Change management requires that every change to the system, whether to code, data, model, configuration, or infrastructure, flows through a controlled process with defined approval authority. The version control governance in, deployment controls in, and substantial change thresholds in collectively satisfy this requirement.

The QMS integrates these controls into a single change management framework: a change request is submitted, assessed for impact (including whether it constitutes a substantial modification requiring new conformity assessment), approved by the appropriate authority, implemented through the controlled deployment pipeline, and verified through post-deployment checks. The AISDP is updated to reflect the change.

The integration with Section 6 is deliberate. Change management for AI systems is not a separate governance process; it is embedded in the development and deployment pipeline. The QMS documents the change management policy; the development infrastructure enforces it.

Key outputs

• Integrated change management framework across code, data, model, and infrastructure
• Substantial modification assessment at each change
• AISDP update requirement per change
• Section 6 development pipeline integration