{"id":567,"date":"2026-09-11T11:10:33","date_gmt":"2026-09-11T09:10:33","guid":{"rendered":"https:\/\/www.pqra.gr\/auditing-a-medical-device-quality-system-iso-13485-mdr-surveillance-and-the-new-qmsr\/"},"modified":"2026-09-11T11:10:40","modified_gmt":"2026-09-11T09:10:40","slug":"auditing-a-medical-device-quality-system-iso-13485-mdr-surveillance-and-the-new-qmsr","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/auditing-a-medical-device-quality-system-iso-13485-mdr-surveillance-and-the-new-qmsr\/","title":{"rendered":"Auditing a Medical Device Quality System: ISO 13485, MDR Surveillance and the New QMSR"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>A medical device manufacturer selling into Europe and the United States is now audited against a quality system standard that both jurisdictions recognise. Since 2 February 2026, FDA&rsquo;s Quality Management System Regulation has incorporated ISO 13485:2016 by reference into 21 CFR Part 820, replacing the Quality System Regulation that had governed device manufacturing for nearly three decades. The convergence is real &mdash; but it is not a merger of audits.<\/strong><\/p>\n\n<h2>Three audit streams, one quality system<\/h2>\n<p>Most manufacturers are subject to several overlapping audit regimes, each with its own scope and cadence:<\/p>\n<ul>\n<li><strong>Notified body surveillance under the MDR.<\/strong> Annex IX requires appropriate audits and assessments at least once every twelve months to confirm the approved quality management system and the post-market surveillance plan are being applied.<\/li>\n<li><strong>Unannounced audits.<\/strong> Separately from surveillance, the notified body must randomly perform unannounced on-site audits at least once every five years, at the manufacturer and where appropriate at suppliers and subcontractors. The plan for these is not disclosed to you.<\/li>\n<li><strong>FDA inspection under the QMSR.<\/strong> From 2 February 2026 FDA began using the updated device inspection approach set out in Compliance Program 7382.850.<\/li>\n<\/ul>\n<p>The European Union is not a member of the Medical Device Single Audit Program. MDSAP certificates are recognised by the United States, Canada, Brazil, Japan and Australia, and can materially reduce audit burden across those five markets &mdash; but they do not substitute for MDR conformity assessment, and positive MDSAP findings do not narrow the scope of MDR surveillance audits.<\/p>\n\n<h2>What the QMSR does and does not change<\/h2>\n<p>The QMSR remains located in 21 CFR Part 820, but most of its provisions now point to clauses of ISO 13485 rather than stating requirements directly. A small number of sections were retained because FDA concluded ISO 13485 did not cover them adequately &mdash; among them scope, definitions, control of records, and device labelling and packaging controls.<\/p>\n<p>For a manufacturer already certified to ISO 13485, the transition is largely a mapping and terminology exercise rather than a rebuild. For one that operated only to the old QSR, it is a genuine change of framework, and internal audit is where the gap tends to surface first.<\/p>\n\n<h2>Making internal audit earn its place<\/h2>\n<p>Regular internal audit is a shared requirement of ISO 13485 and the QMSR, and it is the control that determines whether external audits go well. A programme that works has a few characteristics:<\/p>\n<ul>\n<li>Coverage planned across a defined cycle, weighted towards higher-risk processes rather than spread evenly<\/li>\n<li>Auditors independent of the area audited, and competent in it<\/li>\n<li>Scope that includes design controls, risk management, supplier controls, complaint handling, vigilance reporting and post-market surveillance &mdash; not just manufacturing<\/li>\n<li>Suppliers and critical subcontractors within the programme, since the notified body may audit them unannounced<\/li>\n<li>Findings routed into CAPA with root cause analysis and effectiveness verification<\/li>\n<\/ul>\n\n<h2>Readiness for the unannounced visit<\/h2>\n<p>Because the timing is deliberately unknown, readiness cannot be a project. It means the quality system is in the state you would want it in on any given day: training records current, equipment calibrated, batch and device history records complete and retrievable, and a reception procedure that gets auditors into a room with the right documents quickly. During an unannounced audit the notified body may sample devices or the manufacturing process to verify conformity with the technical documentation.<\/p>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA supports device manufacturers with internal and supplier audit programmes, ISO 13485 implementation and gap assessment, QMSR transition mapping, notified body audit preparation, unannounced audit readiness, and CAPA remediation following findings.<\/p>\n<p>To assess how your quality system would perform under MDR surveillance or an FDA inspection, <a href=\"\/el\/contact\/\">contact PQRA<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>A medical device manufacturer selling into Europe and the United States is now audited against a quality system standard that both jurisdictions recognise. Since 2 February 2026, FDA&rsquo;s Quality Management System Regulation has incorporated ISO 13485:2016 by reference into 21 CFR Part 820, replacing the Quality System Regulation that had governed device manufacturing for nearly [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":568,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-567","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Auditing a Medical Device Quality System: ISO 13485, MDR Surveillance and the New QMSR - PQRA<\/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:\/\/www.pqra.gr\/el\/auditing-a-medical-device-quality-system-iso-13485-mdr-surveillance-and-the-new-qmsr\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Auditing a Medical Device Quality System: ISO 13485, MDR Surveillance and the New QMSR - PQRA\" \/>\n<meta property=\"og:description\" content=\"A medical device manufacturer selling into Europe and the United States is now audited against a quality system standard that both jurisdictions recognise. 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