| Accreditation of medical biochemical laboratory |
| Abbreviation: 46LA03
|
Load: 15(L)
+ 5(S)
+ 0(CP)
+ 0(EXE)
+ 0(P)
+ 0(ST)
+ 0(LE)
+ 0(ME)
+ 0(SCP)
+ 0(FE)
+ 0(PL)
+ 0(PCP)
+ 0(MSCP)
|
| Lecturers in charge: |
dr. sc. Marija Miloš |
| Lecturers: |
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| Course description: Accreditation of a medical-biochemical laboratory according to the standard HRN EN ISO 15189 - rules and procedure of accreditation.
Organization and management of the laboratory, quality management system, document management (so-called 4.1, 4.2, 4.3). Quality
records and technical records, internal independent evaluation, personnel records (ie 4.13, 4.14, 5.1). Accommodation and
environmental conditions - standard requirements and legislation, laboratory equipment (so-called 5.2, 5.3). Pre- and post-test
procedures, reporting of results (i.e. 5.4, 5.7, 5.8). Test procedures - validation of methods, quality assurance of test
procedures (so-called 5.5, 5.6). Identification and records of non-conformities, corrective and preventive actions, continuous
improvement (so-called 4.9, 4.10, 4.11, 4.12).
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| Compulsory literature: |
| 1. |
Vukasović I. Upravljanje kvalitetom u medicinskom laboratoriju, tumačenje zahtjeva u revidiranom upitniku za samoprocjenu.
Priručnik za trajno usavršavanje Hrvatske komore medicinskih biokemičara, Medicinska naklada, Zagreb, 2016.
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| 2. |
Galjanić S, Vukasović I, Flegar Meštrić Z. Akreditacija medicinsko-biokemijskog laboratorija. Priručnik za trajno usavršavanje
Hrvatske komore medicinskih biokemičara, Medicinska naklada, Zagreb, 2010
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| Recommended literature: |
| 3. |
Vukasović I. Cjelovito upravljanje kvalitetom. Priručnik za trajno usavršavanje Hrvatske komore medicinskih biokemičara, Medicinska
naklada, Zagreb, 2015.
|
| 4. |
Šimundić AM Upravljanje kvalitetom laboratorijskog rada. Priručnik za trajno usavršavanje Hrvatske komore medicinskih biokemičara.
Medicinska naklada, Zagreb, 2014
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