{"id":8503,"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\/pl\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; System zarz\u0105dzania jako\u015bci\u0105 dla wyrob\u00f3w medycznych"},"content":{"rendered":"\n<p><strong>Mi\u0119dzynarodowa norma ISO 13485 s\u0142u\u017cy jako podstawa do certyfikacji system\u00f3w zarz\u0105dzania jako\u015bci\u0105 w firmach, kt\u00f3re produkuj\u0105 lub dystrybuuj\u0105 wyroby medyczne lub s\u0105 zaanga\u017cowane w ich produkcj\u0119 w ramach \u0142a\u0144cucha dostaw.<\/strong><\/p>\n\n\n\n<p>System zarz\u0105dzania jako\u015bci\u0105 stanowi podstaw\u0119 dzia\u0142alno\u015bci i zada\u0144 producent\u00f3w wyrob\u00f3w medycznych. Zapewnia on niezawodne przestrzeganie zar\u00f3wno wewn\u0119trznych, jak i zewn\u0119trznych przepis\u00f3w.<\/p>\n\n\n\n<p>Odpowiednio certyfikuj\u0105c sw\u00f3j system, producenci mog\u0105 budowa\u0107 zaufanie do swoich proces\u00f3w i produkt\u00f3w oraz wykaza\u0107 swoje zaanga\u017cowanie w bezpiecze\u0144stwo i jako\u015b\u0107.<\/p>\n\n\n\n<p>Norma odnosi si\u0119 do wymaga\u0144, kt\u00f3re producenci i dostawcy urz\u0105dze\u0144 medycznych musz\u0105 spe\u0142ni\u0107 przy opracowywaniu, wdra\u017caniu i utrzymywaniu system\u00f3w zarz\u0105dzania dla bran\u017cy technologii medycznych.<\/p>\n\n\n\n<p>Zalety:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bezpiecze\u0144stwo proces\u00f3w dzi\u0119ki udokumentowanym procedurom <\/strong><\/li>\n\n\n\n<li><strong>Dow\u00f3d zgodno\u015bci z wymogami prawnymi <\/strong><\/li>\n\n\n\n<li><strong>Zwi\u0119kszone bezpiecze\u0144stwo produkt\u00f3w dla pacjent\u00f3w i u\u017cytkownik\u00f3w <\/strong><\/li>\n\n\n\n<li><strong>Wi\u0119ksza satysfakcja klient\u00f3w i pracownik\u00f3w <\/strong><\/li>\n\n\n\n<li><strong>Podkre\u015blenie kompetencji firmy<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Czym jest norma ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 to samodzielna norma dotycz\u0105ca system\u00f3w zarz\u0105dzania jako\u015bci\u0105 dla producent\u00f3w wyrob\u00f3w medycznych lub diagnostyki in vitro. Wywodzi si\u0119 ona z uznanej i akceptowanej na ca\u0142ym \u015bwiecie serii norm EN ISO 9000. Norma ISO 13485 kontynuuje zorientowane na procesy podej\u015bcie normy ISO 9001 i uzupe\u0142nia je o konkretne aspekty, kt\u00f3re s\u0105 szczeg\u00f3lnie wa\u017cne dla producent\u00f3w wyrob\u00f3w medycznych lub diagnostyki in vitro.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Co zawiera norma ISO 13485?<\/h2>\n\n\n\n<p>Norma ISO 13485 wspiera producent\u00f3w w opracowywaniu systemu zarz\u0105dzania jako\u015bci\u0105, kt\u00f3ry umo\u017cliwia bezpieczne i skuteczne procesy. Procesy te maj\u0105 na celu zapewnienie sp\u00f3jnego projektowania, rozwoju, produkcji, instalacji, dostawy, monitorowania, \u015bledzenia i utylizacji wyrob\u00f3w medycznych, obejmuj\u0105cych ca\u0142y cykl \u017cycia produktu. Ma to na celu zapewnienie, \u017ce wyroby medyczne i diagnostyka in vitro mog\u0105 by\u0107 bezpiecznie stosowane zgodnie z ich przeznaczeniem.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jakie jest znaczenie prawne normy ISO 13485?<\/h2>\n\n\n\n<p>Regulacyjne programy zatwierdzania urz\u0105dze\u0144 medycznych lub diagnostyki in vitro cz\u0119sto opieraj\u0105 si\u0119 na wymaganiach normy ISO 13485. Og\u00f3lne wymagania normy ISO 13485 s\u0105 rozszerzane i dostosowywane do konkretnych wymog\u00f3w prawnych rynku poprzez konkretyzacje i dodatki.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jaka jest r\u00f3\u017cnica mi\u0119dzy ISO 13485 a EN ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 to uznana na ca\u0142ym \u015bwiecie podstawowa wersja normy, ale zosta\u0142a ona zharmonizowana z norm\u0105 europejsk\u0105 przez europejsk\u0105 organizacj\u0119 normalizacyjn\u0105 w celu uwzgl\u0119dnienia jej w europejskich procedurach zatwierdzania przepis\u00f3w. Post\u0119puj\u0105c zgodnie ze zharmonizowan\u0105 norm\u0105, producent mo\u017ce udowodni\u0107, \u017ce jego produkty lub us\u0142ugi spe\u0142niaj\u0105 wymagania techniczne odpowiednich przepis\u00f3w UE, a tak\u017ce, w razie potrzeby, potwierdzi\u0107 tak zwane domniemanie zgodno\u015bci.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Mi\u0119dzynarodowa norma ISO 13485 s\u0142u\u017cy jako podstawa do certyfikacji system\u00f3w zarz\u0105dzania jako\u015bci\u0105 w firmach, kt\u00f3re produkuj\u0105 lub dystrybuuj\u0105 wyroby medyczne lub s\u0105 zaanga\u017cowane w ich produkcj\u0119 w ramach \u0142a\u0144cucha dostaw. System zarz\u0105dzania jako\u015bci\u0105 stanowi podstaw\u0119 dzia\u0142alno\u015bci i zada\u0144 producent\u00f3w wyrob\u00f3w medycznych. Zapewnia on niezawodne przestrzeganie zar\u00f3wno wewn\u0119trznych, jak i zewn\u0119trznych przepis\u00f3w. Odpowiednio certyfikuj\u0105c sw\u00f3j system,<\/p>\n","protected":false},"author":3,"featured_media":8488,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19409,19469],"tags":[],"class_list":["post-8503","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-pl","category-standard-pl"],"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 - System zarz\u0105dzania jako\u015bci\u0105 dla wyrob\u00f3w medycznych - 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\/pl\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - System zarz\u0105dzania jako\u015bci\u0105 dla wyrob\u00f3w medycznych - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"Mi\u0119dzynarodowa norma ISO 13485 s\u0142u\u017cy jako podstawa do certyfikacji system\u00f3w zarz\u0105dzania jako\u015bci\u0105 w firmach, kt\u00f3re produkuj\u0105 lub dystrybuuj\u0105 wyroby medyczne lub s\u0105 zaanga\u017cowane w ich produkcj\u0119 w ramach \u0142a\u0144cucha dostaw. System zarz\u0105dzania jako\u015bci\u0105 stanowi podstaw\u0119 dzia\u0142alno\u015bci i zada\u0144 producent\u00f3w wyrob\u00f3w medycznych. Zapewnia on niezawodne przestrzeganie zar\u00f3wno wewn\u0119trznych, jak i zewn\u0119trznych przepis\u00f3w. 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