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.