{"id":35379,"date":"2026-02-26T14:11:48","date_gmt":"2026-02-26T13:11:48","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35379"},"modified":"2026-02-26T14:26:50","modified_gmt":"2026-02-26T13:26:50","slug":"mdsap-publicada-la-version-010-del-audit-approach-que-cambia","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2026\/02\/26\/mdsap-publicada-la-version-010-del-audit-approach-que-cambia\/","title":{"rendered":"MDSAP: Publicada la Versi\u00f3n 010 del Audit Approach, \u00bfqu\u00e9 cambia?"},"content":{"rendered":"<p>El <strong>2 de febrero de 2026<\/strong> se public\u00f3 la versi\u00f3n 010 del manual <strong>MDSAP AU P0002 \u2013 Audit Approach<\/strong>. Esta actualizaci\u00f3n llega casi 18 meses despu\u00e9s de la versi\u00f3n anterior (009 de agosto de 2024) y es el reflejo de las transformaciones regulatorias ocurridas en los Estados miembros: Australia, Brasil, Canad\u00e1, Jap\u00f3n y Estados Unidos.<\/p>\n<h3><strong>MDSAP y Audit Approach: definici\u00f3n y estructura<\/strong><\/h3>\n<p>Es fundamental que los fabricantes distingan entre el programa y la herramienta operativa que lo rige:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.thema-med.com\/en\/2019\/08\/23\/what-about-the-mdsap\/\"><strong>MDSAP<\/strong><\/a><strong> (Medical Device Single Audit Program):<\/strong> el programa que permite satisfacer, con una \u00fanica auditor\u00eda, los requisitos del Sistema de Gesti\u00f3n de la Calidad (SGC) de las cinco jurisdicciones participantes.<\/li>\n<li><a href=\"https:\/\/www.mdsap.global\/documents\/library\/audit-approach\"><strong>Audit Approach (AU P0002):<\/strong><\/a> el manual operativo utilizado por los auditores para realizar la inspecci\u00f3n. Este documento se basa en una estructura rigurosa dise\u00f1ada para garantizar que los requisitos espec\u00edficos de cada jurisdicci\u00f3n (<strong>Country-specific requirements<\/strong>) se integren correctamente durante las verificaciones.<\/li>\n<\/ul>\n<h3><strong>La estructura de la inspecci\u00f3n: 7 procesos clave<\/strong><\/h3>\n<p>El Audit Approach gu\u00eda al auditor a trav\u00e9s de <strong>7 procesos principales<\/strong>, cada uno de ellos dividido en <strong>Tareas<\/strong> espec\u00edficas (objetivos de verificaci\u00f3n) que integran los requisitos de la ISO 13485 con los nacionales.<\/p>\n<ol>\n<li><strong>Management (Gesti\u00f3n):<\/strong> El n\u00facleo del sistema. Incluye 11 tareas que verifican el compromiso de la Alta Direcci\u00f3n, la disponibilidad de recursos, la planificaci\u00f3n de riesgos y el cumplimiento del Manual de Calidad.<\/li>\n<li><strong>Device Marketing Authorization and Facility Registration:<\/strong> Verifica que el sitio y los dispositivos est\u00e9n debidamente registrados ante las autoridades nacionales competentes. Las <strong>Tareas 1 y 2<\/strong> de este proceso integran en esta versi\u00f3n 010 las nuevas referencias de ANVISA y las obligaciones de la FDA relativas al <em>device listing<\/em> y los planes PCCP.<\/li>\n<li><strong>Measurement, Analysis and Improvement:<\/strong> Enfocado en CAPA, auditor\u00edas internas y mejora continua.<\/li>\n<li><strong>Medical Device Adverse Events and Advisory Notices Reporting:<\/strong> Verifica la gesti\u00f3n de la vigilancia y los informes post-comercializaci\u00f3n espec\u00edficos por jurisdicci\u00f3n. En particular, las <strong>Tareas 4 y 5<\/strong> se han actualizado para incorporar el nuevo protocolo australiano <strong>PRAC<\/strong>.<\/li>\n<li><strong>Design and Development:<\/strong> Control riguroso de los procesos de dise\u00f1o y desarrollo de los dispositivos.<\/li>\n<li><strong>Production and Service Controls:<\/strong> Verificaci\u00f3n de los procesos de fabricaci\u00f3n, control ambiental y prestaci\u00f3n de servicios relacionados.