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
Roseri Roelofsen-de Beer (Avtor), Jos Wielders (Avtor), Guilaine Boursier (Avtor), Tatjana Vodnik (Avtor), Florent Vanstapel (Avtor), Wim Huisman (Avtor), Ines Vukasović (Avtor), Michel Vaubourdolle (Avtor), Çiğdem Sönmez (Avtor), Solveig Linko (Avtor), Pika Meško-Brguljan (Avtor)

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.

Ključne besede

opinion paper;EFLM;ISO 15189:2012;validation;verification;

Podatki

Jezik: Angleški jezik
Leto izida:
Tipologija: 1.01 - Izvirni znanstveni članek
Založnik: Walter de Gruyter
UDK: 542
COBISS: 2048629105 Povezava se bo odprla v novem oknu
ISSN: 1437-4331
Št. ogledov: 921
Št. prenosov: 264
Ocena: 0 (0 glasov)
Metapodatki: JSON JSON-RDF JSON-LD TURTLE N-TRIPLES XML RDFA MICRODATA DC-XML DC-RDF RDF

Ostali podatki

Sekundarne ključne besede: stališče;EFLM;ISO 15189:2012;validacija;verifikacija;Accreditation;Organization and administration;Laboratories, hospital;Standards;Quality control;Quality improvement;Quality assurance, health care;Reference standards;Risk management;Akreditacija;Organizacija in vodenje;Bolnišnični laboratoriji;Standardi;Nadzorovanje kakovosti;Izboljšanje kakovosti;Zagotavljanje kakovost zdravstvene oskrbe;Referenčni standardi;Obvladovanje tveganja;
Komentar vira: Nasl. z nasl. zaslona; Soavtorica iz Slovenije: Pika Meško Brguljan; Opis vira z dne 14. 2. 2020;
Strani: str. 361-367
Letnik: ǂVol. ǂ58
Zvezek: ǂiss. ǂ3
Čas izdaje: Mar. 2020
DOI: 10.1515/cclm-2019-1053
ID: 11946515
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