{"id":8505,"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\/es\/news\/iso-13485-quality-management-system-for-medical-devices\/","title":{"rendered":"ISO 13485 &#8211; Sistema de gesti\u00f3n de la calidad para productos sanitarios"},"content":{"rendered":"\n<p><strong>La norma internacional ISO 13485 sirve de base para certificar los sistemas de gesti\u00f3n de la calidad de las empresas que fabrican o distribuyen productos sanitarios, o que participan en su fabricaci\u00f3n como parte de la cadena de suministro.<\/strong><\/p>\n\n\n\n<p>Un sistema de gesti\u00f3n de la calidad constituye la columna vertebral de las operaciones y tareas de los fabricantes de productos sanitarios. Garantiza el cumplimiento fiable de las normativas internas y externas.<\/p>\n\n\n\n<p>Al certificar adecuadamente su sistema, los fabricantes pueden generar confianza en sus procesos y productos y demostrar su compromiso con la seguridad y la calidad.<\/p>\n\n\n\n<p>La norma aborda los requisitos que deben cumplir los fabricantes y proveedores de productos sanitarios a la hora de desarrollar, implantar y mantener sistemas de gesti\u00f3n para el sector de la tecnolog\u00eda m\u00e9dica.<\/p>\n\n\n\n<p>Ventajas:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Seguridad de los procesos mediante procedimientos documentados <\/strong><\/li>\n\n\n\n<li><strong>Evidencia del cumplimiento de los requisitos legales <\/strong><\/li>\n\n\n\n<li><strong>Mayor seguridad del producto para pacientes y usuarios <\/strong><\/li>\n\n\n\n<li><strong>Mayor satisfacci\u00f3n de clientes y empleados <\/strong><\/li>\n\n\n\n<li><strong>Destacar la competencia de la empresa<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfQu\u00e9 es la norma ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 es una norma independiente para sistemas de gesti\u00f3n de la calidad para fabricantes de productos sanitarios o de diagn\u00f3stico in vitro. Tiene su origen en la serie de normas EN ISO 9000, internacionalmente reconocida y aceptada. La norma ISO 13485 contin\u00faa el enfoque orientado a procesos de la norma ISO 9001 y lo complementa con aspectos espec\u00edficos que son especialmente importantes para los fabricantes de productos sanitarios o diagn\u00f3sticos in vitro.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfQu\u00e9 contiene la norma ISO 13485?<\/h2>\n\n\n\n<p>La norma ISO 13485 ayuda a los fabricantes a desarrollar un sistema de gesti\u00f3n de la calidad que permita procesos seguros y eficaces. Estos procesos est\u00e1n dise\u00f1ados para garantizar la coherencia del dise\u00f1o, el desarrollo, la producci\u00f3n, la instalaci\u00f3n, la entrega, la supervisi\u00f3n, el seguimiento y la eliminaci\u00f3n de los productos sanitarios, abarcando todo su ciclo de vida. De este modo se garantiza que los productos sanitarios y los diagn\u00f3sticos in vitro puedan utilizarse de forma segura para los fines previstos.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfQu\u00e9 importancia jur\u00eddica tiene la norma ISO 13485?<\/h2>\n\n\n\n<p>Los programas de aprobaci\u00f3n reglamentaria de productos sanitarios o diagn\u00f3sticos in vitro suelen basarse en los requisitos de la norma ISO 13485. Los requisitos generales de la norma ISO 13485 se ampl\u00edan y adaptan a los requisitos legales espec\u00edficos del mercado mediante concreciones y adiciones.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00bfCu\u00e1l es la diferencia entre ISO 13485 y EN ISO 13485?<\/h2>\n\n\n\n<p>ISO 13485 es la versi\u00f3n b\u00e1sica de la norma reconocida internacionalmente, pero ha sido armonizada en una norma europea por la organizaci\u00f3n europea de normalizaci\u00f3n para que se tenga en cuenta en los procedimientos europeos de aprobaci\u00f3n reglamentaria. Al seguir una norma armonizada, un fabricante puede demostrar que sus productos o servicios cumplen los requisitos t\u00e9cnicos de la legislaci\u00f3n pertinente de la UE y, en caso necesario, hacer valer tambi\u00e9n la denominada presunci\u00f3n de conformidad.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>La norma internacional ISO 13485 sirve de base para certificar los sistemas de gesti\u00f3n de la calidad de las empresas que fabrican o distribuyen productos sanitarios, o que participan en su fabricaci\u00f3n como parte de la cadena de suministro. Un sistema de gesti\u00f3n de la calidad constituye la columna vertebral de las operaciones y tareas<\/p>\n","protected":false},"author":3,"featured_media":8490,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[19410,19470],"tags":[],"class_list":["post-8505","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-es","category-standard-es"],"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 Gesti\u00f3n de Calidad para Productos Sanitarios - 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\/es\/news\/iso-13485-quality-management-system-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 - Sistema de Gesti\u00f3n de Calidad para Productos Sanitarios - Certifiqat.com\" \/>\n<meta property=\"og:description\" content=\"La norma internacional ISO 13485 sirve de base para certificar los sistemas de gesti\u00f3n de la calidad de las empresas que fabrican o distribuyen productos sanitarios, o que participan en su fabricaci\u00f3n como parte de la cadena de suministro. 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