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Modules/Audits & QMS Governance/Management Reviews
Audits & QMS Governance

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.

Regulatory Context

ISO 13485:2016 §5.6 — Management review
FDA 21 CFR Part 820.20 — Management responsibility
ISO 13485:2016 §5.6.2 — Review input requirements

Key Capabilities

What you get with the Management Reviews module.

Pre-built management review agendas aligned with ISO 13485 requirements
Automated aggregation of quality data including CAPAs, audits, and complaints
Meeting minutes with documented decisions and assigned action items
Trend dashboards presenting key quality metrics to leadership
Action item tracking with accountability and completion verification

Why It Matters

How Management Reviews helps your organisation.

Give leadership clear visibility into quality system effectiveness and risks
Fulfil ISO 13485 management review requirements with automated data aggregation
Drive accountability with documented decisions and tracked action items

How It Connects

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

Ready to see Management Reviews in action?

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

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