How is the NB ISO 13485 audit for CE Marking different from regular ISO audit ?

SGquality

Quite Involved in Discussions
#1
Pls help me - one of our US site is getting ready for Notified Body EN/ISO 13485 audit.

Can you pls tell me how is this different from a regular ISO 13485 audit not meant for CE marking ?

Thanks !
 
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Marcelo

Inactive Registered Visitor
#2
Notified Bodies in principle do not audit per ISO 13485, they audit the the Directives requirements. On the other hand, they usually sell a service (as an CB) to audit per Iso 13485 to fulfill the QMS requirements of the Directives.

So, it?s important to understand what you are being audited for.

If it?s an ISO 13485 audit by an CB, it will be the same as always.

If really an NB audit, it will focus on the Directives requirements.
 

SGquality

Quite Involved in Discussions
#3
Notified Bodies in principle do not audit per ISO 13485, they audit the the Directives requirements. On the other hand, they usually sell a service (as an CB) to audit per Iso 13485 to fulfill the QMS requirements of the Directives.

So, it?s important to understand what you are being audited for.

If it?s an ISO 13485 audit by an CB, it will be the same as always.

If really an NB audit, it will focus on the Directives requirements.
Thanks Marcelo. Where can I find details on how NB would audit for Directives ?
 

Marcelo

Inactive Registered Visitor
#4
On the Directives themselves. They will audit the "route" used for CE Marking. For example, if the route used is a full quality assurance system (might be the case as you mentioned ISO 13485), they will audit per Annex II of the MDD (for example, not sure if that is the directive used)
 

Marcelo

Inactive Registered Visitor
#5
Just an addendum - for Europe, you will probably want to use EN harmonized standards (because they give presumption of conformity). Some EN standards have different texts or interpretations in Europe - in the case of EN Iso 13485:2012, it has additional annexes related to the Directives (they don?t change requirements, but link the requirements with the essential requirements from the Directives).
 
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