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List of items that need to be included in the equipment file

2021-11-29View Original

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1. Contents of equipment records: 1) Equipment purchase contract (or similar agreement); 2) Equipment user manual – if lost, it must be obtained from the supplier; 3) Equipment acceptance report; 4) Equipment calibration or verification certificate; 5) Equipment usage records; 6) Periodic inspection records for the equipment; 7) Equipment maintenance records; 8) Equipment repair records; 9) Equipment disposal form; 10) Equipment name, specifications, and serial number; 11) Equipment management (or fixed asset) identification number; 12) Date of equipment purchase; 13) Equipment manufacturer; 14) Department responsible for using the equipment; 15) Location where the equipment is stored; 16) Person responsible for taking care of the equipment; 17) Information on equipment software and reference materials (if any); 18) List of equipment accessories. 2. Dynamic management of equipment: All instruments and equipment should have corresponding records kept, and dynamic management should be implemented. The equipment records are accumulated over time (such as maintenance records), and these records need to be updated when necessary (for example, if the location of the equipment changes). 3. Retention period for equipment records: In accordance with clause 8.4.2 of CNAS-CL01-G001, 1) all technical records must be retained for at least 6 years. If laws and regulations, CNAS sector-specific acceptance requirements documents, or the client stipulate a longer retention period, the laboratory shall meet such requirements. 2) Equipment records should be retained throughout the entire period of equipment use ; After the equipment is no longer in use, its technical records must be retained for another 6 years. 4 Record format of equipment files Equipment files can be in electronic form or in paper form. Using electronic records is highly recommended, as it offers many advantages.

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