Published at the end of 2023, ISO/IEC 42001 is not yet widely known. It is the first international standard that enables the implementation and at the same time certification of a management system for artificial intelligence (AI) and applies to all types of companies and industries. The standard applies regardless of whether the organization develops, monitors, provides, or merely uses products or services.
It was developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in response to the increasing use of AI.
Does taking the standard into account bring advantages for companies?
Who is recommended to apply it, especially in view of EU GMP Annex 22 or the expected addition to the medical device standard ISO 13485?
gempex addresses this topic in its InfoSheet "ISO/IEC 42001" and classifies the significance of the standard in conjunction with existing regulations.
The purpose, objectives and scope of this relevant standard are highlighted. Recommendations for practical implementation are provided based on the structure. A special focus is placed on the risk and lifecycle aspects.
The German language detailed technical information is available under GMP Knowledge at gempex.de. ((Direct link to the InfoSheet))
For further information, please contact Manuel Goldstein, Senior Consultant at gempex GmbH and author of the technichal information at contact@gempex.com.
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