“ISO 14971 is Changing’’
As many of you may know already, ISO 14971 is changing yet again!
Changes to ISO 14971
The new standard will be known as ISO 14971: 2019. The most significant changes will be that most of the guidance currently contained in the standard will be transferred to a separate guidance document, ISO TR 24971. The purpose of this change is to align the format of ISO 14971 with that of other standards. There will be other changes also but these will be minor changes in nature.
The revised standard standard will now be slightly closer to the current EN version (EN 14971: 2012) but most of the major differences will remain the same.
Tentative Publication Dates for Revised ISO 14971:
Our tutor John Lafferty has enquired about the proposed dates of the above revisions and we were in contact with Eamonn Hoxey of EV Hoxey Ltd. Eamonn has written excellent articles on the revision of ISO 14971. He advised us of the following tentative timetable for the voting on and publication of the revised ISO 14971 as follows:
Final Vote: Opens in early May and closes in late June 2019.
Publication: Possibly as early as July 2019
This article has been submitted by our training partner Northridge Quality & Validation
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