ISO 13485 CMDCAS Registrar Recommendations

Has anyone worked with any of the following registrars for ISO 13485 CMDCAS certification or CE Marking Certification?

BSI, Intertek, KEMA Registered Quality, Lloyds Register QA, Underwriters Lab

Do you have any recommendations for using one over the other or perhaps one I did not list?

We will be pursuing ISO13485 certification this year and I am in the process of choosing a Health Canada recognized registrar. I also am also considering a change to our current CE Marking registrar.

Positive/negative experiences are appreciated.

Thank you,
Quest

We have not used any of the registrars mentioned. We have used QMI for at least 10 years and have a good working relationship.

Quest,

Back in 2002/2003 I was with a company here in California that used BSI and that seemed to work out well. The only problem that we had back then was just with the scheduling and availability. Otherwise BSI seems to be on top of things.

Rick

Also beware of "fly by night" registrars who may not be there next year. If they disappear, so does your registration.

I've experience from TUV and BSI. Both are CMDCAS recognized registrars. I have bad experience from TUV and very good exp from BSI, while for other collegues in other companies its the otherway around. So I guess it is a question of the professianlaity of the persons at the certifying body handling your case.

I recommend you choose the bigger companies (allthough it might be more expensive) since its easier to change to another person handling your case if youre not satisfied with her/him.

ISO 13485 CMDCAS registrar

We have been using SGS for ISO 13485 audit and have been satisfied with the services. SGS is also notified body for Europe.

We just had our 13485 and CMDCAS audit combined with a third party audit for FDA using TUV Rheinland. They were here for one week (one person to do FDA for 4 days joined by a second person to cover 13485 and CMDCAS for one day). They did a great job. We were very pleased with the audit, although it did seem that the auditor was a bit rushed to get everything done in time!

Hope that helps!

I Like SGS, and I like Rolland's answering style.
And we plan to switch all Cert. to SGS (9001, 14001, 18001 and 13485)
So strongly recommend ...SGS.

DRDDO said:

I Like SGS, and I like Rolland's answering style.
And we plan to switch all Cert. to SGS (9001, 14001, 18001 and 13485)
So strongly recommend ...SGS.

Click to expand...

Thanks, DRDDO -
If you don't mind, who are you switching from?

In the UK, we use SGS for CMDCAS registration. It seemed that we needed to identify all of the requirements and find all of the forms and processes to use.

SGS performed the audit in a almost satisfactory manner, but there was no added value.

In my experience, BSI do manage to give added value without compromising their position as an auditor.

Dave