FDA QMSR Inspection Readiness for 2026 and Beyond

With the FDA’s Quality Management System Regulation (QMSR) enforcement date just weeks away, medical device manufacturers are entering a new era of regulatory scrutiny.

While many organizations have already aligned documentation, mapped processes to ISO 13485 and updated risk-management files, fewer have confronted the practical realities of how FDA inspections will change under QMSR.

This article explores those implications, provides ideas on what to expect and offers a practical readiness framework your team can use now.

Contents

How QMSR changes FDA inspections

FDA investigator priorities under QMSR

A practical framework for QMSR inspection readiness

What inspection readiness looks like

Make inspection readiness a competitive advantage

How QMSR changes FDA inspections 

The FDA’s adoption of QMSR marks the most significant overhaul of 21 CFR Part 820 in decades. By harmonizing with ISO 13485:2016, the agency is not only aligning regulations with global practices, but also raising expectations at home.

Recent FDA actions and draft guidance released in late 2025 signal a clear direction:

• Inspectors will expect deeper evidence of risk-based decision-making across an organization’s Quality Management System (QMS).

• Management responsibility is to be more traceable and auditable.

• Internal records, like supplier audits, management reviews and training evidence, will receive increased attention.

• The FDA will examine how well processes work, not just whether they exist.

In other words, “check-the-box” compliance is no longer enough. QMSR requires manufacturers demonstrate the thinking behind the system, not just the system itself.

FDA investigator priorities under QMSR

Below are the areas expected to receive heightened scrutiny once QMSR enforcement begins with 2026 inspections.

Risk-based approach across all processes

QMSR reinforces risk-based thinking as a core operating principle. The FDA’s draft guidance highlights the need for a cohesive risk-based approach summary, showing:

• How your organization evaluates risk
• How risk ties into decision-making
• How risk influences supplier controls, training, CAPA and design
• How risk is reviewed at the management level

What this means in practice:
Have clear, documented links between risk evaluations and the actions taken. Inspectors will ask to see the rationale, not just the SOP.

Integration of ISO 13485 requirements into standard operations

QMSR aligns with ISO 13485, but alignment alone isn’t enough. FDA investigators will want to see where ISO 13485 controls are embedded in workflows. Details requested may include:

• Objective evidence that ISO processes are operational, not theoretical
• Consistent application of requirements across sites
• Documented training and competency on ISO-based changes
• Demonstrated process ownership

Evidence of supplier controls and qualification

Modern medical devices rely more heavily on software, analytics, contract manufacturers and cloud-based partners. In conjunction, supplier management has become a major inspection focal point. Under QMSR, device manufacturers must demonstrate:

• Supplier qualification rationale
• Supplier risk categorization
• Performance metrics and re-evaluation practices
• Documented supplier communications and corrective actions

Internal audit strength and management review traceability

Expect deeper dives into internal audit structure and management involvement. FDA investigators will likely inspect:

• How frequently your internal audits assess process effectiveness, not just compliance
• Whether management review inputs reflect real QMS data
• Corrective actions stemming from audits and reviews
• Leadership’s role in ensuring resources and competency

A practical framework for QMSR inspection readiness

Below is a clear, actionable readiness guide your organization can implement immediately.

1. Create a QMSR-focused inspection playbook

If you haven’t already mapped your inspection processes, create an inspection “playbook,” so employees know how to proceed. It should include:

• A cross-functional response team
• Clear roles during an FDA visit
• A defined process for document retrieval
• A single source for QMSR-aligned documentation
• Standard scripts for common investigator questions

2. Build or update a risk-based approach summary

This is quickly becoming a must-have for 2026 inspections. Ensure your summary:

• Is concise but comprehensive
• Links risks to key quality processes (CAPA, suppliers, design, training)
• Reflects current practices
• Is accessible and review-ready

Tip: Investigators appreciate clarity. A visual risk-integration map can accelerate comprehension.

3. Conduct a QMSR-aligned internal audit before February 2026

Your final pre-QMSR audit should evaluate:

• QMSR-related gaps
• Process effectiveness
• Documentation traceability
• Consistency across sites
• Supplier management rigor
• CAPA cycle time and effectiveness

If possible, simulate FDA inspection scenarios and document the results.

4. Prepare digital records for quick access

Slow document retrieval is one of the top triggers for escalated FDA scrutiny.
Ensure you can instantly pull up:

• Procedures
• Training records
• Supplier files
• CAPA cases
• Design documentation
• Audit results
• Change control history

Tip: Digital QMS platforms, like QT9, dramatically reduce retrieval times and strengthen inspection confidence.

5. Strengthen front-line competency

One of the most overlooked inspection risks is staff uncertainty. Help your employees be prepared by training them to:

• Answer questions accurately and concisely
• Avoid speculating
• Direct investigators to the correct owner when unsure
• Provide evidence quickly

What inspection readiness looks like

Organizations who excel under QMSR typically share these traits:

• They integrate quality into every department: from engineering to operations to leadership, all understand the impact of their role on quality and compliance.

• They use technology to eliminate friction: Digital QMS platforms, automated workflows, supplier portals and real-time dashboards reduce human error and improve traceability.

• They conduct routine micro-audits: Small, frequent, targeted checks reduce pressure and catch issues early.

• They treat QMSR as a strategic upgrade, not a regulatory burden: Companies that view QMSR as an opportunity often see improved efficiency, faster launches, and stronger supplier performance.

Make inspection readiness a competitive advantage

QMSR is a chance to define your organization’s quality identity for years to come.

When your QMS is risk-driven, digital, seamlessly documented, supplier-integrated and globally aligned, you not only satisfy the FDA, you build a more resilient, scalable and efficient company. Inspection readiness becomes less about surviving the audit and more about demonstrating operational maturity.

With the QMSR enforcement date fast approaching, manufacturers must shift their focus from preparation to execution. QMSR inspections will be more rigorous, more risk-focused and more interconnected across the entire quality ecosystem.

If your team hasn’t mapped out your inspection readiness plan yet, now is the time. Look to QT9 QMS to streamline and simplify the process.