The Role of Standardization Bodies in the Harmonization of Analytical Methods
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8261 is being incorporated into EN ISO 6887 series as an additional part 5, and a new part will be dedicated to the sample preparation from the primary production stage. 4. Measurement uncertainty (MU) for quantitative determinations (ISO/TS 19036). This ISO Technical Specification, published at the beginning of 2006, provides a guide on a topic that is currently a main concern for food microbiological laboratories. For laboratory accreditation and according to EN ISO 17025 (ISO, 2005), laboratories have to report the uncertainty associated with their results, if requested by their customers. The guide recommends a ‘global’ or ‘top down’ approach for the MU estimation, based on the experimental reproducibility standard deviation. An amendment to ISO/TS 19036 is currently being developed to cover cases of low count. MU for qualitative determinations is investigated by WG 2 of ISO/TC 34/SC 9 (Table 12.1). 5. Method validation. A set of standards on method validation, for the community of microbiological laboratories and users of analytical results, is under development by the new WG 3 of SC 9 to deal with: Validation of proprietary kits: the Standard EN ISO 16140, providing a technical protocol for the organization and interpretation of validation studies, is being revised, as to update the whole standard and to improve in particular the statistical treatment for quantitative methods. Intra-laboratory (or in-house) method validation. Intermediate validation (between in-house study and a full collaborative study). Method verification: in the particular context of accreditation, to verify that a method already developed and validated is correctly operated in a given laboratory. Technical minimum requirements for the standardization of new or revised reference methods. 6. Proficiency testing (PT) schemes. This topic is covered by WG 4 of SC 9 (Table 12.1). The purpose is to develop a guide dealing with aspects of PTorganization and interpretation that are specific to food microbiology, linked in particular to (i) the living nature of the analyte and its consequences on the homogeneity and stability of the samples, and (ii) the importance of qualitative tests (Leclercq, 2006). This specific guide would be used in addition to the general standard on PT schemes’ organization under development by ISO (ISO 17043).
IV. STATUS OF NOVEL TECHNOLOGIES This section will focus on the status of novel technologies in the standardization of methods. In this context, it is first necessary to mention one