What is ISO 13485?
ISO 13485 is the medical device industry's quality management system (QMS) standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. ISO 13485 requires organisations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in.
ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance. Therefore, ISO 13485 includes particular requirements for organisations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate. This makes it more prescriptive in nature and requires a more thoroughly documented QMS.