| 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 |
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| 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) |
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| Files: |  URL - Source URL, visit https://www.degruyter.com/view/journals/cclm/58/3/article-p361.xml?language=en
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKPBAG - University Clinic of Respiratory and Allergic Diseases Golnik
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| 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. |
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| Keywords: | opinion paper, EFLM, ISO 15189:2012, validation, verification |
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| Publication status: | Published |
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| Place of publishing: | Nemčija, ZDA |
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| Publisher: | Walter de Gruyter |
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| Year of publishing: | 2020 |
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| Number of pages: | str. 361-367 |
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| Numbering: | Vol. 58, iss. 3 |
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| PID: | 20.500.12556/DiRROS-12328  |
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| UDC: | 542 |
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| ISSN on article: | 1437-4331 |
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| DOI: | 10.1515/cclm-2019-1053 |
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| COBISS.SI-ID: | 2048629105 |
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| Copyright: | ©2020 Walter de Gruyter GmbH |
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| Note: | Nasl. z nasl. zaslona;
Soavtorica iz Slovenije: Pika Meško Brguljan;
Opis vira z dne 14. 2. 2020; |
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| Publication date in DiRROS: | 10.08.2020 |
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| Views: | 1848 |
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| Downloads: | 583 |
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