KLA Digital Logo
KLA Digital
EU AI Act
Last updated: Dec 15, 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’re 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.