What is the ISO 13485 standard?
ISO 13485 is an internationally recognised standard for quality management systems in the field of medical devices. The equally common abbreviation DIN EN ISO 13485 emphasises the scope of application in Germany and the European Union. The standard defines requirements for manufacturers, suppliers and service providers to ensure that medical devices are manufactured safely, effectively and in compliance with legal requirements. Unlike the ISO 9001 ISO 13485 focusses explicitly on the regulatory requirements of medical technology.
Requirements of ISO 13485
ISO 13485 requires companies to have a detailed quality management system with clearly defined responsibilities, comprehensive process documentation and systematic risk management. The aim is to ensure the highest product quality and patient safety. Requirements that go beyond the ISO 9001 These include the traceability of all processes and materials and the validation of manufacturing and testing processes.
Scope of ISO 13485
Even though ISO 13485 certification is not mandatory for the market authorisation of medical devices, it is expected by notified bodies and is also an established standard for companies along the supply chain. The ISO 13485 standards are considered a fundamental prerequisite for fulfilling regulatory requirements such as the European MDR (Medical Device Regulation) to fulfil.