The Quality Management System Manager is the management owner of the QMS that makes DAEIOR repeatable. Role 1.1 Directs. Role 1.2 owns the conformity file. This role owns the system of documented information, process control, nonconformity, corrective action and management review that every domain must run through. Competence records are controlled by Role 6.1 (ROLES11, user decision t260u).

Standing duties

• Establish and keep current the AI QMS (EST11) against EN 18286 for AI Act purposes, and against ISO 13485 where the product is a medical device.
• Map every DAEIOR process that is in scope onto a controlled procedure, owner, record type and measure — without turning the QMS into a second process model.
• Run internal quality audit of process effectiveness (distinct from REV04 independent assurance and from Role 1.2 readiness calls).
• Feed management review with process-health inputs Role 1.1 can Direct from.
• Drive CAPA when Implement, Operate or Review shows the process, not only the product, failed.

Accountable to: AI Governance Lead / Top Management (or GM: Quality)

Primary domain: Establish (EST11 QMS). Wraps all domains with documented information, CAPA and management review.

Linked EN 18286 clauses: 4.1, 4.3, 4.4.2, 5.2, 6.1.1, 6.1.2, 6.1.3, 6.2.1, 6.2.2, 7.2.1, 7.2.2, 7.2.3, 7.4, 8.1.4, 8.1.5, 9.4, 9.7.1, 9.7.3, 10.1.1, 10.1.1.2, 10.1.2, 10.2.1, 10.2.2, 10.2.3

Format: 3 hours of training, EUR 200.