ISO 13485 details and specifies the requirements for a quality management system (QMS) by which an Applicant must demonstrate its ability to provide medical devices and related services that consistently meet regulatory requirements applicable to medical devices and related services. In particular, robust procedures for product safety updates and product recalls must be provided.
The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. The requirements of ISO 13485 are not identical to ISO 9001 therefore Applicants with a QMS that is compliant to ISO 13485 cannot claim compliance to ISO 9001 unless their QMS has been separately certified to ISO 9001.
All of the requirements of ISO 13485 are specific and applicable to organisations providing medical devices, regardless of the type or size of the organisation.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organisation to ensure that claims of conformity with ISO 13485 reflect exclusion of design and development controls.