SOP Nonconformance
Loading markdown content...
Ready to generate your document?
Talk to usNo commitments required
Use this SOP template to systematically identify, document, evaluate, and manage nonconformances in hardware and software medical devices during manufacturing, testing, or inspection. Completing this document is essential whenever a product or process deviates from specified requirements, ensuring regulatory compliance, product safety, and traceability of corrective actions. This template helps you fulfill ISO 13485, FDA 21 CFR 820, and EU MDR requirements for controlling nonconforming products and processes.