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A need for clearer terminology and guidance in the role of reference materials in method development and validation

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Abstract

 The fact that various definitions and terminology applied to measurements in analytical chemistry are not always consistent and straightforward, by not only answering the question ”what”, but also ”how”, leads to their various interpretations. This results in non-uniform implementation of very basic and essential metrological principles in chemistry. Such a diverse situation is not conducive to the endorsement of harmonised measurements all across the world, to serve as a tool for improving the quality of life in its broadest sense for all its citizens. The discussion in this paper is focused on problems associated with terminology and definitions of ’reference material’ and ’validation’. The role of reference materials in measurement processes for purposes other than calibration and validation principles in analytical chemistry are also discussed in this paper. Where possible, potential solutions are proposed, but more often, questions of essential importance are raised in order to initiate international discussion which will hopefully lead to equally understandable answers.

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Received: 2 November 2002  Accepted: 3 February 2003

Acknowledgements   The author is grateful to Aleš Fajgelj for his comprehensive comments on the topic described in this paper. Sincere thanks also to Philip Taylor, Ewa Bulska, Emilia Vassileva, Miloslav Suchanek and Margreet Lauwaars for their contribution during fruitful discussions on validation.

Presented at the CERMM-3, Central European Reference Materials and Measurements Conference: The function of reference materials in the measurement process, May 30–June 1, 2002, Rogaška Slatina, Slovenia

Correspondence to N.  Majcen

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Majcen, N. A need for clearer terminology and guidance in the role of reference materials in method development and validation. Accred Qual Assur 8, 108–112 (2003). https://doi.org/10.1007/s00769-003-0598-8

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  • DOI: https://doi.org/10.1007/s00769-003-0598-8

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