Glossary · Document and evidence governance
Audit readiness
In compliance and quality management, audit readiness is the condition in which responsibilities, records, versions, trace links and evidence are current and reviewable, so that an auditor, notified body or authority can check them at any time without a reconstruction effort.
- Compliance
- Technical documentation
In one sentence
Audit readiness means responsibilities, records, versions, trace links and evidence are current and reviewable at any time, not just before an audit.
Example
When a market surveillance authority requests the technical file of a robot cell, the manufacturer delivers the current version with its risk assessment, test reports and declaration within days, because the file is maintained continuously.
How it applies
- Compliance: Authorities can request the technical file on reasoned request, often at short notice. Audit readiness means it already reflects the product as built and shipped.
- Evidence: Each claim should point to evidence that is valid for the current configuration. Evidence control and working traceability are the preconditions.
- Responsibilities: Named owners for each document and record, with deputies, so that questions can be answered without searching for the person who knows.
- Technical documentation: Keep superseded versions accessible and linked to their period of validity. Auditors often ask what was valid at the time of a delivery or incident.
Audit readiness vs. audit preparation
Audit preparation is a project before a known audit date: collecting, updating and filling gaps. Audit readiness is a permanent state produced by everyday document control. A system that needs weeks of preparation is not audit-ready, and the gaps it hides are also gaps in the safety argument.