quality-manager-qmr
Installation
SKILL.md
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 |
QMR Accountability Matrix
| Domain | Accountable For | Reports To | Frequency |
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