<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Roelofsen-de,Beer R.</style></author><author><style face="normal" font="default" size="100%">Wielders,J.</style></author><author><style face="normal" font="default" size="100%">Boursier,G.</style></author><author><style face="normal" font="default" size="100%">Vodnik,T.</style></author><author><style face="normal" font="default" size="100%">Vanstapel,F.</style></author><author><style face="normal" font="default" size="100%">Huisman, W.</style></author><author><style face="normal" font="default" size="100%">Vukasovic,I.</style></author><author><style face="normal" font="default" size="100%">Vaubourdolle,M.</style></author><author><style face="normal" font="default" size="100%">Sonmez,C.</style></author><author><style face="normal" font="default" size="100%">Linko,S.</style></author><author><style face="normal" font="default" size="100%">Brugnoni,D.</style></author><author><style face="normal" font="default" size="100%">Kroupis, C.</style></author><author><style face="normal" font="default" size="100%">Lohmander,M.</style></author><author><style face="normal" font="default" size="100%">Sprongl,L.</style></author><author><style face="normal" font="default" size="100%">Bernabeu-Andreu,F.</style></author><author><style face="normal" font="default" size="100%">Mesko,Brguljan P.</style></author><author><style face="normal" font="default" size="100%">Thelen,M.</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation</style></title><secondary-title><style face="normal" font="default" size="100%">Clin.Chem.Lab Med.</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Accreditation</style></keyword><keyword><style  face="normal" font="default" size="100%">Clinical Laboratory Techniques</style></keyword><keyword><style  face="normal" font="default" size="100%">Documentation</style></keyword><keyword><style  face="normal" font="default" size="100%">Europe</style></keyword><keyword><style  face="normal" font="default" size="100%">Greece</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">methods</style></keyword><keyword><style  face="normal" font="default" size="100%">Reference Standards</style></keyword><keyword><style  face="normal" font="default" size="100%">Societies,Scientific</style></keyword><keyword><style  face="normal" font="default" size="100%">Standards</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2020</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2020/02/25/</style></date></pub-dates></dates><urls><web-urls><url><style face="normal" font="default" size="100%">PM:31714885</style></url></web-urls></urls><volume><style face="normal" font="default" size="100%">58</style></volume><pages><style face="normal" font="default" size="100%">361 - 367</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle</style></abstract><issue><style face="normal" font="default" size="100%">3</style></issue><notes><style face="normal" font="default" size="100%">IS - 1437-4331 (Electronic)IS - 1434-6621 (Linking)LA - engPT - Journal ArticlePT - Validation StudySB - IM</style></notes></record></records></xml>