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QA/RA Consulting, Auditing & Training
Are you anticipating an FDA inspection in the near future? Things have changed under the new QMSR. In this blog post we discuss what you can now expect when FDA inspectors come calling.
What’s different isn’t a sudden wave of new requirements. After all, FDA aligned its quality system rule to ISO 13485:2016, which many companies already know. What has changed is how FDA evaluates the effectiveness of your quality management system – they now look at how the system works end to end, not whether individual procedures exist in isolation.
Under the QMSR, FDA inspections are explicitly risk based. Inspectors use your own risk management and lifecycle documentation to decide where to spend time during the inspection rather than walking through a fixed subsystem checklist like QSIT.
FDA has been very clear: ISO 13485 certification does not replace an FDA inspection. Early inspections show that FDA often expects deeper evidence of integration and management accountability than many Notified Bodies historically have required.
One of the biggest changes manufacturers notice is that FDA no longer treats design, suppliers, corrective actions / preventive actions (formerly grouped together as CAPA), and post‑market data as separate silos. Inspectors now expect to see:
This is exactly how ISO 13485 is written, but FDA inspections now actively test it.
QMSR elevated management oversight to a primary inspection focus area. Inspectors now routinely review management review outputs, decision rationales, and follow through, not just whether meetings occurred.
FDA has confirmed that enforcement began on February 2, 2026. At the same time:
This signals expectation clarity, not a punitive reset.
Manufacturers that treated ISO 13485 primarily as a documentation exercise are the ones who feel the most friction. Organizations that already use risk management as a decision making tool are generally finding inspections more predictable, even if more probing.
As a final reminder: QMSR hasn’t raised the bar so much as moved it, away from checklists and toward how quality decisions are actually made via a process and risk-based approach.
ELIQUENT helps manufacturers respond to FDA’s QMSR inspection approach through:
Reach out to ELIQUENT Life Sciences to learn how we can help you act on these early QMSR enforcement signals.
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