Implement quality management system
Establish a quality management system for high-risk AI systems proportionate to the size of the organization
Control activities
Documenting strategy for compliance with conformity assessment procedures.
Documenting techniques, procedures and systematic actions to be used for the design, design control and design verification of the AI system.
Documenting techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the AI system.
Documenting the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties.
Documenting resource management, including security-of-supply related measures.
Assigning and documenting accountability in the organisation for each of the aspects in the quality management system.
Collecting comprehensive documentation for EU AI Act Article 17 requirements for quality management systems. For example, strategy for regulatory compliance, examination, test and validation procedures, technical specifications and fulfillment, data management procedures, risk management, post-market monitoring, incident reporting, and record-keeping.
Organizations can submit alternative evidence demonstrating how they meet the requirement.
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