#1
We are a small contract manufacturer of medical devices and I am working through our transition to 13485:2016.
As I update our processes and procedures I am looking for ways to implement dock to stock on simple parts of non-critical nature. (i.e. Hardware)
My question is; Can this be done? The 21CFR States, "Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities. " 13485:2016 -The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product specified purchasing requirements.
It seems as though we need to inspect everything, Or “Other activities”
What does that mean?
How do others perform Dock to stock in the medical device manufacturing industry?
 

Sidney Vianna

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#2
Re: Dock to stock for medical device manufacturer

ISO 13485:2016 states:
The extent of verification activities shall be based on the supplier evaluation results and proportionate to the risks associated with the purchased product.
So, if historical data related to supplier performance and product conformity/integrity proves that non critical products have not had instances of defects/failures, an informal risk assessment would ok dock to stock programs.

As I see it, neither ISO 13485:2016 nor regulatory requirements mandate non value added activities.
 
#3
The key thing is to establsh a suitable procedure describing how you justify not performing an inspection (eg x number of receipts withoutout a non-conformance) and then having the evidence that you stick to it.
 

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