quality-manager-qmr

1. Overall Quality System Responsibility (ISO 13485 Clause 5.5.2)

Provide comprehensive oversight and accountability for quality management system effectiveness and regulatory compliance.

QMR Accountability Framework:

```

QMR RESPONSIBILITY MATRIX

├── Quality Management System Oversight

│ ├── QMS effectiveness monitoring

│ ├── Quality policy implementation

│ ├── Quality objectives achievement

│ └── Resource adequacy assessment

├── Regulatory Compliance Oversight

│ ├── Regulatory requirement monitoring

│ ├── Compliance status assessment

│ ├── Regulatory submission oversight

│ └── Authority relationship management

├── Management Responsibility

│ ├── Senior management reporting

│ ├── Quality performance communication

│ ├── Strategic quality planning

│ └── Organizational quality culture

└── Continuous Improvement Leadership

├── Quality system enhancement

├── Performance improvement initiatives

├── Best practice implementation

└── Innovation and modernization

```

2. Regulatory Compliance Oversight

Ensure comprehensive regulatory compliance across all applicable jurisdictions and standards.

Compliance Monitoring System:

1. Multi-jurisdictional Compliance Tracking

- EU MDR 2017/745 compliance status monitoring

- FDA QSR 21 CFR 820 compliance verification

- ISO 13485 certification maintenance

- National regulatory requirements adherence

1. Compliance Risk Assessment

- Regulatory risk identification and assessment

- Compliance gap analysis and remediation

- Regulatory change impact evaluation

- Decision Point: Escalate significant compliance risks to senior management

1. Regulatory Authority Interface

- For EU Authorities: Coordinate with Notified Bodies and Competent Authorities

- For FDA: Manage FDA communications and inspection readiness

- For Other Markets: Oversee international regulatory compliance

- Authority communication oversight and strategy

3. Management Review and Reporting (ISO 13485 Clause 5.6)

Lead management review processes ensuring systematic quality system evaluation and strategic quality planning.

Management Review Leadership:

• Quarterly Management Reviews with C-level executives
• Quality Performance Dashboards with real-time KPIs
• Annual Quality Strategy Planning sessions
• Regulatory Compliance Reports to board and senior management

Key Review Topics:

• Quality management system performance and effectiveness
• Regulatory compliance status and emerging requirements
• Customer satisfaction trends and market feedback
• Quality costs and return on quality investments
• Strategic quality initiatives and resource requirements

4. Quality Culture and Leadership

Foster organizational quality culture ensuring quality excellence throughout the organization.

Quality Culture Initiatives:

• Quality Leadership Development programs
• Quality Awareness Training for all employees
• Quality Recognition Programs and incentives
• Quality Communication strategies and campaigns

Quality Strategic Planning

Develop and implement comprehensive quality strategies aligned with business objectives and regulatory requirements.

Strategic Planning Process:

1. Quality Strategy Development

- Business objective alignment and integration

- Regulatory landscape analysis and planning

- Quality investment prioritization and ROI analysis

- Competitive quality positioning assessment

1. Quality Resource Management

- Quality team capability assessment and development

- Quality technology and system modernization

- Quality infrastructure investment planning

- External quality resource utilization

1. Quality Performance Management

- Quality KPI framework development and monitoring

- Quality scorecards and dashboard implementation

- Quality benchmarking and best practice identification

- Quality improvement initiative prioritization

Cross-functional Quality Integration

Ensure quality considerations are integrated across all organizational functions and processes.

Quality Integration Framework:

• R&D Integration: Design quality and design controls oversight
• Manufacturing Integration: Production quality and process validation
• Supply Chain Integration: Supplier quality and supply chain risk management
• Commercial Integration: Customer quality and market quality feedback

Quality Policy and Objectives (ISO 13485 Clause 5.3 & 5.4.1)

Establish and maintain organizational quality policy and measurable quality objectives.

Quality Governance Structure:

• Quality Policy: Top-level quality commitment and direction
• Quality Objectives: Measurable quality targets and KPIs
• Quality Planning: Strategic and operational quality planning
• Quality Communication: Quality policy and objective communication

Document and Change Control Oversight

Ensure robust document control and change management processes throughout the organization.

Document Control Oversight:

• Document control system effectiveness monitoring
• Change control process compliance verification
• Document review and approval process optimization
• Configuration management and version control oversight

Quality Audit Program Oversight

Provide strategic oversight of internal and external audit programs ensuring comprehensive quality system assessment.

Audit Program Management:

• Internal Audit Program: Strategic audit planning and resource allocation
• External Audit Coordination: Regulatory and certification body audit management
• Audit Follow-up Oversight: Corrective action effectiveness verification
• Audit Performance Assessment: Audit program effectiveness evaluation

Regulatory Authority Relationships

Maintain strategic relationships with regulatory authorities ensuring effective communication and collaboration.

Authority Relationship Management:

• Regulatory Authority Meetings: Strategic regulatory discussions and planning
• Regulatory Submission Oversight: Quality and completeness verification
• Regulatory Inspection Management: Preparation, coordination, and follow-up
• Regulatory Intelligence: Authority position monitoring and trend analysis

Quality System Certification Management

Oversee all quality system certifications ensuring compliance and continuous improvement.

Certification Management:

• ISO 13485 Certification: Maintenance and continuous improvement
• Regulatory Certifications: FDA registration, CE marking, other market certifications
• Quality Certifications: Additional quality certifications and accreditations
• Certification Strategy: Multi-market certification planning and optimization

Quality Key Performance Indicators (KPIs)

Monitor comprehensive quality performance metrics ensuring quality excellence and regulatory compliance.

Quality Performance Dashboard:

• Quality System Effectiveness: Process performance, audit results, nonconformity trends
• Customer Quality: Customer satisfaction, complaint rates, return rates
• Product Quality: Product conformity, defect rates, quality costs
• Regulatory Compliance: Compliance scores, submission success rates, inspection outcomes
• Quality Culture: Training completion, quality awareness, employee engagement

Quality Cost Management

Monitor and optimize quality costs ensuring cost-effective quality management.

Quality Cost Categories:

• Prevention Costs: Quality planning, training, prevention activities
• Appraisal Costs: Inspection, testing, audit activities
• Internal Failure Costs: Rework, scrap, internal quality failures
• External Failure Costs: Returns, recalls, customer complaints, regulatory sanctions

scripts/

• qmr-dashboard.py: Comprehensive QMR performance monitoring and reporting
• regulatory-compliance-tracker.py: Multi-jurisdictional compliance status monitoring
• quality-cost-analyzer.py: Quality cost analysis and optimization tool
• management-review-automation.py: Management review preparation and follow-up automation

references/

• qmr-responsibilities-matrix.md: Comprehensive QMR responsibility framework
• regulatory-compliance-requirements.md: Multi-jurisdictional regulatory requirement library
• quality-strategic-planning-guide.md: Quality strategy development methodologies
• quality-culture-development.md: Quality culture assessment and development frameworks
• quality-kpi-library.md: Comprehensive quality performance indicator definitions

assets/

• qmr-templates/: QMR reporting templates, quality policy templates, strategic planning tools
• compliance-dashboards/: Regulatory compliance monitoring dashboards
• quality-communication/: Quality communication templates and presentation materials
• training-materials/: QMR and quality leadership training programs