01
Regulation-first structure
Workflows mirror EN 18286 and the EU AI Act: classification, essentials, technical documentation, logging, human oversight, and post-market duties.
EN 18286 · EU AI Act · High-risk AI providers
Quality management built for AI systems
Establish, operate, and evidence an AI Quality Management System that protects health, safety, and fundamental rights — with continuous control across the full AI lifecycle.
AI system register
Risk & cybersecurity
Change & CAPA
Post-market monitoring
10-year record retention
Clauses 4–10
Structured coverage of EN 18286 management-system requirements
Pervasive controls
Traceability, approval, evidence, nonconformity, and change on every controlled record
Inspection-ready
Linked evidence packages, signed records, and retention aligned with Article 18
Why AI QMS Online
One system for justified confidence in every AI system
Built for organisations that place high-risk AI on the Union market and need a living quality system — not a static policy folder.
02
End-to-end lifecycle
From intended purpose and design inputs through release, operation, modification, monitoring, and end-of-life — with gates that prevent uncontrolled progression.
03
Defensible evidence
Structured fields, review chains, signed packages, and long-term archive support so auditors and market surveillance can follow the story of each AI system.
Platform capabilities
What you can run in the QMS
Core management-system capabilities mapped to how high-risk AI providers actually work.
- ✓AI system identity & scope
Register systems, intended purpose, versions, and QMS scope boundaries. - ✓Regulatory determination
Track applicable obligations and essentials applicability for each context. - ✓Leadership & accountability
Roles, authorities, RACI across lifecycle phases, and decision ownership. - ✓Risk management file
Hazard analysis, residual risk, and continuous risk process aligned with AI risk practice. - ✓Cybersecurity controls
Structured cyber framework evidence linked to the same AI systems. - ✓Data quality & governance
Lineage, metrics, drift, and data roles for training and operational data.
- ✓Design, V&V, release & TD
Realisation records, verification gates, instructions for use, and documentation assembly. - ✓Operation, logging & oversight
Deployment control, logging profiles, and human oversight measures. - ✓Supply chain & components
Supplier due diligence, component inventory, and third-party model control. - ✓Change & substantial modification
Planned and unintended change control with impact on risk and technical documentation. - ✓PMS, incidents & CAPA
Post-market monitoring, serious incidents, nonconformity, and corrective action. - ✓Audit, management review & archive
Internal audit programmes, management review inputs, and long-term retention.
Standards alignment
Designed around EN 18286 and the EU AI Act
Use the platform as the operational backbone of your AI QMS and conformity evidence.
EN 18286
Quality management system for AI systems — context, leadership, planning, support, operation, performance evaluation, and improvement.
EU AI Act
Support for high-risk provider duties: risk, data, transparency, human oversight, logging, quality management, and post-market obligations.
Supporting practice
Risk management and cybersecurity workflows designed to sit beside EN 18286 essentials and produce linked, signed evidence.
See the QMS in action
Request a demonstration, ask a compliance question, or register interest in EN 18286 / EU AI Act QMS training.