How to Comply with Quality Management System — EU AI Act

EU Regulation · EU · Effective Aug 2, 2026

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Implement a quality management system for high-risk AI.

Implementation steps

  1. Establish QMS covering design, development, testing, deployment, and monitoring.
  2. Document procedures and responsibilities.
  3. Review and improve continuously.

Evidence needed

  • QMS documentation
  • Review records

Passing criteria

  • QMS in place
  • Documented
Penalties: Up to $35M per violation. Enforced by National Authorities.

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