Checks / EN 18286:2026 (AI Act QMS)
EN 18286:2026 (AI Act QMS)
EN 18286:2026 (AI Act QMS) compliance checks
The first harmonised standard under the EU AI Act (Implementing Decision (EU) 2026/2274, 14 Oct 2026): the quality management system providers of high-risk AI need under Article 17. Meeting it gives a presumption of conformity.
36 controls, each a live check with a tamper-evident receipt. Run the whole framework at once from any AI assistant with sebbi_run_framework and framework=en18286.
Free EN 18286 readiness check. Answer one question per control and get your score, every gap and a sealed readiness report in five minutes. Check my organisation
- EN 18286 Cl.4 - quality management system established and documented
- EN 18286 Cl.4 - applicable AI Act requirements identified
- EN 18286 Cl.4 - QMS scope defined
- EN 18286 Cl.4 / Art.17(1)(a) - regulatory compliance strategy incl. conformity assessment
- EN 18286 Cl.4 - documented information controlled
- EN 18286 Cl.5 - top management commitment
- EN 18286 Cl.5 - quality policy
- EN 18286 Cl.5 - roles, responsibilities and authorities assigned
- EN 18286 Cl.5 / Art.17(1)(m) - accountability framework
- EN 18286 Cl.6 - risks to the QMS itself addressed
- EN 18286 Cl.6 - quality objectives set
- EN 18286 Cl.7 / Art.17(1)(l) - resource management incl. security of supply
- EN 18286 Cl.7 - staff competence evidenced
- EN 18286 Cl.7 / Art.17(1)(j) - communication with authorities and notified bodies
- EN 18286 Cl.8.1 - AI system life cycle defined
- EN 18286 Cl.8.2 / Art.17(1)(g) - life-cycle risk management system
- EN 18286 Cl.8.3 / Art.17(1)(b) - design and design control
- EN 18286 Cl.8.4 / Art.17(1)(d) - verification and validation before release
- EN 18286 Cl.8.5 / Art.17(1)(f) - data management procedures
- EN 18286 Cl.8.6 - retirement plan and deployer measures
- EN 18286 Cl.8.7 - unique reference for each assessed version
- EN 18286 Cl.8.8 - pre-determined changes documented
- EN 18286 Cl.8.9 / Art.11(1) - technical documentation before market
- EN 18286 Cl.9.1 - unique identifier for each system placed on the market
- EN 18286 Cl.9.2 - deployer support and risk feedback channel
- EN 18286 Cl.9.3 - supply chain controls
- EN 18286 Cl.9.4 / Art.17(1)(a) - modification management
- EN 18286 Cl.9.5 / Art.17(1)(h) - post-market monitoring
- EN 18286 Cl.9.6 / Art.17(1)(i) - serious incident reporting procedure
- EN 18286 Cl.9.6 - serious incident reported within 15 days
- EN 18286 Cl.9.7 - non-compliance action (comply, withdraw, disable or recall)
- EN 18286 Art.17(1)(k) - record-keeping system
- EN 18286 Art.12 - automatic logging feeding QMS records
- EN 18286 Art.18 - QMS documentation kept >= 10 years
- EN 18286 Cl.10.1 - last management review date
- EN 18286 Cl.10.2 - change planning recorded