Comprehensive ISO 17025 Audit Checklist for Calibration Processes and Compliance

ISO 17025 is an international standard for laboratory performance, ensuring the accuracy and reliability of results in calibration and testing. An important part of maintaining compliance is conducting regular internal and external reviews of measurement systems. The following ISO 17025 audit checklist provides detailed guidance for auditors to assess the key elements of measurement under the standard.

General Requirements for Calibration

• Scope of Accreditation: Verify that calibration performed by the laboratory matches its scope of accreditation. Confirm that the equipment listed is within its calibration scope by the laboratory.
• Laboratory Environmental Conditions: The laboratory environment (temperature, humidity, dust, vibration) should be suitable for performing the calibration activities.
• Personnel Competency: Ensure that calibration undertaken is carried out by trained and suitably qualified cleanness with experience in carrying out calibration activities.

Written Procedures and Work Instructions

• Calibration Procedure: Ensure that, for all of the equipment and instruments used, there exist written, up-to-date procedures for calibration that are by the ISO 17025 audit checklist and include the details of measurement methods, calibration standards, and tolerances.
• Control of Documentations: All records for calibration must be maintained properly, accessible, and meet the requirements for document control, including revision history and approval processes.

Measurement Traceability

• Calibration Standards: Ensure that all calibration standards being used in the laboratory are traceable to national or international standards. Ensure that those calibration standards are recalibrated in regular intervals and records of calibration are available.
• Measurement Uncertainty: Is the measurement uncertainty properly assessed and documented for all calibrations?

ISO 17025 calibration laboratories have to consider and report the uncertainty related to every measurement.

Equipment and Instrument Maintenance

• Calibration and Maintenance of Equipment: Check all the equipment for regularly scheduled calibrations and maintenance. Read maintenance records and check if the instruments are still working within set limits.
• Verification of Calibration Intervals: Validate that the set intervals for calibration are based on the manufacturer's user manual, risk assessment, and historical performance data.

Non-Conformance & Corrective Actions

• Non-Conformance Record: Check the non-location of the non-conformance in any calibration activity, documented promptly and assessed promptly.
• Corrective and preventive actions: Review the effectiveness of corrective action in response to discrepancies noted during calibration with the necessary follow-up to aid continuous improvement.

Calibration Reporting

• Calibration Certificates: Each calibration certificate shall be included with all pertinent details such as equipment identification, calibration results, measurement uncertainties, and traceability to national/international standards.
• Reporting Format: Check that all reports are clear and consistent and contain all relevant data necessary for complete traceability and repeatability of results.

Internal Audit and Continuous Improvement

• Internal Audit Process: Confirm to the extent possible that the laboratories conduct an internal audit now and then to keep themselves aligned with ISO 17025. Review audit reports and follow up on corrective action.
• Management Reviews: Check whether management reviews are conducted regularly to evaluate the validity of calibration operations and identify potential improvements.

The normal ISO 17025 audits are quite important for maintaining the integrity of a laboratory's calibration process. This checklist provides a framework for auditors to ensure that the labs can achieve a high standard of accuracy, reliability, and compliance, which leads to consistent and trustworthy calibration results. Regular audits carry on adherence to international standards for competence and quality.

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Iso 14001 Audit Checklist can be used as an internal audit to assess your organization's Ems and your readiness for third-party Iso 14001:2015 certification.