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KLA Digital
EU AI Act
Last updated: Dec 15, 2025 · 7 min

Conformity assessment explained (operationally)

What “assessment” means in practice: processes, artifacts, and an audit-ready evidence bundle.

Orientation only. Not legal advice.

Who this matters for

High-risk teams preparing for audits and go-live.

What you’ll leave with

A practical plan for assembling evidence and de-risking the assessment process.

What it is (plain language)

  • A structured way to show your system meets applicable requirements.
  • In practice: documentation, controls, tests, and repeatable processes (QMS).
  • Treat it as an evidence program, not a one-time document sprint.

Minimum viable assessment prep

  • Define intended purpose and high-risk rationale (or non-high-risk rationale).
  • Build Annex IV-aligned technical documentation early (iterate on every release).
  • Establish risk management + verification evidence for mitigations.
  • Implement logging + human oversight and retain intervention records.
  • Create a consistent evidence export package you can regenerate.

Evidence you keep

  • Technical documentation and change history
  • Evaluation reports (accuracy/robustness) and thresholds
  • Policy packs, approvals, and review records
  • Post-deployment monitoring reports and incident response outcomes

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.