I work with a manufacturer of general purpose disinfectants and these are clearly regulated by EPA through a memo of understanding with FDA. All EPA registration and approvals have been completed. Because these can be used in healthcare settings, customers are requiring that we are GMP-certified. EPA has no requirements for QMS, and since general purpose disinfectants are not medical devices, we're having a dilemma in representing our QMS being GMP compliant. Would ISO 13485 be applicable here if exclusions are detailed and properly justified?