Writing a Sterilization Procedure when the Process is Subcontracted - ISO13485

I am filling in gaps in our ISO 13485 for the purposes of CE marking and I am having trouble writing a Sterilization procedure (our product is gamma radiated at a subcontracted facility and then tested for sterility at a subcontracted lab) to fulfill 7.5.1.3 and 7.5.2.2.

I am having trouble because I am not expert in the particular procedures the companies use, but I do have a basic SOP and laboratory analysis reports.

Help! Any examples/templates would be marvelous too. Thanks!

ckrasner,

Since sterilisation and sterility test has been subcontracted, you can just write a procedure stating that how the pallets are organised before the non-sterile products leaves your door and what you do when they arrive back (quarantine, aeration etc) before we check the sterility report from your lab. Once the sterility reports passes and aeration has been completed as per your internal specification the sterile products are released for sale. This is what I will do if I understood your question correctly.

Hope this helps.
Romit