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View Full Version : Inputs/Guidance/Information related to ISO 13485 and CE marking


mahasatta2002
15th April 2009, 02:21 PM
Hello everybody,

I have recently registered.

The Elsmar Cove Forum is a late lucky discovery for me.

Better late than never.

I am an ISO 9001,14001,18001,22001 Lead Auditor, recently migrated to the US from

India and also a Trainer qualified to conduct Lead Auditor courses.

Want to qualify to audit Medical Devices and ISMS (ISO 13485 & 27000 (respectively).

Understand I will have to do the Lead Auditor course for both.

Observe that with regards to Information Security Management System there are 3 routes.

1) ISO 27001
2) CISA
3) CISSP

Request further inputs.

ISMS-Which is more preferred? Or which one should be done first?
Recommended Institutions/Certifying Bodies offering these training courses?
Any additional inputs/Guidance/Suggestions.

ISO 13485/CE Marking:
Recommended Institutions/Certifying Bodies offering these training courses?
Any additional inputs/Guidance/Suggestions.

My Best of Wishes to one and all in the Forum.

Madhu.

Marc
16th April 2009, 12:37 AM
Can anyone give any advice on this?

Chris Ford
16th April 2009, 08:26 PM
Hello everybody,

I have recently registered.

The Elsmar Cove Forum is a late lucky discovery for me.

Better late than never.

I am an ISO 9001,14001,18001,22001 Lead Auditor, recently migrated to the US from... <snip>

I'd recommend RAB/QSA (http://www.rabqsa.com/)
and / or BSI (http://www.bsiamerica.com/)

mahasatta2002
17th April 2009, 11:38 AM
Chris,

Thank you for the info./help.

Regards

Madhu