Tools · ISO 19011
Size your sample, then read what it allows you to conclude. Zero findings does not mean zero nonconformity.
The figures you enter stay in your browser: nothing is transmitted or stored.
You want to quantify the population's conformity rate to a given precision.
The number of examinable items over the period: records, batches, interventions, entries.
The sampling risk you accept. Also used for the reading below.
The gap you tolerate between the rate measured on the sample and the population's.
Enter the population size to get a result.
Enter what you actually examined. The result is the upper bound on the population's nonconformity rate, at the confidence level chosen above.
Enter the number of items examined to read your result.
No standard imposes a sample size: these values are statistical, not normative.
HEMC
Sample size for an internal audit
Indicative value. None of the standards cited imposes a threshold or a calculation method: the method used, the boundary and the source of the data must be stated beside the result.
ISO 19011 is a guidance document: its Annex A.6 distinguishes judgement-based sampling from statistical sampling, and imposes no size, no method and no threshold. No standard says how many records to examine. What can be established is what a given sample allows you to state, and that is statistics, not conformity. The point is less to fix a number than to read the result: too small a sample does not make an audit wrong, it makes its conclusion far weaker than people assume.
Define the population
The number of items genuinely examinable over the period and within the audit scope: records, batches, interventions, entries. A poorly defined population distorts everything that follows.
Choose between judging and counting
Judgement-based sampling targets risk areas and relies on experience; it supports no statistical estimate. Statistical sampling does, at the price of a genuinely random selection.
Set confidence and precision
Confidence is the sampling risk you accept. The margin is the gap you tolerate between sample and population. Tightening either one raises the number of items to examine quickly.
Select at random, genuinely
A statistical sample chosen for convenience, alphabetically, or from what the auditee puts forward is no longer a statistical sample. The draw is made on the full list, before the visit.
Read what the result allows
This is the step almost always missing. A sample with no findings does not demonstrate the conformity of the population: it gives an upper bound on the nonconformity rate, and that bound can be computed.
Sources and verification
Values and definitions verified on 2026-09-02.
Indicative result. It helps you position yourself; it replaces neither a specialist's analysis nor the reporting obligations that apply to your activity.
Sizing a sample assumes you know what you are looking for in it. The two resources below carry the requirements and the audit conduct tools.
If the audit itself takes more time than you have, our audit expertise describes the assignments we run and how they unfold. See this expertise
The ISO 9001 self-assessment checklist covers the requirements of clauses 4 to 10, including internal audit in clause 9.2.
View the checklistThe ISO 9001 auditor pack contains the audit checklists, the consolidation workbook and the report and finding templates.
View the auditor packOnline version
The ISO 9001 workbook you have here also exists as an online audit, with 57 control points, a rate that updates as you go and a history of your passes. It is not the same document, it is the same standard tooled differently.
NormePulse is published by HEM Consulting. The trial commits you to nothing and asks for no payment method.