It is an international standard that has been created on the basis of the ISO 9001 Quality Management Standard and includes special requirements for medical device manufacturers.
It covers more comprehensive and special quality system requirements than ISO 9001, which should be followed by organizations that want to provide medical devices and related services and to prove their ability to meet customer and legislation requirements that are applicable to medical devices in a consistent manner.
Its main purpose is a standard that defines the specific requirements of quality systems for manufacturers operating in the field of the trade and manufacture of medical devices.
ISO 13485 provides access to the CE mark on medical devices, ensures compliance with the regulations of the Ministry of Health, ensures compliance with the European Union legislation, increases the sense of trust in customers, ensures national and international acceptance.
ISO 13485 Medical Devices Quality Management System Standard; It was created to structure manufacturers, distributors, importers and exporters, and organizations that provide these services.