{"id":8502,"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":"2024-08-23T12:08:02","modified_gmt":"2024-08-23T12:08:02","slug":"iso-13485-quality-management-system-for-medical-devices","status":"publish","type":"post","link":"https:\/\/certifiqat.com\/nb\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; Kvalitetsstyringssystem for medisinsk utstyr"},"content":{"rendered":"\n<p><strong>Den internasjonale standarden ISO 13485 danner grunnlaget for sertifisering av kvalitetsstyringssystemer i bedrifter som produserer eller distribuerer medisinsk utstyr, eller som er involvert i produksjonen av slikt utstyr som en del av leverand\u00f8rkjeden.<\/strong><\/p>\n\n\n\n<p>Et kvalitetsstyringssystem utgj\u00f8r ryggraden i virksomheten og arbeidsoppgavene til produsenter av medisinsk utstyr. Det sikrer at b\u00e5de interne og eksterne forskrifter f\u00f8lges p\u00e5 en p\u00e5litelig m\u00e5te.<\/p>\n\n\n\n<p>Ved \u00e5 sertifisere systemet sitt p\u00e5 riktig m\u00e5te kan produsentene bygge tillit til prosessene og produktene sine og vise at de er opptatt av sikkerhet og kvalitet.<\/p>\n\n\n\n<p>Standarden tar for seg kravene som produsenter og leverand\u00f8rer av medisinsk utstyr m\u00e5 oppfylle n\u00e5r de utvikler, implementerer og vedlikeholder styringssystemer for den medisinsktekniske industrien.<\/p>\n\n\n\n<p>Fordelene:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Prosesssikkerhet gjennom dokumenterte prosedyrer <\/strong><\/li>\n\n\n\n<li><strong>Bevis p\u00e5 samsvar med juridiske krav <\/strong><\/li>\n\n\n\n<li><strong>\u00d8kt produktsikkerhet for pasienter og brukere <\/strong><\/li>\n\n\n\n<li><strong>\u00d8kt tilfredshet blant kunder og ansatte <\/strong><\/li>\n\n\n\n<li><strong>Fremhever selskapets kompetanse<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Hva er ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 er en frittst\u00e5ende standard for kvalitetsstyringssystemer for produsenter av medisinsk utstyr eller in vitro-diagnostikk. Den har sitt utspring i den internasjonalt anerkjente og aksepterte standardserien EN ISO 9000. ISO 13485 videref\u00f8rer den prosessorienterte tiln\u00e6rmingen i ISO 9001 og supplerer den med spesifikke aspekter som er spesielt viktige for produsenter av medisinsk utstyr eller in vitro-diagnostikk.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hva inneholder ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 hjelper produsenter med \u00e5 utvikle et kvalitetsstyringssystem som muliggj\u00f8r sikre og effektive prosesser. Disse prosessene er utformet for \u00e5 sikre konsekvent design, utvikling, produksjon, installasjon, levering, overv\u00e5king, sporing og avhending av medisinsk utstyr gjennom hele produktets livssyklus. Dette er for \u00e5 sikre at medisinsk utstyr og in vitro-diagnostikk kan brukes trygt til det tiltenkte form\u00e5let.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hva er den juridiske betydningen av ISO 13485?<\/h2>\n\n\n\n<p>Regulatoriske godkjenningsprogrammer for medisinsk utstyr eller in vitro-diagnostikk baserer seg ofte p\u00e5 kravene i ISO 13485. De generelle kravene i ISO 13485 utvides og tilpasses til spesifikke juridiske markedskrav gjennom konkretiseringer og tillegg.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hva er forskjellen mellom ISO 13485 og EN ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 er den internasjonalt anerkjente grunnversjonen av standarden, men den har blitt harmonisert til en europeisk standard av den europeiske standardiseringsorganisasjonen for \u00e5 kunne tas i betraktning i europeiske godkjenningsprosedyrer. Ved \u00e5 f\u00f8lge en harmonisert standard kan en produsent bevise at produktene eller tjenestene oppfyller de tekniske kravene i den relevante EU-lovgivningen og, om n\u00f8dvendig, ogs\u00e5 p\u00e5berope seg den s\u00e5kalte formodningen om samsvar.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Den internasjonale standarden ISO 13485 danner grunnlaget for sertifisering av kvalitetsstyringssystemer i bedrifter som produserer eller distribuerer medisinsk utstyr, eller som er involvert i produksjonen av slikt utstyr som en del av leverand\u00f8rkjeden. Et kvalitetsstyringssystem utgj\u00f8r ryggraden i virksomheten og arbeidsoppgavene til produsenter av medisinsk utstyr. Det sikrer at b\u00e5de interne og eksterne forskrifter f\u00f8lges<\/p>\n","protected":false},"author":3,"featured_media":8487,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19414,19474],"tags":[],"class_list":["post-8502","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-nb","category-standard-nb"],"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 medisinsk utstyr - 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\/nb\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - Kvalitetsstyringssystem for medisinsk utstyr - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"Den internasjonale standarden ISO 13485 danner grunnlaget for sertifisering av kvalitetsstyringssystemer i bedrifter som produserer eller distribuerer medisinsk utstyr, eller som er involvert i produksjonen av slikt utstyr som en del av leverand\u00f8rkjeden. Et kvalitetsstyringssystem utgj\u00f8r ryggraden i virksomheten og arbeidsoppgavene til produsenter av medisinsk utstyr. 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