ISO 13485 - Quality management for medical devices
Prove your commitment to the quality of medical devices.
What is the ISO 13485 standard?
ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organizations certified to ISO 13485 can not claim conformity to ISO 9001.
Connection with national requirements for approval of medical devices
ISO 13485 is a globally recognized standard that medical device organizations can adopt to demonstrate adherence to applicable regulatory requirements. By implementing ISO 13485, manufacturers establish a solid groundwork for navigating regulatory demands and obligations while showcasing their dedication to producing safe and effective medical devices. ISO 13485 serves as an excellent preliminary step for organizations considering compliance with the EU Medical Device Regulation (MDR) 2017/745.
DNV as an internationally recognized certification body, offers ISO 13485 certification with global recognition and we can partner with you on your MDR certification journey, which can be in combination with ISO 13485 certification if required.
Related standard
ISO 14971: This standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control. How can we help you? We are an accredited third party certification body. For certification, you need to implement an effective quality management system complying with the requirements of the standard.
