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View Full Version : Website that lists Certified ISO13485 Registrars


RCW
5th September 2007, 10:46 AM
Does anyone know if there a website that lists certified registars for ISO 13485, similar to what the OASIS website does for aerospace/AS9100??

Le Chiffre
5th September 2007, 11:36 AM
This isn't exactly what you asked for but it's Health Canada's list of registrars that they recognize for the Canadian Medical Device Regs...
http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/list_liste_regist_2_e.html

Sidney Vianna
5th September 2007, 11:37 AM
No, there is no central repository of ACCREDITED CB's for ISO 13485. You would have to go the different Accreditation Bodies websites and search their Directories.

Stijloor
5th September 2007, 12:09 PM
Does anyone know if there a website that lists certified registars for ISO 13485, similar to what the OASIS website does for aerospace/AS9100??

From the ANAB site:

HSB RS-1217904-HSB CT dba HSB Registration Services
IMS-1301643-International Management Systems, Inc.
ISOQAR-1301651-ISOQAR
NQA USA-478089-National Quality Assurance, USA
NSF ISR-1301672-NSF International Strategic Registrations, Ltd.
PJR-551582-Perry Johnson Registrars, Inc.
Stijloor.

Al Rosen
5th September 2007, 01:02 PM
Consider this list of Notified Bodies (http://elsmar.com/Forums/attachment.php?attachmentid=6958&d=1181928075).

Roland Cooke
12th September 2007, 01:29 PM
Just a note of caution, there is no obligation for one registrar/Notified Body to "blindly" accept the certificates of another*, even ones that are accredited.

It is the duty of any subsequent registrar/Notified Body to base their certification decisions on evidence that they have adequate confidence in.

Whilst this might potentially unfairly count against a smaller or newer registrar, at the end of the day it is entirely your decision as the purchaser of the service. Find a provider that will give you not just a certificate, but a certificate that will meet all of your requirements.

So always be a little careful in your selection, especially if you are a supplier/subcontractor seeking ISO13485.


*(There is a clear understanding that EC certs will be universally recognised between Notified Bodies unless there is a good reason not to accept an individual one.)