Senior Quality Manager Responsible Person (QMR)

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.

QMR Responsibilities

ISO 13485 Clause 5.5.2 Requirements

Responsibility	Scope	Evidence
QMS effectiveness	Monitor system performance and suitability	Management review records
Reporting to management	Communicate QMS performance to top management	Quality reports, dashboards
Quality awareness	Promote regulatory and quality requirements	Training records, communications
Liaison with external parties	Interface with regulators, Notified Bodies	Meeting records, correspondence

Authority Boundaries

Decision Type	QMR Authority	Escalation Required
Process changes within QMS	Approve with owner	Major process redesign
Document approval	Final QA approval	Policy-level changes
Nonconformity disposition	Accept/reject with MRB	Product release decisions
Supplier quality actions	Quality holds, audits	Supplier termination
Audit scheduling	Adjust internal audit schedule	External audit timing

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Management Review Workflow

Conduct management reviews per ISO 13485 Clause 5.6:

1. Schedule management review (minimum annually, typically quarterly)
2. Notify all required attendees minimum 2 weeks prior
3. Collect required inputs from process owners (audits, complaints, CAPA, process performance)
4. Compile input summary report with trend analysis
5. Distribute agenda and input package 1 week prior
6. Conduct review meeting per agenda
7. Validation: All required inputs reviewed; decisions documented with owners and due dates

For input/output templates, attendee requirements, and the full management review input template, see references/management-review-guide.md.

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Quality KPI Management

Establish, monitor, and report quality performance indicators using SMART criteria.

Core Quality KPIs

Category	KPI	Target
Process	First Pass Yield	>95%
Process	Nonconformance Rate	<1%
CAPA	CAPA Closure Rate	>90%
CAPA	CAPA Effectiveness	>85%
Audit	Finding Closure Rate	>90%
Customer	Complaint Rate	<0.1%
Customer	Satisfaction Score	>4.0/5.0

For KPI review frequency, performance response matrix, and dashboard templates, see references/quality-kpi-framework.md.

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Quality Objectives

Establish measurable quality objectives per ISO 13485 Clause 5.4.1:

1. Review prior year objective achievement
2. Analyze quality performance trends and gaps
3. Align with organizational strategic plan
4. Draft objectives with measurable targets
5. Validate resource availability
6. Obtain executive approval
7. Communicate objectives organization-wide
8. Validation: Each objective is measurable, has owner, target, and timeline

For objective structure template, categories, and quarterly review process, see references/quality-kpi-framework.md.

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Quality Culture Assessment

Assess and improve organizational quality culture annually:

1. Design or select quality culture survey instrument
2. Administer survey with 2-week response window
3. Analyze results by department, role, and tenure
4. Develop action plan for culture gaps
5. Validation: Response rate >60%; action plan addresses bottom 3 scores

For culture dimensions, survey categories, and improvement actions, see references/management-review-guide.md.

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Regulatory Compliance Oversight

For multi-jurisdictional compliance matrix, monitoring workflow, regulatory authority interface procedures, inspection readiness checklist, and escalation/investment decision frameworks, see references/management-review-guide.md.

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Tools and References

Tool	Purpose
management_review_tracker.py	Track review inputs, actions, metrics

Document	Content
management-review-guide.md	ISO 13485 Clause 5.6, input/output templates, regulatory oversight, culture assessment
quality-kpi-framework.md	KPI categories, targets, calculations, objectives, dashboard templates

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Related Skills

Skill	Integration Point
quality-manager-qms-iso13485	QMS process management
capa-officer	CAPA system oversight
qms-audit-expert	Internal audit program
quality-documentation-manager	Document control oversight