{"id":44502,"date":"2023-12-21T12:07:42","date_gmt":"2023-12-21T20:07:42","guid":{"rendered":"https:\/\/www.arenasolutions.com\/cumplimiento-normativo-del-qms\/"},"modified":"2025-10-17T09:23:39","modified_gmt":"2025-10-17T16:23:39","slug":"cumplimiento-normativo-del-qms","status":"publish","type":"page","link":"https:\/\/www.arenasolutions.com\/es\/solutions\/compliance-management\/qms-compliance\/","title":{"rendered":"Cumplimiento normativo del QMS"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbhero section\u00bb module_class=\u00bbhero-section\u00bb _builder_version=\u00bb4.23.1&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Hero-QMS-Compliance.jpg\u00bb custom_padding=\u00bb30px||30px||true|false\u00bb background_last_edited=\u00bbon|tablet\u00bb background_image_tablet=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00bb background_enable_image_tablet=\u00bbon\u00bb collapsed=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb title_text_tablet=\u00bbdark-purple-background\u00bb alt_tablet=\u00bbDark Purple Background\u00bb][et_pb_row column_structure=\u00bb1_2,1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.2&#8243; header_text_color=\u00bb#FFFFFF\u00bb header_3_text_color=\u00bb#FFFFFF\u00bb header_4_font=\u00bbOpen Sans|600|||||||\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb custom_margin=\u00bb||0px||false|false\u00bb custom_padding=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h1>CUMPLIMIENTO DEL SISTEMA DE <br \/>ADMINISTRACI\u00d3N DE LA CALIDAD<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.23.1&#8243; header_4_text_color=\u00bb#FFFFFF\u00bb custom_padding=\u00bb0px|||||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>REDUZCA LOS RIESGOS DE AUDITOR\u00cdA CON UN ENFOQUE CENTRADO EN EL PRODUCTO<\/h4>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb15px||55px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||18px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; header_2_text_align=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\">CUMPLA LOS REQUISITOS NORMATIVOS PARA LOGRAR UN QMS EFICAZ<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,2_3&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_margin=\u00bb||50px||false|false\u00bb custom_padding=\u00bb||||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; custom_css_main_element=\u00bbdisplay: grid;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/EFFECTIVE-QMS-ES.png\u00bb alt=\u00bbCumplimiento de la normativa de seguridad sobre dispositivos m\u00e9dicos\u00bb title_text=\u00bbQMS-EFICAZ\u00bb align=\u00bbcenter\u00bb _builder_version=\u00bb4.23.1&#8243; max_width=\u00bb575px\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb2_3&#8243; _builder_version=\u00bb4.16&#8243; custom_css_main_element=\u00bbdisplay: grid;||align-items: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>Toda empresa, independientemente de su tama\u00f1o, debe disponer de un s\u00f3lido sistema de administraci\u00f3n de la calidad (QMS) para ofrecer productos de calidad y conformes a normativa que cumplan con las expectativas de sus clientes.<\/p>\n<p>Organismos regulatorios como la ISO (del ingl\u00e9s International Organization for Standardization), el IAQG (del ingl\u00e9s International Aerospace Quality Group) y la IATF (del ingl\u00e9s International Automotive Task Force) publican directrices para establecer y mantener un QMS eficaz.<\/p>\n<p>Aparte de la norma ISO\u00a013485, que se aplica a las empresas de <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/compliance-management\/medical-devices\/\">dispositivos m\u00e9dicos<\/a>, la ISO\u00a09001 es la norma de administraci\u00f3n de la calidad reconocida en todo el mundo para la mayor\u00eda de industrias. Aunque no es obligatorio, muchas empresas aplican las directrices de la norma ISO\u00a09001 para mejorar sus procesos, aumentar la satisfacci\u00f3n de sus clientes y acrecentar su competitividad. El IAQG public\u00f3 la norma AS9100, basada en los principios de la ISO\u00a09001 y que ofrece directrices sobre los QMS a las organizaciones que fabriquen productos aereoespaciales y de defensa. De modo similar, la IATF public\u00f3 la norma IATF\u00a016949, que detalla los requisitos en materia de QMS para las empresas de la industria automovil\u00edstica.