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 include 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 have to be carried out;
(e)
technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set o