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Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Providers of high- risk AI systems that are subject to obligations regarding quality management systems under relevant sectorial Union law should have the possibility to include the elements of the quality management system provided for in this Regulation as part of the existing quality management system provided for in that other sectorial Union legislation. The complementarity between this Regulation and existing sectorial Union law should also be taken into account in future standardization activities or guidance adopted by the Commission. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority in question.

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Establishment of Quality Management System

The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority in question.

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