ISO 13485 — Medical Devices

ISO 13485 is the international standard for quality management systems for organisations that design, manufacture or distribute medical devices.

Its current edition is from 2016. It is based on the structure of ISO 9001, but its objective is different: rather than continual improvement and customer satisfaction, it seeks to demonstrate that medical devices consistently meet regulatory and safety requirements. That is why it places the emphasis on risk management throughout the product life cycle (developed in the ISO 14971 standard), design control, process validation (for example, sterilisation), supplier control, traceability, complaint handling and documentation.

In the European Union, Regulation (EU) 2017/745 on medical devices requires manufacturers to have a quality management system. The European version of the standard, EN ISO 13485, is the usual reference for demonstrating this to the notified body that assesses conformity and allows CE marking. ISO 13485 certification is not, on its own, CE marking.

In hygiene, the standard affects specific products. Disinfectants intended specifically for disinfecting medical devices, such as instruments, are themselves medical devices and follow this framework. By contrast, general-purpose surface and environmental disinfectants are regulated as biocides, and skin antiseptics have their own authorisation regime. That is why the quality standard required of a manufacturer depends on the regulatory category of each product, not on the sector where it is used.

More information: ISO 9001 · Biocides (BPR) · Autoclave and sterilisation