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ISO 17025 Equipment Calibration and Maintenance Checklist for Pharmaceutical Labs

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.

ISO 17025 Equipment Calibration and Maintenance Checklist for Pharmaceutical Labs

by: audit-now
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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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Industry

Healthcare

Standard

ISO/IEC 17025 - Testing Laboratory Competence

Workspaces

Pharmaceutical Facilities

Occupations

Laboratory Manager
Equipment Specialist
Calibration Technician
Quality Control Analyst
Metrologist
1
Is the calibration status of the equipment documented and compliant with ISO 17025?
2
What is the measurement uncertainty for the calibrated instruments?
Min: 0
Target: 1.0
Max: 5
3
Are the calibration records accessible and organized?
4
Is there a documented maintenance schedule for the analytical instruments?
5
Are written procedures for calibration of instruments available and followed?
6
What was the date of the last calibration performed?
7
What equipment was used for the calibration?
8
What is the frequency of calibration for this instrument?
Min: 1
Target: 6
Max: 12
9
Are the quality control results within the acceptable limits for the instruments?
10
What methodology is used for the calibration of instruments?
11
What is the calibration tolerance set for the analytical instruments?
Min: 0
Target: 0.01
Max: 1
12
What is the due date for the next calibration?
13
Is the calibration documentation complete and properly filled out?
14
What is the identification number of the instrument being calibrated?
15
What was the interval since the last calibration in months?
Min: 0
Target: 6
Max: 12
16
When does the calibration certificate expire?

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 of ISO 17025 Equipment Calibration and Maintenance Checklist for Pharmaceutical Labs

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