Calibration before being placed into service Equipment operated by authorized personnel 5.5.3 Up-to-date instructions on use and maintenance Unique identification of equipment 5.5.4 Equipment records: 5.5.5 identity of equipment and its software a) manufacturer's name, type identification, b) and serial number or other unique identification; initial checks (see 5.5.2); c) current location, where appropriate; d) manufacturer's instructions, if available, e) or reference to their location; dates, results and copies of reports and certificates of all calibrations, f) adjustments, acceptance criteria, due date of next calibration; maintenance plan, where appropriate; g) maintenance carried out to d ate; any damage, malfunction, modification h) or repair to the equipment. Procedures for safe handling, transport, 5.5.6 storage, use and planned maintenance Overloaded, mishandling, suspect, or 5.5.7 defective equipment Isolation of out-of-service equipment Effect of defect or departure from specified limits on previous results Indication of calibration status 5.5.8 Checking equipment that goes outside 5.5.9 the direct control of the laboratory
Calibration before being placed into service 5.5.3 Equipment operated by authorized personnel Up-to-date instructions on use and maintenance 5.5.4 Unique identification of equipment 5.5.5 Equipment records: a) identity of equipment and its software b) manufacturer's name, type identification, and serial number or other unique identification; c) initial checks (see 5.5.2); d) current location, where appropriate; e) manufacturer's instructions, if available, or reference to their location; f) dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, due date of next calibration; g) maintenance plan, where appropriate; maintenance carried out to d ate; h) any damage, malfunction, modification or repair to the equipment. 5.5.6 Procedures for safe handling, transport, storage, use and planned maintenance 5.5.7 Overloaded, mishandling, suspect, or defective equipment Isolation of out-of-service equipment Effect of defect or departure from specified limits on previous results 5.5.8 Indication of calibration status 5.5.9 Checking equipment that goes outside the direct control of the laboratory
CRA-F-05-%2017025-ASSESSMENT%20CHECKLIST%20&%20REPORT(TESTING)-.docx