Monitoring, measurement, analysis & evaluation — general
Carried over from ISO 9001:2015
Checked — unchanged.
Checked against the published text on 27 September 2026.
Plain-language summary
Decide what to measure, how, when, and when to analyse it — then actually evaluate QMS performance and effectiveness from the data, keeping the evidence.
What the clause is really asking
Determine: what needs monitoring/measuring, the methods (valid results required), when to measure, when to analyse and evaluate. Then evaluate the performance and effectiveness of the QMS and retain records. The clause turns gut-feel management into data-driven management.
What auditors look for
Auditors map your KPI architecture against your processes (4.4): does every process have a measure, does data actually get analysed (not just collected), and do evaluations lead anywhere? Dusty dashboards that nobody acts on fail the intent.
Typical evidence
KPI definitions and data; analysis reports; evaluation records feeding management review.
How to comply — recommendations
One measurement plan: KPI, process, method, frequency, owner, where reviewed. Collect less, act more — five live KPIs beat thirty dead ones.
Common nonconformities
Data collected but never analysed; no defined methods (numbers nobody can reproduce); processes with no measure of effectiveness.
Related clauses
IATF 16949: extended by 9.1.1.1-9.1.1.3; ISO 14001/45001 9.1
In the book
Chapter 9 — Evaluation — Reading Your Own Instruments treats this clause family in full: what it is really asking, what auditors look for, the evidence that satisfies, how to make it work on a real floor, and where companies stumble.
Resources for this clause
- ArticleControl charts explained: telling signal from noise
- ArticleThe benefits of control charts: stop reacting, start predicting
- Toolkit · $29SPC Control Chart ToolkitPick the right tab, fill the yellow cells, and watch control limits and charts calculate live — no SPC maths, no macros, no setup.
- Free downloadCpk CalculatorPaste your measurements, get Cp, Cpk and predicted yield instantly — prove the process is capable.
- Free masterclass · ~18 minControl Charts MasterclassStatistical process control in plain English — common vs special cause, choosing and building the right chart (X̄-R, X̄-S, I-MR, p/np/c/u), reading the signals, and proving capability with Cp/Cpk.
- Course modulePractitioner course — Monitoring, Internal Audit & Management ReviewClauses 9.1–9.3
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