Services
AI QMS Management as a Service
We operate an EN 18286-aligned QMS for high-risk AI providers — covering Article 17, risk, cybersecurity, post-market monitoring, and incident reporting — and produce the audit-ready files authorities expect.
The service
This is a managed Quality Management System for providers of high-risk AI systems. We run the QMS with your teams on the EN 18286 platform already used on this site — not a slide deck and not a one-off policy pack.
Under the EU AI Act (Regulation 2024/1689), providers must implement a QMS that protects health, safety, and fundamental rights across the AI system life cycle. The service covers Article 17 and the seven essential requirements, including risk management, cybersecurity, data governance, traceability, and documentation, aligned with EN 18286.
What we operate for you
- Article 17 QMS — system-level document control, management review, approval workflows, and operational processes from design through deployment.
- Risk management (Article 9 + prEN 18228) — hazard identification, risk scenarios, residual-risk evaluation, and the Risk Management File.
- AI cybersecurity (prEN 18282) — threat identification, prevent/detect/respond measures, and support for poisoning, adversarial, and red-team testing evidence.
- Post-market monitoring (Article 72) and serious-incident reporting (Article 73) — closed-loop records that feed back into the QMS.
- Fundamental rights impact — structured assessment outcomes and mitigations, kept with the QMS file.
- Five pervasive processes — traceability, review and sign-off, evidence generation, CAPA, and change management, including the universal QMS control footer used on governed records.
How the engagement runs
| Step | What we do |
|---|---|
| Onboarding | Import AI system details, intended purpose, and current QMS artefacts. |
| Current-state assessment | Map systems against Article 17, EN 18286, and the seven essential requirements. |
| Guided implementation | Stand up QMS, risk, cybersecurity, and post-market workflows on the platform. |
| Evidence production | Generate Risk Management Files, technical documentation, and instructions for use. |
| Ongoing operation | We operate reviews, change control, monitoring alerts, and file maintenance with your named owners. |
Who it is for
- Providers of high-risk AI systems that need a living QMS, not a static manual
- SMEs and enterprise teams that want an out-of-the-box EN 18286 system operated with them
- Organisations that must show audit-ready QMS and technical files on demand
The managed service runs on our EN 18286 Quality Management System platform. Related design notes: Our QMS design and accountability framework.
