ISO 17025 Equipment Calibration and Maintenance Checklist for Pharmaceutical Labs

The frequency of calibration depends on the type of equipment, manufacturer recommendations, and usage patterns. However, ISO 17025 requires that all equipment used for testing be calibrated or checked before being put into service and on a scheduled basis thereafter.

Records should include calibration certificates, maintenance logs, equipment history files, and any out-of-specification incidents or repairs. These records must be easily retrievable and maintained for the life of the equipment plus additional time as specified by regulations or laboratory policies.

While laboratory managers have overall responsibility, typically a designated equipment manager or metrology specialist oversees the calibration and maintenance program. However, all laboratory staff using the equipment should be trained in proper usage and basic maintenance procedures.

The checklist includes items to verify that measurement uncertainty is calculated and documented for each calibration, as required by ISO 17025. It also ensures that these uncertainty values are considered when interpreting test results and establishing equipment tolerances.

Yes, the checklist is designed to cover both internal calibration procedures performed by laboratory staff and external calibration services provided by accredited calibration laboratories, ensuring compliance with ISO 17025 requirements in both scenarios.