Article 17 Quality management system

1. a strategy for regulatory compliance, including compliance with conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedures and procedures for the management of modifications to the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;;

2. techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;;

3. techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;;

4. examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;, and the frequency with which they have to be carried out;

5. technical specifications, including standards, to be applied and, where the relevant harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; complies with those requirements;

6. systems and procedures for data management, including data acquisition, 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 means the first making available of an AI system or a general-purpose AI model on the Union market; or the putting into service means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;;

7. the risk means the combination of the probability of an occurrence of harm and the severity of that harm; management system referred to in Article 9;

8. the setting-up, implementation and maintenance of a post-market monitoring system means all activities carried out by providers of AI systems to collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;, in accordance with Article 72;

9. procedures related to the reporting of a serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; in accordance with Article 73;

10. the handling of communication with national competent authorities means a notifying authority or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection Supervisor;, other relevant authorities, including those providing or supporting the access to data, notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;, other operators means a provider, product manufacturer, deployer, authorised representative, importer or distributor;, customers or other interested parties;

11. systems and procedures for record-keeping of all relevant documentation and information;

12. resource management, including security-of-supply related measures;

13. an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.

The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;’s organisation. Providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; with this Regulation.

Providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; that are subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law.

For providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; that are financial institutions subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; referred to in Article 40 shall be taken into account.