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

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;

Data

Language: English
Year of publishing:
Typology: 1.01 - Original Scientific Article
Publisher: Walter de Gruyter
UDC: 542
COBISS: 2048629105 Link will open in a new window
ISSN: 1437-4331
Views: 921
Downloads: 264
Average score: 0 (0 votes)
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Other data

Secondary keywords: 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;
Source comment: Nasl. z nasl. zaslona; Soavtorica iz Slovenije: Pika Meško Brguljan; Opis vira z dne 14. 2. 2020;
Pages: str. 361-367
Volume: ǂVol. ǂ58
Issue: ǂiss. ǂ3
Chronology: Mar. 2020
DOI: 10.1515/cclm-2019-1053
ID: 11946515
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