Quality management system for high-risk AI systems

Providers of high-risk AI systems must establish and maintain a documented quality management system to ensure compliance with the AI Act. The system must cover regulatory compliance strategies, design and development controls, testing and validation procedures, data management practices, risk management, post-market monitoring, incident reporting, and communication with authorities. It should also include record-keeping, resource management, and accountability frameworks for management and staff. The implementation must be proportionate to the provider's size while ensuring rigorous compliance. Providers subject to equivalent sectoral or financial services laws may integrate these requirements into existing systems.