ISO 13485:2016 Transition Guidance

We would like to inform you about the ISO 13485: 2016 standard.

 

Each standard is revised and revised periodically for adaptation and improvement purposes. In this context, the new version of ISO 13485 was published on March 1, 2016 and a 3-year period for the transition from EN ISO 13485: 2012 was envisaged by the International Accreditation Form (IAF). The deadline for applications to be certified for the first time according to EN ISO 13485: 2012 is 01 March 2018, no application will be taken for 2012.