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ISO Guide 31:2015, Reference materials – Contents of certificates, labels and accompanying documentation

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Document Date:

2022-08-19

The ISO Committee on Reference Materials (ISO/REMCO) published the first and second editions of this Guide in 1981 and 2000, respectively. Since the second edition was published, there has been considerable growth in the number and variety of reference materials (RMs) produced, and in their use. The demand for reliability in the results obtained by analytical techniques has risen, especially due to growing concern about legal requirements, environment, and clinical applications. This has led to a need for a wide range of RMs used for quality control purposes, as well as certified reference materials (CRMs) used in the validation of measurement methods, evaluation of the performance of new measurement procedures or laboratories, and calibration of instruments.

According to the definition of an RM in ISO Guide 30, information on the homogeneity and stability of the material is required. Moreover, it is mandatory for a CRM that all certified values are accompanied by an associated uncertainty at a stated level of confidence and a statement on the metrological traceability of these values. Therefore, guidance is required on the content and the format of the information that accompanies a reference material, whether it is certified or not.