Implementation of a Quality Management System according to ISO 13485 standard
Implementing a quality management system in a company is always a challenge, often requiring a significant amount of resources. However, this implementation can offer several advantages over your competitors. For instance, when participating in tenders, companies and government institutions that issue tenders often consider the presence of a quality management system certification. Additionally, a certification for a quality management system according to ISO 13485 indicates the company’s commitment to being closer to its clients, providing the highest quality services, and supplying products of the highest quality.
ISO 13485 “Medical Devices. Requirements for Regulatory Purposes” was introduced in 1996 by the International Organization for Standardization (ISO) as a voluntary standard aimed at improving quality systems in companies involved in the design, development, manufacturing, or handling of medical devices. The latest version of the standard was published in 2016, and in Ukraine, the latest version was adopted in 2018.
To implement a quality management system in a company, the following steps should be taken:
- Familiarize yourself with the requirements of the ISO 13485 standard
- Develop documented procedures and forms, a Quality Manual, Quality Objectives, and Policy
- Develop a technical file
- Conduct an internal audit
- Address identified non-conformities and implement corrective and preventive actions
- Submit an application to the certifying body and undergo
News
Med Quality at OTWorld 2026: What Foreign Manufacturers Asked Us About Entering Ukraine
The Director of Med Quality conducted a training on the requirements of ISO 13485:2016 on April 2, 2025.
