**Target:** Proposal for a regulation — Recital 54 ## Text proposed by the Commission (54) 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. (54) (54) ## Amendment of the European Parliament (54) 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 . For providers that have already in place quality management systems based on standards such as ISO 9001 or other relevant standards, no duplicative quality management system in full should be expected but rather an adaptation of their existing systems to certain aspects linked to compliance with specific requirements of this Regulation. This should also be reflected in future standardization activities or guidance adopted by the Commission in this respect . 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. 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. 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 . For providers that have already in place quality management systems based on standards such as ISO 9001 or other relevant standards, no duplicative quality management system in full should be expected but rather an adaptation of their existing systems to certain aspects linked to compliance with specific requirements of this Regulation. This should also be reflected in future standardization activities or guidance adopted by the Commission in this respect . 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.
aiact/history/parliament-2023/amendments/89 · 2023-06-14
Amends: recital 54
Proposal for a regulation — Recital 54