Outsourced Processes
In addition to the outsourced processes already mentioned here are a couple of others that you should consider; if they have impact on product:
Facility Cleaning
Pest Control
Facility Maintenence
As you can see you need to look beyond the obvious processes that we normally think about such as Design & Development, Key or Critical Processes that might be done outside more efficiently or more expertly; the most obvious is Sterilization.
In the end you need to show the Notified Body auditor how you control these outsourced processes, through supplier audits, supplier contracts, specifications, etc.
They are extensions of all the processes you need to control to assure your products are not being compromised by one of these Outsourced processes.

In addition to the outsourced processes already mentioned here are a couple of others that you should consider; if they have impact on product:
Facility Cleaning
Pest Control
Facility Maintenence
As you can see you need to look beyond the obvious processes that we normally think about such as Design & Development, Key or Critical Processes that might be done outside more efficiently or more expertly; the most obvious is Sterilization.
In the end you need to show the Notified Body auditor how you control these outsourced processes, through supplier audits, supplier contracts, specifications, etc.
They are extensions of all the processes you need to control to assure your products are not being compromised by one of these Outsourced processes.



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