After nearly four years of work, the International Organization for Standardization (ISO) has published an updated version of its standard for quality management systems used by medical device manufacturers.
ISO 13485, Medical devices – Quality Management Systems – Requirements for regulatory purposes, specifies requirements for quality management systems used in connection with the development, manufacture, distribution or servicing of medical devices. Evidence of a suitable quality management system is typically required by regulatory authorities as part of the medical device approval process, or as a condition of procurement of medical devices.
Work on the newly released revision of ISO 13485 began in April 2012 and represents the first revision of the standard since it was initially introduced in 2003. The revised standard significantly expands the application of risk management principles to all processes covered by a quality management system. Importantly, the revised standard does not adopt the “high-level” structure presented in Annex SL of the ISO Directive, which is being adopted in other ISO management systems standards.