ISO 9001

ISO 9001:2015 is the international standard for quality management systems and the most widely certified management-system standard in the world. It is built on seven quality principles — customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management — and runs on the process approach and the PDCA cycle as its operating philosophy.

Risk-based thinking is what the 2015 revision adds: it asks the organisation to identify the risks and opportunities that affect the quality of its product or service, rather than treating quality as a corrective-action problem alone. The clauses that drive day-to-day quality work are clause 8 (operational planning, design, and control of nonconforming output) and clause 10 (corrective action and continual improvement, where CAPA lives). A site running ISO 9001 beside ISO 14001 and 45001 shares the document control, the internal audit, and the management review across all three, which is the integration thesis a QEHS platform is built for. See ISO 45001, ISO 14001, and CAPA.