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbHOW ARENA SIMPLIFIES ISO, AS9100, and IATF 16949 COMPLIANCE\u00bb _builder_version=\u00bb4.23.1&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/gray-bg-1.jpg\u00bb custom_padding=\u00bb26px||54px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; text_text_color=\u00bb#FFFFFF\u00bb header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#000000&#8243; text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\"><span style=\"color: #00890b;\">C\u00d3MO SIMPLIFICA ARENA EL CUMPLIMIENTO DE LAS NORMAS ISO, AS9100 e IATF\u00a016949<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb16px||32px|||\u00bb custom_css_main_element=\u00bbmax-width: 1100px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; text_orientation=\u00bbcenter\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>Arena QMS y Arena PLM para AWS GovCloud ofrecen plataformas seguras y nativas en la nube para que sus equipos internos y sus socios externos puedan administrar con facilidad <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/design-controls\/\">controles de dise\u00f1o<\/a>, aprovisionamientos, medidas correctoras y preventivas (CAPA), <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/training-management\/\">formaci\u00f3n<\/a> y otros procesos de calidad, siempre de conformidad con los requisitos que figuran en las normas ISO, AS9100 e IATF\u00a016949. La capacidad de colaborar en cualquier momento y desde cualquier lugar mantiene coordinados a todos y reduce los riesgos de auditor\u00eda.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb module_class=\u00bbfive-column-boxes white-boxes-row\u00bb _builder_version=\u00bb4.16&#8243; max_width=\u00bb1200px\u00bb module_alignment=\u00bbcenter\u00bb custom_padding=\u00bb6px||6px||true|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-QUALITY-TEAMS.svg\u00bb alt=\u00bbIcono de garant\u00eda de calidad\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243; title_text=\u00bbIcon-QUALITY TEAMS\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">CALIDAD<\/span><br \/><span style=\"color: #00890b;\">&nbsp;<\/span><\/h4>\n<p>para demostrar un control y rastreabilidad totales mediante procesos de calidad cerrados<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Doc-Mgmt.svg\u00bb alt=\u00bbIcono de control de documentos\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-Document Management\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">CONTROL DE<\/span><br \/><span style=\"color: #00890b;\"> DOCUMENTOS<\/span><\/h4>\n<p>para recopilar de inmediato la documentaci\u00f3n del QMS y acelerar las auditor\u00edas y certificaciones<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Product-Teams.svg\u00bb alt=\u00bbIcon-Product-Teams\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243; title_text=\u00bbIcon-Product-Teams\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">EQUIPOS DE<\/span><br \/><span style=\"color: #00890b;\"> PRODUCTO<\/span><\/h4>\n<p>para obtener mayor visibilidad de los cambios de dise\u00f1o, los incumplimientos y otros asuntos que afectan a los lanzamientos de productos<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb module_class=\u00bbfive-column-boxes white-boxes-row\u00bb _builder_version=\u00bb4.16&#8243; max_width=\u00bb1200px\u00bb module_alignment=\u00bbcenter\u00bb custom_padding=\u00bb6px||6px||true|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-ENGINEERING-TEAMS.svg\u00bb alt=\u00bbIcono de equipos de ingenier\u00eda\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-ENGINEERING TEAMS\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">EQUIPOS DE<br \/>INGENIER\u00cdA<\/span><\/h4>\n<p>para establecer estrictos controles de dise\u00f1o mediante la vinculaci\u00f3n directa de las necesidades y requisitos de los usuarios y las entradas y salidas de dise\u00f1o<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-MGMT-Teams.svg\u00bb alt=\u00bbIcon-MGMT-Teams\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-MGMT-Teams\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">EQUIPOS DE<\/span><br \/><span style=\"color: #00890b;\"> ADMINISTRACI\u00d3N<\/span><\/h4>\n<p>para administrar f\u00e1cilmente los planes de formaci\u00f3n de los empleados y garantizar el cumplimiento de los SOP, las pol\u00edticas, las instrucciones de trabajo, etc.<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icons-EXECUTIVE-MANAGEMENT.svg\u00bb alt=\u00bbIcono de ejecutivo\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcons-EXECUTIVE MANAGEMENT\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">ADMINISTRACI\u00d3N EJECUTIVA<\/span><\/h4>\n<p>para evaluar el rendimiento respecto a los objetivos comerciales fijados, mediante c\u00f3modas herramientas de an\u00e1lisis<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbA PRODUCT-CENTRIC APPROACH TO QUALITY MANAGEMENT\u00bb _builder_version=\u00bb4.23.1&#8243; custom_padding=\u00bb||60px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||15px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbH2&#8243; _builder_version=\u00bb4.23.1&#8243; header_2_text_align=\u00bbcenter\u00bb custom_margin=\u00bb||17px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\">UN ENFOQUE CENTRADO EN EL PRODUCTO PARA LA ADMINISTRACI\u00d3N DE LA CALIDAD<\/h2>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbparagraph\u00bb _builder_version=\u00bb4.23.1&#8243; text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>La clave para lograr el cumplimiento normativo es mantener una estrecha conexi\u00f3n entre su producto y la informaci\u00f3n de calidad. Arena vincula los registros de calidad y los procesos de cambios correspondientes a la lista de materiales del producto. Este enfoque de la administraci\u00f3n de la calidad, centrado en el producto, posibilita un control y una visibilidad totales durante todo el proceso de desarrollo e introducci\u00f3n de nuevos productos (NPDI).