Wondering if anyone can share experiences with respect to the likelihood that critical suppliers/sub-contractors may be audited by Notified Bodies.
I'm looking at an article from LNE-GMED, which raises some concerns...
The article states:
"Per the NBOG’s Best Practice Guide 2010-1; a critical supplier is one that is delivering materials, components, or services that may influence the safety and performance of the device. "
With respect to electrical components populating PCBs, by this definition, this could be quite a lengthy list...
It further goes on to say:
"Auditing the Legal manufacturers’ critical subcontractor is becoming the new normal and it is no secret that the level of scrutiny is on the rise. "
Given that, following an assessment, NBs may deem on-site audits of critical suppliers necessary, my concerns are:
My concern, obviously, is to avoid unexpected costs of having NBs conduct on-site audits of critical suppliers...
Any input much appreciated!
MM
I'm looking at an article from LNE-GMED, which raises some concerns...
The article states:
"Per the NBOG’s Best Practice Guide 2010-1; a critical supplier is one that is delivering materials, components, or services that may influence the safety and performance of the device. "
With respect to electrical components populating PCBs, by this definition, this could be quite a lengthy list...
It further goes on to say:
"Auditing the Legal manufacturers’ critical subcontractor is becoming the new normal and it is no secret that the level of scrutiny is on the rise. "
Given that, following an assessment, NBs may deem on-site audits of critical suppliers necessary, my concerns are:
- Given a complicated PCB, with many components (capacitors, integrated-circuits, LEDs, fuses...etc.), many influencing safety, and arguably all influencing performance, is it commonplace for such manufacturers to have dozens of identified critical suppliers?
- How often to NBs deem on-site audits necessary for such suppliers? (hopefully not often...)
- Are these on-site audits at the expense of the manufacturer? (presumably yes...)
My concern, obviously, is to avoid unexpected costs of having NBs conduct on-site audits of critical suppliers...
Any input much appreciated!
MM