Title: Principles for the characterisation and the value assignment of the candidate reference material in the new ISO Guide 35:2017
Citation: ACCREDITATION AND QUALITY ASSURANCE vol. 24 no. 2 p. 157-161
Publisher: SPRINGER
Publication Year: 2018
JRC N°: JRC112961
ISSN: 0949-1775 (online)
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC112961
DOI: 10.1007/s00769-018-1364-2
Type: Articles in periodicals and books
Abstract: The production of reference materials (RMs) is a key activity for the improvement and maintenance of a worldwide coherent measurement system. General requirements for the production of all types of RMs are set out in ISO 17034. These general requirements include a characterisation strategy with a note that references the list of approaches that is discussed in more details in the new ISO Guide 35:2017. This paper provides an overview of the characterisation approaches explained in technical detail in the new ISO Guide 35, with particular attention being paid to changes from the 2006 edition. Important changes include a clear distinction between the use of a single method in a single laboratory approach when the method can be validated with a certified reference material (CRM) of the same kind as the candidate reference material compared to when a similar CRM is not available. For the approach where more than one method is used in one or more laboratories the concept of the importance of the number of independent data sets is explained in more details. A lot more technical detail is also provided for the use of an interlaboratory comparison for the certification study.
JRC Directorate:Health, Consumers and Reference Materials

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