SOLUTIONS · INTERNAL AUDITS

Your internal audit says 100% coverage.
Your sample says otherwise.

The audit plan promises full clause coverage. The week you're given covers a fraction — five CAPAs of two hundred, a handful of complaint records, a skim of the rest. You sample because you have a week, not because sampling is better. Aligntra reads all of it against the standard, applies one rubric to every clause, and cites the exact paragraph behind each finding — in 30 minutes.

Book a 30-min demo → See how it works

ISO 13485 · ISO 9001 · AS9100D · FDA QMSR · +5 100% COVERAGE · NO SAMPLING FIRST-PARTY · RUN ON YOUR OWN DOCS

THE SAMPLING MATH

You sample because you have a week. Not because it's better.

ISO 19011 §6.4.7 names sampling risk because auditors have to sample — reading two hundred CAPAs by hand takes a month. Here's what that costs you on a systemic problem.

Sampled · the manual audit

5 of 200 records · 2.5%

The other 197 — judged by inference.

Read · Aligntra

200 of 200 records · 100%

All of it, one rubric, 30 minutes.

If a problem affects…	A 5-record sample catches it	Reading all 200
8% of records	~34% — worse than a coin-flip	100%
15% of records	~56%	100%
25% of records	~76%	100%

The math on a systemic finding changes when the denominator is all of them.

CONSISTENCY

The same rubric on clause 240 as on clause 1.

A human audit decays across the week — clause 1 gets a rigorous read on Monday morning; clause 240 gets a tired skim at 4pm on day three. Aligntra applies the standard the same way, in the same depth, to the first record and the last — more thorough than any human has the hours to be, and every verdict is one click from the paragraph that earned it.

ONE FINDING, IN CONTEXT

The kind of gap a sample never reaches.

finding #4471 · internal audit MAJOR NC

ISO 13485 · §7.5.1 · CONTROL OF PRODUCTION

Your SOP permits product release before final inspection is signed.

Sampling a week of records, you'd likely never see it. Reading all of them, it's the third release of the month.

What the standard requires

"…release of product shall not proceed until the planned arrangements have been satisfactorily completed."

What your SOP says

"Product may be released by the line lead; final inspection sign-off is completed within 24 hours." — SOP-PRD-011 §6.3. The procedure permits release before verification is complete. Cited to the paragraph.

Read across every release record — not a sample

Run your next internal audit at 100% coverage — in 30 minutes.

Bring a folder of your own procedures, or run a live audit on a published example QMS we maintain. No sampling to defend, no second party, no migration — the whole quality system read against the standard, cited to the paragraph.

Book a 30-min demo → See pricing