Quality Management System

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, and the frequency with which they are to be carried out.