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LABORATORY QUALITY GLOSSARY

calibration

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Definition

Calibration establishes the relationship between indications from a measurement system and values supplied by suitable measurement standards, under specified conditions. In a laboratory analyzer, this relationship may support conversion of instrument response into reported concentration. Calibration is distinct from adjustment, which changes system behavior, and from quality control, which monitors whether performance remains acceptable during use.

Follow an approved calibration plan that defines materials, intervals or triggers, acceptance criteria, responsibilities, and records. Relevant triggers can include particular maintenance activities, reagent changes, or performance problems, depending on the procedure and manufacturer instructions. Review calibration results rather than accepting a completion message alone. After calibration, perform the checks needed to confirm that the examination system is suitable before releasing patient results, and investigate unexpected changes.

Why it matters for accreditation

For accreditation, calibration records connect equipment performance, traceability, and result validity. Assessors may examine certificates, material lot information, acceptance decisions, and actions after failed calibration. A current date on a label is not enough: the laboratory needs evidence that the calibration was appropriate, accepted, and followed by satisfactory performance checks for its intended examinations.