{"id":98,"date":"2025-05-28T12:09:59","date_gmt":"2025-05-28T10:09:59","guid":{"rendered":"https:\/\/smarthen.com\/?page_id=98"},"modified":"2026-05-18T09:42:48","modified_gmt":"2026-05-18T07:42:48","slug":"quality-policy","status":"publish","type":"page","link":"https:\/\/smarthen.com\/es\/quality-policy\/","title":{"rendered":"Pol\u00edtica de calidad"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><div class=\"vc_row wpb_row vc_row-fluid\"><div class=\"wpb_column vc_column_container vc_col-sm-12\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p style=\"font-weight: 400;\">La Pol\u00edtica de calidad SmartHEN est\u00e1 encaminada a garantizar que tanto los productos sanitarios dise\u00f1ados, fabricados y comercializados satisfagan las expectativas de nuestros clientes y usuarios, nuestras obligaciones contractuales, los requisitos legales y reglamentarios generales y espec\u00edficos de nuestra actividad, as\u00ed como para garantizar la mejora continua de los procesos y del SGC.<\/p>\n<p style=\"font-weight: 400;\">Para alcanzar este objetivo, la estrategia de actuaci\u00f3n de la empresa se basa en los siguientes principios y compromisos:<\/p>\n<ul style=\"font-weight: 400;\">\n<li>Garantizar la excelencia en la calidad de realizaci\u00f3n en los productos dise\u00f1ados, fabricados y comercializados.<\/li>\n<li>Entender y satisfacer las necesidades y requisitos de nuestros clientes.<\/li>\n<li>Entender y cumplir nuestras obligaciones contractuales.<\/li>\n<li>Mantener un Sistema de Gesti\u00f3n de la Calidad de forma eficaz, poniendo en juego todos los recursos que considere necesarios para el fortalecimiento de estas bases y la consecuci\u00f3n de nuestros objetivos<\/li>\n<li>Entender y cumplir nuestras obligaciones contractuales.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Asegurar el cumplimiento de los requisitos Legales y Reglamentarios aplicables. La Direcci\u00f3n General asume la responsabilidad de definir, implantar y mantener esta Pol\u00edtica de Calidad, para lo cual, ha implantado un Sistema de Gesti\u00f3n de Calidad conforme a los requisitos de:<\/p>\n<ul style=\"font-weight: 400;\">\n<li>La norma vigente EN-ISO 13485 \u201cSistemas de Gesti\u00f3n de la Calidad. Productos Sanitarios<\/li>\n<li>Reglamento (EU) 2017\/745 de productos sanitarios<\/li>\n<li>Real Decreto 192\/2023 de productos sanitarios<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Adecuado al alcance de la organizaci\u00f3n:<\/p>\n<p style=\"font-weight: 400;\">\u201cDise\u00f1o, desarrollo y fabricaci\u00f3n de productos sanitarios electrom\u00e9dicos para alimentaci\u00f3n enteral\u201d<\/p>\n<p style=\"font-weight: 400;\">La eficacia del Sistema de Gesti\u00f3n Calidad de SmartHEN depende del apoyo incondicional de todos nuestros empleados por lo que el personal hace suya la preocupaci\u00f3n por la Calidad, entendiendo la importancia de la tarea que desempe\u00f1a y que la suma de todas hace posible el logro de los objetivos.<\/p>\n<p style=\"font-weight: 400;\">La Direcci\u00f3n General se asegura de la difusi\u00f3n de la Pol\u00edtica de Calidad en todas las \u00e1reas de la Compa\u00f1\u00eda, comprometi\u00e9ndose a que sea entendida, aplicada, revisada y puesta al d\u00eda.<\/p>\n<p style=\"font-weight: 400;\">La Direcci\u00f3n General define los objetivos concretos de la empresa y los elementos clave para cumplirlos seg\u00fan lo definido en su pol\u00edtica de Calidad, adjudicando a cada departamento, la autoridad y responsabilidad necesaria, poniendo a su disposici\u00f3n la infraestructura y los recursos humanos, t\u00e9cnicos y econ\u00f3micos para el cumplimiento de los objetivos.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"SmartHEN's Quality Policy is aimed at ensuring that both the medical devices designed, manufactured, and marketed meet the expectations of our customers and users, our contractual obligations, and the general and specific legal and regulatory requirements applicable to our activity, as well as ensuring the continuous improvement of processes and the Quality Management System (QMS). 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