- Art. 6Classification rules for high-risk AI systems
- Art. 7Amendments to Annex III
- Art. 8Compliance with the requirements
- Art. 9Risk management system
- Art. 10Data and data governance
- Art. 11Technical documentation
- Art. 12Record-keeping
- Art. 13Transparency and provision of information to deployers
- Art. 14Human oversight
- Art. 15Accuracy, robustness and cybersecurity
- Art. 16Obligations of providers of high-risk AI systems
- Art. 17Quality management system
- Art. 18Documentation keeping
- Art. 19Automatically generated logs
- Art. 20Corrective actions and duty of information
- Art. 21Cooperation with competent authorities
- Art. 22Authorised representatives of providers of high-risk AI systems
- Art. 23Obligations of importers
- Art. 24Obligations of distributors
- Art. 25Responsibilities along the AI value chain
- Art. 26Obligations of deployers of high-risk AI systems
- Art. 27Fundamental rights impact assessment for high-risk AI systems
- Art. 28Notifying authorities
- Art. 29Application of a conformity assessment body for notification
- Art. 30Notification procedure
- Art. 31Requirements relating to notified bodies
- Art. 32Presumption of conformity with requirements relating to notified bodies
- Art. 33Subsidiaries of notified bodies and subcontracting
- Art. 34Operational obligations of notified bodies
- Art. 35Identification numbers and lists of notified bodies
- Art. 36Changes to notifications
- Art. 37Challenge to the competence of notified bodies
- Art. 38Coordination of notified bodies
- Art. 39Conformity assessment bodies of third countries
- Art. 40Harmonised standards and standardisation deliverables
- Art. 41Common specifications
- Art. 42Presumption of conformity with certain requirements
- Art. 43Conformity assessment
- Art. 44Certificates
- Art. 45Information obligations of notified bodies
- Art. 46Derogation from conformity assessment procedure
- Art. 47EU declaration of conformity
- Art. 48CE marking
- Art. 49Registration
- Art. 51Classification of general-purpose AI models as general-purpose AI models with systemic risk
- Art. 52Procedure
- Art. 53Obligations for providers of general-purpose AI models
- Art. 54Authorised representatives of providers of general-purpose AI models
- Art. 55Obligations of providers of general-purpose AI models with systemic risk
- Art. 56Codes of practice
- Art. 57AI regulatory sandboxes
- Art. 58Detailed arrangements for, and functioning of, AI regulatory sandboxes
- Art. 59Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
- Art. 60Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
- Art. 60aTesting of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes
- Art. 61Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
- Art. 62Measures for providers and deployers, in particular SMEs, including start-ups
- Art. 63Derogations for specific operators
- Art. 64AI Office
- Art. 65Establishment and structure of the European Artificial Intelligence Board
- Art. 66Tasks of the Board
- Art. 67Advisory forum
- Art. 68Scientific panel of independent experts
- Art. 69Access to the pool of experts by the Member States
- Art. 70Designation of national competent authorities and single points of contact
- Art. 72Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
- Art. 73Reporting of serious incidents
- Art. 74Market surveillance and control of AI systems in the Union market
- Art. 75Market surveillance and control of AI systems and mutual assistance
- Art. 75aSupervisory and enforcement powers of the AI Office
- Art. 75bCommitments
- Art. 75cNon-compliance, fines and periodic penalty payments
- Art. 75dSafeguards and further specification
- Art. 76Supervision of testing in real world conditions by market surveillance authorities
- Art. 77Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities
- Art. 78Confidentiality
- Art. 79Procedure at national level for dealing with AI systems presenting a risk
- Art. 80Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
- Art. 81Union safeguard procedure
- Art. 82Compliant AI systems which present a risk
- Art. 83Formal non-compliance
- Art. 84Union AI testing support structures
- Art. 85Right to lodge a complaint with a market surveillance authority
- Art. 86Right to explanation of individual decision-making
- Art. 87Reporting of infringements and protection of reporting persons
- Art. 88Enforcement of the obligations of providers of general-purpose AI models
- Art. 89Monitoring actions
- Art. 90Alerts of systemic risks by the scientific panel
- Art. 91Power to request documentation and information
- Art. 92Power to conduct evaluations
- Art. 93Power to request measures
- Art. 94Procedural rights of economic operators of the general-purpose AI model
- Art. 102Amendment to Regulation (EC) No 300/2008
- Art. 103Amendment to Regulation (EU) No 167/2013
- Art. 104Amendment to Regulation (EU) No 168/2013
- Art. 105Amendment to Directive 2014/90/EU
- Art. 106Amendment to Directive (EU) 2016/797
- Art. 107Amendment to Regulation (EU) 2018/858
- Art. 108Amendments to Regulation (EU) 2018/1139
- Art. 109Amendment to Regulation (EU) 2019/2144
- Art. 110Amendment to Directive (EU) 2020/1828
- Art. 111AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
- Art. 112Evaluation and review
- Art. 113Entry into force and application
AI Act Article 17
Quality management system
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 strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;
techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;
techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;
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;
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 out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;
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 or the putting into service of high-risk AI systems;
the risk management system referred to in Article 9;
the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
procedures related to the reporting of a serious incident in accordance with Article 73;
the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
systems and procedures for record-keeping of all relevant documentation and information;
resource management, including security-of-supply related measures;
an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.
