A specialized checklist for ensuring ISO 17025 compliance in equipment calibration and maintenance processes within pharmaceutical laboratories, focusing on accuracy, traceability, and documentation of analytical instruments.
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About This Checklist
Proper equipment calibration and maintenance are critical aspects of ISO 17025 compliance in pharmaceutical laboratories. This specialized checklist focuses on ensuring that all laboratory equipment meets the stringent requirements set forth by ISO 17025, particularly in the context of pharmaceutical testing. By systematically addressing equipment calibration schedules, maintenance procedures, and record-keeping practices, this checklist helps laboratory managers and technicians maintain the accuracy and reliability of their analytical instruments. Implementing this checklist can significantly reduce measurement errors, enhance data integrity, and support overall quality assurance in pharmaceutical testing processes.
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Select the availability status of the calibration procedures.
Enter the last calibration date.
List the equipment used for calibration.
Enter the calibration frequency in months.
Select the status of the quality control results.
Describe the calibration methodology used.
Enter the calibration tolerance value.
Enter the due date for the next calibration.
Select the completeness status of the calibration documentation.
Enter the identification number of the instrument.
Enter the interval since the last calibration.
Enter the calibration certificate expiration date.
FAQs
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.
Benefits
Ensures compliance with ISO 17025 equipment management requirements specific to pharmaceutical labs
Reduces the risk of measurement errors and enhances data reliability
Facilitates consistent equipment performance and extends instrument lifespan
Supports traceability and documentation for regulatory inspections
Improves overall efficiency of laboratory operations through proper equipment management