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ISO 13485 Checklist

Identify gaps in your current quality management system by performing regular audits using digital internal control checklists.

Go paperless, conduct inspections easily and solve issues quicker with your teammates.

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ISO 13485 Audit Checklist

Use this checklist to find out if the company’s QMS is aligned with the ISO 13485:2016 standard.

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ISO 13485:2016 Standard Checklist

Use this checklist to find gaps in the company’s current methods.

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What is ISO 13485?


ISO 13485:2016 is an international standard for QMS in companies. It especially addresses industries such as distribution, manufacturing, service etc. Establish a flawless reputation by getting a ISO 13485:2016 standard certification.


How does an ISO 13485 audit checklist work?


An ISO 13485 checklist determines whether your companys' QM System is compliant with the standard. It is utilized by quality management teams or external inspectors.



This article describes briefly:


1. How to prepare for an ISO 13485:2016 certification audit


2. Digital technology enabling certification to ISO 13485:2016



How to prepare for an ISO 13485:2016 certification audit


  • Try to identify the specific areas which the standard addresses by researching it.

  • Analyse the current status of you Quality Management System and identify risks and possibilities to improve. In order to do so you should utilize our GAP analysis or readiness audit.

  • Perform quality audits and review whether they are compliant with ISO 13485.

  • Establish a team to ensure the upkeep of compliance with the standard by performing regular checks.


Lumiform: Your Digital Software& App for the ISO 13485 Audit Checklist


Lumiform makes it easier for you to comply with the ever-increasing legal requirements for process documentation by using the mobile app to document via smartphone or tablet and being guided by the system through all documentation processes. Clean, transparent documentation helps you avoid high fines. The easiest way to do this is with a digital solution like Lumiform.


Digitize checklists and internal procedures with Lumiform:


  • The flexible checklist builder from Lumiform helps you to convert any individual paper list into a digital checklist without much effort.

  • In addition, we offer more than 9,000 ready-made templates to help companies get started digitally in no time.

  • Using the super intuitive mobile App, you and your teammates conduct check in the field with ease and in no time.

  • All results, images and comments are automatically bundled in a digital report.

  • Comprehensive analyses help you to identify inefficient areas in your company more quickly and thus to continuously improve your auditing and inspection processes.


Your contact for all questions concerning ISO 13485 Checklist

You have questions or would like to schedule a personal demo? We are happy to help you!