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Free ISO 13485 Medical Devices Quality Management Systems templates and checklists, ready to download and adapt.
ISO 13485 is the international standard for quality management systems specific to medical devices. It sets out requirements for organisations that design, produce, install or service medical devices and related products, with a strong focus on regulatory compliance, risk management and product safety throughout the device life cycle.
A compliant medical device quality management system demands rigorous documentation, traceability and control. Proven templates help you meet these expectations without starting from scratch.
These free ISO 13485 templates and checklists give your team a dependable starting point. Use the gap analysis to benchmark your system, apply the internal audit checklist to verify compliance, and adapt the quality manual, policy templates and registers to your operations. Together they help you implement and audit a quality management system fit for the medical device sector.
Stop starting from scratch on your quality policy. This ready to customise template is structured to ISO 13485:2016 and covers the statement, commitments, communication, approval and version control.
Conduct a thorough internal audit of your medical devices QMS against ISO 13485:2016. Every requirement is a clear audit question — including design controls, sterile product requirements, complaint handling, and CAPA — so nothing gets missed and your records stand up to external scrutiny.
Before pursuing ISO 13485 medical devices certification, use this to assess where your quality management system currently stands. It covers every requirement — including design controls, sterile product requirements, complaint handling, and regulatory reporting — so you can identify gaps and build a realistic implementation plan.
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