Improvement

Description

Requires continual improvement of the AI management system through identification and correction of nonconformities and proactive enhancement of AIMS effectiveness.

Requirements

• 10.1 Nonconformity and corrective action
• 10.2 Continual improvement

Implementation Guidance

10.1 Corrective Action

Establish processes to identify, document, and correct AI system or AIMS nonconformities; analyze root causes and implement preventive measures.

10.2 Continual Improvement

Systematically enhance AIMS suitability, adequacy, and effectiveness based on performance data, audit findings, and emerging AI risks and best practices.

Evidence Requirements

Nonconformity reports and corrective action records

Root cause analysis documentation

Improvement initiatives and outcomes

Trend analysis reports