International Harmonised Protocol for

ISO/IUPAC/AOAC International Harmonised Protocol For Proficiency Testing of (Chemical) Analytical Laboratories... 

The International Standardising Organisations, AOAC, ISO and IUPAC, have co-operated to produce an agreed International Harmonised Protocol For... 

INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY, The International Harmonised Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories, ed. Thompson M and Wood R, Pure Appl. Chem., 1993 65 2123-2144 (also published in J. AOAC International, 1993 76 926-940). 

Thompson M and Wood R, 1993, The International harmonised protocol for the proficiency testing of (chemical) analytical laboratories. Pure and Applied Chem. 65,2123-2144. 

It is a study, which focuses on the performance of the laboratory and of the analyst. Several examples of such studies are described in literature [42,43]. It helps participants to compare their performance and their method to the performance of other laboratories and/or to an assigned value [44,45]. Repetitive laboratory performance studies to evaluate if laboratories are able to fulfil a given task are often called proficiency testing schemes. First guidelines have been set under the ISO Guide 43 [46]. In 1993, lUPAC has published an international harmonised protocol for the proficiency testing of (chemical) analytical laboratories [3] which sets the basic criteria for the organisation of laboratory performance studies. 

The ability to provide accurate and reliable data is central to the role of analytical chemists, not only in areas like the development and manufacture of drugs, food control or drinking water analysis, but also in the field of environmental chemistry, where there is an increasing need for certified laboratories (ISO 9000 standards). The quality of analytical data is a key factor in successfully identifying and monitoring contamination of environmental compartments. In this context, a large collection of methods applied to the routine analysis of prime environmental pollutants has been developed and validated, and adapted in nationally or internationally harmonised protocols (DIN, EPA). Information on method performance generally provides data on specificity, accuracy, precision (repeatability and reproducibility), limit of detection, sensitivity, applicability and practicability, as appropriate. 

ISO, IUPAC and AOAC INTERNATIONAL have co-operated to produce agreed protocols on the Design, Conduct and Interpretation of Collaborative Studies 14 and on the Proficiency Testing of [Chemical] Analytical Laboratories .11 The Working Group that produced these protocols has prepared a further protocol on the internal quality control of data produced in analytical laboratories. The document was finalised in 1994 and published in 1995 as the Harmonised Guidelines For Internal Quality Control In Analytical Chemistry Laboratories .12 The use of the procedures outlined in the Protocol should aid compliance with the accreditation requirements specified above. 

Recently there has been progress towards a universal acceptance of collaboratively tested methods and collaborative trial results and methods, no matter by whom these trials are organised. This has been aided by the publication of the IUPAC/ISO/AOAC Harmonisation Protocol on Collaborative Studies.14 That Protocol was developed under the auspices of the International Union of Pure and Applied Chemists (IUPAC) aided by representatives from the major organisations interested in conducting collaborative studies. In particular, from the food sector, the AO AC International, the International Organisation for Standardisation (ISO), the International Dairy Federation (IDF), the Collaborative International Analytical Council for Pesticides (CIPAC), the Nordic Analytical Committee (NMKL), the Codex Committee on Methods of... 

Other methods used in the context of official controls such as those used for in-house control purposes may be single laboratory validated according to internationally accepted protocols (e.g. lUPAC harmonised guidelines). General criteria for the characterisation of methods of analysis exist. 

Reference laboratories are important resources within animal disease diagnosis. These are internationally recognised facilities that have a combination of skilled personnel, validated diagnostic tests, reagents and appropriate archive material. The European Union Reference Laboratory (EURL-FISH) is funded by the EU Commission and is located in the national veterinary institute, Aarhus, Denmark. The main purpose of the EURL is to ensure high quality of all fish diagnostics performed in the member states of the EU. Furthermore this aids in the harmonisation of the protocols and methodologies applied for the various fish diseases, as described in Council Directive 2006/88/EC. The EURL is primarily concerned with notifiable viral diseases of fish (www.crl-fish.eu). 

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