Application of ISO 15189 standard on accreditation of medical laboratories

Abstract

Application of external quality control in clinical biochemical laboratories imposed the necessity of introduction of system quality management and accreditation in identical and different medical laboratories. ?Good laboratory practice? and the principals thereof were adopted by the appointed bodies, both international and national ones. In the beginning, ISO 9001 standard was applied to certification, and EN 45001 and ISO Guide 25 to accreditation; both were prepared for testing and calibration laboratories. ISO 17025 standard is the successor of the previous documents and presently used as reference by the listed laboratories. The Working Group of European Communities Confederation of Clinical Chemistry (EC4) set up out the additional requirements for the medical laboratories. The draft standard ISO 15189 was adopted in February of 2003 as the final version of the requirements set forth for all the medical laboratories.Primena spoljasnje kontrole kvaliteta u klinicko biohemijskim laboratorijama nametnula je potrebu uvodjenja menadzmenta sistema kvaliteta i akreditaciju u istim i drugim medicinskim laboratorijama. ?Dobra laboratorijska praksa? i njeni principi bili su usvojeni od strane nominovanih tela, kako medjunarodnih, tako i nacionalnih. U pocetku je za sertifikaciju primenjivan standard ISO 9001, a za akreditaciju EN 45001 i ISO Guide 25, koji su pripremani za ispitne i kalibracione laboratorije. Standard ISO 17025 je naslednik predhodnih dokumenata i za sada referentan za navedene laboratorije. Radna grupa Konfederacije evropskih drustava za klinicku hemiju (EC4) izradila je dopunu zahteva neophodnih za medicinske laboratorije, koji su opisani novim standardom. Nacrt standarda ISO 15189 usvojen je februara 2003. godine kao definitivna verzija sa zahtevima potrebnim za sve medicinske laboratorije.