TS EN ISO 15195

TS EN ISO 15195 is a laboratory medicine standard concerned with the requirements for reference measurement laboratories in medical laboratories. It provides a technical framework for the high-accuracy measurement environment that supports traceability, comparability, and metrological confidence in clinical laboratory testing. This standard has been withdrawn, but the concept of a reference measurement laboratory remains important in understanding how laboratory medicine achieves consistent results across methods and sites.

What a reference measurement laboratory means

Reference measurement laboratories sit above routine testing laboratories in the measurement hierarchy. They are associated with reference measurement procedures, calibration support, verification of measurement systems, and the maintenance of metrological traceability. In laboratory medicine, their role is to help ensure that results produced by different instruments and laboratories can be aligned to a common reference basis.

In general technical terms, a reference measurement laboratory is not the same as an ordinary clinical testing laboratory. The former is centered on reference-level accuracy and comparability, while the latter is focused on day-to-day patient testing. That distinction matters because traceability chains, measurement uncertainty, and method harmonization are central to reliable laboratory medicine.

Why this topic matters in laboratory medicine

• Reference laboratories provide a technical anchor for trustworthy clinical measurement results.
• Comparability across laboratories depends on reducing method-related differences and maintaining traceability.
• Quality management and measurement uncertainty are key concepts in the reference measurement environment.
• The standard helps define the terminology and role of this specialized laboratory category.