13485 – Medical Devices Quality Management System
Within the context of EU harmonization process, all producers of medical devices seek to establish and have certified a quality management system to satify existing legal requirements and customer demands, improve efficiency and establish legal assurance. Quality system certification as per TS EN ISO 13485 standard is a necessary step for medical device producers to be able to use CE marking on their products.
TS EN ISO 13485 standard sets out quality system requirements for organizations operating in the medical sector.
This standard is based on the process model of ISO 9001 standard. However, in introduces additional requirement such as conformance to GMP (Good Manufacturing Practices) rules, risk management (TS EN ISO 14971), validation and if applicable strelization process validation, stability studies, applications in relation to clinical and biological assessments. TS EN ISO 13485 is compatible with other management systems such as ISO 14001 and OHSAS 18001.
TS EN ISO 13485 facilitates;