High-risk AI: an EU-recognised quality management standard
In brief
According to the European Commission, the reference to standard EN 18286:2026 has been published in the Official Journal of the EU. Developed by CEN and CENELEC, it sets out a quality management system for providers of high-risk AI systems under Article 17 of the AI Act. The Commission states that organisations that apply it are presumed to meet the Article 17 requirements the standard covers.
What it changes for an SME
If you do not place high-risk AI systems on the EU market or put them into service in the EU, nothing changes for your company for now. If you are a provider of such systems, the European Commission says that applying EN 18286 means you are presumed to meet the Article 17 requirements the standard covers, which reduces legal uncertainty. The standard is organised around the AI system lifecycle and can extend an existing system such as ISO 9001, ISO/IEC 42001 or a sectoral system like ISO 13485, without a duplicate management system. According to the Commission, the requirements for high-risk AI systems apply from December 2027 or August 2028.
What you can do
- Check whether you provide or put into service in the EU an AI system that may be classified as high-risk.
- If so, review whether your current quality management system can be extended with EN 18286 instead of running a second one.
- Schedule an internal review ahead of the December 2027 and August 2028 dates given by the Commission.
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