{"id":8496,"date":"2024-08-22T14:44:04","date_gmt":"2024-08-22T14:44:04","guid":{"rendered":"https:\/\/certifiqat.com\/news\/iso-13485-quality-management-system-for-medical-devices\/"},"modified":"2024-08-23T12:08:01","modified_gmt":"2024-08-23T12:08:01","slug":"iso-13485-quality-management-system-for-medical-devices","status":"publish","type":"post","link":"https:\/\/certifiqat.com\/da\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; Kvalitetsstyringssystem for medicinsk udstyr"},"content":{"rendered":"\n<p><strong>Den internationale standard ISO 13485 fungerer som grundlag for certificering af kvalitetsstyringssystemer i virksomheder, der fremstiller eller distribuerer medicinsk udstyr eller er involveret i fremstillingen som en del af forsyningsk\u00e6den.<\/strong><\/p>\n\n\n\n<p>Et kvalitetsstyringssystem udg\u00f8r rygraden i driften og opgaverne for producenter af medicinsk udstyr. Det sikrer, at b\u00e5de interne og eksterne regler f\u00f8lges p\u00e5lideligt.<\/p>\n\n\n\n<p>Ved at certificere deres system p\u00e5 passende vis kan producenterne opbygge tillid til deres processer og produkter og demonstrere deres engagement i sikkerhed og kvalitet.<\/p>\n\n\n\n<p>Standarden omhandler de krav, som producenter og leverand\u00f8rer af medicinsk udstyr skal opfylde, n\u00e5r de udvikler, implementerer og vedligeholder ledelsessystemer til den medicinske teknologibranche.<\/p>\n\n\n\n<p>Fordele ved standarden:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Processikkerhed gennem dokumenterede procedurer <\/strong><\/li>\n\n\n\n<li><strong>Bevis for overholdelse af lovkrav <\/strong><\/li>\n\n\n\n<li><strong>\u00d8get produktsikkerhed for patienter og brugere <\/strong><\/li>\n\n\n\n<li><strong>\u00d8get tilfredshed blandt kunder og medarbejdere <\/strong><\/li>\n\n\n\n<li><strong>Fremh\u00e6ver virksomhedens kompetence<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Hvad er ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 er en selvst\u00e6ndig standard for kvalitetsstyringssystemer for producenter af medicinsk udstyr eller in vitro-diagnostik. Den stammer fra den internationalt anerkendte og accepterede standardserie EN ISO 9000. ISO 13485 forts\u00e6tter den procesorienterede tilgang i ISO 9001 og supplerer den med specifikke aspekter, der er s\u00e6rligt vigtige for producenter af medicinsk udstyr eller in vitro-diagnostik.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hvad indeholder ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 hj\u00e6lper producenter med at udvikle et kvalitetsstyringssystem, der muligg\u00f8r sikre og effektive processer. Disse processer er designet til at sikre konsekvent design, udvikling, produktion, installation, levering, overv\u00e5gning, sporing og bortskaffelse af medicinsk udstyr, der d\u00e6kker hele produktets livscyklus. Dette er for at sikre, at medicinsk udstyr og in vitro-diagnostik kan bruges sikkert til det tilsigtede form\u00e5l.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hvad er den juridiske betydning af ISO 13485?<\/h2>\n\n\n\n<p>Regulatoriske godkendelsesprogrammer for medicinsk udstyr eller in vitro-diagnostik er ofte afh\u00e6ngige af kravene i ISO 13485. De generelle krav i ISO 13485 udvides og tilpasses til specifikke juridiske markedskrav gennem konkretiseringer og tilf\u00f8jelser.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hvad er forskellen mellem ISO 13485 og EN ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 er den internationalt anerkendte basisversion af standarden, men den er blevet harmoniseret til en europ\u00e6isk standard af den europ\u00e6iske standardiseringsorganisation for at blive taget i betragtning i de europ\u00e6iske myndigheders godkendelsesprocedurer. Ved at f\u00f8lge en harmoniseret standard kan en producent bevise, at dens produkter eller tjenester opfylder de tekniske krav i den relevante EU-lovgivning og om n\u00f8dvendigt ogs\u00e5 h\u00e6vde den s\u00e5kaldte formodning om overensstemmelse.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Den internationale standard ISO 13485 fungerer som grundlag for certificering af kvalitetsstyringssystemer i virksomheder, der fremstiller eller distribuerer medicinsk udstyr eller er involveret i fremstillingen som en del af forsyningsk\u00e6den. Et kvalitetsstyringssystem udg\u00f8r rygraden i driften og opgaverne for producenter af medicinsk udstyr. Det sikrer, at b\u00e5de interne og eksterne regler f\u00f8lges p\u00e5lideligt. Ved at<\/p>\n","protected":false},"author":3,"featured_media":8481,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19402,19462],"tags":[],"class_list":["post-8496","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-da","category-standard-da"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 - Kvalitetsstyringssystem for medicinsk udstyr - Certifiqat.com<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/certifiqat.com\/da\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - Kvalitetsstyringssystem for medicinsk udstyr - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"Den internationale standard ISO 13485 fungerer som grundlag for certificering af kvalitetsstyringssystemer i virksomheder, der fremstiller eller distribuerer medicinsk udstyr eller er involveret i fremstillingen som en del af forsyningsk\u00e6den. Et kvalitetsstyringssystem udg\u00f8r rygraden i driften og opgaverne for producenter af medicinsk udstyr. Det sikrer, at b\u00e5de interne og eksterne regler f\u00f8lges p\u00e5lideligt. 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