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?

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.

Thanks, Danny K.

Any one else?

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).

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 ?

SilverHawk: we have an accreditation for all types of quality/environmental management systems (http://www.bmwa.gv.at/NR/rdonlyres/E956BE3D-B8A9-4922-9A2A-420182E8ED7A/9752/Akkrzmd1.pdf) (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 :bonk:

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 (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html) (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.

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?

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 (http://www.european-accreditation.org/) or IAF (http://www.iaf.nu/) 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 (http://www.ukas.com/about_accreditation/International/international_agreements.asp) you can find some informations on UKAS International and European Recognition Agreements.

Our SGS auditor do not think so. He insisted that we have to have ISO 13485:1996 to get CE mark for our products.
SilverHawk:

Ask him to show you where it says this in the MDD or later legislation. I can't find it.

SilverHawk:
Ask him to show you where it says this in the MDD or later legislation. I can't find it.

100% agree. :tunnel:

I just went through the annexes of all three directives last week (writing new checklists) and it still didn't appeare as a requirement. :cool:

You do not need ISO13485 to get your product CE marked. It most cases it is the easiest route of compliance with the directive. BUT CE marking is a PRODUCT certification NOT a SYSTEM certification and it is down to the company to decide (with the advice of the notified body) the route to conformance.

SGS is also our notified bodt and I just had an audit yesterday and we spoke about ISO13485. This is the situation;

SGS can audit to ISO13485;2003 BUT UKAS has not accredited them to do this yet. So if they audit you against this standard there will be no UKAS mark on it. When they get clearance from UKAS they can then apply the UKAS mark.

There is no big deal about getting accreditation for this standard immediately. We all have to 2006 before ISO13485;1996 is superseeded. So I plan to work to the current standard to the end of 2004 at least, and by that time SGS will be UKAS accredited.

Some additional thoughts:

CE-certification is always doe according to one of the three directives (eg. MDD) and not to a standard.

I already posted a link to the actual list of the harmonized standards (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html). EN ISO 13485:2003 is not a harmonized standard yet.

So there is no need to run after a 13485:2003 certificate, if one wants to have a CE-certification (in none of the directives a standard is directly referenced, nor on any CE-certificate AFAIK).

Wrodnigg, if I have a Class II Sterile Surgical Gloves, pls advise which Annex route, I should follow?

Having an ISO 13485:1996 certification which is valid until 2006, the next surveillance is in July 2004. How would one maintain CE Mark without maintaining QMS? Which annex route that you will advise?

If it is the cheaper and possible route, we will just affix the CE Mark and not going for the surveillance until some CBs has UKAS accreditation.

SilverHawk, as long as you have a valid certificate (in your case ISO 13485:1996 valid until 2006) you should just follow the Annex you have chosen. I do not see an urgent reason for changing the whole system.

You should maintain your QMS, "as usual" and keep on achieving the requirements of the MDD.

Your CB/NB should do his job (monitoring your system).

Which Annex are you following at the moment?

And I am not sure, what you mean with "without maintaining QMS". You have to maintain your QMS, but you do not have to "upgrade" to 13485:2003 until the current standard (EN ISO 13485:2000) is revoked.

But: if you do not follow the yearly surveillance, your certificates are revoked 6 months after the due date.

The European Commission has issued two notes in the Official Journal of the European Communities:
2002/C 182/05 (http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/c_182/c_18220020731en00080008.pdf), 2003/C 32/04 (http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/c_032/c_03220030211en00140014.pdf)
Thus the Commission states that EN 46001/2:1996 are revoked. Therefore the presumption of conformity (compare Article 5 MDD) to EN 46001/2 ends after 2004-03-01. Certificates acc. EN 46001/2 are void after this date.

In the latter document EN ISO 13485/8:2000 are defined as Harmonized Standards for MDD IVDD and AIMDD, they are valid until July 2006 and therefore they are the basis for the presumption of conformity (Article 5 MDD). They can be used as basis for certification of QMS (allthough they are no independent standard and the referenced EN ISO 9001/2 have been revoked by 2003-12-14), certificates have a duration of max. 5 years.

Formally a certificate acc. EN ISO 13485:2003 does not presume conformity becaue this standard is not harmonized yet. Of course it is possible to set up a QMS acc. this standard and achieve conformity with the directives. But there is no need to run after the 2003-version at the moment.

My advice: do, what you have done the last years (do you have a "normal" surveillance ot a re-certification this Summer?), manage your QMS acc. to EN ISO 13485:2000 (which is almost identical to EN 46001:1996) and don't worry.

In other words, we can still stick to our "old" certificate and maintaining it with the annual surveillance audits until 2006.

We adopted Module B (Annex III) and Module D (Annex V) for our CE Mark. Is it right?

What if the customers are asking for ISO 13485:2003? Can we say that several CBs have yet to get their accreditation....

SilverHawk,

I am a little bit courious, because:

Your product "sterile surgical gloves", so they should be a Class IIa Product (Rule 6) (S/31/97 Devices for use in heart surgery; Classification (http://www.donawa.com/3.pdf)).

The path you desciribe (Annex III + V) is primary intended for Class IIb devices (see Article 11 MDD).

Yes, ISO 13485:1996 is a valid (harmonized to MDD as EN ISO 13485:2000) Standard until July 2006, so you can follow this Standard until Juyl 2006.

If you are asked for an ISO 13485:2003 Certificate, you can reply that there is no urgent need for this standard now, and that it is no harmonized standard (to the European Community Directives) at present.

I am not sure if this is still of any interest to SilverHawk, but just to inform that my company will be certified to ISO 13485 : 2003 soon (as soon as i close all the NC and Remark from the last audit in February) by KEMA. Our company had been using KEMA for many years and they travel to KL, M'sia once every 6 months to audit us. If you are interested to have them audit you to ISO 13485:2003, i can provide you the contact number. BTW, i do not work for KEMA. Thought that it would be good to have someone share the cost for the auditor's travelling expenses!!

Dear Zuran,

Thanks. We have decided to go to TUV PS after much delibration with other CBs. This CB is also acceptable by the Canadian agency and FDA.