Pretraga

Pretražite po imenu i prezimenu autora, mentora, urednika, prevoditelja

Napredna pretraga

Pregled bibliografske jedinice broj: 1057949

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

Roelofsen-de Beer; Roseri; Wielders, Jos; Boursier, Guilaine; Vodnik, Tatjana; Vanstapel, Florent; Huisman, Willem; Vukasović, Ines; Vaubourdolle, Michel; Sönmez, Çiğdem et al.
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, 58 (2020), 3; 361-367 doi:10.1515/cclm-2019-1053 (međunarodna recenzija, ostalo, znanstveni)

CROSBI ID: 1057949 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

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

Autori
Roelofsen-de Beer ; Roseri ; Wielders, Jos ; Boursier, Guilaine ; Vodnik, Tatjana ; Vanstapel, Florent ; Huisman, Willem ; Vukasović, Ines ; Vaubourdolle, Michel ; Sönmez, Çiğdem ; Linko, Solveig ; Brugnoni, Duilio ; Kroupis, Christos ; Lohmander, Maria ; Šprongl, Luděk ; Bernabeu- Andreu, Francisco ; Meško Brguljan, Pika ; Thelen, Marc

Izvornik
Clinical chemistry and laboratory medicine (1434-6621) 58 (2020), 3; 361-367

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, ostalo, znanstveni

Ključne riječi
EFLM ; ISO 15189 ; examination procedure ; opinion paper ; validation ; verification

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti, Kliničke medicinske znanosti, Farmacija, Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)



POVEZANOST RADA

Ustanove:
KBC "Sestre Milosrdnice",
Hrvatsko katoličko sveučilište, Zagreb

Profili:

Avatar Url Ines Vukasović (autor)

Poveznice na cjeloviti tekst rada:

doi www.ncbi.nlm.nih.gov

Citiraj ovu publikaciju:

Roelofsen-de Beer; Roseri; Wielders, Jos; Boursier, Guilaine; Vodnik, Tatjana; Vanstapel, Florent; Huisman, Willem; Vukasović, Ines; Vaubourdolle, Michel; Sönmez, Çiğdem et al.
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, 58 (2020), 3; 361-367 doi:10.1515/cclm-2019-1053 (međunarodna recenzija, ostalo, znanstveni)
Roelofsen-de Beer, Roseri, Wielders, J., Boursier, G., Vodnik, T., Vanstapel, F., Huisman, W., Vukasović, I., Vaubourdolle, M. & Sönmez, Ç. (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, 58 (3), 361-367 doi:10.1515/cclm-2019-1053.
@article{article, author = {Wielders, Jos and Boursier, Guilaine and Vodnik, Tatjana and Vanstapel, Florent and Huisman, Willem and Vukasovi\'{c}, Ines and Vaubourdolle, Michel and S\"{o}nmez, \c{C}i\u{g}dem and Linko, Solveig and Brugnoni, Duilio and Kroupis, Christos and Lohmander, Maria and \v{S}prongl, Lud\v{e}k and Bernabeu- Andreu, Francisco and Me\v{s}ko Brguljan, Pika and Thelen, Marc}, year = {2020}, pages = {361-367}, DOI = {10.1515/cclm-2019-1053}, keywords = {EFLM, ISO 15189, examination procedure, opinion paper, validation, verification}, journal = {Clinical chemistry and laboratory medicine}, doi = {10.1515/cclm-2019-1053}, volume = {58}, number = {3}, issn = {1434-6621}, 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}, keyword = {EFLM, ISO 15189, examination procedure, opinion paper, validation, verification} }
@article{article, author = {Wielders, Jos and Boursier, Guilaine and Vodnik, Tatjana and Vanstapel, Florent and Huisman, Willem and Vukasovi\'{c}, Ines and Vaubourdolle, Michel and S\"{o}nmez, \c{C}i\u{g}dem and Linko, Solveig and Brugnoni, Duilio and Kroupis, Christos and Lohmander, Maria and \v{S}prongl, Lud\v{e}k and Bernabeu- Andreu, Francisco and Me\v{s}ko Brguljan, Pika and Thelen, Marc}, year = {2020}, pages = {361-367}, DOI = {10.1515/cclm-2019-1053}, keywords = {EFLM, ISO 15189, examination procedure, opinion paper, validation, verification}, journal = {Clinical chemistry and laboratory medicine}, doi = {10.1515/cclm-2019-1053}, volume = {58}, number = {3}, issn = {1434-6621}, 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}, keyword = {EFLM, ISO 15189, examination procedure, opinion paper, validation, verification} }

Citati:

    Altmetrijski pokazatelji:


    Podijeli:





    Contrast
    Increase Font
    Decrease Font
    Dyslexic Font
    CROSBI koristi kolačiće (cookies) kako bi poboljšao funkcionalnost stranice.