SOP Document and Record Control
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Use this SOP Document and Record Control template to establish standardized procedures for creating, reviewing, approving, labeling, and archiving quality management system documents and records throughout your medical device organization. This template is essential for ensuring regulatory compliance, document traceability, and secure retention, and should be filled out when implementing or updating document control processes, especially prior to audits or regulatory submissions. Proper use of this template helps you maintain up-to-date, accessible, and auditable documentation as required by ISO 13485, FDA 21 CFR Part 820, and EU MDR/IVDR.