ISO 9001 Quality Policy and Documented Information

Required sections

• Scope of the quality management system, with justification for any requirement not applicable (4.3)
• Quality policy (5.2)
• Quality objectives at relevant functions and levels, with plans to achieve them (6.2)
• Documented information the organization determines necessary for the effectiveness of the QMS, typically process descriptions or a quality manual (4.4.2, 7.5.1)
• Document control procedure: identification, format, review and approval, distribution, access, change control, retention and disposition, control of obsolete documents, external documents (7.5.2, 7.5.3)
• Context of the organization analysis including the climate change determination (4.1, 4.2 as amended 2024)
• Records the standard requires to be retained: calibration and traceability (7.1.5), competence evidence (7.2), review of requirements for products and services (8.2.3), design and development inputs, controls, outputs and changes (8.3), supplier evaluation (8.4.1), production and service identification and traceability where required (8.5.2), customer property (8.5.3), change control (8.5.6), release of products and services (8.6), nonconforming outputs (8.7.2), monitoring and measurement results (9.1.1), internal audit program and results (9.2.2), management review outputs (9.3.3), nonconformity and corrective action (10.2.2)
• Operational planning outputs and criteria for processes (8.1)
• Risk and opportunity actions and their evaluation (6.1; documentation not mandated but auditors expect a record)
• Master list or register of documented information with current revision status (not mandated; the common way to evidence 7.5.3)
• Communication plan for the quality policy and awareness (5.2.2, 7.3, 7.4)

What the examiner asks for