Overview
ISO 15193:2009 - "In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures" specifies what a reference measurement procedure (RMP) document must contain and how it should be presented. The standard applies to RMPs that provide values for differential or rational quantities (Annex A covers nominal/ordinal properties). It is intended for anyone writing an RMP in laboratory medicine, in vitro diagnostics (IVD) manufacturers, reference laboratories and bodies producing reference materials.
Key Topics and Requirements
- Structure and mandatory elements: Title, scope, safety/warnings, measurement principle/method, reagents, apparatus, sampling, preparation of analytical portion, operation, data processing, analytical reliability, validation (inter‑laboratory), reporting, quality assurance, and dates of authorization/revision.
- Presentation guidance: Clear introduction (measurand definition, measurement model, metrological traceability, and hierarchy of methods), check lists and special cases where needed.
- Analytical reliability: Requirements to describe precision, trueness (bias), detection limits, analytical specificity/sensitivity, influence quantities and interference assessment.
- Validation: Mandatory inter‑laboratory comparison to demonstrate that the RMP produces fit‑for‑purpose results and supports metrological traceability.
- Safety and legal compliance: Explicit warnings, disposal and regulatory considerations for biological samples and reagents.
- Traceability and uncertainty: Guidance consistent with GUM principles for expressing measurement uncertainty and ensuring traceability of measured values.
- Target audience clarity: The RMP should be written so an experienced laboratory worker following it achieves results within the stipulated measurement uncertainty.
Applications and Who Uses ISO 15193:2009
- Reference laboratories developing and publishing RMPs to support measurement trueness and calibration.
- IVD manufacturers seeking to demonstrate instrument/reagent performance and to link routine assays to higher‑order methods.
- Producers of certified reference materials who need validated procedures to assign reference values.
- Medical laboratories and clinical chemists implementing standardized methods for patient testing, quality control and inter‑laboratory comparability.
- Regulators and accreditation bodies evaluating conformity of measurement procedures, documentation and traceability claims.
Practical uses include assigning values to reference materials, assessing interchangeability of routine methods, detecting analytical interferences in patient samples, and establishing metrological traceability for clinical results.
Related Standards
- ISO 15194 - Requirements for certified reference materials and supporting documentation (related to value assignment).
- ISO/IEC Guide 98‑3 (GUM) - Guide to the expression of uncertainty in measurement.
- ISO/IEC Guide 99 (VIM) - International vocabulary of metrology (basic concepts and terms).
- Roles of RMPs are further detailed in ISO 17511 and ISO 18153.