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Establish, implement, and maintain a declaration of conformity.


CONTROL ID
15038
CONTROL TYPE
Establish/Maintain Documentation
CLASSIFICATION
Preventive

SUPPORTING AND SUPPORTED CONTROLS




This Control directly supports the implied Control(s):
  • Operational management, CC ID: 00805

This Control has the following implementation support Control(s):
  • Include compliance requirements in the declaration of conformity., CC ID: 15105
  • Translate the declaration of conformity into an official language., CC ID: 15103
  • Disseminate and communicate the declaration of conformity to interested personnel and affected parties., CC ID: 15102
  • Include all required information in the declaration of conformity., CC ID: 15101
  • Include a statement that the artificial intelligence system meets all requirements in the declaration of conformity., CC ID: 15100
  • Identify the artificial intelligence system in the declaration of conformity., CC ID: 15098


SELECTED AUTHORITY DOCUMENTS COMPLIED WITH




  • The provider shall draw up a written EU declaration of conformity for each AI system and keep it at the disposal of the national competent authorities for 10 years after the AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the AI system for… (Article 48 1., Proposal for a Regulation of The European Parliament and of The Council Laying Down Harmonized Rules On Artificial Intelligence (Artificial Intelligence Act) and Ameding Certain Union Legislative Acts)
  • Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union legislations applicable to the high-risk AI system. The declaration shall contain all t… (Article 48 3., Proposal for a Regulation of The European Parliament and of The Council Laying Down Harmonized Rules On Artificial Intelligence (Artificial Intelligence Act) and Ameding Certain Union Legislative Acts)
  • Providers of high-risk AI systems shall ensure that their systems undergo the relevant conformity assessment procedure in accordance with Article 43, prior to their placing on the market or putting into service. Where the compliance of the AI systems with the requirements set out in Chapter 2 of thi… (Article 19 1., Proposal for a Regulation of The European Parliament and of The Council Laying Down Harmonized Rules On Artificial Intelligence (Artificial Intelligence Act) and Ameding Certain Union Legislative Acts)
  • By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Chapter 2 of this Title. The provider shall keep the EU declaration of conformity up-to-date as appropriate. (Article 48 4., Proposal for a Regulation of The European Parliament and of The Council Laying Down Harmonized Rules On Artificial Intelligence (Artificial Intelligence Act) and Ameding Certain Union Legislative Acts)