Certification Body, Registrar, Notified Body - What is the difference?

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paulag

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#2
Hi SGquality,

A notified body is designated to assess the conformity of certain products before being placed on the market, eg medical devices.

For me, certification bodies only have something to do with safety, like safes, data rooms, or archives?!

Registrars can issue ISO certificates, eg 13485, but are not involved in CE marking of medical devices.

Just my opinion ...
 
#3
Hi SGquality,

A notified body is designated to assess the conformity of certain products before being placed on the market, eg medical devices.

For me, certification bodies only have something to do with safety, like safes, data rooms, or archives?!

Registrars can issue ISO certificates, eg 13485, but are not involved in CE marking of medical devices.

Just my opinion ...
The term "Certification Body" was used (universally) until ISO Certification came to the USA. For some reason, the term "Registrar" was coined and has (partially) stuck. There is ZERO difference between certification and registration in the context of ISO 9001 type audits. "Registrar" = "Certification Body". The actual, correct terminology is "Conformity Assessment Body", BTW...

Nothing to do with certification of products etc.
 
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