ISO 13485:2003 specifies quality management system (QMS) requirements for organizations that need to demonstrate their ability to provide medical devices and related services that consistently meet applicable customer and regulatory requirements.

ISO 13485:2003 contains specific requirements for medical devices and excludes non-applicable requirements from ISO 9001. Consequently, an organization with a QMS that conforms to ISO 13485:2003 cannot claim to conformity to ISO 9001 unless the QMS meets all of ISO 9001’s requirements.