<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb2&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.23.1&#8243; width=\u00bb90%\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; module_class=\u00bbhover-copy-column red\u00bb _builder_version=\u00bb4.23.1&#8243; background_enable_color=\u00bboff\u00bb background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/single-system-of-truth.jpg\u00bb custom_padding=\u00bb||||true|true\u00bb background_last_edited=\u00bbon|desktop\u00bb global_colors_info=\u00bb{}\u00bb background__hover_enabled=\u00bbon|hover\u00bb background_color__hover=\u00bb#dc5000&#8243; background_enable_color__hover=\u00bbon\u00bb][et_pb_text admin_label=\u00bbPre-hover copy\u00bb module_class=\u00bbpre-hover-copy red\u00bb _builder_version=\u00bb4.23.1&#8243; header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_4_text_align=\u00bbcenter\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb width=\u00bb100%\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>H\u00c1GASE CON EL CONTROL DE LOS PROCESOS DE PRODUCTO Y CALIDAD<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbHover copy\u00bb module_class=\u00bbhover-copy red\u00bb _builder_version=\u00bb4.23.1&#8243; text_text_color=\u00bb#FFFFFF\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li>La automatizaci\u00f3n de los procesos de modificaci\u00f3n y de los controles de revisi\u00f3n se aplica a la documentaci\u00f3n para lograr una mejor rastreabilidad y una mayor precisi\u00f3n<\/li>\n<li>Los equipos pueden identificar, analizar y resolver los problemas con rapidez, para aplicar los procesos de medidas correctoras y preventivas (CAPA)<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; module_class=\u00bbhover-copy-column orange\u00bb _builder_version=\u00bb4.18.0&#8243; background_enable_color=\u00bboff\u00bb background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/issue-resolution.jpg\u00bb global_colors_info=\u00bb{}\u00bb background__hover_enabled=\u00bbon|hover\u00bb background_color__hover=\u00bb#f99238&#8243; background_enable_color__hover=\u00bbon\u00bb][et_pb_text admin_label=\u00bbPre-hover copy\u00bb module_class=\u00bbpre-hover-copy orange\u00bb _builder_version=\u00bb4.23.1&#8243; header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_4_text_align=\u00bbcenter\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb width=\u00bb100%\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>ACELERE LAS AUDITOR\u00cdAS Y CERTIFICACIONES INTERNAS<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbHover copy\u00bb module_class=\u00bbhover-copy orange\u00bb _builder_version=\u00bb4.23.1&#8243; text_text_color=\u00bb#FFFFFF\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li>Documente, controle y monitorice los procesos conforme a normativa en Arena<\/li>\n<li>Recopile r\u00e1pidamente las versiones m\u00e1s recientes de los SOP, los DHF, las listas de proveedores, los registros de formaci\u00f3n y otras acreditaciones de cumplimiento normativo <\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; module_class=\u00bbhover-copy-column blue\u00bb _builder_version=\u00bb4.23.1&#8243; background_enable_color=\u00bboff\u00bb background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/3D-Viewer-Hover-Easy-Adoption.jpg\u00bb background_last_edited=\u00bbon|desktop\u00bb global_colors_info=\u00bb{}\u00bb background__hover_enabled=\u00bbon|desktop\u00bb background_color__hover=\u00bb#7b7bc1&#8243; background_enable_color__hover=\u00bbon\u00bb][et_pb_text admin_label=\u00bbPre-hover copy\u00bb module_class=\u00bbpre-hover-copy blue\u00bb _builder_version=\u00bb4.23.1&#8243; header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_4_text_align=\u00bbcenter\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb width=\u00bb100%\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>IMPULSE<br \/>LA MEJORA<br \/>CONTINUA<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbHover copy\u00bb module_class=\u00bbhover-copy blue\u00bb _builder_version=\u00bb4.23.1&#8243; text_text_color=\u00bb#FFFFFF\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li>Supervise y monitorice f\u00e1cilmente los indicadores clave de rendimiento (KPI) mediante <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/product-analytics\/\">Arena Analytics<\/a><\/li>\n<li>Mejore el rendimiento del producto y de la calidad gracias a informaci\u00f3n cr\u00edtica de car\u00e1cter pr\u00e1ctico<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row module_class=\u00bblocale-hide-cn\u00bb _builder_version=\u00bb4.20.0&#8243; custom_padding=\u00bb29px||21px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||5px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>Descubra c\u00f3mo el enfoque conectado para la administraci\u00f3n de la calidad de Arena mejora el cumplimiento normativo y acelera el desarrollo de productos.