Efektivnost obuka izvršilaca u sistemu menadžmenta kvaliteta u medicinskoj i farmaceutskoj industriji

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Objavljeno Jul 18, 2026

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Nevena Krstajić
Univerzitet u Beogradu, Fakultet organizacionih nauka, Beograd
http://orcid.org/0009-0002-6447-7572 Mladen Đurić
Univerzitet u Beogradu, Fakultet organizacionih nauka, Beograd
http://orcid.org/0000-0002-8219-2899

Apstrakt

Efektivnost obuka izvršilaca predstavlja jedan od ključnih elemenata uspešnog funkcionisanja sistema menadžmenta kvaliteta u medicinskoj i farmaceutskoj industriji, naročito u kontekstu zahteva standarda ISO 13485 i dobre dokumentacione prakse (GDP). Ovaj rad bavi se analizom značaja i efektivnosti obuka zaposlenih, sa posebnim fokusom na primenu GDP principa i ALCOA koncepta u cilju obezbeđivanja integriteta podataka.


U radu su razmatrani relevantni zahtevi standarda ISO 13485, kao i primer iz prakse koji ukazuje na posledice neadekvatne obučenosti zaposlenih u oblasti upravljanja dokumentacijom. Primenom Ishikawa metode identifikovani su uzroci neusaglašenosti, dok je analiza CAPA procesa ukazala na ograničenja postojećih mehanizama za unapređenje kvaliteta.


Rezultati pokazuju da formalno sprovedene obuke ne garantuju njihovu efektivnu primenu u praksi, već je neophodan sistemski pristup koji obuhvata kontinuirano praćenje, evaluaciju i unapređenje programa obuka. Zaključuje se da adekvatno planirane i sprovedene obuke značajno doprinose smanjenju rizika, unapređenju usaglašenosti i jačanju sistema menadžmenta kvaliteta.

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Kako citirati
KRSTAJIĆ, Nevena; ĐURIĆ, Mladen. Efektivnost obuka izvršilaca u sistemu menadžmenta kvaliteta u medicinskoj i farmaceutskoj industriji. Zbornik Međunarodnog kongresa o procesnoj industriji – Procesing, [S.l.], v. 39, n. 1, p. 265-273, july 2026. Dostupno na: <http://izdanja.smeits.rs/index.php/ptk/article/view/8353>. Datum pristupa: 07 aug. 2026
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Broj časopisa
God. 39 Br. 1 (2026): 39. Međunarodni kongres o procesnoj industriji
Sekcija
Menadžment kvaliteta i standardizacija u organizacijama
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Ovaj rad je pod Creative Commons Autorstvo-Nekomercijalno-Deli pod istim uslovima 4.0 Internacionalna licenca.

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