ISO 13485 SOP Template | GDP-Compliant Medical Device Procedure (Editable Word)

ISO 13485 SOP Template

GDP-Compliant Procedure for Medical Device Documentation (Editable Word Format)

A complete, professionally structured SOP template designed for medical device manufacturers, quality consultants, and life science startups. This document provides all essential sections required for a compliant and audit-ready quality management system under ISO 13485.

What’s Inside:

• ✅ SOP Master Template (Microsoft Word)
• ✅ 17+ Sections with Subsections
• ✅ Risk Management Integration
• ✅ Training Matrix (Pre-filled example)
• ✅ Document Control & Change History Table
• ✅ Compliant with ALCOA+, GDP, and ISO 14971

Ideal For:

• Quality & Process Engineers
• Regulatory or QA Consultants
• Freelancers building QMS documentation for clients
• Internal teams preparing for ISO 13485 or FDA audits.