003 I already asked about that before, don't know if you remember but I couldn't find anybody that could audit using 13485:2003.
 

Aaron Lupo

Inactive Registered Visitor
#5
MiniP said:
Thanks for the help guys however canyou clear it up a little bit more for me,

so the ISO 13485:1996 will remain valid after Dec. 15, 2003. What if you don't already have the 13485 certificate, or any other ISO certificate. Can you still get the 13485:1996 certificate after Dec and once again that is without having any other certification to go with it such as the ISO 9001.

Oh, and about 13485:2003 I already asked about that before, don't know if you remember but I couldn't find anybody that could audit using 13485:2003.
Yes, 13485:96 will remain valid even after 12/15/03 and yes you cn still be certified to 13485:96 without having ISO 9001, however, I would suggest if you are not already 13485 Certified that you look to go for 13485:2003, there are numerous Registrars that can audit to 13485:2003 KEMA, NSF-ISR, OMI, Entela I would assume DNV etc...
 

howste

Thaumaturge
Forum Moderator
#6
MiniP said:
Oh, and about 13485:2003 I already asked about that before, don't know if you remember but I couldn't find anybody that could audit using 13485:2003.
I checked with the RAB and they said that they have not approved any registrars to issue certificates to 13485 yet. I know that there are other international accreditation bodies though that have. ISO GUY has listed some, and I believe that BSI is also accredited (probably by UKAS). In any case, I'm sure that when you are ready to be certified to 13485:2003 there will be more than enough registrars to choose from.
 
C

Cathy

Guest
#7
Howeste,

I checked with BSI and they are not UKAS accredited yet. Like all notified bodies over here they all will audit against ISO13485:2003 but none of them have UKAS approval. I'd say it will be at least another 6 months before they get it.

My version of ISO13485:1996 is not standalone. They copy I got through BSI is particular reqs for MD related to ISO9001;1994 and I could not have implemented it on its own!
 
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