ISO 42001 AI Management System

ISO 42001 AI Management System


Why is an ISO 42001 AI management system needed?

Providers of high-risk AI systems are required to put an AI risk management system, AI compliance management system, an accountability framework, and post-market monitoring in place setting out the responsibilities of the management and other staff with regard to:

  • strategy for regulatory compliance, conformity assessments and change control
  • techniques, procedures and systematic actions to be used for:
  • design, design control and design verification of the high-risk AI system
  • 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 high-risk AI systems
  • data management systems, procedures and internal controls
  • maintaining a risk management system
  • maintaining a quality management system
  • maintaining a post-market monitoring system
  • serious incident and malfunction reporting procedures
  • communicating with national and other competent authorities.
  • record keeping systems and procedures
  • resource management, including security measures.

ISO 42001 requirements for establishing, implementing, maintaining and continually improving an artificial intelligence (AI) management system within the context of an organization


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