FDA’s deadline to the Quality Management System Regulation (QMSR)—harmonizing with ISO 13485:2016 - February 2, 2026
The Kent Group: Audit Integrity in the QMSR Era
If your suppliers are still operating on legacy QSR checklists, your 2026 market access is already at risk.
In this new regulatory landscape, a “generic” GMP audit is a liability. Now you will need auditors who understand that the FDA now expects risk-based decision-making to permeate every layer of your supply chain.
Why The Kent Group stands out from the competition:
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- Forensic Risk Integration: While other firms simply check for a “Risk Management File,” we audit the effectiveness of the risk controls. We trace risk from design inputs through to supplier manufacturing processes, ensuring no gaps exist for FDA inspectors to find.
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- MDF (Medical Device File) Specialists: We don’t just look for old DHF/DHR records. We ensure your suppliers have successfully transitioned to the Medical Device File structure required under ISO 13485 and QMSR.
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- Regulatory Translators: Our auditors are experts in the “FDA-specific supplements.” We ensure your global suppliers meet the unique U.S. requirements for Labeling, UDI, and MDR reporting that ISO 13485 alone does not cover.
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- Ground Truth Verification: We don’t take a supplier’s word for it. We provide “boots-on-the-ground” verification to ensure their internal “QMSR Transition Plan” is a reality, not just a document stored in a folder.
Is Your Supply Chain Ready?
Under the QMSR framework, the FDA has clarified that they will have increased scrutiny over outsourced activities. Your suppliers’ failures are now, more than ever, your failures in the eyes of the agency.
Don’t Wait for a Form 483 to Find the Gaps. The clock is ticking toward February 2026. Secure your market access by partnering with an audit firm that provides more than a checklist—we provide the Ground Truth.
The Kent Group is currently booking QMSR Gap Analysis Audits for the remainder of 2026.
FAQS:
What is changing when the FDA moves from QSR (21 CFR Part 820) to QMSR?
The FDA is transitioning from the long-standing QSR framework to QMSR, which aligns more closely with ISO 13485:2016. This shift raises expectations around risk-based thinking, supplier oversight, and lifecycle documentation—so companies need systems that demonstrate control and effectiveness, not just completed checklists.
Why isn’t this just a “paperwork update”?
Because QMSR pushes risk-based decision-making into how you manage suppliers, controls, and documentation across the product lifecycle. If your program is built around legacy QSR checklists, you may have gaps in traceability and supplier accountability that become visible under FDA scrutiny—especially for outsourced activities
How does QMSR increase risk for companies with outsourced manufacturing or critical suppliers?
Under QMSR, the FDA has clarified increased scrutiny of outsourced activities—meaning supplier failures can be treated as your failures. If suppliers haven’t truly transitioned their processes (not just their documents), you can face findings that impact market access, timelines, and remediation costs.
What is a QMSR gap analysis audit, and what should it include?
A QMSR gap analysis audit evaluates how ready your quality system and supply chain are for QMSR/ISO 13485 expectations. It should go beyond “do you have a file?” and test whether controls work in practice—tracing risk through design, manufacturing, supplier processes, and documentation to identify gaps before an inspection does.
Why choose The Kent Group for QMSR supplier readiness audits?
The Kent Group positions its audits around “ground truth” verification—testing whether supplier risk controls are effective, confirming transition readiness in real operations, and ensuring U.S.-specific FDA requirements (like labeling, UDI, and MDR reporting) are covered—not assumed. This helps reduce the chance of surprises, findings, or a Form 483.