ISO 13485 Templates

Implementing ISO 13485:2016 requires comprehensive documented processes to manage your medical device Quality Management System (QMS). Our professionally developed ISO 13485 templates provide editable procedures, forms, policies and records designed to help medical device manufacturers establish, implement and maintain an effective QMS.

Browse individual templates covering document control, risk management, supplier management, CAPA, internal audits, design and development, validation, training, complaints, post-market activities and more, or choose the complete ISO 13485 QMS Template Bundle for a comprehensive documentation package.

All templates are supplied in editable digital formats, allowing you to adapt them to your organisation, devices, processes and regulatory requirements.

Why Choose Our ISO 13485 Templates? 

  • Comprehensive Coverage – Complete set of templates covering all ISO 13485:2016 documentation requirements. 
  • Regulatory Compliant – Aligned with FDA, EU MDR, and QSR, and global regulatory standards. 
  • Customisable & Ready-to-Use – Simply add your company information and implement immediately. 
  • Expert-Developed – Created by regulatory professionals with decades of medical device experience. 
  • Regular Updates – Templates updated to reflect the latest regulatory changes and interpretations. 

These templates provide structured guidance through complex ISO 13485 requirements including document control, production planning, design controls, and complaint handling processes – ensuring your quality management system is both compliant and efficient.