Priprava laboratorija na akreditacijo po standardu ISO 15189

Bursič, Niki (author), Božič, Borut (mentor), Omersel, Jasna (comentor)

Namen magistrske naloge je bila teoretična priprava medicinskega laboratorija na akreditacijo po standardu ISO 15189 in ugotovitve predstaviti na način, da bi drugim olajšali postopek. Sistematično smo pregledali literaturo, da smo našli vire, ki bi nam pomagali pri postopku priprave. Iz strokovnih člankov smo ugotovili, s katerimi izzivi so se soočali laboratoriji po svetu, pri vpeljavi zahtev standarda ISO 15189. Nato smo izvedli analizo stanja pripravljenosti na akreditacijo dveh laboratorijev, enega na primarnem in drugega na terciarnem nivoju zdravstvenega sistema. Primerjali smo izzive med laboratorijema in ponudili možne rešitve za dosego skladnosti. Ugotovili smo, da je priprava jasnega in jedrnatega navodila, ki bi veljala za vsak laboratorij zelo zahtevna naloga.

• Language: Slovenian
• Keywords: medicinski laboratorij, ISO 15189, kakovost, akreditacija
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2026
• PID: 20.500.12556/RUL-179875
• Publication date in RUL: 26.02.2026

Secondary language

• Language: English
• Title: Preparation of the laboratory for accreditation according to the standard ISO 15189

Abstract

The aim of the master’s thesis was the theoretical preparation of a medical laboratory for accreditation according to the ISO 15189 standard and present our findings in a way to help others in the same situation. We systematically reviewed the literature to identify sources that would assist us in the preparation process. We identified the challenges laboratories around the world faced when implementing the requirements of the ISO 15189 standard from published articles. We then conducted an analysis of the state of preparedness for accreditation in two laboratories—one at the primary level and the other at the tertiary level of the healthcare system. We compared the challenges between the two laboratories and proposed possible solutions for achieving compliance. We found that preparing clear and concise guidelines applicable to every laboratory is a very complex task.

• Keywords: medical laboratory, ISO 15189, quality, accreditation