ISO 13485:2016 Update and Transition Requirements

Tuesday, August 9, 2016

ISO 13485: 2016 - Medical devices — Quality management systems —Requirements for regulatory purposes - was published in March 2016. IAF Resolution 2015/13 allocates a 3 year transition period. Thus from 31 March 2019 all certifications to ISO 13485:2003 will cease to be valid. IAF has also stated that 2 years from publication all new certifications and recertifications issued must be to ISO 13485: 2016.