DIS Approved and Progresses to FDIS. ISO 9001:2015 Development Process Remains on Time

The buzz about voting on the ISO 9001:2015 has been all over the internet recently. There has been an unbelievable amount of dissent in the discussions from the American camp. Does anybody out there except my colleagues and I think this is a great evolution of the standard? Everybody seems to be moaning about it. They don’t like “risk” – it’s not defined enough. Requirements are thin. There is no management rep. They don’t like the change in terminology. They don’t like “strategic” stuff. Often they don’t explain, they just whine! Very little of the discussion is positive or even hopeful. You don’t have to look far.

So with the doom and gloom group leading the way, we went into the vote. The vote from the US TAG group was to vote to disapprove of the DIS standard. They didn’t like “risk”, they didn’t like……you get the idea. The detail is not officially available yet but again, you don’t have to look far. The US TAG voted among them to disapprove. They wanted to stop this DIS and cause a rewrite which would probably create a 6-9 month delay in the process – delaying ISO 9001:2015 well into 2016. Why?

The vote among the US group was about 100+ votes against, and 0 for, and about 40-50 non-abstaining missed votes. They REALLY wanted to kill this standard. Does this make sense to anybody else? How does an unbiased vote get 100% of the vote? This group includes the “experts” and professionals and other interested parties. Who influenced them to all vote one way? Perhaps we should just assume for the moment that they were all-in with the negative comments.

Then we hear tentative information about the international vote. The DIS passed the international vote with a 90% vote in favor. It was “pointed out” that those that disapproved are mostly involved in the working groups (who work on the wording etc.). I read this to mean that generally, the world thinks it’s a pretty good standard. I can’t wait to hear why the US “experts” think the rest of the world is wrong.

And so the development of basically a good new standard moves forward, on time. In this camp, we are looking forward to the FDIS in early/mid-2015.

Upgrading to ISO 13485 from ISO 9001