Non-significant notice of change to notified body

shimonv

Trusted Information Resource
#1
Hi Fellows,
I'd like to hear what is your experience with none-significant notice of changes to notified bodies.
In principle, the manufactures are not obligated to report non-significant changes but with the frequent technology changes often the manufacturers chose to notify the NBs just to be on the safe side (abundance of caution).

1. Do you tell them in the NoC that this is non-significant change?
2. Would you proceed to implement immediately without waiting for their response?
3. Have you had push backs from NBs saying that you don't need to notify them about such changes?


Thanks,
Shimon
 
Last edited:
Elsmar Forum Sponsor
#2
1- No
2- N/A
3- No, as I have only ever notified them of a significant change

My recent experience however has been quite different with inexperienced NB's auditors telling me changes are significant when they aren't! For example a non-significant design change needing a new EC Certification!
 

shimonv

Trusted Information Resource
#3
The relationship with notified bodies is becoming more delicate than it was before. I know of few manufacturers who will chose to update the notified bodies when they do a relatively big design change even though it does not meet the definition of significant change. The reason for doing so is abundance of caution and wanting to maintain good relationship with the auditor.
They do so in an "unofficial" way so as to get their approval that indeed it is non-significant and they can implement immediately; in such situations the auditor will review the change as part of the annual surveillance/renewal audit.

Shimon
 

shimonv

Trusted Information Resource
#5
True, but this guidance is five years old and not all notified bodies are completely aligned with it. There are some differences between notified bodies and the human factor (NB project manager) is significant.
 
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