Looking for Registrar to audit using ISO 13485:2003

[MiniP]

I'm wondering if anybody knows of a registrar that can audit using the new 13485:2003. The people we were going to go with are still using the old 13485.

Thanks

[Aaron Lupo]

Originally Posted by MiniP

I'm wondering if anybody knows of a registrar that can audit using the new 13485:2003. The people we were going to go with are still using the old 13485.

Thanks

It will more than likely be a little bit before any of the Registrars start auditing to 13485:2003 as they have not received the training yet. Call your current registrar and ask them what there plan is for switching to the new 13485, remember you do have a 3 year transition period.

What registrar do you currently use?

[MiniP]

Well the thing is we are not registered with anybody yet but are planning to, and TUV was our choice.

We bought the ISO 13485:2003 and now we find out that TUV would audit using the 1996. We should have checked before we bought the guide I guess, but done is done.

So now it's either find a copy of ISO 13485:1996 or find somebody that can audit with the ISO 13485:2003.

[Aaron Lupo]

Originally Posted by MiniP

Well the thing is we are not registered with anybody yet but are planning to, and TUV was our choice.

We bought the ISO 13485:2003 and now we find out that TUV would audit using the 1996. We should have checked before we bought the guide I guess, but done is done.

So now it's either find a copy of ISO 13485:1996 or find somebody that can audit with the ISO 13485:2003.

Mini, now this is just my opinion so take it for what it is worth. We used to use TUV butwere very unhappy with their services, we expressed this to them and they didn't care so we left them. If it were me I would steer clear of TUV.

If you would like to talk about this off-line drop me a PM.

[Randy]

BSI is offering both training and registration services to ISO 13485:2003.

Check out www.bsiamericas.com for registration services and www.ceem.com for training.

I'm sure there are others out there, I know about this one.

[Sidney Vianna]

You might be right, Randy, but where is the objective evidence?

My point is that Accreditation Bodies, such as RAB, RvA, UKAS, etc., might impose additional training/competence/controls before they accredit a certification Body to a new revision of a Standard, just like it happened when ISO 9001:2000 was released. Both certification bodies and auditors had to be “approved” for the new version of the Standard.

So, with ISO 13485:2003 being a stand-alone document, the AB’s might impose further training before certification bodies are “accredited” and authorized to issue certificates to the new version of the document.

When I look at the RAB website for registrars approved for that Standard (13485), nobody is listed as approved.

When I look at the UKAS website and open BSI’s scope of accreditation for QMS, it is dated August 8th, 2002. Prior to the release of ISO 13485:2003. The document also lists the following sector schemes BSI is approved for:

Sector Scheme Accreditation
Aerospace AS/EN 9100 IAQG Sector Scheme & TS157 Issue 4
Business Links
Land Mobile Radio
#Medical Devices (ISO13485 & ISO 13488)
NATO Codification
QS-9000
TickIT

But unfortunately this UKAS document does not specify the versions of the Standards registrars are accredited for.

Not trying to create controversy, but sometimes there is as disconnect between the Standard development bodies and the Accreditation Bodies.

So far, I have not seen any evidence that certification bodies have been formally accredited for ISO 13485:2003. I believe that the IAF must be evaluating this issue, right now.

[Randy]

I just checked the web site. I don't have any personal info on this and I personally have nothing to gain, but this is what is being advertised.

"Registration to ISO 13485:1996 / ISO 13488:1996 / ISO 13485:2003 takes place when an accredited 3rd party, such as BSI Management Systems visits an organization, assesses the quality management system and if satisfactory issues a certificate confirming that the organization's quality management system meets the requirements of the standard.

Your BSI Quality Management Systems certificate is objective accredited recognized evidence of your companies commitment to quality and helps you demonstrate this to discriminating customers. ISO 13485:1996, ISO 13488:1966 and increasingly ISO 13485:2003 are becoming widely accepted as the international standards to address medical device regulations around the world."

Based upon the above what is your interpretation?

[Sidney Vianna]

I agree with what the text says.

However, I have not seen yet any Registrar formally accredited under any Accreditation Scheme for ISO 13485:2003.

The certificates of accreditation should define the scopes for which each CB is accredited. Unfortunately, as I mentioned above, UKAS, for example does not clarify the editions of the Standards they have accredited the CB's for.

If a Registrar claims that they are accredited for ISO 13485:2003, they should have a certificate of accreditation that CLEARLY indicates that.