Risk Management
Walk through MoniDoseQMS's risk management module — create risk assessments based on ISO 14971, score probability and severity, apply control measures, and track residual risk with full traceability.
Risk management is one of the most important modules in your QMS. MoniDoseQMS follows ISO 14971, giving you a structured process for identifying, evaluating, and controlling risks throughout the product lifecycle.
What you'll learn
- 1
Dashboard overview
See all your risk records at a glance — risk ID, title, category, type, and initial risk level. Filter and search to find what you need.
- 2
Create a risk assessment
Custom ID, risk type (product, process, quality, compliance, supply chain, operations, finance, or custom), and upload supporting documents from your library.
- 3
Risk scoring
Score probability and severity on a 1-to-10 scale. The risk level — low, medium, high, very high, or critical — is calculated automatically.
- 4
ISO 14971 guided workflow
Follow the standard step by step: risk analysis, hazard identification, risk evaluation, risk control, verification, and review.
- 5
Risk control measures
Select and document control measures, define implementation details, and specify the mitigation type and strategy.
- 6
Residual risk assessment
Evaluate the risk remaining after control measures have been applied — essential for demonstrating that benefits outweigh residual risks.
- 7
Verification, review & monitoring
Set monitoring frequency (monthly, quarterly, semi-annually, annually, or as needed) and assign reviewers and tasks to team members.
- 8
Traceability & audit trail
Every action is logged. View details, request reviews, create tasks, and edit records — all fully traceable.