By Song X.
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Extra resources for A marginal model approach for analysis of multi-reader multi-test receiver operating characteristic
A fourth, revised edition, is under preparation by the ISO/CASCO Working Group 10 and, after publication, will serve as the basis for the next revision of EN 45001. ISO/IEC Guide 25 is much more clearly defined than EN 45001. If an analytical laboratory is able to choose its quality model to follow, it is recommended that the ISOlIEC Guide 25 is used. This also has the additional advantage in that the ISO/IEC Guide is the model that is accepted on a worldwide basis whereas EN 45001 is the European Standard.
Sometimes the model to be chosen is prescribed by legislation as described in Chapter 1. The intent of each model that the laboratory is most likely to choose is described below: 0 0 EN 45001 and ISO/IEC Guide 25 are developed for the operation of testing laboratories that sell their analytical services; OECD GLP principles are developed to promote quality in toxicological studies on chemicals and pharmaceuticals; EN 45002 and 45003, I S 0 10011, OECD Environment Monographs 110 18 Chapter 2 and 111 give information on subjects such as assessment, monitoring, inspection and accreditation of different types of laboratories; EN IS0 900 1-9003 are quality system standards developed to facilitate the dialogue in between producers and their customers (they also influence laboratories that are an integral part of a IS0 9000 certified company); EN IS0 9000-1, 9000-3, 9004 and 9004-2 are guidelines for the application of I S 0 9001-9003 standards in different situations; EQA, BQA, USK, etc.
A description of these requirements is therefore given below as food analysts will increasing be required to justify their choice of method in the light 36 Methods of Analysis-Their Selection, Acceptability and Validation 37 of these ‘fully validated’ requirements. The meaning of ‘fully validated’ within the food sector is illustrated by the requirements of the various international organisations which develop or adopt Standard Methods of Analysis; these are described in Part A of this chapter.