What’s Really Cool About ISO 9001:2015

Benefits and enhancements in the new revision

OK, so “cool” probably isn't the precise term—unless you happen to be a standards uber-geek. But there are definitely some enhancements to the 2015 revision of ISO 9001 that are worth getting a little excited about.

The final draft international standard (FDIS) is finally out for ballot, so most of the changes that may transpire after the vote and before the ultimate publication should not be of any major consequence. It’s getting to be an increasingly safer bet to anticipate what will be in the published version.

That said, we can now take a look at what’s new, improved, and likely to result in benefits for organizations. After almost three years of angst, we all deserve some good news. And, there are some things that do warrant positive press.

Here’s a sampling.

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Comments

Cool, or Kool-Aid?

The article is a shameless, last minute attempt to convince voters of the standard to approve it. Whether it works within the US will be seen, but if it doesn't get approved, Ms. Robitaille will have to answer for her blind support.

The removal of preventive action is one of the WORST things to happen to ISO 9001, since that was the only clause in the current version that allowed companies to use a formal method to seek out improvement opportunities and fix problems before they happen. It was replaced by "risk based thinking" which provides NO such formal methods, and has no actual firm requirements. As a result, companies that adopt the 2015 standard without ever having seen its predecessors will never know they should do a root cause on potential nonconformities, or how to resolve them in a structured, universally-accepted manner.

The benefit for Ms. Robitaille and her TAG friends, of course, is that it's a boon for consultants. In fact, they even said so in during their TAG meetings, and wrote it into the minutes.

It's shameful that the only view of ISO 9001 comes from the TAG leadership, nearly all of whom are consultants. As a result, we've never been able to have an honest discussion about the pros and cons of the standard.

We should be rejecting this craven marketing posed as "consensus standards development." Or at least be allowing user-focused viewpoints to get equal column inches to counterpoint the cynicism.

That's not Cool!

I have had the blessing to have come across Denise E. Robitaille and her articles and books and I have never been bored or consider her writings subliminal with a hidden agenda ($$$). Her contributions to my understanding of the maze that ISO requirements can be, have been beneficial to my personal success as an auditor and Quality Manager of our company since 2007.

The only thing I found “shameless’ is how some people don’t like or accept change. How many great inventions have been the product of changing steps that previously resulted in failure? I personally embrace the change regarding Preventive Action. We manufacture a medical device that has the highest failure in the field, not due to the product but, due to the user. We have had auditors tell us; “You need to find out how to prevent that failure”. And year after year we have the same answer; “we can’t”. Changes and modifications to our products have been made to mitigate the problem but there is no solution when the root cause is beyond our control.

The shame here is that some auditors might consider the standard changes as choking their golden goose. Well, as I love to say; “Boo, Hoo!”

Kudos to Denise and I look forward to your next article!