{"id":116412,"date":"2026-05-18T09:15:22","date_gmt":"2026-05-18T07:15:22","guid":{"rendered":"https:\/\/novak-m.com\/?p=116412"},"modified":"2026-05-18T09:15:22","modified_gmt":"2026-05-18T07:15:22","slug":"pridobili-iso-13485","status":"publish","type":"post","link":"https:\/\/novak-m.com\/sl\/pridobili-iso-13485\/","title":{"rendered":"ISO 13485: standard, ki stoji za na\u0161imi izdelki"},"content":{"rendered":"

Kaj pomeni ISO 13485?<\/h2>\n

Do sedaj smo poslovali v skladu s standardom ISO 9001, ki potrjuje urejen sistem vodenja kakovosti. Z ISO 13485 pa stopamo \u0161e korak dlje. Je namre\u010d posebej prilagojen zahtevam medicinske industrije, kjer so varnost, sledljivost, nadzor nad procesi in dosledno izpolnjevanje regulativnih zahtev klju\u010dnega pomena.<\/p>\n

Povedano preprosto: ISO 13485 je na\u0161a zaveza, da pri kakovosti in varnosti medicinskih pripomo\u010dkov ne sklepamo kompromisov.<\/p>\n

\"\"<\/p>\n

Kaj to pomeni za uporabnike?<\/h2>\n

Za kon\u010dne uporabnike to pomeni ve\u010d kot formalno skladnost. Je dodatno zagotovilo, da so na\u0161i postopki na\u010drtovanja, proizvodnje, kontrole in dokumentiranja skladni z visokimi zahtevami, ki veljajo za podro\u010dje medicinske opreme. Certifikat potrjuje, da pri svojem delu sistemati\u010dno obvladujemo tveganja, zagotavljamo sledljivost materialov in procesov ter nenehno skrbimo za izbolj\u0161ave.<\/p>\n

Razi\u0161\u010di na\u0161e izdelke<\/a><\/div>\n

Skladnost z MDR<\/h2>\n

Na\u0161i izdelki so skladni tudi z evropsko uredbo o medicinskih pripomo\u010dkih (MDR). V kombinaciji z ISO 13485 to pomeni, da ne sledimo le dobrim praksam, temve\u010d izpolnjujemo najnovej\u0161e zakonodajne zahteve<\/strong><\/a> evropskega trga. Za uporabnike je to dodatno zagotovilo, da uporabljajo kakovostno in zanesljivo opremo.<\/p>\n

Korak naprej<\/h2>\n

Ponosni smo, da smo s pridobitvijo standarda ISO 13485 potrdili svojo zavezanost kakovosti, varnosti in zanesljivosti. Na\u0161 cilj ostaja enak: uporabnikom, torej medicinskemu osebju in pacientom, zagotavljati izdelke in re\u0161itve, ki jim lahko zaupajo.<\/p>\n

pi\u0161ite nam<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

Uspe\u0161no smo pridobili certifikat ISO 13485, mednarodno priznan standard sistema vodenja kakovosti za organizacije, ki delujejo na podro\u010dju medicinskih pripomo\u010dkov in medicinske opreme.<\/p>\n","protected":false},"author":5,"featured_media":116386,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[],"class_list":["post-116412","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-novice"],"acf":[],"yoast_head":"\nPridobili smo certifikat ISO 13485 \u2502 Novak M<\/title>\n<meta name=\"description\" content=\"Standard ISO 13485 je na\u0161a zaveza, da pri kakovosti in varnosti medicinskih pripomo\u010dkov ne sklepamo kompromisov.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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