Overview
ISO 15195:2018 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - defines competence criteria for calibration laboratories (often called reference measurement laboratories) that perform high‑order reference measurement procedures in laboratory medicine. It uses ISO/IEC 17025:2017 as a normative reference and adds sector‑specific requirements to ensure accurate, traceable, and fit‑for‑purpose reference measurements. The standard explicitly excludes examinations reported on nominal or ordinal scales and is not applicable to routine medical laboratories (see ISO 15189 for those requirements).
Key topics and requirements
ISO 15195:2018 supplements ISO/IEC 17025:2017 with specialized requirements relevant to laboratory medicine. Major topics include:
- Reference measurement procedures: Implementation and documentation of higher‑order procedures used to assess trueness and assign values to reference materials.
- Metrological traceability: Establishing traceability of results to national or international reference materials and SI units wherever possible (in line with ISO 17511).
- Measurement uncertainty: Systematic evaluation and reporting of measurement uncertainty for reference measurements (aligned with GUM principles).
- Reference materials: Use, characterization and value assignment of certified or higher‑order reference materials.
- Personnel and competence: Specific qualifications, training and competence expectations for staff performing reference measurements.
- Equipment and facilities: Availability and performance of laboratory equipment capable of achieving required accuracy for listed reference procedures.
- Process control and records: Handling of samples, measurement records, result validation and reporting of results with appropriate metadata.
- Management and audits: Internal audits, organization structure and arrangements to avoid conflict of interest (especially when co‑located with medical laboratories).
- Relationship to ISO/IEC 17025: Annex A summarizes clause mapping between ISO 15195 and ISO/IEC 17025:2017.
Applications and who uses this standard
ISO 15195:2018 is intended for:
- National metrology institutes and specialized calibration laboratories performing reference measurement procedures in clinical chemistry, immunoassays, enzymology and related fields.
- Laboratories involved in value assignment for reference materials, calibrators and control materials used by clinical laboratories.
- Accreditation bodies and laboratory managers seeking a framework for accrediting or demonstrating competence in high‑order clinical calibrations.
- Manufacturers and developers of in vitro diagnostic (IVD) reference procedures who need to document metrological traceability and uncertainty.
Practical benefits include improved comparability of patient results across laboratories, robust value assignment for calibrators, and a clear pathway for accreditation of reference measurement services.
Related standards