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Friday, October 21, 2011
The Maturing of ISO 15189
I am just back from our ISO technical committee 212 meeting and another session working on the next iteration of ISO 15189 in Las Vegas. It would be easy to go to comparing standards development and rolling of dice, but I won’t bother.
This was perhaps one of the most significant ISO meetings that I have ever attended (and I have attended them all!). It was much like being a proud parent. I was there at the beginning with all the excitement and enthusiasm associated. As the committee started to grow and we saw all the lurches and pitfalls and wondered if this thing is going to ever survive. And now we are starting to see the signs of beginning of growing up with some maturity. And similar to the child analogy, this process has taken has taken near 17 years.
I5189 has had its struggles. We have been working on this new iteration for three years. By now it should be a near finished document with a lot of support and consensus. But instead we had over 1000 comments and concerns raised very late in the game. This could be well interpreted as someone has not been listening.
One always has a choice, bulldoze ahead, or pause and review. And this time, for the first time, the approach was the latter. Considering that this is a document about Quality and Competence, it is refreshing that the technical committee actually did an examination and Root Cause and identified the causes and proposed a solution.
The findings were disappointing. People not knowing or following ISO rules, focusing on votes rather than consensus, irregular participation of experts, and prematurely pushing on, when consolidation would have made more sense. All the things that you would not want to see in the creation of a standard of significant international import. So we turned over a new leaf and that is good.
One example, the best example. Measurement Uncertainty. It is a tragic story described by one as READY-SHOOT-AIM. I saw it as an exercise in counter Quality. Deming taught the world about PDSA. Well we did something different. We inserted MU into the document in 2003 when no one (and I mean NO ONE!) had a clue what it was about. Then when we studied the impact and opinions of users, it was clear that folks were unsettled and divided and confused about MU. We ignored the evidence and forged onward. Kind of a NO_PLAN - DO – STUDY – NO_ACTION (NP D S NA) sort of cycle. Not something that a group of Qualitologists should be doing.
So this time we actually started to fix the MU problem. Stricter definition, more guidance, and clearer message.
It is OK to make some errors along the way even in the production of documents, but when you leave them and ignore them and don’t learn from through the exercise, then at some point it is reasonable for folks to wonder if you are really up to the task of developing quality standards.
Well finally we have done the right and positive thing, we have actually acknowledged that moving forward is not an issue of guilt or embarrassment. It is a step along continual improvement.
With luck we will see this next iteration perhaps as ISO15189:2012. It will be the third iteration and the first with significant change.
Good standards have a lot in common with good wines; they take time to mature and they get better with age. They distinguish themselves from the plonk-du-jour that collapse into vinegar… bad vinegar.
We will see what happens. This can still go off the rails. A nutso relative can still cause problems, can take these first forward and maturing steps and dash them all. I know it and I understand it and I (in quiet moments) worry about it.
In that case the document will probably disappear.
But in the meantime we can celebrate our taking a good idea for a great international standard and making it better.
I am such a proud parent.
Posted by Quality Doc at 10:40 AM