{"id":317,"date":"2026-11-03T14:07:12","date_gmt":"2026-11-03T20:07:12","guid":{"rendered":"https:\/\/qteam-service-llc.com\/?page_id=317"},"modified":"2026-11-05T22:18:39","modified_gmt":"2026-11-06T04:18:39","slug":"fda-qmsr-2026","status":"publish","type":"page","link":"https:\/\/qteam-service-llc.com\/fr\/fda-qmsr-2026\/","title":{"rendered":"FDA QMSR 2026"},"content":{"rendered":"
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FDA QMSR 2026<\/p>\n\n\n\n

Votre syst\u00e8me de qualit\u00e9 de fabrication est-il pr\u00eat \u00e0 \u00eatre inspect\u00e9 ?<\/h1>\n\n\n\n

The FDA\u2019s Quality Management System Regulation (QMSR) took effect on February 2, 2026. It incorporates ISO 13485:2016 into the medical device quality framework \u2013 and FDA inspections now follow an updated, risk-based process.<\/p>\n\n\n\n

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Schedule your free 30-minute introductory consultation<\/a><\/div>\n\n\n\n
What changed<\/a><\/div>\n<\/div>\n\n\n\n
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In effect since<\/p>\n\n\n\n

February 2, 2026<\/p>\n<\/div>\n\n\n\n

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Incorporated by reference<\/p>\n\n\n\n

ISO 13485:2016<\/p>\n<\/div>\n\n\n\n

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New inspection process<\/p>\n\n\n\n

CP 7382.850 replaces QSIT<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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What changed<\/p>\n\n\n\n

A new regulation \u2013 and a new way of inspecting.<\/h2>\n\n\n\n

For most manufacturers, the QMSR is less about new paperwork and more about evidence: does your quality system work, is it driven by risk, and can you show it?<\/p>\n<\/div>\n\n\n\n

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01<\/p>\n\n\n\n

ISO 13485:2016 is now the framework<\/h3>\n\n\n\n

21 CFR Part 820 now incorporates ISO 13485:2016 by reference, together with the terms and definitions of ISO 9000:2015. Where they conflict, the FD&C Act and FDA\u2019s regulations take precedence \u2013 so FDA-specific requirements still apply on top.<\/p>\n<\/div>\n\n\n\n

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02<\/p>\n\n\n\n

Risk management runs through everything<\/h3>\n\n\n\n

The QMSR specifically requires risk management. Risk is expected to drive decisions across the whole quality system \u2013 from design and production to suppliers, complaints and CAPA.<\/p>\n<\/div>\n\n\n\n

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03<\/p>\n\n\n\n

QSIT is retired<\/h3>\n\n\n\n

Since February 2, 2026, FDA investigators use Compliance Program 7382.850. Inspections are organized around six QMS areas and follow patient and user risk \u2013 and the scope can expand when problems are found.<\/p>\n<\/div>\n\n\n\n

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04<\/p>\n\n\n\n

Your internal records are in scope<\/h3>\n\n\n\n

Management review records, internal audit results and supplier audit reports are no longer off-limits. Investigators can read them to judge whether your oversight is effective \u2013 not just documented.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Early inspection findings<\/p>\n\n\n\n

Where FDA is finding gaps.<\/h2>\n\n\n\n

In May 2026, an FDA official shared the most common Form 483 observations from the first QMSR inspections (February to mid-April 2026):<\/p>\n\n\n\n

Source: RAPS Regulatory Focus, May 2026<\/a><\/p>\n<\/div>\n\n\n\n

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