Digital ISO 13485 Audit Checklists & PDF Reports

Identify gaps in the current QMS and determine corrective actions
Achieve ISO 13485 certification using a mobile app

Jump to featured templates
Get everyone on the same paperless page.
Rated 4.6/5 stars on Capterra from 76 ratings
Available on iOS, Android and Web
Get started for FREE

Published December 8th, 2020

What is ISO 13485:2016?

ISO 13485:2016 is an international standard for the Quality Management System (QMS) of organizations involved in the manufacturing, distribution, servicing, and disposal of medical devices. Organizations with ISO 13485:2016 certification are recognized to produce medical devices that are at par with industry standards.

This article briefly discusses

What is an ISO 13485:2016 Audit Checklist?

An ISO 13485:2016 audit checklist is a tool used by quality managers to determine if the QMS of organizations align with the ISO 13485:2016 standard. This checklist is useful in evaluating readiness for a third-party ISO 13485:2016 certification audit.

5 Steps to Prepare for ISO 13485:2016 Certification

  1. Obtain a copy and gain an understanding of the ISO 13485:2016 standard.
  2. Identify areas for improvement in the current QMS by conducting a gap analysis or a readiness audit to ensure adherence to ISO 13485:2016 requirements.
  3. Perform quality monitoring audits and maintain a record of results.
  4. Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the audit results.
  5. Ensure competence needs are met and that all parties involved are kept in the loop.

ISO 13485:2016 Audit Tool

Paper-based audits can be burdensome and time-consuming. Time spent on documentation and manual filing of records can be better spent working on gaps found in the current QMS and working towards getting certified for ISO 13485. iAuditor, a cloud-based auditing app, can help organizations meet ISO requirements and maintain the quality of medical devices. Be ready for third-party ISO certification by doing the following:

  • Create a mobile-ready ISO 13485 checklist.
  • Empower teams to conduct efficient monitoring procedures and analysis using a smartphone or tablet.
  • Save time with a mobile app that generates comprehensive ISO 13485 reports as you finish an audit.
  • Save the ISO 13485 template online and automatically share reports with members of the organization. Preview a sample ISO 13485 PDF report here.
  • Use for free with small teams. Unlimited reports and storage for premium accounts.

Here is a collection of our carefully prepared ISO 13485 audit checklists you can browse and use as part of achieving ISO 13485 certification and ongoing compliance.


Erick Brent Francisco

SafetyCulture staff writer

As a staff writer for SafetyCulture, Erick is interested in learning and sharing how technology can improve work processes and workplace safety. Prior to SafetyCulture, Erick worked in logistics, banking and financial services, and retail.