QMS and its processes
Carried over from ISO 9001:2015
Checked — the process approach and its nine determinations are unchanged; the documented-information paragraph now names its two purposes (supporting operation; evidencing that processes run as planned).
Checked against the published text on 27 September 2026.
Plain-language summary
Run the business as a set of connected processes — each with an owner, inputs, outputs, performance measures and risks — supported by the documents and records they need.
What the clause is really asking
This is the process approach made compulsory: define your processes and how they interact, set criteria and KPIs that show each one works, give them resources and owners, address their risks, and improve them. Keep the documented information needed to operate them and the records that prove they ran as planned. The org chart says who reports to whom; the process map says how value actually flows.
What auditors look for
Auditors start from your process map and test whether it describes reality: pick a process, meet its owner, ask for inputs, outputs, KPIs and current performance. They look for interactions (does purchasing know what production needs?), for outsourced processes on the map, and for KPI data actually used to act.
Typical evidence
Process map; turtle diagrams or process definitions; KPI dashboards per process; process owner appointments; records demonstrating operation.
How to comply — recommendations
For a typical SME plant, 8-12 processes is plenty — more becomes wallpaper. One-page turtle per process: inputs, outputs, who, with what, how measured, risks. Review process KPIs monthly with owners present. Put outsourced processes (plating, heat treatment, calibration) on the map with their controls.
Common nonconformities
An elegant map that nobody on the floor recognises; processes with no measure of effectiveness; outsourced processes invisible in the system; owners unaware they are owners.
Related clauses
IATF 16949: extended by 4.4.1.1 & 4.4.1.2; ISO 14001 4.4; ISO 45001 4.4
In the book
Chapter 4 — Context — The Questions Before the System 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
- Toolkit · $99ISO 9001 Documentation ToolkitStop writing your QMS from a blank page: a fully-written quality manual, ten complete procedures and the working forms, logs and registers behind them — one numbering scheme, already cross-referenced, ready to adapt.
- Free downloadProcess Flow TemplateThe first document of the core-tools chain — every step the part actually takes, including the storage, transport and rework loops the control plan never shows.
- Course modulePractitioner course — Context, Interested Parties & ScopeClauses 4.1–4.4
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