ISO 13485:2015 Pre-Release News and Discussion

Re: ISO 13485:2016 Pre-Release News and Discussion

As mentioned before, ISO TC 210 WG 1 will have an extraordinary meeting to finish the review of the comments of the first DIS. It will be in New Orleans, USA, December 03-05. After that, there will be some polishing on the draft and it will be circulated as a second DIS.

Re: ISO 13485:2016 Pre-Release News and Discussion

Is New Orleans just as a result of earlier over-workload, or did something(s) come up that has necessitated another face-to-face?

Re: ISO 13485:2016 Pre-Release News and Discussion

Workload. We could not finish reviewing all the comments.

Re: ISO 13485:2016 Pre-Release News and Discussion

Just a heads-up. I changed the title of the thread to reflect that the revision may not be publised in 2015, but after discussing with some people, it seems that there?s still a small possibility that it?s published in the very end of 2015 - but everything would need to be done in time, including revisions, translations, etc - so I still think 2016 is a best bet

Re: ISO 13485:2016 Pre-Release News and Discussion

John FitzGerald mentions a Transition Period of three years. Can you confirm this? Thanks

Re: ISO 13485:2016 Pre-Release News and Discussion

WG 1 is meeting right now, and in fact we just discussed the transition. We will do as the last time, when a transition was commented in a separate document And yes, we just decided to keep the 3 years as was done in the past.

Please note this means nothing in principle, as if we are dealing with certification, the certification process has to define the transition (and may follow WG 1 recommendation or not).

Re: ISO 13485:2016 Pre-Release News and Discussion

Live update from WG 1 New Orleans meeting: the meeting is going quite well. Some members of the group made a previous work of analyzing and suggesting resolutions to all the comments that were left from Stockholm - we ended up with a 298-page document .

However, things are going smoothly, and we already reviewed 1/3 of the comments (and we have two more days, so it?s really under control).

We have less people at the meeting too (less than 30 here, almost 70 in Stockholm) which leads to a smoother meeting too.

Re: ISO 13485:2016 Pre-Release News and Discussion

Thank-you

Re: ISO 13485:2016 Pre-Release News and Discussion

ISO TC 210 WG 1 just finished the meeting being held in New Orleans to address the comments of the DIS.

We have managed to go thru all the remaining comments to the DIS.

Now, it?s time to the finishing touches. DIS 2 will be formally prepared and circulated to National Committes near the first week of March 2015. There will be a 2-month ballot and the group will have a meeting in June 2015 to review the comments.

There?s a new rule on ISO and IEC that makes FDIS optional, and that it will only be required based, for example, in the resulting of voting and comments. Personally, I think we will need a FDIS in this case. If so, there will be another two month ballot which will probably mean that the standard will be published in first few months of 2016.

Re: ISO 13485:2016 Pre-Release News and Discussion

So it seems that the process was sped up a bit - the DIS2 ballot was initiated yesterday and will be open until April 05.