Hello, I am a new elsmer user.Apprecite if you can advise me on the following issues:

Would like to know how do I check if any of the Certification Bodies are accredited by UKAS now for ISO 13485:2003.

What if we obtain an unaccreditated certificate from SGS now. Will it be accepted by Canada, US and other European Country?

Hello Melisa,

Welcome to the Cove!!

Do a browse using the Search function as this topic has been raised a few times in the last week. It's one of the best and quickest ways to find what you seek.

More when I get a chance.

Regards,

Kevin

Hello Melisa,

you can check any accreditation in the EC online at:
http://www.european-accreditation.org/ (members and there "database")

Canada is a story on its own. "The canadians" are a little bit mulish although there is a MRA between EC and CAN. Same with the US authorities.

It depends, if you need an acceptance by a company, or an authority.

In many cases certificates which have not been issued by an accredited organization are not accepted.

Special UKAS information can be found at http://www.ukas.com/

regards~ghw

Dear Kevin and ghw,

Thank you for the info. Appreciate it.

Melisa

Melisa,

ghw's call is pretty much what I've come to believe with regard's the Canadian view. However, SGS is a well recognized registrar so while immediate recognition may be in question (country by country), I think that ultimately, you will have full recognition with an SGS registration.

Kevin

Hello, I am a new elsmer user.Apprecite if you can advise me on the following issues:

Would like to know how do I check if any of the Certification Bodies are accredited by UKAS now for ISO 13485:2003.

What if we obtain an unaccreditated certificate from SGS now. Will it be accepted by Canada, US and other European Country?


If you go to www.ukas.com you can do a search, however, i am not sure how complete the list is.

Your other queston- if your Certificate is not accredited it will not be accepted by any of the countries.

The company is ready for ISO 13485:2003 Certification audit but non of the Certification Body (CB) in Malaysia can offer accreditated certificate at this point in time and the EN46002 Cert will be expired soon.

If we go for the 1996 version it will incur extra cost on training & consultancy of the old standard.

This is a big headict. Any of you face the face problem. Kindly share.

Thx and have a nice working day.

Melisa

Check out this post:
http://elsmar.com/Forums/showpost.php?p=64923&postcount=12

It looks like DNV is accredited to issue certificates to 13485:2003 under the Norwegian Accreditation Body. Do they audit in Malaysia?

...I also know some notified bodies, which already have issued 13485:2003 cerfificates together with CE (MD and IVD) certification.

And one of them would definitely audit in Malaysia... ;)

regards~ghw

wrodnigg,

may I know who are the other notify body & certification body that offer ISO 13485:2003accredited certification?
Need to source a CB that can do the audit in January,04.
thx. again

Melisa

melisa,

I am still a little bit curious, what you actually need.

Do you need just an ISO 13485:2003 certificate for your quality management system, or do you need CE certification for one of your products?

You can also contact me at ce@dagegen.org