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bbhttps:\/\/www.arenasolutions.com\/white-papers\/product-centric-qms\/approach\/\u00bb button_text=\u00bbLEER LA DOCUMENTACI\u00d3N T\u00c9CNICA\u00bb button_alignment=\u00bbcenter\u00bb _builder_version=\u00bb4.23.1&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.23.1&#8243; background_color=\u00bbrgba(64,170,29,0.06)\u00bb custom_margin=\u00bb||||false|false\u00bb custom_padding=\u00bb0px|||||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb0px||18px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbIMPROVE QUALITY MANAGEMENT WITH INTERNAL AUDITS\u00bb _builder_version=\u00bb4.23.1&#8243; header_2_text_align=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\">MEJORE LA ADMINISTRACI\u00d3N DE LA CALIDAD CON AUDITOR\u00cdAS INTERNAS<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb4&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_margin=\u00bb||50px||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Carousel-Internal-Audits.jpg\u00bb alt=\u00bbAuditor\u00eda de dispositivos m\u00e9dicos\u00bb title_text=\u00bbCarrusel-Auditor\u00edas-Internas\u00bb _builder_version=\u00bb4.23.1&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; header_4_text_align=\u00bbleft\u00bb custom_margin=\u00bb||0px||false|false\u00bb header_4_text_align_tablet=\u00bbright\u00bb header_4_text_align_phone=\u00bb\u00bb header_4_text_align_last_edited=\u00bbon|tablet\u00bb text_orientation_tablet=\u00bbright\u00bb text_orientation_phone=\u00bbleft\u00bb text_orientation_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>Las auditor\u00edas internas ayudan a las organizaciones a detectar deficiencias en sus procesos que afectan a la eficiencia operativa, a la calidad de los productos y al rendimiento general. Tambi\u00e9n permiten a las empresas supervisar sus QMS y evaluar si cumplen los requisitos normativos.<\/p>\n<p>Descubra consejos y pr\u00e1cticas recomendadas para planificar e implementar una auditor\u00eda interna de su QMS.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bbhttps:\/\/www.arenasolutions.com\/resources\/articles\/how-to-improve-your-quality-management-with-internal-audits\/\u00bb button_text=\u00bbLEER LA PR\u00c1CTICA RECOMENDADA\u00bb module_class=\u00bblocale-hide-cn\u00bb _builder_version=\u00bb4.23.1&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbQuote\u00bb module_class=\u00bbquote-section\u00bb _builder_version=\u00bb4.23.1&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00bb custom_padding=\u00bb19px||19px||true|\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb20px||20px||true|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb30px||30px|40px|true|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|tablet\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.23.1&#8243; text_text_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb max_width=\u00bb985px\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>\u00abDe cara a nuestros clientes institucionales, necesitamos demostrar que hemos construido una plataforma de gesti\u00f3n del ciclo de vida del producto (PLM) y un QMS coordinados y que trabajan conjuntamente en el cumplimiento de la normativa ISO\u00a09000.\u00bb<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.23.1&#8243; text_text_color=\u00bb#afb1ff\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb24px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span style=\"color: #ffffff;\"><strong style=\"letter-spacing: 0 !important;\">Steve Anderson, <\/strong>vicepresidente de Operaciones<\/span><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-42401 \" src=\"https:\/\/www.arenasolutions.com\/wp-content\/uploads\/SIONYX-Logo-White.png\" alt=\"\" width=\"150\" height=\"35\" srcset=\"https:\/\/www.arenasolutions.com\/wp-content\/uploads\/SIONYX-Logo-White.png 808w, https:\/\/www.arenasolutions.com\/wp-content\/uploads\/SIONYX-Logo-White-300x70.png 300w, https:\/\/www.arenasolutions.com\/wp-content\/uploads\/SIONYX-Logo-White-500x116.png 500w, https:\/\/www.arenasolutions.com\/wp-content\/uploads\/SIONYX-Logo-White-768x179.png 768w, https:\/\/www.arenasolutions.com\/wp-content\/uploads\/SIONYX-Logo-White-248x58.png 248w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; module_id=\u00bbcustomer-logo-slider\u00bb _builder_version=\u00bb4.24.2&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.18.0&#8243; header_2_text_align=\u00bbcenter\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||10px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">\u00daNASE A ESTOS CLIENTES INNOVADORES<\/h2>\n<p>[\/et_pb_text][mt-divi-logo-slider images=\u00bb10033,10031,10032,10383,10029,10028,10021,10025,10023,10020,10026,13718,32928,67326&#8243; admin_label=\u00bbQMS Logo Slider\u00bb _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb global_module=\u00bb10396&#8243; saved_tabs=\u00bball\u00bb global_colors_info=\u00bb{}\u00bb][\/mt-divi-logo-slider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbQMS CTA &#8211; See Arena In Action\u00bb module_id=\u00bbbefore-footer-cta\u00bb module_class=\u00bbcta-section blue-button footer-cta-section\u00bb _builder_version=\u00bb4.24.2&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/orange-bg.jpg\u00bb custom_padding=\u00bb30px||30px||true|\u00bb link_option_url=\u00bb\/qms-demo\/\u00bb global_module=\u00bb15757&#8243; saved_tabs=\u00bball\u00bb locked=\u00bboff\u00bb collapsed=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_2,1_2&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb|40px|||false|false\u00bb custom_padding_tablet=\u00bb|0px|0px||false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|desktop\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb border_width_right=\u00bb1px\u00bb border_color_right=\u00bb#FFFFFF\u00bb border_width_all_tablet=\u00bb\u00bb border_width_all_phone=\u00bb\u00bb border_width_all_last_edited=\u00bbon|desktop\u00bb border_width_right_tablet=\u00bb0px\u00bb border_width_right_phone=\u00bb\u00bb border_width_right_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb custom_css_main_element_last_edited=\u00bbon|tablet\u00bb custom_css_main_element_tablet=\u00bbpadding-bottom: 0 !important;\u00bb custom_css_main_element_phone=\u00bbpadding-bottom: 0 !important;\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; header_2_text_align=\u00bbright\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_2_font_size=\u00bb36px\u00bb custom_padding=\u00bb||||false|true\u00bb header_2_text_align_tablet=\u00bbcenter\u00bb header_2_text_align_phone=\u00bbcenter\u00bb header_2_text_align_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2>VER Arena<br \/> <span style=\"font-family: 'acier-bat-outline';\">EN ACCI\u00d3N<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb25px|||40px|false|false\u00bb custom_padding_tablet=\u00bb10px|||0px|false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|tablet\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb global_colors_info=\u00bb{}\u00bb custom_css_main_element_last_edited=\u00bbon|tablet\u00bb custom_css_main_element_tablet=\u00bbpadding-top: 25px !important;\u00bb custom_css_main_element_phone=\u00bbpadding-top: 25px !important;\u00bb][et_pb_button button_url=\u00bbhttps:\/\/www.arenasolutions.com\/es\/qms-demo\/\u00bb button_text=\u00bbOBTENER UNA DEMO\u00bb button_alignment=\u00bbleft\u00bb button_alignment_tablet=\u00bbcenter\u00bb button_alignment_phone=\u00bb\u00bb button_alignment_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16&#8243; custom_margin=\u00bb||||false|false\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb25px||||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>CUMPLIMIENTO DEL SISTEMA DE ADMINISTRACI\u00d3N DE LA CALIDAD REDUZCA LOS RIESGOS DE AUDITOR\u00cdA CON UN ENFOQUE CENTRADO EN EL PRODUCTO CUMPLA LOS REQUISITOS NORMATIVOS PARA LOGRAR UN QMS EFICAZ Toda&#8230;<\/p>\n","protected":false},"author":61,"featured_media":43130,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"divi.php","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-44502","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Cumplimiento normativo del sistema de administraci\u00f3n de la calidad (QMS) | Arena<\/title>\n<meta name=\"description\" content=\"El software Arena QMS le ayuda a alcanzar el cumplimiento de la normativa de la FDA y de la ISO. Simplificamos el cumplimiento normativo con la secci\u00f3n 820 del t\u00edtulo 21 de las CFR publicadas por la FDA y con la norma ISO\u00a013485. Arena centraliza el control de los procedimientos operativos est\u00e1ndar (SOP), de los archivos de historial de dispositivos (DHF), de los registros de dispositivos maestros (DMR), de los registros de formaci\u00f3n, etc.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/compliance-management\/qms-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cumplimiento normativo del QMS\" \/>\n<meta property=\"og:description\" content=\"El software Arena QMS le ayuda a alcanzar el cumplimiento de la normativa de la FDA y de la ISO. Simplificamos el cumplimiento normativo con la secci\u00f3n 820 del t\u00edtulo 21 de las CFR publicadas por la FDA y con la norma ISO\u00a013485. 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