<\/li>\n<li><strong>Purchasing (Compras):<\/strong> Dedicado a la evaluaci\u00f3n y control de proveedores y productos\/servicios adquiridos. Las <strong>Tareas 3 y 4<\/strong> reflejan ahora la superaci\u00f3n del concepto de \u00abproveedor cr\u00edtico\u00bb en favor de un enfoque din\u00e1mico basado en la participaci\u00f3n real dentro del alcance de la auditor\u00eda.<\/li>\n<\/ol>\n<h3><strong>Novedades de la versi\u00f3n 010<\/strong><\/h3>\n<p>La actualizaci\u00f3n de 2026 introduce cambios sustanciales que los fabricantes deben reflejar en su SGC:<\/p>\n<ul>\n<li><strong>Gesti\u00f3n de Proveedores:<\/strong> Se ha eliminado el t\u00e9rmino \u00abproveedor cr\u00edtico\u00bb (<em>critical supplier<\/em>), sustituy\u00e9ndolo por una denominaci\u00f3n m\u00e1s operativa: <strong>\u00abproveedores que deben ser considerados para la auditor\u00eda como parte de la auditor\u00eda MDSAP de la organizaci\u00f3n\u00bb<\/strong>. Esto refleja un enfoque m\u00e1s din\u00e1mico de la cadena de suministro.<\/li>\n<li><strong>Australia (TGA):<\/strong> El procedimiento <em>Uniform Recall Procedure for Therapeutic Goods<\/em> (URPTG) ha sido sustituido oficialmente por el nuevo protocolo <strong>PRAC<\/strong> (<em>Procedure for recalls, product alerts and product corrections<\/em>).<\/li>\n<li><strong>Estados Unidos (FDA):<\/strong> En la nueva versi\u00f3n del manual se han eliminado todas las referencias a la antigua <em>Quality System Regulation<\/em> (QSR), completando la transici\u00f3n normativa a la <a href=\"https:\/\/www.thema-med.com\/en\/2025\/12\/02\/the-new-fda-qmsr-aligned-with-iso-13485-what-changes\/\"><strong>QMSR<\/strong><\/a>, vigente desde el 2 de febrero de 2026. Adem\u00e1s, se ha incorporado la obligaci\u00f3n de actualizar la informaci\u00f3n del <strong>device listing<\/strong> entre el 1 de octubre y el 31 de diciembre. Se introduce tambi\u00e9n una secci\u00f3n espec\u00edfica dedicada a los <strong>PCCP<\/strong> (<em>Predetermined Change Control Plans<\/em>), vital para la gesti\u00f3n de cambios en software e IA.<\/li>\n<li><strong>Brasil (ANVISA):<\/strong> Actualizaci\u00f3n de las referencias normativas para el proceso de registro:\n<ul>\n<li>La <strong>RDC 830\/2023<\/strong> sustituye a la antigua RDC 36\/2015.<\/li>\n<li>La <strong>RDC 751\/2022<\/strong> sustituye a la antigua RDC 40\/2015.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>&gt;&gt;&gt; Thema <\/strong>le apoya en la adecuaci\u00f3n de su Sistema de Gesti\u00f3n de la Calidad y en la alineaci\u00f3n total con las nuevas tareas del programa MDSAP.<\/p>\n<p><strong>FUENTE:<\/strong><br \/>\n<a href=\"https:\/\/www.mdsap.global\/documents\/library\/audit-approach\">Audit Approach | Medical Device Single Audit Program (MDSAP)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 2 de febrero de 2026 se public\u00f3 la versi\u00f3n 010 del manual MDSAP AU P0002 \u2013 Audit Approach. Esta actualizaci\u00f3n  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":35373,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-35379","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDSAP: Publicada la Versi\u00f3n 010 del Audit Approach, \u00bfqu\u00e9 cambia? - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/es\/2026\/02\/26\/mdsap-publicada-la-version-010-del-audit-approach-que-cambia\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDSAP: Publicada la Versi\u00f3n 010 del Audit Approach, \u00bfqu\u00e9 cambia? - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"El 2 de febrero de 2026 se public\u00f3 la versi\u00f3n 010 del manual MDSAP AU P0002 \u2013 Audit Approach. 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