General requirements for the competence of reference material producers
General requirements for the competence of reference material producers
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PD ISO Guide 34:2009 General requirements for the competence of reference material producers Accurate measurements are important for a number of reasons. For example, they are needed to detect dangerous amounts of toxins in food, to diagnose diseases, and to check whether a sample of steel is strong enough for safely constructing a building. These measurements can only be done when the measurement instruments being used have been calibrated correctly. Materials that can be used for instrument calibration are needed, and are known as “reference materials”. Vital decisions often depend on measurements such as those mentioned above, confidence is required in the measurement data. As a result, the measurement procedures must also be controlled by using reference materials similar to the material to be tested, and for which the measured value is already known. This means labs are able to verify their ability to measure accurately. ISO Guide 34 ensures reference material producers are competent to manufacture their products to a given quality. It covers all the elements of ISO/IEC 17025 and some additional ones for production, storage and distribution (ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling). This is particularly important with complex materials such as seawater, soil, and clay where traceability, homogeneity and stability are not necessarily inherent characteristics of the product. The United Kingdon Accreditation Service (UKAS) operate an accreditation scheme to ISO Guide 34, and UKAS-accredited testing laboratories should be using either ISO Guide 34 or ISO 17025 accredited certified reference materials wherever possible. Once UKAS accredit a lab with ISO Guide 34 , the reference material producer has the competency to manufacture CRM’s, and have the authority to self-certify these products. Therefore...
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