QSR-to-QMSR Paper Gap Audit
MDP services for our clients
Is Your Quality System Really Ready for QMSR?
As FDA’s transition from the QSR to the QMSR approaches, many medical device manufacturers are discovering that “substantially equivalent” doesn’t mean “completely aligned.” Even companies with solid QSR documentation are finding hidden gaps when measured against ISO 13485:2016.
Medical Devices and Pharma, offers QMSR Paper Gap Audits – a focused, affordable review of your Quality Manual and top-level SOPs. We map your current documentation to the QMSR, identify missing or outdated content, and highlight the updates you’ll need to meet FDA’s new expectations.
If you’re unsure whether your documentation will pass inspection after February 6, 2026, this audit is a smart first step.
What You Get with MDP’s QMSR Paper Gap Audit:
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Clause-by-Clause Mapping – We compare your Quality Manual and SOPs against ISO 13485:2016 / QMSR requirements
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Clear Gap Identification – We flag missing content, outdated QSR references, and areas needing structural updates
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Risk-Based Prioritization – Each finding is rated by urgency and regulatory risk so you know what to fix first
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Actionable Recommendations – Guidance on how to remediate gaps and prepare for a full QMSR rollout
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No Disruption – This is a paper audit—no site visit or internal disruptions required
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Fast Turnaround – Most reports delivered within 10 business days.
Get Ahead of the Deadline
The QMSR becomes fully enforceable in February 2026—but smart companies are taking action now. Our paper gap audit gives you a head start, reduces compliance risk, and helps you budget and plan your transition with confidence.
Ready to see where you stand?
Contact us today to schedule your QMSR Paper Audit or learn more about how Medical Devices and Pharma can support your full transition strategy.
Overview of Changes
QMSR Info Request Form
Definitions
Affected Regulations and Standards
Assembling the Puzzle
Implementation Strategies
Small Manufacturers
Comparison of QSR and QMSR Requirements for Management Responsibility
| Management Responsibility Requirement | QSR (21 CFR 820.20) | QMSR (ISO 13485:2016 Clause 5 / QMSR) | Key Differences / Changes |
|---|---|---|---|
| Management Commitment | Requires executive responsibility for QMS effectiveness, communication, and resource allocation. | More explicitly requires top management to document and demonstrate commitment through quality policy, objectives, and management reviews. | QMSR places greater emphasis on documenting leadership commitment. |
| Customer Focus | Not explicitly stated but implied through quality planning and compliance responsibilities. | Explicitly requires top management to ensure customer and regulatory requirements are determined and met. | QMSR makes customer focus a direct management responsibility. |
| Quality Policy | Requires establishment of a policy ensuring QMS effectiveness. | Policy must be documented, communicated, and regularly reviewed for suitability. | QMSR demands stronger documentation and communication of the quality policy. |
| Quality Objectives | Implied through QMS requirements but not explicitly mandated. | Requires documented, measurable quality objectives that align with regulatory and product requirements. | Organizations must now establish specific, measurable quality objectives. |
| Quality Management System Planning | General QMS planning required, but not as detailed. | Requires QMS planning to meet Clause 4.1 requirements and maintain system integrity during changes. | Organizations must ensure system integrity during changes. |
| Responsibility & Authority | Requires defining management responsibilities, with a single person assigned executive oversight. | Requires defining and documenting responsibilities, authority, and interrelation of personnel. | Stronger emphasis on documenting roles and responsibilities in QMSR. |
| Management Representative | Requires an individual with executive responsibility to oversee QMS compliance and reporting. | Requires a designated management representative responsible for QMS documentation, regulatory awareness, and reporting to management. | Management rep now must promote regulatory awareness throughout the organization. |
| Internal Communication | Implied under management responsibility but not explicitly required. | Requires established communication processes to ensure QMS effectiveness. | Internal communication is now a formal QMS requirement. |
| Management Review | Requires periodic review of the QMS with procedures documented. | More structured, requiring documented inputs and outputs (e.g., audit results, complaints, regulatory reports, resource needs). | Organizations must formalize review inputs/outputs for regulatory alignment. |