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

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A medical laboratory is undergoing an internal audit to assess its compliance with ISO 15189:2022. The audit team is reviewing the procedures for ensuring the reliability of quantitative test results. They are particularly interested in how the laboratory establishes and maintains the traceability of its measurements. Considering the standard\'s emphasis on metrological traceability, what is the most critical element the laboratory must demonstrate to satisfy this requirement for its analytical instruments?

Comprehensive documentation of calibration or verification procedures, including the use of national or international standards and clearly indicated calibration status.

A detailed inventory of all analytical instruments, including their purchase dates and assigned laboratory personnel.

A statistically significant number of proficiency testing results that fall within acceptable performance limits for all tested analytes.

A documented risk assessment for each analytical method, identifying potential sources of error and mitigation strategies.

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