Announcement For ISO 13485:2016 Transition

As you might know the ISO 13485:2003 standard has been revised and ISO 13485:2016 has been published. 31.03.2019 is defined as the deadline for transition to ISO 13485:2016 by ISO. The transition to ISO 13485:2016 will be evaluated in an additional time which will be added to surveillance audits. This additional time will be invoiced separately. The additional duration is for transition evaluation is estimated as 0.5 man/days. For our clients who request seperate transition audit will be performed according to available resources and will be evaluated individually.

Until the end of transition we will define the deadline of our certificates as 31.03.2019. In case of a successful transition the certificates given according to ISO 13485:2003 will be revised and updated according to ISO 13485:2016 and the validity period will be extended to 3 years. After the 31.03.2018 certification will not be done acording to ISO 13485:2003 version of standart.

Szutest continues to implement ISO 13485:2016 changes. Once we get the approval of our Accreditation Agencies we will be contacting you for choosing proper timelines.

It is very important that you initiate necessary actions for transition, prepare transition plans and prepare documentation updates and implementations to submit in the agreed surveillance audit.