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KLA Digital
EU AI Act
Last updated: 15. Dez. 2025 · 8 min

Quality management system (QMS) essentials

Minimum viable QMS processes for repeatable compliance, plus the evidence you should retain.

Orientation only. Not legal advice.

Who this matters for

Providers operationalizing repeatable compliance across releases and teams.

What you'll leave with

A pragmatic QMS checklist you can implement without a bureaucracy spiral.

Minimum viable QMS (orientation)

  • Document control: versioning for policies, specs, and templates
  • Change control: approvals for model/policy changes and risk exceptions
  • Supplier management: vendor due diligence and documentation snapshots
  • Training and competence: playbooks for reviewers and operators
  • Incident management: detection, escalation, postmortems, corrective actions
  • Post-market monitoring: metrics, thresholds, and periodic reports

Evidence you keep

  • Process definitions + owners
  • Approvals and review records (who, when, why)
  • Monitoring reports and incident logs
  • Audit/export packages tied to releases

How to avoid "paper compliance"

  • Make evidence generation automatic (logs + exports) wherever possible.
  • Keep a small set of templates and enforce them via tooling.
  • Measure near-misses and exceptions. They are your leading indicators.

Next step: artifacts

Compliance work gets funded when the output is forwardable. Use the starter templates to convert obligations into controls and evidence.

Govern - Measure - Prove

Need a defensible evidence path?

KLA Digital turns obligations into controls, controls into measurements, and measurements into exportable evidence.