ISO 9001 — Quality Management System

The findings that open most often in an ISO 9001 audit do not come from missing documentation but from a documented system that is not running on the floor: the approval step written in the procedure is skipped, the performance indicator has not been measured for a year, the corrective action addresses the symptom rather than the root cause. Our readiness work starts from the process map — clarifying each process input, output, owner and the indicator it is measured by — and then builds a monitoring routine that actually collects those indicators. For surveillance and recertification audits we plan the records the auditor will ask for backwards from the date, so what is presented on the day has been accumulated rather than produced.