DIN EN 16101:2012-12

This European Standard provides guidance on interlaboratory comparison with a special focus on biological methods. Guidance on the methods and procedures given in this standard should ensure that field survey results and laboratory analyses are comparable within specified limits. This guidance enables participants in interlaboratory comparison to demonstrate their level of performance. In addition it provides a mechanism for quality improvement. This standard describes a general course of the procedure. Detailed elements can be found in EN 14996, EN ISO/IEC 17000, EN ISO/IEC 17025, and EN ISO/IEC 17043. Results of biological and ecological assessments from laboratories across the European Union are increasingly used to inform decision making and investment programmes. There is a clear need to ensure that these assessments are based upon sound science and validated data, comparable between laboratories within member states and between member states. Effective interlaboratory comparisons are based on the adoption of procedures to quantify and control process errors (clause 4) within specified limits, and to enable participants to demonstrate that their analyses fulfil requirements for quality, and to maintain their performance. This guidance standard describes the principles required for effective interlaboratory comparisons, as well as permitting laboratories to apply appropriate corrective action in relation to both analyst performance and analytical results, thereby driving improvement in quality. Interlaboratory comparison does not exist in isolation as it is part of a framework on quality assurance, which must not ignore the human dimension (for example, significant recent experience of professionals and repeated instruction). The preliminary work has been carried out by Working Group "Biological methods" (WG 2) of CEN/TC 230, the chairmanship of which is held by BSI (secretariat: United Kingdom). NA 119-01-03-05-06 AK "Biologisch-ökologische Gewässeruntersuchung" ("Biological ecological analysis of water") of NA 119-01-03 AA "Wasseruntersuchung" ("Water Analysis") has collaborated on the work which has been funded by the Länderfinanzierungsprogramm "Wasser, Boden und Abfall" (federal funding programme "Water, soil and waste").