BS EN ISO 13485-2016,Medical Devices—Quality Management Systems—Requirements For Regulatory Purposes (British Standard)
BS EN ISO13485-2016 PDF can be downloaded free of charge on this website.BS EN ISO13485-2016 replaces BS EN ISO 13485-2012.
This International Standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the”process approach.“
Download BS EN ISO 13485-2016 pdf