河北省MedAccred —AC8121电子电缆和线束组件的审核标准 （24）

6.MEDICAL RECORD KEEPING

6.1 Device Master Record (DMR)

6.1.1 P- Is there an internal procedure defining DMR consistent with requirements such as 21 CFR part 820.181, 93/42/EEC or regional/ country regulatory requirements? YES/NO

6.1.2 C- Is the supplier compliant with the procedure requirement for DMR? YES/NO

6.2 Device History Record (DHR)

6.2.1 P- Is there an internal procedure defining DMR consistent with

requirements such as 21 CFR part 820.184, 93/42/EEC or regional/ country regulatory requirements? YES/NO

6.2.2 C- Is the supplier compliant with the procedure requirement for DHR? YES/NO

6.3 Product Traceability

6.3.1 P- Is there a procedure for assembly traceability throughout the manufacture and rework of the Cable and Wire Harness by lot or date code or if required, serial number, of the assembly down to the component level: YES/NO

6.3.2 P- For final QA acceptance for each assembly? YES/NO

6.3.3 P- For process and testing steps performed internally? YES/NO

6.3.4 P- For process and testing steps performed during rework?YES/NO

6.3.5 P- For process steps performed by an outside source?YES/NO/NA

6.3.6 P- For work in process? YES/NO

6.3.7 C- Are records available showing traceability for Cable and Wire Harness by lot or date code, or if required, by serial number of the assembly down to the component level: YES/NO

6.3.8 C- For final QA acceptance for each assembly? YES/NO

6.3.9 C- For process and testing steps performed internally?YES/NO