| Naslov: | 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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| Avtorji: | ID Roelofsen-de Beer, Roseri (Avtor)
ID Wielders, Jos (Avtor)
ID Boursier, Guilaine (Avtor)
ID Vodnik, Tatjana (Avtor)
ID Vanstapel, Florent (Avtor)
ID Huisman, Wim (Avtor)
ID Vukasović, Ines (Avtor)
ID Vaubourdolle, Michel (Avtor)
ID Sönmez, Çiğdem (Avtor)
ID Linko, Solveig (Avtor)
ID Meško-Brguljan, Pika, Klinika Golnik, Medicinska fakulteta UM (Avtor) |
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| Datoteke: |  URL - Izvorni URL, za dostop obiščite https://www.degruyter.com/view/journals/cclm/58/3/article-p361.xml?language=en
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| Jezik: | Angleški jezik |
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| Tipologija: | 1.01 - Izvirni znanstveni članek |
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| Organizacija: |  UKPBAG - Univerzitetna klinika za pljučne bolezni in alergijo Golnik
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| Povzetek: | 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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| Ključne besede: | opinion paper, EFLM, ISO 15189:2012, validation, verification |
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| Status publikacije: | Objavljeno |
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| Kraj izida: | Nemčija, ZDA |
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| Založnik: | Walter de Gruyter |
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| Leto izida: | 2020 |
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| Št. strani: | str. 361-367 |
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| Številčenje: | Vol. 58, iss. 3 |
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| PID: | 20.500.12556/DiRROS-12328  |
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| UDK: | 542 |
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| ISSN pri članku: | 1437-4331 |
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| DOI: | 10.1515/cclm-2019-1053 |
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| COBISS.SI-ID: | 2048629105 |
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| Avtorske pravice: | ©2020 Walter de Gruyter GmbH |
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| Opomba: | Nasl. z nasl. zaslona;
Soavtorica iz Slovenije: Pika Meško Brguljan;
Opis vira z dne 14. 2. 2020; |
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| Datum objave v DiRROS: | 10.08.2020 |
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| Število ogledov: | 1680 |
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| Število prenosov: | 515 |
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| Metapodatki: |     |
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