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Implementing ISO 13485 QMS

Αύγουστος 27, 2021 - By Σοφία Καργιώτη - Insights

Implementing ISO 13485 QMS

What is a QMS according to ISO 13485?

ISO 13485 is the most widely used type of QMS within the medical device industry. ISO 13485 is an effective solution for medical device manufacturers to meet the requirements for a Quality Management System in the industry. It is the foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations.

Steps to implement ISO 13485

There are 10 steps you need to follow in order to achieve ISO 13485 as follows:

  1. Obtain the Documents and study the requirements. You have determined that ISO 13485 is the most suitable standard for your business, now you have to learn about its requirements by obtaining a copy of it, as well as any supporting documents.

  2. Conduct a Gap Analysis. Performing gap analysis is one of the most critical steps for implementing ISO 13485 since it will reveal any gaps between your current system and the system needed for your company to reach compliance.

  3. Develop an implementation plan. For the next step, you have to start planning the way you’re going to address the gaps you discovered by conducting the gap analysis.

  4. Design the Documentation. You will need documentation to control your processes. It will help you prove your compliance and guide your processes.

  5. Provide training. Another critical step is that of providing employee training. Your employees need to know in advance that your organization is going to implement ISO 13485 so they can be prepared.

  6. Carry out your plan. Now it is time to start implementing your plan. Keep in mind that the implementation of the standard will look different from other companies since it depends on your company’s processes and the implementation plan.

  7. Perform internal audits and reviews. Before continuing to the third-party audits you must conduct internal audits.

  8. Select a certification body. When you think your Quality Management System is ready it’s time to start searching for a third-party certification body.

  9. Complete the third-party audit and certification process. You found the auditor you want to work with, now you are ready to undergo third-party audits. Once you pass them, you will become certified to ISO 13485.

  10. Maintain your certification. The certification cycle lasts 3 years, to maintain your certification you must complete an annual surveillance audit.


iso 13485