Quality guide

An audit trail that stands up to ISO 15189 and inspection

ISO 15189 expects a laboratory to control its records and to show who did what and when. An audit trail that cannot be altered silently is the strongest answer to that expectation.

What inspectors look for

They sample records and ask three things: who made this change, when, and can anyone have altered the history since? Complete records that are attributable and dated answer the first two. The third is where most systems are weak.

Why tamper evidence matters

A log that can be edited without trace is a claim, not evidence. If each entry is cryptographically linked to the one before it, any alteration or deletion breaks the chain and can be detected.

Capture it automatically

Records created by people after the fact are the weakest. The better design writes the audit entry as a by-product of the action itself, so it exists whether or not anyone remembers to document it.

Verify, do not assume

Run an integrity check before an audit, not during it. A clean result is evidence in itself, and a break gives you time to investigate.

Common questions

No. It supports the records and traceability requirements. Accreditation depends on the whole quality system.

Entries are chained, so removing or changing one breaks the chain and the integrity check reports it.

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