We don't do medical devices but do make biologics that people may want to use in things like diagnostic kits and vaccine manufacture, which why we got certified under 13485, even though we are not required to be.
We are now in the process of going from contract manufacturing were the customer does the QC to developing out own products, and are planning to outsource all of our QC. (We are doing the initial test method development, they will handle doing validation and lot testing).
Obviously we will need a quality agreements with the company we are considering (It's 13485 and not 17025 BTW).
The Quality agreements templates that we have in house are focused on purchasing materials. We have 2, one for purchase of catalog items where we need primarily just need to be notified of changes, and a more in depth one for when/if we need to have people make stuff specifically for us.
But as it is material focused, the more extensive don't seem appropriate for a provider suppling such a critical service. I have never worked for a company that outsourced it's QC before.
Does anyone have , or can anyone point me to, an appropriate quality agreement template that they could share with me?
Thanks,
-Karen
We are now in the process of going from contract manufacturing were the customer does the QC to developing out own products, and are planning to outsource all of our QC. (We are doing the initial test method development, they will handle doing validation and lot testing).
Obviously we will need a quality agreements with the company we are considering (It's 13485 and not 17025 BTW).
The Quality agreements templates that we have in house are focused on purchasing materials. We have 2, one for purchase of catalog items where we need primarily just need to be notified of changes, and a more in depth one for when/if we need to have people make stuff specifically for us.
But as it is material focused, the more extensive don't seem appropriate for a provider suppling such a critical service. I have never worked for a company that outsourced it's QC before.
Does anyone have , or can anyone point me to, an appropriate quality agreement template that they could share with me?
Thanks,
-Karen
