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I find myself in the unenviable position of having to perform an audit of the Development function of my company. Although I have plenty of experience auditing all other functions, this one is a little different. So many of the QSR requirements are not applicable.
Does it seem reasonable to assume that I can perform a desktop audit of one of the design history files for a recent project and determine compliance to both the QSR and ISO 9001?
Does it seem reasonable to assume that I can perform a desktop audit of one of the design history files for a recent project and determine compliance to both the QSR and ISO 9001?