One of our Customers (Gambro BCT) sends a SCAR even if it is only one part and a cheap one at that. I received one 2 days ago on a ten dollar part. We have shipped them 6000 of these parts in the last 5 years with no defects. I answered the corrective action that this was normal production fallout and required no corrective action on our part. I have done this before with no problem. This time one of their engineers said I couldn't answer the SCAR that way because their BSI auditor wouldn't like it. Does anybody no of a requirement by ISO 13485 or the FDA that requires a Corrective action to be issued for one stinking part.