How's the unannounced inspection by notified bodies going?

[ScottK]

Just wondering if the unannounced inspection of subcontractors by notified bodies is really taking off and if any headaches are being caused by it.

Has there been resistance from "critical subcontractors" that have been chosen?

 

[Sidney Vianna]

We've had a few threads on this, such as the one at EU Commission requires NB (Notified Body) Unannounced Visits

 

[Philip B]

Everyone I encounter seems to think that the EU NBs don't have enough resource for this. BSi have already downscaled their requirement for Class I / IIa manufacturers from every 3 years to every 5. I also think they will go to where the device is manufactured, not to sub-contractors such as sterilisation etc.
We are a smallish company and if they knock on the door when I am not here we're in trouble!

 

[rob73]

Funny, we had an unannounced audit 6 weeks after our re-cert audit! This was for one class 1M device, the lead auditor was just as bemused as to why he was there as we were. We lodged a complain but didn't get very far.