How many CBs have been accredited to perform ISO 13485:2003?

[SilverHawk]

Hi, Let's do another round of couting again. How many CBs have been accredited to perform ISO 13485:2003?

I have freinds calling me to share with their horrific experiences. His company has been certified by one CB under ISO 13488:1996 with UKAS accreditation. For the next surveillance audit and/or upgrade to ISO 13485:2003 in June 2004, but this CB now requested the company to apply for another accreditation scheme (other than UKAS).

I have been told that UKAS has yet to issue any accreditation to any CB in the world for ISO 13485:2003. What's the delay? What's the issue?

How many accredited CBs can really conducted ISO 13485:2003 certification? In the previous thread, DNV was mentioned.... who else?

[DannyK]

Hi,

I know that Intertek has been approved by the Standards Council of Canada to provide registration certificates to ISO 13485:2003. Intertek is the first registrar in Canada to get approval.

[SilverHawk]

Thanks, Danny K.

Any one else?

[wrodnigg]

Hmmm... our accreditation is for "quality management systems", so we do not need to get a special accreditation for 13485:2003. Since we are also notified body (EC-guidelines) I think we are competent enough

But I know, that especially the canadian authorities only accept 13485-certificates "approved" by them (wellcome in the wonderful world of MRAs).

[SilverHawk]

Can TUEV Austria clearify that your organization is a Notified Body and would not be bother to be accredited for ISO 13485:2003? In your own words, if I can read your mind, you are trying to express that as a Notified Body, you are suggest to MDD manufacturers that they are not required to meet the requirments of ISO 13485:2003...yet we can get CE mark for our Class II product????

Pls. forgive me if I "misunderstand" you> You are trying to run down that ISO 13485:2003 is NOT for the purposes of medical device regulations and any QMS is good enough for CE mark registration.

Am I reading correctly that TUEV Austria would be able to issue CE marks for medical devices class II without certifying to ISO 13485:2003....

AM I right to assume that if my products meet the EC-guideliens to affix the CE marks for class II products with only a "QMS" certification and NOT to ISO 13485:2003?

If it is true, we should be writing to you and invited TUEV Austria to certify our Class II product with CE mark? What is your quote ?

[wrodnigg]

SilverHawk: we have an accreditation for all types of quality/environmental management systems (all EA-Scopes 1-39). Therefore our accreditation is not limited to any standard.

I think, there is some kind of knot in our communication

To the other question: You do not need to have a 13485:2003-Certificate to get a CE-Mark, but it helps. ISO 13405:1995 is still a harmonized standard (for some weeks).

And when you follow a harmonized standard, the assumption of conformity helps you and your notified body within the conformity assessment. But you can make your own rules, as long as you fulfill the requirements of the MDD. If you decide not to follow a harmonized standard, you have to demonstrate the conformity to the requirements of the MDD (note: there is no explicit requirement for a 13485 certificate).

One CE-path for a Class II product is Annex III (EC-Type Examination) and Annex IV (EC Verification). In this case you do not need any certified quality management system (but each product/lot is examined by a notified body).

The other thing: you might have problems selling your products without having a 13485-certificate... But you do not need it.

[SilverHawk]

Our SGS auditor do not think so. He insisted that we have to have ISO 13485:1996 to get CE mark for our products. But Annex III and IV route is expensive. We have a CE Mark under SGS - UKAS accreditation.

Now, we wanted to certified to ISO 13485:2003 and SGS could not give us the UKAS accreditation but suggested another accreditation.

Do you think that the CE Notified Body Number will be the same????

It is a delimma. Can I use old Notified Body Number and get a new ISO 13485:2002 with another accreditation scheme? I am confused.

Can Notified Body clear the doubts?

[wrodnigg]

SilverHawk,

I do not think, that a NB can keep the CE-number when switching to another accreditation authority.

A (QMS)13485-certificate is independent from a CE-certification.

You could obtain a 13485-certificate from any EA or IAF accredited Certification Body. The Notified Body should accept this certificate within the CE-certification procedure (they are independent from each other). [We also have customers, which have a QMS-Certificate from an other CB and they do their CE-stuff with us]

Here you can find some informations on UKAS International and European Recognition Agreements.