Exact public version
quality-manager-qmr v1
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.
2b168b03c77b562f69877d6dab99a44b857a2b2cf34cb51687ee1f92e2961bacPackage contents
Manifest
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.
b05b2205c2ac0fea1242ba28fe1373257bb52bab81cd6c6cc5319a4bf9912521- SKILL.md18,747 bytes
- references/management-review-guide.md10,296 bytes
- references/quality-kpi-framework.md11,786 bytes
- scripts/management_review_tracker.py19,492 bytes
- scripts/quality_effectiveness_monitor.py19,297 bytes