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Title: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
Authors:ID Roelofsen-de Beer, Roseri (Author)
ID Wielders, Jos (Author)
ID Boursier, Guilaine (Author)
ID Vodnik, Tatjana (Author)
ID Vanstapel, Florent (Author)
ID Huisman, Wim (Author)
ID Vukasović, Ines (Author)
ID Vaubourdolle, Michel (Author)
ID Sönmez, Çiğdem (Author)
ID Linko, Solveig (Author)
ID Meško-Brguljan, Pika, Klinika Golnik, Medicinska fakulteta UM (Author)
Files:URL URL - Source URL, visit https://www.degruyter.com/view/journals/cclm/58/3/article-p361.xml?language=en
 
Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo UKPBAG - University Clinic of Respiratory and Allergic Diseases Golnik
Abstract: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.
Keywords:opinion paper, EFLM, ISO 15189:2012, validation, verification
Publication status:Published
Place of publishing:Nemčija, ZDA
Publisher:Walter de Gruyter
Year of publishing:2020
Number of pages:str. 361-367
Numbering:Vol. 58, iss. 3
PID:20.500.12556/DiRROS-12328 New window
UDC:542
ISSN on article:1437-4331
DOI:10.1515/cclm-2019-1053 New window
COBISS.SI-ID:2048629105 New window
Copyright:©2020 Walter de Gruyter GmbH
Note:Nasl. z nasl. zaslona; Soavtorica iz Slovenije: Pika Meško Brguljan; Opis vira z dne 14. 2. 2020;
Publication date in DiRROS:10.08.2020
Views:1891
Downloads:594
Metadata:XML DC-XML DC-RDF
:
ROELOFSEN-DE BEER, Roseri, WIELDERS, Jos, BOURSIER, Guilaine, VODNIK, Tatjana, VANSTAPEL, Florent, HUISMAN, Wim, VUKASOVIĆ, Ines, VAUBOURDOLLE, Michel, SÖNMEZ, Çiğdem, LINKO, Solveig and MEŠKO-BRGULJAN, Pika, 2020, 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. Clinical chemistry and laboratory medicine [online]. 2020. Vol. 58, no. 3, p. 361–367. [Accessed 7 April 2025]. DOI 10.1515/cclm-2019-1053. Retrieved from: https://www.degruyter.com/view/journals/cclm/58/3/article-p361.xml?language=en
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Record is a part of a journal

Title:Clinical chemistry and laboratory medicine
Shortened title:Clin. chem. lab. med.
Publisher:de Gruyter
ISSN:1437-4331
COBISS.SI-ID:680355 New window

Secondary language

Language:Undetermined
Keywords:stališče, EFLM, ISO 15189:2012, validacija, verifikacija


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