Internal Audit: Planning and Production Controls

This internal audit checklist helps manufacturers evaluate planning and production controls against ISO 9001 and ISO 13485. It covers production planning, works orders, materials availability, machine scheduling, communication to operators, and downstream steps such as finishing and quality. It guides review of WIP identification, drawings and revisions, first-off inspections, calibrated tools, validated processes, and issue logging. Sections address subcontract processes, packing and despatch, documentation such as certificates of conformity, and delivery accuracy. It also prompts checks on training, PPE, health and safety, and environment. A final section maps findings to relevant ISO 13485 and ISO 9001 clauses for compliance and continual improvement.