QMSR Quality Management System Requirements

Management Responsibility

Transitioning from QSR to QMSR – Management Responsibility

The QMSR Management Responsibility requirements bring a more structured, documented, and proactive approach compared to QSR §820.20. While many concepts remain similar, organizations must focus on:
✅ Stronger documentation of leadership commitment and decision-making.
✅ More defined and measurable quality objectives.
✅ A formalized management review process with specific inputs/outputs.
✅ Expanded role of the management representative to ensure regulatory awareness.
✅ Improved internal communication on QMS effectiveness.

By proactively addressing these areas, companies can seamlessly transition from QSR to QMSR while strengthening their global regulatory compliance under ISO 13485:2016.

Key Actions for Compliance with QMSR Clause 5

Organizations must enhance documentation, formalize management reviews, and ensure leadership is actively engaged in QMS oversight. Below are the critical transition steps:

Strengthening Documentation of Management Commitment

Develop written records of top management’s commitment to QMS implementation and maintenance. Ensure leadership actively communicates the importance of meeting customer and regulatory requirements, and document leadership involvement in QMS planning and resource allocation.

Establish Documented Quality Objectives

Define measurable, regulatory-aligned quality objectives at different organizational levels. Ensure those objectives are documented and reviewed regularly for effectiveness and integrate quality objectives into performance evaluations and strategic planning.

Enhance Customer and Regulatory Focus

Implement processes to systematically identify and meet customer needs. Ensure management actively reviews customer complaints, regulatory feedback, and audit results, and establish formal procedures to monitor regulatory changes and their impact on quality objectives.

Expand the Role of the Management Representative

Assign a management representative with clear documentation of responsibilities. Ensure the rep actively monitors QMS effectiveness and promotes regulatory awareness across the organization and require formal reporting on QMS performance during management reviews.

Improve Internal Communication on QMS Effectiveness

Develop structured internal communication procedures to share quality-related information. Use communication tools (meetings, reports, digital platforms) to enhance QMS transparency, and regularly update teams on regulatory changes, audit findings, and quality performance.

Formalize and Expand Management Reviews

Conduct documented, structured management reviews at planned intervals.

Ensure reviews include specific inputs such as:

Customer feedback and complaints
Audit findings and regulatory reports
Corrective and preventive actions (CAPA)
QMS effectiveness and resource needs

Maintain detailed records of review outcomes, including improvement actions and regulatory compliance updates.

Assembling the Puzzle

Implementation Strategies

Small Manufacturers

ISO 13485:2016 Clauses

1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
♦ 7.3 Design and development
♦ 7.4 Purchasing controls
8 Measurement, analysis & improvement

Comparison of QSR and QMSR Requirements

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.