Certified reference materials

Certified Reference Materials (CRMs) are ‘controls’ or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. A certified reference material is a particular form of measurement standard.

Reference materials are particularly important for analytical chemistry and clinical analysis. Since most analytical instrumentation is comparative, it requires a sample of known composition (reference material) for accurate calibration. These reference materials are produced under stringent manufacturing procedures and differ from laboratory reagents in their certification and the traceability of the data provided.

Quality management systems involving laboratory accreditation under national and international accreditation/certification standards such as ISO/IEC 17025 require metrological traceability to Certified Reference Materials (where possible) when using reference materials for calibration.

Whilst Certified Reference Materials are preferred where available, their availability is limited. Reference Materials that do not meet all the criteria for certified reference materials are more widely available: the principal difference is the additional evidence of metrological traceability and statement of measurement uncertainty provided on the certificate for certified reference materials.

ISO REMCO, the ISO committee responsible for guidance on reference materials within ISO, defines the following classes of reference material:

Other bodies may define classes of reference material differently. WHO guidelines for biological reference materials provide the terms:

For chemical substances some pharmacopoeias use the WHO terms

The United States National Institute of Standards and Technology (NIST) uses the trade marked term Standard Reference Material (SRM) to denote a certified reference material that satisfies additional NIST-specific criteria. In addition, commercial producers adhering to criteria and protocols defined by NIST may use the trademark "NIST traceable reference material" to designate certified reference materials with a well-defined traceability linkage to existing NIST standards for chemical measurements. The term European reference material (ERM) is, similarly, a trademarked term referring to CRMs produced by the European Reference Materials consortium.

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