Overview
EN ISO 15195:2019 (ISO 15195:2018) is a specialised standard for calibration laboratories in the field of laboratory medicine that perform reference measurement procedures. It specifies competence requirements by referencing ISO/IEC 17025:2017 as the normative baseline and adds specific provisions needed for calibration (reference measurement) laboratories to produce accurate, traceable results. The document excludes examinations reported on nominal or ordinal scales and is not applicable to routine medical laboratories (see ISO 15189 for medical laboratory requirements). Annex A summarizes the relationship between this standard and ISO/IEC 17025:2017.
Key Topics
- Scope and purpose
- Defines competence requirements specifically for laboratories that implement reference measurement procedures in clinical/biological measurement.
- Normative references
- Structural and resource requirements
- Personnel competence, laboratory facilities, equipment, and environmental conditions needed for high-level calibration work.
- Metrological traceability
- Requirements to establish traceability to national/international reference materials or procedures and, where possible, to SI units.
- Reference materials
- Expectations for handling and assigning traceable values to reference materials and customer-supplied materials.
- Process requirements
- Review of requests, implementation of reference measurement procedures, sample handling, measurement records, uncertainty evaluation, validity checks, and reporting of results.
- Management and quality
- Internal audits and management processes aligned with ISO/IEC 17025:2017; Annex A clarifies overlapping clauses.
Applications
- Provides a framework for reference measurement laboratories (often called calibration laboratories) that:
- Develop and apply reference measurement procedures for clinical analytes.
- Assign traceable values to reference materials and calibrators used by medical laboratories and IVD manufacturers.
- Support harmonization and comparability of patient results across laboratories and time.
- Useful for organizations seeking accreditation for reference measurement procedures or recognition of high-level calibration services in laboratory medicine.
Who should use this standard
- National metrology institutes and specialist clinical calibration laboratories
- Reference measurement laboratories in hospitals, universities, research institutes
- Accreditation bodies assessing competence for reference measurement procedures
- IVD manufacturers and quality managers involved in calibrator and control value assignment
Related Standards
- ISO/IEC 17025:2017 - general competence for testing and calibration laboratories (normative reference)
- ISO 15189 - requirements for medical laboratories (not applicable here)
- ISO 17511 - metrological traceability for calibrators and control materials
Keywords: EN ISO 15195:2019, reference measurement procedures, calibration laboratories, laboratory medicine, ISO/IEC 17025:2017, metrological traceability, reference materials, accreditation.
