System identity spine
Every controlled record links to AI system identity, intended purpose, and version so evidence stays attributable.
High-risk AI providers need more than a legal memo. AI QMS Online helps you run the quality management, technical, and post-market processes the Act assumes will exist — and produce evidence you can show.
Generic capability mapping for common high-risk provider obligations (not legal advice).
| Theme | How the QMS helps |
|---|---|
| Risk management | Classification decisions, structured risk management files, residual risk acceptance, re-evaluation after change or field data. |
| Data governance | Records for data quality, lineage, governance roles, and issues that feed risk and design controls. |
| Technical documentation | Realisation and documentation workflows that assemble design, evaluation, and system information for conformity. |
| Record-keeping | Mandatory record matrices, evidence libraries, automatic-log related operational records, and long-term archive. |
| Transparency | Structured transparency / marking records and process evidence where Article 50-type duties apply. |
| Human oversight | Oversight measures, roles, and operational evidence that intervention and override are designed and practised. |
| Accuracy, robustness, cyber | Performance and cybersecurity control evidence integrated with risk and operational monitoring. |
| Quality management | EN 18286-style QMS processes, accountability, competence, audit, management review, and continual improvement. |
| Logging | Logging design and operational control profiles derived from risk context and deployment characteristics. |
| Post-market | Monitoring plans, incidents, serious-incident cues, nonconformity, CAPA, and feedback into risk and change. |
| Substantial modification | Change control with impact assessment, documentation updates, and conformity re-assessment triggers. |
| Conformity & CE pathway | Conformity assessment route records, declaration readiness, and registration-oriented data capture. |
Most providers do not run a single model. The platform treats each AI system as a governed product with its own evidence trail.
Every controlled record links to AI system identity, intended purpose, and version so evidence stays attributable.
Risk, product, data, operations, compliance, and audit share one environment instead of disconnected fileshares.
Dashboards and exports help reconstruct what was decided, who approved it, what changed, and what the field showed later.
Request a demo on high-risk provider workflows, or register for QMS training focused on EN 18286 and the Act.