AI Quality Management System Solution
One unified platform. Full conformity with the EU AI Act.
The Requirement Under the EU AI Act
Under the EU AI Act (Regulation 2024/1689), providers of high-risk AI systems must implement a robust Quality Management System (QMS) that ensures the protection of health, safety, and fundamental rights throughout the entire AI system life cycle. This QMS must integrate seven essential requirements, including a risk management system, cybersecurity measures, data governance, traceability, and comprehensive documentation - all aligned with Article 17 and the European standard EN 18286.
The Solution
This AI Quality Management System Platform is a purpose-built solution that fully addresses all seven essential requirements of the EU AI Act in a single, integrated environment. Designed specifically for high-risk AI providers, the platform automates compliance workflows, generates audit-ready documentation, and delivers continuous assurance across quality, risk, cybersecurity, and data management - from initial design through to post-market monitoring.
Key Capabilities
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Quality Management System (EN 18286)
- Complete QMS aligned with the EU AI Act regulatory strategy
- System-level document control and version management
- Management review, approval workflows, and task tracking
- Operational processes covering design, development, testing, and deployment
- Full traceability from operational tasks to quality policy and objectives
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AI Risk Management System (Article 9 + prEN 18228)
- Automated risk analysis, including hazard identification and risk scenario development
- Definition and justification of risk acceptability criteria with objective evidence
- Implementation of the risk control hierarchy with complete traceability
- Evaluation of overall residual risk and fundamental rights impact
- Automated generation of the full Risk Management File
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AI Cybersecurity (prEN 18282)
- AI-specific threat identification and vulnerability assessment
- Cybersecurity risk determination and acceptance criteria
- Comprehensive prevent, detect, respond, resolve, and control measures
- Support for poisoning resistance, adversarial, confidentiality, and model flaw testing
- Composite and red-team testing capabilities
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Data governance, traceability, and technical documentation
- Data quality and provenance records appropriate to the risk level
- End-to-end traceability from intended purpose to operational tasks and evidence
- Version-controlled technical documentation and instructions for use
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Post-market monitoring (Article 72) and serious-incident reporting (Article 73)
- Continuous performance tracking with alerts and improvement recommendations
- Structured incident workflows with supporting evidence for authority notification
- Closed-loop feedback into risk treatment and change control
Five pervasive QMS processes
Protection is not an add-on. Five processes apply across every high-risk AI activity, reinforced by a universal QMS control footer on governed records:
- Traceability - every action and decision is linked to AI system ID, purpose, and the controls in force at the time.
- Review and approval - structured sign-off with timestamps before critical activities proceed.
- Evidence generation - immutable snapshots of governance structures, risk files, and control configurations.
- Nonconformity and CAPA - deviations that could affect health, safety, or rights are logged and tracked to closure.
- Change management - modifications to systems, configurations, and the QMS itself are controlled events.
Why Choose This Solution?
| Benefit | How We Deliver It |
|---|---|
| Single Source of Truth | One integrated platform covering all seven essential requirements |
| Audit-Ready Documentation | Automatically generated, regulator-ready QMS and technical files |
| Reduced Compliance Burden | Significant time savings through automation and guided workflows |
| Continuous Assurance | Real-time monitoring with post-market feedback integration |
| Focus on Protection | Built-in tools for health, safety, and fundamental rights |
| Future-Proof | Regular updates aligned with evolving harmonized standards |
Who It Is For
- Providers of high-risk AI systems
- Organizations seeking conformity with the EU AI Act
- Companies looking to implement a robust, auditable QMS efficiently
- Teams requiring an integrated approach across risk, quality, and cybersecurity
How It Works
| Step | Description |
|---|---|
| Onboarding | Import your AI system details and intended purpose |
| Current State Assessment | Map your systems against EU AI Act requirements |
| Guided Implementation | Step-by-step workflows for QMS setup, risk management, cybersecurity, and post-market monitoring |
| Automated Documentation | One-click generation of Risk Management Files, technical documentation, and instructions for use |
| Continuous Monitoring | Ongoing performance tracking with intelligent alerts and improvement recommendations |
Related pages
- Our QMS design
- Protecting what matters most
- System lifecycle
- AI Act QMS lifecycle management
- Accountability framework (EN 18286)
- QMS Management as a Service if you want the platform operated with you
Trusted by Forward-Thinking AI Providers
Leading organizations can rely on this platform to achieve competitive advantage, protect health, safety and fundamental rights, and maintain EU AI Act conformity with confidence and efficiency.
