I work at a software company and our work is for other companies. We are 13485 certified. When we are hired by a company to write software for a medical device we say we will create not only the software but a series of documents to support that code from simple things like code and design review meeting minutes to software requirements to hazard analysis, and the list goes on. Many times, the customer is not eager to sign a document, even after explaining this is the first draft, not the final thing. Some customers want to wait until the very end. Some just never seem to want to sign at all. They know in the back of their head they need this stuff in their DHF for an eventual FDA consideration but try as we might, no signature happens. The sticky part comes when we ourselves are audited against 13485 by our 3rd party auditor. We get dinged for not having signed documents. Our process says we'll create documents and sign them and if the customer won't sign them, shame on us. Essentially, "if you have a requirements doc and have signed it and they have not, why have you moved forward?" Well, because the customer doesn't want to sign right now and the customer has asked us to continue with work. Ding. Over the years and especially the last 5 years, this has become more common. So we say we'll code and write documents, per 13485, but the customer has little concern about the documents. Is the answer to say we can't do your work for you or do we need to change our SOPs to reflect the attitude of the customer? Can you be 13485 compliant while doing work for a customer and not supplying them with the documentation you think they need? Thanks.