Website that lists Certified ISO13485 Registrars
- Thread starter RCW
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Le Chiffre
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Re: website for ISO13485 registrars
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
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
Re: website for ISO13485 registrars
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.
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.
Re: website for ISO13485 registrars
From the ANAB site:
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.
Consider this list of Notified Bodies.
R
Roland Cooke
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.)
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.)
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