Author: H. Cantwell
This guide was first issued in 1998 and the second edition published in 2014. Over the years it has been one of the most popular of the Eurachem guides. Since the release of the first edition, however, there have been many changes in terminology, working practices, reference documents and requirements. This third edition, produced by the Eurachem Method Validation Working Group, forms a thorough revision of the 2014 edition.
This third edition includes a section on sampling and sample handling as ISO/IEC 17025:2017 introduced a focus on sampling associated with the testing or calibration being carried out by the laboratory and further guidance on assessing the calibration function has been included. The Guide is also now supported by a number of supplementary guidance documents – please see the section on supplementary guidance below.
This third edition includes guidance on:
Annexes also describe the statistical basis of detection limits and analysis of variance for precision studies, and add a check list to aid users in selecting and determining the validity of a test kit.
In preparing this guidance, the Working Group has aimed at the right balance between giving a solid theoretical background for method validation studies and providing practical guidelines on how to plan, perform and evaluate such studies in the laboratories.
The approach is generic in the sense that the Guide does not focus on particular fields of application (food, environment, pharmaceuticals etc.). However, the guide includes references to a number of specific guides in fields where different practices have been developed and become common.
The guide also includes a full bibliography. Further literature references on method validation can be found in the section "Validation of analytical methods" in the Reading list on this website.
