The ISO 9001 standard is currently under revision. The decision to do so wasn’t driven by one dramatic event happening in the marketplace, but rather by due diligence of the International Organization for Standardization (ISO) committees and working groups that perform systematic reviews of standards. From a review completed in 2012 plus activities including open workshops with users of the standard, a web-based survey of users and potential users, and studying trends in quality management, it was determined that the standard needed to be updated.
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Comments
Double-Edged Sword?
Thanks for the article, I like the history lesson.
About the double-edged sword, though, I disagree. I don't believe there is any downside to making management responsible for determining how to manage quality systemically in thier organizations. It's always been up to management to manage quality in their organizations and it was a mistake to think ISO 9001 demanded otherwise. ISO 9001 never assumed the responsibility for configuring QMSs. ISO 9001 requires a QMS to be established, but it never represented a configuration to accomplish it. The downside of ISO 9001 is that it was commonly treated as a management system design specificiation.
So I don't see any double edges being presented by the 2015 standard. It's making more clear what was apparently not clear enough since the original release of the standard: management is responsible for defining thier management systems, ISO 9001 is not. (This is all part of the process approach push.) Management system definition should be process-centric, not ISO centric.
The standard never did prescribe how to configure a QMS. ISO-centric (clause-by-clause) QMSs never met the intent of ISO 9001 in any of its revisions. The standard has always given companies the freedom to do what's best for them (assuming conformity can be demonstrated). The idea that the standard ever did prescribe HOW managment should configure or run its operations to assure quality is incorrect. Tighter controls aren't necessarily required of 2015, but sensible controls are (those exhuding effective risk-based thinking and a process approach).
As it becomes more clear to organizations that the standard encourages them to "do their own thing" to assure quality instead of "doing the ISO 9001 thing" to assure quality--as has always been the case--management will stop viewing ISO 9001 as being a problem. At that point, they'll begin to take responsibility for their own management systems and those with troubled systems will stop blaming ISO for it.
A Standard Without A Standard!
If one would search for a definition of “standard”, several definitions would be encountered. Although they may not be using exactly the same words, the basic idea covered under various definitions would point to a consensus about the concept of “standard”.
The definition given under the heading of “What is a standard?” on the web page of International Organization for Standardization (ISO) summarizes this consensus very well: “A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.”
The keyword that distinguishes a “standard” from other types of regulatory documents is “consistency”. The great-grand father of quality management standards, the venerable MIL-Q-9858 reflects this principle idea of consistency in an exemplary manner. Starting from its initial issue in 1959 to its withdrawal in 1996, it has gone through only one single revision. The robustness, expected from a standard, is demonstrated by the minimal effect of that single revision on the users of the document.
However, the ISO 9000, and even its off-spring ISO 9001, has been defying the most basic principle of a standard, as if denying its lineage to MIL-Q-9858. The revisions ISO 9000 went through in its short life to date have been more than annoying for the businesses that have tried to adopt it. Even ISO admits on its own web site that the ISO 9000 series of documents had a “muddled” character. This is revealed by the succession of revisions that play around with words without any effective contribution to the functions of a business. Unfortunately, the extent to which the change in terminology is to be reflected in the quality management documents of the business is left to the whims of the independent auditor.
Those who work in the committees to review the ISO 9000 series, and those that request the revisions and changes, may have had fun in their sand-box, but the businesses who had to re-write their internal documents to comply with the latest wording of the revised “so called standards” were very much aware of the cost, both in time and money, they were incurring because of trivia.
As if the grievance caused was not enough, the upcoming revision to ISO 9001 is changing the complete paragraph structure. A gross violation that renders “characteristics that can be used consistently” obsolete; a sin! While the committee members may emerge from their playground with smiling faces, the businesses will have to trash all of their current quality management documents and re-write them to align with the new paragraphs.
Once more; ISO 9000 and its off-spring ISO 9001 will carve fame for themselves as being “a standard without a standard”.
P.S.: If management has not already taken responsibility for managing the business, they will be already out-of-business.
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