ISO 9001 - Clause 7.5 Documented Information

ISO 9001:2015 Clause 7.5, titled "Documented Information," requires organizations to establish, maintain, and control documented information necessary for the effective planning, operation, and control of its processes. This includes procedures, instructions, records, and other documented information required by the quality management system (QMS). The clause emphasizes the importance of ensuring the availability, accessibility, and proper management of documented information to support the organization's ability to consistently deliver products and services that meet customer requirements and regulatory standards. Compliance with this clause helps organizations maintain consistency, traceability, and accountability in their operations, facilitating continual improvement and compliance with ISO 9001 requirements.