ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product

#1
Hi all,

First post here!
I'm trying to come up with some examples of "appropriate actions" in response to nonconforming products detected after delivery as stated in Clause 8.3.3 of ISO 13485:2016. Would anyone be able to help in giving some appropriate actions, ranging from less severe nonconformances to critical health risks?

Thanks!
 
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shimonv

Trusted Information Resource
#2
After delivery your options are limited and should correspond to the risk level associated with the nonconformance.
Such type of actions include stock recovery, servicing (routine /non-routine), marketing withdrawal, and recall (correction or removal).

Shimon
 

Teyla

Starting to get Involved
#3
This is a part of our SOP:

"The Management shall decide if the product will be:
-use as is (if the product or part does not fully conform to the intended requirements, but it may still be used with acceptable degraded results);
- SCRAP (make sure that product or part is not used, and some industries require the product or part to be destroyed);
- customer returns (product recall)"
 
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