Cari, as I look at your T&C document (thank you) I see that some of the items in 8.4.3 are not directly noted - design & development controls, use of statistical techniques, etc. - I'm assuming that the omissions were purposeful, by not noting these items you are, in effect, communicating that you do not have requirements specific to these areas? This was the reason I initially posted, I was trying to get a better feel for a "correct" way of addressing 8.4.3. As I mentioned earlier, I have a draft of a document that speaks to each element of 8.4.3, even if it just says "Where design and development requirements apply, OUR COMPANY will determine appropriate controls on a case by case basis and communicate those required controls to the supplier." I understand that this is a very broad statement (One of many in the document), and it might not be the best plan but, I'm not sure that I have a better one so I think I'm going to run with it.