ISO 15189:2022 - Medical Laboratories Lead Implementer Quiz 01 26Jul25 - Practice Quiz

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Question 1 of 30

A recent internal audit of a diagnostic laboratory accredited to ISO 15189:2022 identified that several critical analytical instruments, including a spectrophotometer used for biochemical assays and a centrifuge vital for sample processing, have not undergone documented calibration or verification for over 18 months. The audit report highlights a potential risk to the accuracy and reliability of patient test results. Considering the principles of metrological traceability and the laboratory\'s quality management system, what is the most immediate and critical corrective action required to address this non-conformity?

Immediately implement a comprehensive calibration and verification schedule for all identified critical measuring instruments, ensuring traceability to national or international standards.

Retrain all laboratory personnel on the importance of instrument calibration and the procedures outlined in the laboratory's quality manual regarding equipment maintenance.

Review and update the laboratory's risk management documentation to include the potential impact of uncalibrated instruments on patient safety and test result integrity.

Conduct a retrospective analysis of all patient results generated by the affected instruments during the period of unverified operation to assess the extent of potential impact.

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