New Risk Requirements in 11607 series

[Philip B]

I've just obtained a copy of the A1:2023 revision to 11607 parts 1 & 2. Annex F of part 1 (and annex B of part 2) are new normative sections on risk management. There doesn't appear to be anything in this that shouldn't already be covered by a good 14971 risk plan. Has anyone else had a look at this and found anything 'new' we should be considering?

 

[contigo123]

We had a similar take away after reading it... so far haven't identified anything extra we need to do as we already follow ISO 14971