BS EN 18286:2026 Artificial intelligence – quality management system
This new Standard specifies requirements and provides guidance for defining, implementing, maintaining, and improving a quality management system (QMS) for organisations that provide artificial intelligence systems. It is intended to give support in meeting applicable regulatory requirements, with a primary focus on organisations placing on the market or putting into service high risk artificial intelligence systems. The Standard is not specific to any one sector, which means it can be applied across industries where AI systems are provided. The Standard is primarily intended for organisations providing high risk AI systems that need a structured QMS approach aligned to regulatory expectations. It is also relevant for those working in or alongside AI compliance and assurance, including:- AI governance, risk, and compliance teams.
- Quality, regulatory, and conformity assessment roles.
- AI product, engineering, and delivery leaders who need lifecycle controls and documentation.
- Legal, audit, and accountability stakeholders responsible for oversight and evidence.
- Identifies regulatory requirements and sets out a strategy for regulatory compliance.
- Defines management responsibility, quality policy, roles, responsibilities, and authorities.
- Covers planning, resources, competence, and communication.
- Addresses product realisation and actions to manage and mitigate risks.
- Covers lifecycle stages, including inception, design and development, verification and validation, and deployment, operation, and monitoring.
- Includes requirements and guidance on data management and environmental sustainability.
- Covers supply chain management, changes to AI systems, post market monitoring, reporting serious incidents, and handling non-conformities.
- Addresses performance evaluation, consultation on fundamental rights, and estimating risk and impact on affected persons.
- Explains relationships and correspondence with other standards and frameworks, including ISO 9001 and ISO/IEC 42001.
As artificial intelligence becomes increasingly embedded in products, services and workplace decision-making, organisations need clear controls to ensure AI systems are safe, reliable, transparent and compliant with emerging regulations. This Standard provides a structured framework for governing AI throughout its entire lifecycle, covering areas such as risk management, data quality, accountability, monitoring and continual improvement. By adopting this standard, organisations can reduce compliance risks, build greater trust in their AI systems, and demonstrate that AI is being developed and managed responsibly, ethically and in line with regulatory expectations.
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