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Audit & Compliance

Quality KPIs

Define, track, and report on key quality performance indicators that give leadership clear visibility into quality system health. Drive data-informed decisions with real-time dashboards and trend analysis across all quality processes.

Regulatory Context

ISO 13485:2016 §5.6 — Management review (quality data input)
ISO 13485:2016 §8.2.4 — Monitoring and measurement of product
FDA 21 CFR Part 820.20 — Management responsibility

Key Capabilities

What you get with the Quality KPIs module.

Customizable KPI dashboards covering CAPA, complaint, audit, and training metrics
Automated data collection from across the quality system for real-time reporting
Trend analysis with configurable thresholds and alert triggers
Benchmarking capabilities to compare performance across sites and periods
Management-ready reports exportable for board presentations and reviews

Why It Matters

How Quality KPIs helps your organisation.

Make data-driven quality decisions with real-time performance dashboards
Spot negative trends early and take corrective action before they escalate
Provide leadership with clear, quantifiable evidence of quality system health

How It Connects

Quality KPIsdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Ready to see Quality KPIs in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Quality KPIs works within your specific compliance context.

More in Audit & Compliance

Explore other modules in the Audit & Compliance category.

Audit Management

Plan, execute, and track internal and external audits with configurable checklists and finding management. Generate audit reports and ensure every observation is linked to corrective actions for complete regulatory traceability.

Audit Reports

Generate professional, regulatory-compliant audit reports with consolidated findings, observations, and recommendations. Streamline report creation with structured templates that ensure consistency and completeness across all your audit activities.

Inspection Readiness

Stay prepared for regulatory inspections at all times with a centralized readiness dashboard and structured preparation checklists. Identify gaps before inspectors arrive and ensure your team is confident, organized, and audit-ready.

Compliance Calendar

Never miss a regulatory deadline with a centralized compliance calendar that tracks all your quality system activities, submissions, and renewal dates. Get proactive notifications and maintain visibility into upcoming obligations across your entire organization.

Management Reviews

Conduct structured management reviews with comprehensive input data aggregation and output tracking. Meet ISO 13485 management review requirements with pre-built agendas, automated data collection, and documented action items that drive continuous improvement.

Cost of Quality

Quantify and track the financial impact of quality activities, failures, and improvements across your organization. Make the business case for quality investments by measuring prevention costs, appraisal costs, and failure costs with clear, actionable metrics.