Analysis & evaluation
Carried over from ISO 9001:2015
Checked — the evaluation list grows from seven items to eight: the effectiveness of actions on risks and on opportunities are now separate evaluations, matching the split in 6.1.
Checked against the published text on 27 September 2026.
Plain-language summary
Turn your data into decisions: analyse and evaluate to judge conformity, satisfaction, QMS performance, planning effectiveness, actions on risks and — separately — on opportunities, supplier performance and improvement needs.
What the clause is really asking
Analyse appropriate data from monitoring/measurement to evaluate: product/service conformity, customer satisfaction, QMS performance and effectiveness, whether planning was implemented effectively, effectiveness of actions on risks and, as its own item in 2026, of actions on opportunities, external provider performance, and the need for improvements. Statistical methods among the tools.
What auditors look for
Auditors look for genuine analysis — trends, comparisons, correlations — rather than raw data tables, and for each of the listed evaluation outputs appearing somewhere (typically management review).
Typical evidence
Trend analyses; quality reports; supplier performance evaluations; analysis inputs to management review.
How to comply — recommendations
Build the analysis around the listed questions — one page per question per quarter answers the clause and gives management review real content instead of data dumps.
Common nonconformities
Raw data presented as 'analysis'; no trending across periods; risk or opportunity action effectiveness never evaluated, or the two reported as one blended line.
Related clauses
IATF 16949: extended by 9.1.3.1 prioritization
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
- ArticleThe benefits of control charts: stop reacting, start predicting
- ArticleWhich control chart should I use?
- 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 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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