{"id":8504,"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\/pt-pt\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; Sistema de Gest\u00e3o da Qualidade para Dispositivos M\u00e9dicos"},"content":{"rendered":"\n<p><strong>A norma internacional ISO 13485 serve de base para a certifica\u00e7\u00e3o de sistemas de gest\u00e3o da qualidade em empresas que fabricam ou distribuem dispositivos m\u00e9dicos, ou que est\u00e3o envolvidas no seu fabrico como parte da cadeia de fornecimento.<\/strong><\/p>\n\n\n\n<p>Um sistema de gest\u00e3o da qualidade constitui a espinha dorsal das opera\u00e7\u00f5es e tarefas dos fabricantes de dispositivos m\u00e9dicos. Garante que os regulamentos internos e externos s\u00e3o seguidos de forma fi\u00e1vel.<\/p>\n\n\n\n<p>Ao certificar adequadamente o seu sistema, os fabricantes podem criar confian\u00e7a nos seus processos e produtos e demonstrar o seu empenhamento na seguran\u00e7a e na qualidade.<\/p>\n\n\n\n<p>A norma aborda os requisitos que os fabricantes e fornecedores de dispositivos m\u00e9dicos devem cumprir ao desenvolver, implementar e manter sistemas de gest\u00e3o para a ind\u00fastria de tecnologia m\u00e9dica.<\/p>\n\n\n\n<p>Vantagens:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Seguran\u00e7a do processo atrav\u00e9s de procedimentos documentados <\/strong><\/li>\n\n\n\n<li><strong>Evid\u00eancia de conformidade com os requisitos legais <\/strong><\/li>\n\n\n\n<li><strong>Aumento da seguran\u00e7a dos produtos para os doentes e utilizadores <\/strong><\/li>\n\n\n\n<li><strong>Aumento da satisfa\u00e7\u00e3o dos clientes e funcion\u00e1rios <\/strong><\/li>\n\n\n\n<li><strong>Destaque para a compet\u00eancia da empresa<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">O que \u00e9 a ISO 13485?<\/h2>\n\n\n\n<p>A ISO 13485 \u00e9 uma norma aut\u00f3noma para sistemas de gest\u00e3o da qualidade para fabricantes de dispositivos m\u00e9dicos ou de diagn\u00f3stico in vitro. Tem origem na s\u00e9rie de normas internacionalmente reconhecidas e aceites EN ISO 9000. A ISO 13485 continua a abordagem orientada para os processos da ISO 9001 e complementa-a com aspectos espec\u00edficos que s\u00e3o particularmente importantes para os fabricantes de dispositivos m\u00e9dicos ou de diagn\u00f3stico in vitro.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">O que \u00e9 que a ISO 13485 cont\u00e9m?<\/h2>\n\n\n\n<p>A ISO 13485 apoia os fabricantes no desenvolvimento de um sistema de gest\u00e3o da qualidade que permite processos seguros e eficazes. Estes processos s\u00e3o concebidos para garantir uma conce\u00e7\u00e3o, desenvolvimento, produ\u00e7\u00e3o, instala\u00e7\u00e3o, entrega, monitoriza\u00e7\u00e3o, rastreio e elimina\u00e7\u00e3o consistentes dos dispositivos m\u00e9dicos, cobrindo todo o seu ciclo de vida. O objetivo \u00e9 garantir que os dispositivos m\u00e9dicos e os diagn\u00f3sticos in vitro possam ser utilizados com seguran\u00e7a para o fim a que se destinam.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Qual \u00e9 o significado legal da ISO 13485?<\/h2>\n\n\n\n<p>Os programas de aprova\u00e7\u00e3o regulamentar para dispositivos m\u00e9dicos ou diagn\u00f3sticos in vitro baseiam-se frequentemente nos requisitos da norma ISO 13485. Os requisitos gerais da ISO 13485 s\u00e3o expandidos e adaptados aos requisitos legais espec\u00edficos do mercado atrav\u00e9s de concretiza\u00e7\u00f5es e adi\u00e7\u00f5es.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Qual \u00e9 a diferen\u00e7a entre a ISO 13485 e a EN ISO 13485?<\/h2>\n\n\n\n<p>A ISO 13485 \u00e9 a vers\u00e3o b\u00e1sica da norma reconhecida internacionalmente, mas foi harmonizada numa norma europeia pela organiza\u00e7\u00e3o europeia de normaliza\u00e7\u00e3o para ser considerada nos procedimentos europeus de aprova\u00e7\u00e3o regulamentar. Ao seguir uma norma harmonizada, um fabricante pode provar que os seus produtos ou servi\u00e7os cumprem os requisitos t\u00e9cnicos da legisla\u00e7\u00e3o relevante da UE e, se necess\u00e1rio, tamb\u00e9m afirmar a chamada presun\u00e7\u00e3o de conformidade.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>A norma internacional ISO 13485 serve de base para a certifica\u00e7\u00e3o de sistemas de gest\u00e3o da qualidade em empresas que fabricam ou distribuem dispositivos m\u00e9dicos, ou que est\u00e3o envolvidas no seu fabrico como parte da cadeia de fornecimento. Um sistema de gest\u00e3o da qualidade constitui a espinha dorsal das opera\u00e7\u00f5es e tarefas dos fabricantes de<\/p>\n","protected":false},"author":3,"featured_media":8489,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19413,19473],"tags":[],"class_list":["post-8504","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-pt-pt","category-standard-pt-pt"],"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 - Sistema de Gest\u00e3o da Qualidade para Dispositivos M\u00e9dicos - 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\/pt-pt\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - Sistema de Gest\u00e3o da Qualidade para Dispositivos M\u00e9dicos - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"A norma internacional ISO 13485 serve de base para a certifica\u00e7\u00e3o de sistemas de gest\u00e3o da qualidade em empresas que fabricam ou distribuem dispositivos m\u00e9dicos, ou que est\u00e3o envolvidas no seu fabrico como parte da cadeia de fornecimento. 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