20.500.12556/DiRROS-12328 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 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. opinion paper EFLM ISO 15189:2012 validation verification stališče EFLM ISO 15189:2012 validacija verifikacija true false true Walter de Gruyter Angleški jezik Ni določen ©2020 Walter de Gruyter GmbH Neznano 2020-08-10 11:27:32 2020-08-10 11:27:32 2022-08-18 03:36:41 0000-00-00 00:00:00 2020 0 Nemčija, ZDA 0 Nasl. z nasl. zaslona; Soavtorica iz Slovenije: Pika Meško Brguljan; Opis vira z dne 14. 2. 2020; str. 361-367 iss. 3 Vol. 58 Mar. 2020 0000-00-00 NiDoloceno Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 542 1437-4331 10.1515/cclm-2019-1053 2048629105 680355 https://www.degruyter.com/view/journals/cclm/58/3/article-p361.xml?language=en 1 https://dirros.openscience.si/Dokument.php?lang=slv&id=14858 Univerzitetna klinika za pljučne bolezni in alergijo Golnik 0 0 0