ISO 13485 - Medical devices, quality management systems

How to certify ISO 13485 Quality Management System for Medical Devices

Where can I find the official name of the standard ISO 13485 and the valid version of the standard?

  • You can always find the current edition of the standard, amendments or corrections to the standard on the website of the Lithuanian Department of Standardization.
  • ISO 13485 Medical devices, quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Overview of ISO 13485 standard

ISO 13485 is an international standard for quality management systems for manufacturers and suppliers of medical devices. It defines requirements that help organizations design, manufacture, install and maintain medical devices to ensure their safety and effectiveness. The standard emphasizes risk management, satisfaction of customer needs and adherence to strict international requirements. ISO 13485 is an essential tool for organizations seeking to demonstrate their commitment to providing high-quality medical devices and services, as well as ensuring continuous improvement and customer satisfaction.

Presentation of Sertika services

Certification procedures are carried out according to the basic model:

Certification audit steps

Benefits of certification for the company

ISO 13485 certification provides for company many advantages:
  • Systematic planning, execution, control, improvement of the organization's operational processes is ensured;
  • The quality of products, processes and services is managed and continuously improved;
  • Effective use of resources;
  • Continuous assessment of risks and their management is carried out;
  • In Europe, ISO 13485:2016 is harmonized with the European Medical Regulation. In this way, the ISO 13485 certificate becomes particularly important for obtaining the right to label medical products with the CE mark.

Benefits of certification for the client

Our certification services guarantee that the companies you cooperate with comply with the requirements of the ISO 13485 standard. It means:

  • Confidence in the manufacturer or service provider is increased;
  • Compliance with legal requirements is ensured;
  • Sustainable products and quality services;
  • Lower risk of losses.

Is it possible to integrate ISO 13485 with other standards?

The ISO 13485 standard can be integrated into one efficiently managed system together with the following standards:
  1. ISO 9001 is a generic standard for quality management systems that is the basis for ISO 13485. Although ISO 13485 is tailored to the medical device sector, it still shares key principles with ISO 9001, allowing them to be effectively integrated.
  2. ISO 14971 - risk management standard for medical devices. It is very important in the medical device industry and complements ISO 13485 by helping to identify, assess and control the risks associated with the use of medical devices.
  3. ISO/IEC 27001 - information security management system standard. Integration with ISO 13485 benefits medical device manufacturers and suppliers, especially those who use or provide digital services and data processing, it is important to ensure that their information security management practices are aligned with quality management requirements.
  4. ISO 14001 - environmental management system standard. Although not directly related to the quality management of medical devices, it can be integrated with ISO 13485 to ensure that an organization's activities comply with both environmental and quality management principles.
  5. ISO 45001 - occupational safety and health management system standard. Integration with ISO 13485 is important to ensure that the production and supply of medical devices is carried out not only in accordance with the principles of quality, but also with the principles of worker safety.
You can find more about the integrated quality management system in the section: "Integrated quality management system".

Frequently Asked Questions (FAQ)

Here we provide answers to frequently asked questions about our ISO 13485 certification process, its duration, costs and other important information.

Where to start the certification process?

In order for us to submit an offer, please fill out the application and send it by e-mail:;

Link to download the application

Do you have additional questions about management system certification?

Your question is waiting Head of the Management Systems Certification Department