ISO 13485:2016

ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world. ISO 13845 is beneficial for many organisations, and can be used by suppliers and external parties that are involved with providing medical device products.

Requirements of ISO 13485 are applicable to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services as supplied by the organisation. The requirements may vary based upon the class of medical device – from a wheelchair to a pacemaker. The processes required by ISO 13485 that are applicable to the organisation, but are not performed by the organisation, are the responsibility of the organisation and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organisation to ensure that claims of conformity to ISO 13485: reflect any exclusion of design and development controls.