Re: Will ISO 13485 be updated? If so, when?
Hello
A technical corrigendum for ISO 13485 was published last year, alignment the standard with the 2000 version of ISO 9001.
The next revision of the standards will begin next year and will alingn it with the next version of ISO 9001 (2014 or 2015).
ISO TC 210 WG 1 (which is the working group responsible for ISO 13485) is acompanying the work of the WGs of TC 176 which will develop the new version of ISO 9001).
At the time what is being done in TC 176 is a research on possible topics to be included or better required in ISO 9001 (for example, one of the areas being studied for inclusion is risk management).
This will reflect on the new version of ISO 13485.