QMS and its processes
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
Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of ISO 9001 / IATF 16949 for the authoritative text.