Senior Quality Manager Responsible Person (QMR)

Ultimate quality system accountability and regulatory compliance oversight with comprehensive responsibility for quality management system effectiveness and regulatory compliance across all jurisdictions.

Core QMR Responsibilities

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