{"id":873,"date":"2021-08-04T11:31:13","date_gmt":"2021-08-04T09:31:13","guid":{"rendered":"https:\/\/alenta.net\/?page_id=873"},"modified":"2022-11-08T18:13:53","modified_gmt":"2022-11-08T17:13:53","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/alenta.net\/iso-13485\/","title":{"rendered":"ISO13485"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"873\" class=\"elementor elementor-873\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ac9c9b8 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"ac9c9b8\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-8575cdd\" data-id=\"8575cdd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-52f892f elementor-widget elementor-widget-heading\" data-id=\"52f892f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">C\u00f3mo podemos ayudarle con las norma ISO 13485<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-070cc3a elementor-widget elementor-widget-heading\" data-id=\"070cc3a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Nuestros consultores\/auditores son expertos en sistemas de gesti\u00f3n basados en la norma ISO 13485<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b09f6fc elementor-widget elementor-widget-text-editor\" data-id=\"b09f6fc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Si usted fabrica, comercializa, distribuye o da soporte de alg\u00fan tipo debe tener implantado un Sistema de Gesti\u00f3n de la Calidad para los productos sanitarios basado en la norma ISO 13485.\u00a0<\/p><p><span style=\"color: var( --e-global-color-660fd93 ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var( --e-global-typography-text-font-size );\"><b>Alenta <\/b><\/span><span style=\"color: var( --e-global-color-660fd93 ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var( --e-global-typography-text-font-size ); font-weight: var( --e-global-typography-text-font-weight );\">interviene en el proceso completo de\u00a0 dise\u00f1o, implantaci\u00f3n, evaluaci\u00f3n y acompa\u00f1amiento durante las auditor\u00edas.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ea49451\" data-id=\"ea49451\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-45784f8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"45784f8\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0f61e2f\" data-id=\"0f61e2f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-554ca70 elementor-widget elementor-widget-heading\" data-id=\"554ca70\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/alenta.net\/articulos\/\">Puede obtener m\u00e1s informaci\u00f3n en nuestra secci\u00f3n de Art\u00edculos<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cbac736 elementor-widget elementor-widget-heading\" data-id=\"cbac736\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Servicios norma ISO 13485<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b22324 elementor-widget elementor-widget-text-editor\" data-id=\"1b22324\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Si ya cuenta con un sistema ISO13485 puede que necesite actualizarlo o mejorarlo, o si el sistema que tiene est\u00e1 basado en la norma ISO9001, o por el contrario no tiene ning\u00fan sistema de gesti\u00f3n en su organizaci\u00f3n, en todos estos casos podemos ayudarle a:<\/p><ul><li>Definir y documentar la pol\u00edtica y alinear los objetivos con ella.<\/li><li>Definir\/redise\u00f1ar el mapa de procesos y documentar los procedimientos que den soporte a dichos procesos.<\/li><li>Documentar nuevos procedimientos o mejorar los que ya tenga para hacerlos m\u00e1s ligeros y manejables.<\/li><li>Implantar en la organizaci\u00f3n el sistema dise\u00f1ado mediante visitas y apoyo continuo al responsable del proyecto.<\/li><li>Realizar auditor\u00edas internas para verificar el nivel de cumplimiento con la norma.<\/li><li>Acompa\u00f1ar durante la auditor\u00eda del organismo que corresponda, para dar soporte hasta el final.<\/li><\/ul><p>Podemos asesorarle en un\u00a0<strong>aspecto concreto<\/strong>, en el que\u00a0 necesite un soporte puntual o\u00a0<strong>gestionar el proceso completo de principio a fin.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69dd904 elementor-widget elementor-widget-button\" data-id=\"69dd904\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/alenta.net\/contacto\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACTO<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f84f264 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f84f264\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6234841\" data-id=\"6234841\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-82fe4e3 elementor-widget elementor-widget-image\" data-id=\"82fe4e3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"401\" height=\"295\" src=\"https:\/\/alenta.net\/wp-content\/uploads\/2021\/06\/isotipo_svg.svg\" class=\"attachment-full size-full wp-image-56\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-70f2452\" data-id=\"70f2452\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f520e29 elementor-widget elementor-widget-heading\" data-id=\"f520e29\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">CONTACTO<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b08cae elementor-widget elementor-widget-heading\" data-id=\"4b08cae\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Contacta con nosotros<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c49ff4 elementor-widget elementor-widget-text-editor\" data-id=\"1c49ff4\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\u00bfEn que podemos ayudarte?\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08c0bab elementor-widget elementor-widget-button\" data-id=\"08c0bab\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/alenta.net\/contacto\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACTO<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>C\u00f3mo podemos ayudarle con las norma ISO 13485 Nuestros consultores\/auditores son expertos en sistemas de gesti\u00f3n basados en la norma ISO 13485 Si usted fabrica, comercializa, distribuye o da soporte de alg\u00fan tipo debe tener implantado un Sistema de Gesti\u00f3n de la Calidad para los productos sanitarios basado en la norma ISO 13485.&nbsp; Alenta interviene &#8230; <a title=\"ISO13485\" class=\"read-more\" href=\"https:\/\/alenta.net\/iso-13485\/\" aria-label=\"M\u00e1s en ISO13485\">Leer m\u00e1s<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"om_disable_all_campaigns":false,"inline_featured_image":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-873","page","type-page","status-publish"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/pages\/873"}],"collection":[{"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/comments?post=873"}],"version-history":[{"count":71,"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/pages\/873\/revisions"}],"predecessor-version":[{"id":2523,"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/pages\/873\/revisions\/2523"}],"wp:attachment":[{"href":"https:\/\/alenta.net\/wp-json\/wp\/v2\/media?parent=873"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}