20.500.12556/DKUM-40583 UPORABA STANDARDA SIST EN ISO 13485:2012 PRI IZDELAVI INDIVIDUALNIH MEDICINSKIH VSADKOV THE USE OF STANDARD SIST EN ISO 13485:2012 FOR THE MANUFACTURE OF INDIVIDUAL MEDICAL IMPLANTS Organizacija, ki izdeluje individualne medicinske vsadke mora imeti vzpostavljen standard nadzora kakovosti v procesu izdelave. Treba je definirati metode in postopke zagotavljanja kakovosti, ki bodo v skladu s standardom ISO 13485. V prvem delu diplomske naloge je predstavljen standard in izdelava individualnega medicinskega vsadka. V drugem delu pa je predstavljena tehnologija izdelave vsadka. Rezultat diplomskega dela je oblikovana in za uporabo pripravljena vsa potrebna dokumentacija, ki zajema obrazce od naročila do izdelanega vsadka. Poleg dokumentacije je izdelana tudi kalkulacija predvidenih stroškov posameznih procesov, ki nastanejo med izdelavo vsadka. In the organisation which produces individual medical implants a standard for quality management system in the manufacturing process must be established. The methods and procedures for quality management system must be defined to meet ISO 13485 requirements. In the first part of the thesis, the standard and the manufacturing of the individual medical implant are presented. In the second part, the technology for the medical implant manufacturing is described. The result of the thesis is the whole documentation needed, ready and prepared to be used including all forms from customer orders to the manufctured implants. Beside documentation also the calculation of estimated cost of individual processes ocurring during the implant manufacturing is included. tehnologija izdelave standard ISO 13485 medicinski vsadek stroški kalkulacija stroškov dokumentacija manufactoring technology standard ISO 13485 medical implant costs calculation costs documentation true true false [T. Valand] Slovenski jezik Angleški jezik Diplomsko delo 2013-05-31 07:34:55 2013-07-12 07:49:41 2022-05-12 23:47:38 2021-04-24 03:10:48 2013 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 658.51+657.474.5(043.2) 17140502 URN:SI:UM:DK:QLWJWJTL UNI_Valand_Tomaz_2013.pdf UNI_Valand_Tomaz_2013.pdf 1 8F2E930F98DA97B79A0A081F6BF617D0 16aac97f0d947d2dfff1e59f2e488fb507f5538972521965f080bd1233ec7248 fddddd18-7c09-11eb-bb7a-00155d0001ca 20.500.12556/dkum/0e82f13e-447a-40e3-95a9-df536492a22b https://dk.um.si/Dokument.php?lang=slv&id=55650 Fakulteta za strojništvo 0 0 0