Determination of Significant Subcontractor listing on QMS certificates 1. Do they provide: Finished device (or significant component that impacts the safety and quality of the final device) that is subjected to no further processing Special processes (sterilisation/primary packaging of sterile devices) NO YES 2. If they provide a finished device then is there a comprehensive in-coming inspection process ?* (If sterilizer or special process provider then go straight to 3.) DO NOT LIST ON CERTIFICATE 3. LIST ON CERTIFICATE NO YES DO NOT LIST ON CERTIFICATE 4. Do they possess ISO 13485 certificate issued by a notified body with an appropriate scope?# YES: List as usual NO: audit of subcontractor facility by BSI *If the manufacturer accepts a finished component already packaged or accepts a component 'as-is' with no incoming inspection and no final cleaning process, the subcontractor is considered significant. Significant subcontractors must be listed on the Full Quality Assurance certificate. #A current and valid ISO 13485 Certificate is required for significant subcontractors. Otherwise, they may be subject to an audit by BSi for those aspects related to finished processing of devices.