Article 17

Article 17 — Quality Management System

1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall comprise at least the following aspects:
(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system;
(e) technical specifications, including standards, to be applied and, where relevant harmonised standards are not fully complied with, the means to be used to ensure that the high-risk AI system complies with the requirements set out in Section 2;
(f) systems and procedures for data management, including data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or putting into service of high-risk AI systems;
(g) the risk management system referred to in Article 9;
(h) the setting-up, implementation, and maintenance of a post-market monitoring system, in accordance with Article 72;
(i) procedures related to the reporting of serious incidents in accordance with Article 73;
(j) the handling of communication with national competent authorities, competent authorities, notified bodies, other operators, customers or other interested parties.