Big changes ahead
In response to "Open to Change" (July 2015):
The proposed changes to ISO 9001, as I understand them, come as a breath of fresh air to me. For example, Clause 10.21.1—Nonconformity and corrective action gives some flexibility.
I work in nanotechnology, where things are complex. There is not just one root cause or corrective action, but rather a number of interacting, interrelated factors which, depending on the situation and environment, can behave differently together. Plus, the operator can only detect the results several steps after the fact.
The previous approach wasted too much time and money, calling something "the" root cause and giving "the" corrective action only to be disappointed when something else changes in the system.
For those of you linear thinkers, who work in a less complex field, the old school approach is probably fine for you.
R. Dan Reid, author of "Open to Change," provided a good summary of expected changes to the 2015 edition of ISO 9001. He noted several of the important differences, perhaps the most significant of which is the new, mandatory terminology in the standard.
While the International Organization of Standardization’s (ISO) motive is to generalize the applicability of ISO 9001 to broader business sectors, much of the new terminology is unfamiliar to current ISO 9001 users. This may result in much confusion during implementation and in substantial costs to the organization attempting to use the new version because personnel will need more training and understanding of the new requirements (such as risk and innovation) to effectively implement the standard.
It remains to be seen if the new terminology actually achieves the value that ISO suggests or if it will it cause some users to decline further.
Building on methods
In response to "Change in Flow" (June 2015): The planning, executing, evaluating and improving cycle is a routine execution method that is implemented by engineering companies. Some companies also use a more elaborate method called the project execution model.
Thane, Maharashtra, India
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Quick Poll RESULTS
Each month at www.qualityprogress.com, visitors can take an informal survey. Here are the numbers from last month’s Quick Poll:
How will your organization be affected by the revision to ISO 9001?
We must transition to ISO 9001:2015 and other aligned standards, such as ISO 14001. 60%
We are unaffected by the ISO 9001 revision. 37.1%
We plan to be certified to ISO 9001 for the first time. 2%
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