Keep Calm and Prepare for ISO 9001:2015

Abstract:ISO 9001:2008, the international quality management system (QMS) standard, has been in use for many years and the more than one million certified organizations that abide by it are understandably wary of the impending change to ISO 9000:2015. The reality, however, is that the changes that have been implemented are designed to improve organizational QMSs by addressing the growing need for risk-based thinking. Risk-based thinking means that when an organization decides to change something, there are choices, consequences, opportunities and, of course, risk. It encompasses the varying acceptable degrees in which organizations choose (or don't choose) to manage risk. Because a QMS touches virtually every part of an organization, applying risk-based thinking allows organizations of any size to assess the value of its decision-making and makes higher level management less about giving direction and more about being an integral part of the decision-making process. Understanding risk means …

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Excellent Article .Well Conceived > Top Managements of the organizations have to be alert now.instead of dumping everything on MR.
--Kishore Sitamraju, 10-20-2015

Very informative
--Mohan Ratanchandani, 09-23-2015

Agree on the inclusion and focus on risk-awareness and management of risk are hidden treasures on the road to performance excellence even when other quality practices are mature in an organization.
--John Watson, 09-23-2015

Good timing for this article. Some good nuggets for use as training points for teams in transitions and/or new to the ISO approach.
--H. Couture, 09-22-2015

The last paragraph of the introduction seems like an apology for yet another revision to ISO 9001 that still falls short. That is probably justified when you look at the changes. How much do the changes really impact improvements that will be implemented to the actual operating QMS? The one change that will impact the QMS (and the credibility of the company Quality activities) is the change on risk. Many of the true risks to our operating units are strategic and extremely confidential. I can't imagine that any of our operating units will want to document these risks in an open document that could leak outside of the company.
--Robert, 09-14-2015

Extremely informative and relevant given the anxiety regarding the changes seen.
--j. Scott-Brown, 09-12-2015

There is not enough detail in any part of this article for a reader to be able to use the information to plan. The question, "What do I need to do?" is presented in various categories, but the answers presented are rambling and not organized in a useful format.
--G. Bush, 09-11-2015

September 2015 QP “Keep Calm and Prepare for ISO 9001:2015” is a well written publication in plain language that users at all levels of familiarity can understand. I think all the contributors to this publication have done a great job explaining various aspects of the standard including the implementation challenges for small businesses. Risk based thinking is extensively covered which is a plus. I would have preferred to see more content on requirements under organizational knowledge. This is an area of opportunity for improvement for any organization. One obvious absence in this publication is coverage of content related to ISO 9000:2015, the “unsung hero”. ISO 9001: 2015 normative reference call out ISO 9000:2015 and describe as “indispensable for its application”. Yet we have missed an opportunity to emphasize that reviewing ISO 9000 is essential to consistent application of ISO 9001 standard. I hope QP will contact a SC1 experts to add this content to the online version. With that said, I still recommend this publication as a must read for all ISO 9001 users.

--Govind Ramu, 09-10-2015

Excellent - of all the articles I have read - this series was the best!!
--Daryl Schwald, 09-10-2015

The current standard has served us well for the last 15 years. I wonder if there would be a revision is those of us in the Trench every day were involved in 1) deciding if a revision is necessary; 2) deciding what to revise when it was needed; and 3) removing the 5 year ISO rule for revision. As far as I'm concerned, the 2000 / 2008 version has been superb and the ink has just dried on the document. We are just starting to run this machine as it is and find out what it an really do. For those of us in automotive who are working in the TS vineyard everyday, we take a dim view of the new documentation requirements. Having worked with ISO since 1987 and MIL-Q-9858a before, and QS and TS, I'm not seeing these changes as being driven for real improvement, but rather change for the sake of change because ISO says so. As far as Risk based thinking goes - we have spoken FMEA for a number of years now. We have the examples of the Challenger & Columbia disasters where management had to learn again that "Physics doesn't care." The country is beginning to see a backlash against a distant remote bureaucracy in DC, and I think the US quality profession is beginning to view ISO in the same manner. Even though you jump through all the ISO clauses, your customers are still going to audit you. But wait - wasn't this something we were going to get away from with ISO or TS certification? Not here - not yet.
--Joe Druecker, 09-10-2015

This article help me lot, outstanding.
--D.Tapadar, 09-10-2015

With respect to the term "relevant interested parties", who might the "relevant but disinterested" and "interested but irrelevant" parties be? If anyone is interested to any extent whatsoever, aren't they relevant?
--Stephen, 09-09-2015

How will this change effect AS9100, this standard already incorporates all current ISO 9001 requirements.
--versie adams, 09-08-2015

Excellent as a first article.
--terrence awai, 09-03-2015

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