Instruments and Equipment

Where the laboratory needs to use instruments and equipments outside its permanent control, it must ensure that all relevant accreditation criteria are met.
 

Each instrument/ equipment shall, when appropriate, be uniquely labelled, marked or otherwise identified. Each major instrument/ equipment must be recorded in an inventory, which includes:

• Name of the instrument/equipment,

• The manufacturer's name, type, identification and serial number or other unique identification,

• Date received and date placed in service, where appropriate

• Current location, where appropriate

• Condition when received (for example, new, reconditioned), where appropriate.

Instruments/equipment must be maintained in proper working order. Maintenance procedures must be documented. Records must be kept of all maintenance, servicing and repairs.

Equipment known or suspected to be defective shall be taken out of service and clearly labelled or marked until it has been repaired and shown by calibration, verification or test, to perform correctly. Whenever practicable, all equipment under the control of the laboratory and requiring calibration or verification, shall be labelled, coded or otherwise identified to indicate the status of the calibration or verification and the date when re-calibration or re-verification is due. Documented operating instructions (for example, the manufacturer's operating instructions) must be available for each significant item of equipment.

When, for whatever reason, equipment goes outside the direct control of the laboratory for a period of time, it shall be ensured that the function and, where necessary, the calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service. The laboratory shall have procedures for safe handling, transportation, storage and use of equipment in order to prevent contamination and deterioration. Special procedures may be necessary for equipment used for testing and related activities performedoutside the permanent laboratory facilities.