ISO 17034 General Requirements for the Competence of Reference Material Producers
ISO 17034 specifies general requirements for the competence and consistent operation of reference material producers.
Reference materials (RMs) are used in all stages of the measurement process, including for method validation, calibration and quality control. They are also used in interlaboratory comparisons for method validation and for assessing laboratory proficiency.
The demonstration of the scientific and technical competence of reference material producers (RMPs) is a basic requirement for ensuring the quality of RMs. The demand for new RMs of higher quality is increasing as a consequence of both the improved precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. It is not only necessary for RMPs to provide information about their materials in the form of RM documents, but also to demonstrate their competence in producing RMs of appropriate quality.
Further guidance (e.g. concerning the content of certificates and the design of characterization, homogeneity and stability studies) is provided in ISO Guide 31 and ISO Guide 35. While the approaches outlined in ISO Guide 31 and ISO Guide 35 meet the relevant requirements of this standard, there might be alternative ways to achieve compliance to this standard.
This standard outlines the general requirements for the producers of RMs, including certified reference materials (CRMs). It supersedes ISO Guide 34:2009 and is aligned with the relevant requirements of ISO/IEC 17025.