Biochemia Medica, Vol. 20 No. 1, 2010.
Review article
Method validation and measurement uncertainty
Višnja Gašljević
; Croatian Metrology Society, Zagreb, Croatia
Abstract
In today's global world, accurate, reliable and comparable measurement results are of vital importance. Therefore, the standards which regulate laboratory requirements (ISO/IEC 17025, ISO 15189) demand a metrological approach to the measurement processes, requiring method validation, establishment of metrological traceability, estimation of measurement uncertainty, monitoring of trends in measurement processes etc.
Making the right decision on whether or not some measurement procedure is adequate for a stated use (validation), as well as a realistic estimation of measurement uncertainty, is only possible when a measurement process is well known. Its 'goodness' is characterized in terms of random and systematic errors that affect the measurements. Experiments conducted in order to validate a method can give good insight into their magnitude and also into their sources and therefore can be used for measurement uncertainty estimation. The scope of performed experiments surpasses the need for the assessment of measurement uncertainties. They are used to explore method behavior in all realistic operational conditions, to finds its weak points, prove coordinated work of personnel as well as to prove selectivity or check limits of detection etc. Even though it will not have a major impact on the information about measurement accuracy, it will ensure more reliable work, easier detection of errors in work and a higher level of confidence in results' accuracy.
Keywords
method validation; measurement uncertainty
Hrčak ID:
47850
URI
Publication date:
1.2.2010.
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