Quality Management System Procedure

Purpose

This procedure establishes a comprehensive Quality Management System (QMS) for AI systems in compliance with EU AI Act Article 17, ensuring systematic quality control throughout the entire AI system lifecycle from design through deployment, operation, and decommissioning. The QMS integrates all compliance requirements from Articles 8-15, providing a unified framework for: - Design, development, and testing quality controls - Technical documentation accuracy and completeness - Data governance and quality assurance - Risk management integration - Post-market monitoring and incident reporting - Continuous improvement and corrective action

Applies To

• All high-risk AI systems as classified per AI System Classification Procedure (PROC-AI-CLS-001)
• All AI system development, deployment, and operational activities
• All providers and deployers of AI systems within the organization
• All third-party suppliers and vendors supporting AI systems
• All personnel involved in AI system lifecycle activities

Does Not Apply To

• Minimal-risk AI systems (unless specifically designated)
• Research and development prototypes not intended for deployment
• Third-party AI systems where provider maintains QMS responsibility (covered by AI Vendor Management Procedure (PROC-AI-VENDOR-001))