ISO 13485 Medical Devices Quality Management System

ISO 13485 Medical Devices Quality Management System is a parallel standard with ISO 9001 Quality Management System and is prepared based on the ISO 9001 Quality Management System Standard. It is a version of the ISO 9001 Quality Management System Standard which has been adapted to medical devices and developed in this field. It is an international standard including the special requirements for medical devices.

The ISO 13485 Medical Devices Quality Management System is one of the most important arguments which medical device manufacturers can apply during the process of CE Marking. It is a system which companies must establish if the production quality assurance module is selected within the scope of CE Marking. Although it includes the ISO 9001 Quality Management System as a basis, it has become a standard for medical device manufacturers, especially with additional requests at the design stage and special conditions for sterile medical devices.

This standard, which is based on the ISO 9001 Quality Management System process approach model, provides more comprehensive and special quality system requirements than ISO 9001, which institutions are required to comply with in order to provide medical devices and relevant services, and to provide their ability to meet customer and regulatory requirements which are consistently applicable to medical devices. 

Who Needs Medical Devices Quality Management System?

The ISO 13485 Medical Devices Quality Management System must be established and implemented by businesses manufacturing in the medical field and documented with the ISO 13485 Certificate. The enterprises engaged in the production of medical devices in Turkey in accordance with the European Union legislations of Turkey have to conduct CE product marking operations within the European medical device directives.

Benefits of Application of the Medical Devices Quality Management System

Provision of competitive advantage.

Adopting a process-oriented approach.

Increasing the institution’s reputation in the market.

Ensuring the global compliance of medical devices with quality rules.

Increasing the design, production and service quality of the medical devices.

Provision of advantage especially for exportation operations to European Union countries.