ISO 9001 is the international standard establishing requirements for a quality management system (QMS) focused on customer satisfaction.
ISO 9001:2015 specifies QMS requirements when an organization needs to demonstrate its ability to provide products and services meeting customer and regulatory requirements. It is the most certified management system standard worldwide.
The 2015 version incorporated risk-based thinking as a cross-cutting principle without requiring a specific assessment methodology.
Requires managing activities as interrelated processes functioning as a coherent system.
The PDCA cycle (Plan-Do-Check-Act) is the continual improvement engine underpinning the entire standard.
ISO 9000 defines QMS fundamentals and vocabulary. ISO 9001 contains the certifiable requirements. Only ISO 9001 is audited for certification.
It applies to any organization regardless of type, size or product/service. Sectors like healthcare, education, technology and government implement it extensively.
The certification cycle is 3 years. Annual surveillance audits are conducted and a recertification audit at the end of the cycle.
Assessment within 72 business hours. ISO methodology. No ties to certification bodies.
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