Multiple Notified Bodies

KhPat

Involved In Discussions
Hello

Hope someone can assist with the following question;

We have the same NB for ISO, CE and MDSAP certificate but due to the current pricing offered by our current NB for the CE MDR 2017/745 certification it does not make sense to get it certified by them and looking for other sources. It is possible to have two different notified bodies; one for the CE and the other for MDSAP and ISO?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I think so but...

There is a lot of turmoil right now in NB industry. For the last 6 years, NB has been hiring like crazy to prepare for MDR 2024 deadline/MDD expiration.

There is a proposed delay to 2028 for Class IIa devices that throws a wrench into all this. They are not going to have revenue and bookings to support their headcount now. They are trying to bring as much revenue into this year as possible so understand that as a new customer, there is substantial risk in changing NB today.
 

Jean_B

Trusted Information Resource
Hello

Hope someone can assist with the following question;

We have the same NB for ISO, CE and MDSAP certificate but due to the current pricing offered by our current NB for the CE MDR 2017/745 certification it does not make sense to get it certified by them and looking for other sources. It is possible to have two different notified bodies; one for the CE and the other for MDSAP and ISO?

You can have a notified body (for the CE part) that differs from your certification body (for the ISO/MDSAP part).

However, this would usually increase the total time spent on being audited substantially, as the synergy is lost. It is also pretty certain certain aspects will be audited in duplicate, with all that entails.
You may find yourself losing money in total due to the (less easy to consider) costs of internal time as well as doubled external time for identical issues which can no longer be joined into a single finding and follow-up.
 

Enghabashy

Quite Involved in Discussions
additional to comments above ; I have 1 certification body for both ISO 9001 & IATF 16949 , many of findings in IATF 16949 report are applicable to write in ISO 9001 ; hence we can gain minimal findings rather than the separation of NBs & separation of audits & auditors also ;

* although the man /day charge for the auditor is high but the total cost , time & findings are ok
 
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