quality-manager-qmr

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements. Conduct management reviews per ISO 13485 Clause 5.6 requirements. See: references/management-review-guide.md Establish, monitor, and report quality performance indicators. See: references/quality-kpi-framework.md Establish and maintain measurable quality objectives per ISO 13485 Clause 5.4.1. Assess and improve organizational quality culture. Monitor and maintain regulatory compliance across jurisdictions. Management Review Tracker Features: - QMR Responsibilities - Management Review Workflow - Quality KPI Management Workflow - Quality Objectives Workflow - Quality Culture Assessment Workflow - Regulatory Compliance Oversight - Decision Frameworks - Tools and References - Schedule management review (minimum annually, typically quarterly or semi-annually) - Notify all required attendees minimum 2 weeks prior - Collect required inputs from process owners: - Audit results (internal and external) - Customer feedback (complaints, satisfaction, returns) - Process performance and product conformity - CAPA status and effectiveness - Previous review action items - Changes affecting QMS (regulatory, organizational) - Recommendations for improvement - Compile input summary report with trend analysis - Prepare presentation materials with supporting data...