The updated version of ISO 13485, the medical devices industry quality management system standard, was published in February 2016. The ISO 13485 Standard has defined the requirements that indicate whether the products of medical device organizations meet the required criteria. The standard ensures that the design, development, manufacture, installation and delivery of medical devices are always carried out with safety in mind. It also supports medical device manufacturers in establishing and maintaining a Quality Management System in all their business processes.
The new ISO 13485: 2016 is applicable to the entire supply chain and covers the entire product life cycle of medical devices.
There is a 3-year transition period between February 2016 and February 2019. During this period, the old and new versions of the standard will be in effect together. After February 2019, documents from ISO 13485: 2003 and the corresponding European Standard EN ISO 13485: 2012 will not be valid.
