QMSR vs QSR: 15 Critical Differences You Need to Know
QMSR vs QSR: 15 Critical Differences You Need to Know The FDA's Quality Management System Regulation (QMSR) replaces the Quality System Regulation (QSR) on February 2, 2026.
QMSR vs QSR: 15 Critical Differences You Need to Know
The FDA's Quality Management System Regulation (QMSR) replaces the Quality System Regulation (QSR) on February 2, 2026. Here are the 15 differences that require actual operational changes—not just terminology updates.
🚨 Differences That Require Immediate Action
1. Management Review Records Are Now Inspectable
QSR Management review required under 820.20(c), but records were explicitly exempt from FDA inspection under QSIT.
QMSR No exemption. FDA investigators can request and review management review records during inspections.
Why it matters: Many companies conducted management reviews with candid language, incomplete documentation, or poor follow-up tracking—knowing FDA wouldn't see them. That changes.
🔧 Action Required:
- Review existing management review records for completeness
- Ensure all required inputs are addressed (feedback, complaints, audits, CAPA status)
- Document decisions and action items with clear ownership
- Track follow-up on action items to closure
- Consider language and professionalism as if records were public
2. Internal Audit Records Are Now Inspectable
QSR Internal audit required under 820.22, but records were explicitly exempt from FDA inspection.
QMSR No exemption. FDA investigators can request audit schedules, audit reports, and corrective action records.
Why it matters: Some organizations have audit programs that look good on paper but lack substance. Others have findings that were never properly addressed. Both situations become visible.
🔧 Action Required:
- Verify audit schedule is current and appropriate
- Ensure audit reports document findings clearly
- Track all findings to corrective action closure
- Maintain auditor qualification records
- Document corrective action effectiveness verification
3. Supplier Audit Records Are Now Inspectable
QSR Supplier audit records were explicitly exempt from FDA inspection.
QMSR No exemption. If you conduct supplier audits, FDA can request those records.
Why it matters: Supplier audits often identify significant issues that may reflect poorly on your supplier management program if not properly addressed.
🔧 Action Required:
- Review supplier audit reports for inspection readiness
- Ensure all supplier audit findings have documented corrective actions
- Track corrective action effectiveness
- Document auditor qualifications
4. CAPA Must Be Separated Into Corrective and Preventive Action
QSR Combined "Corrective and Preventive Action" requirement under 820.100.
QMSR Combined CAPA must explicitly and distinctly meet both corrective and preventive action requirements (ISO 13485 8.5.2 / 8.5.3).
Why it matters: This isn't just organizational—it reflects a fundamental difference:
- Corrective Action: Eliminating causes of existing nonconformities to prevent recurrence (reactive)
- Preventive Action: Eliminating causes of potential nonconformities to prevent occurrence (proactive)
🔧 Action Required:
- Create separate procedures for CA and PA (or clearly separate sections)
- Define different triggers for each process
- Establish different metrics and success criteria
- Retrain personnel on the distinction
- Review recent CAPAs and reclassify appropriately
đź“„ Differences That Require New Documentation
5. QMS Software Requires Explicit Validation
QSR Software validation required under 820.70(i) for production and QMS functions, but requirements were implicit.
QMSR Explicit requirement under 820.35 for validation of software used in the quality management system.
Why it matters: If you use software for document control, training management, CAPA tracking, complaint handling, or audit management—that software requires documented validation.
🔧 Action Required:
- Inventory all QMS software
- Assess current validation status for each system
- Create or update validation documentation
- Establish revalidation criteria for software changes
6. Customer Communication Procedure Is Required
QSR No explicit customer communication requirement beyond complaint handling (820.198).
QMSR Documented arrangements required (ISO 13485 Clause 7.2.3) for communication about product information, inquiries, contracts, order handling, amendments, and feedback.
Why it matters: You probably do these things, but you may not have a documented procedure. Under QMSR, you need one.
🔧 Action Required:
- Document how customer inquiries are handled
- Document order and contract processing
- Document how product information is communicated
- Define responsibility for customer communication
7. Customer Feedback System Is Required
QSR Complaint handling required (820.198), but proactive feedback collection was not explicitly required.
QMSR Documented feedback system required (ISO 13485 Clause 8.2.1) as an early warning mechanism and input to risk management.
Why it matters: Feedback is broader than complaints. It includes proactive collection of customer satisfaction data, service reports, sales feedback, and market experience.
🔧 Action Required:
- Document feedback collection mechanisms
- Define how feedback is aggregated and analyzed
- Establish trending and reporting
- Link feedback analysis to management review inputs
⚙️ Differences That Change How You Operate
8. Risk Management Extends Beyond Design Controls
QSR Risk analysis explicitly required only in design validation (820.30(g)).
QMSR Risk-based thinking required throughout QMS (ISO 13485 Clauses 4.1, 7.1, 7.4, 7.5, 8.5).
Demonstrate risk consideration in: Process design decisions, supplier evaluation, validation scope, CAPA prioritization, resource allocation.
9. Top Management Accountability Is More Explicit
QSR Management representative concept (820.20)—delegate authority to someone.
QMSR Top management accountability (ISO 13485 Clauses 5.1, 5.5)—executive responsibility cannot be fully delegated.
Expectation: C-level executives personally understand and actively support the QMS.
10. Process Interactions Must Be Documented
QSR QMS required but process interaction documentation was implicit.
QMSR Explicit requirement (ISO 13485 Clause 4.1) to document the interaction between QMS processes.
Show: How design outputs feed production, how feedback connects to CAPA, how supplier issues trigger reviews.
11. Outsourced Process Control Requirements Are Clearer
QSR Supplier controls required (820.50), but outsourced process management was not differentiated.
QMSR Explicit requirement (ISO 13485 Clause 4.1) to identify outsourced processes and apply risk-based controls.
Outsourced processes (sterilization, testing, component manufacturing) require different controls than purchased components.
🔄 Primarily Structural Differences
| # | Change | QSR | QMSR |
|---|---|---|---|
| 12 | Documentation Structure | DMR, DHF, DHR | MDF, Design File, Batch Record |
| 13 | Regulatory References | 820.xx section numbers | ISO 13485:2016 clause numbers |
| 14 | Record Retention | Specific periods defined | Organization determines based on device lifetime |
| 15 | Statistical Techniques | Required where applicable | Required where appropriate for data analysis |
đź“‹ Prioritizing Your Transition Effort
đź”´ Address Immediately (High Inspection Risk)
- 1 CAPA procedure separation
- 2 Management review record preparation
- 3 Internal audit record preparation
- 4 QMS software validation documentation
🟡 Address Within 30 Days
- 5 Customer communication procedure
- 6 Customer feedback system
- 7 Risk management integration
- 8 Supplier audit record preparation
🟢 Address Before Deadline
- 9 Documentation terminology updates
- 10 Regulatory reference updates
- 11 Record retention review
- 12 Process interaction documentation
Free Download: QMSR vs QSR Comparison Chart
Printable PDF summarizing all 15 differences with action items and timeline recommendations.
Related Resources
- → Complete QMSR Compliance Guide 2025=2026
- → How to Conduct a QMSR Gap Analysis (Free
Template). - → QMSR Timeline: Every Critical Date Before
February 2026 - → Take the QMSR Readiness Assessment Need Help Prioritizing Your QMSR Transition?
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