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Document Control & Quality

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 Document Control & Quality

Explore other modules in the Document Control & Quality category.

Document Management Hub

Centralize all quality documents in a single, secure hub with powerful search, categorization, and lifecycle management. Ensure every team member always accesses the latest approved version while maintaining full traceability across your entire document ecosystem.

Document Control

Manage the entire lifecycle of quality documents with version control, electronic signatures, and automated workflows. Ensure every SOP, work instruction, and form meets regulatory requirements with a fully auditable document management system built for regulated industries.

SOP Template Library

Accelerate SOP creation with a curated library of industry-standard templates designed for regulated environments. Reduce drafting time and ensure consistency across your organization with templates aligned to ISO 13485, EU MDR, and FDA requirements.

CAPA Management

Track and manage all corrective and preventive actions with built-in root cause analysis tools. Ensure every CAPA follows a structured workflow from identification through effectiveness verification, with full audit trail and regulatory-ready documentation.

Preventive Actions

Proactively identify and eliminate potential quality problems before they occur. Systematically analyze trends, near-misses, and risk indicators to implement preventive measures that strengthen your quality system and reduce costly corrective actions.

Deviation Management

Capture, investigate, and resolve deviations from established procedures with a structured workflow that ensures nothing falls through the cracks. Classify deviations by severity, conduct thorough investigations, and drive timely resolution with full regulatory traceability.