The ISO 13485 is the standard for quality management in the medical device industry. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the ISO 13485 so far. Additionally, we publish all our document templates for the ISO 13485 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)

The best news is that we’ve published all our ISO 13485 templates for free! Check them out below.

Also note that we have many more templates besides the ones for ISO 13485 - head over to our templates page for more templates.

And finally, do you want to draft your own QMS with just one click? With Formwork, our eQMS software, combined with our free templates and a little bit of ChatGPT magic, you can draft your QMS in minutes. Check out the video below to see how it works.

All ISO 13485 Templates

Template: Internal Audit Report

Template: PRRC Appointment Letter

Template: Internal Audit Program

Template: Internal Audit Plan

Template: List of Regulatory Requirements

Template: SOP Sales

Template: List of Medical Device Consultants

Template: ISO 13485: Mapping of Requirements to Documents

Template: Training Record

Template: Software Validation Form

Template: SOP Software Validation

Template: List of Qualified Suppliers

Template: Supplier Checklist

Template: SOP Purchasing

Template: List of Training Documentation

Template: SOP Human Resources Administration

Template: SOP Clinical Evaluation

Template: Management Review Report

Template: SOP Management Review

Template: SOP Internal Audit

Template: SOP Product Certification and Registration

Template: SOP Update of Regulations

Template: Incident Assessment Form

Template: Field Safety Notice

Template: SOP Vigilance

Template: SOP Feedback Management and Customer Complaints

Template: Document List QMS

Template: Post-Market Clinical Follow-Up Report (PMCFR)

Template: Post-Market Clinical Follow-Up Plan (PMCFP)

Template: Periodic Safety Update Report

Template: Post-Market Surveillance Plan

Template: SOP Post-Market Surveillance

Template: Quality Manual, Policy, Objectives

Template: SOP Document and Record Control

Template: SOP Corrective and Preventive Action (CAPA)

Template: CAPA List

Template: Software List

Questions Other Companies Ask Us About ISO 13485

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Software Validation Procedure for ISO 13485 compliance?

All ISO 13485 Articles

MDR Post-Market Surveillance: The Ultimate Guide

ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes

CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?