The short answer: the standard has been widely misinterpreted and misapplied. A lack of understanding how to approach quality management vis-à-vis ISO 9001 has stymied proper use of the standard. As a result, many ISO 9001-certified organizations (I dare say most) have adopted a poor approach to quality management in the name of ISO 9001 certification. No wonder they don’t like it.
What tool produces good results when it is used contrary to its manufacturer’s instructions? Misusing a tool often produces undesirable results. Before discarding a tool as being useless, it might be worth the effort to ensure that it is being used properly. After all, misusing a tool can also be costly in many ways.
While auditors have mistakenly been accepting a poor approach for years, this should stop when the 2015 version of ISO 9001 is released, more clearly requiring application of the proper approach. Otherwise, the intent of the standard will continue to be defeated while the value of ISO 9001 will continue to escape those hoping it would be useful.
The approach many organizations have taken to define their ISO 9001-certified quality management systems misses the point of the standard. They are operating dysfunctional-yet-certified systems, yet they are often unaware of this system error. Consequently, they turn their disdain toward the standard itself. But the standard is good, as are the teachings of Deming. It’s an application problem that is just now coming to light in anticipation of the 2015 standard.
IMPLEMENT PDCA BASED SYSTEMS – NOT ISO 9001 BASED SYSTEMS
While successful organizations abide by Deming’s basic teachings at some level, one would never know it by reading their ISO 9001-based system documentation. Nobody using this “ISO” documentation likes it. They often see no value in it, often also failing to see the value of ISO 9001. Even though system documentation is confusing and counterproductive, it passes audits. Beyond that, management sees no value in it. Nor should they.
It is, always has been, and always will be management’s job to drive quality and improvement. Yet ISO 9001 was viewed as some kind of recipe, a guide to be followed to assure quality. It was never intended to be applied that way. ISO 9001 is for auditors, not for management. It is simply an audit tool, a set of audit criteria.
Organizations relying upon the standard to define their management systems seem to expect ISO 9001 itself to drive quality and improvement. ISO 9001 doesn’t drive quality, management does. Properly managed quality has proven to be powerfully profitable.
“Every system is perfectly designed to get the results it gets.”
–Dr. Paul Batalden, MD. (“What System?” Dartmouth Medicine magazine, Summer, 2006 http://dartmed.dartmouth.edu/summer06/html/what_system_03.php .)
It seems Dr. Batalden’s very insightful statement can be applied to all kinds of systems. A quality management system designed using a process approach is a system designed to manage quality. Although such a system will pass audits easily, passing audits is not its primary intent. Managing quality is the objective of the process approach (PDCA).
In designing systems to pass audits, organizations have overlooked the effectiveness problem of the systems they have defined. Structured according to the standard, these systems cannot be effective management systems. The focus on conformity over effectiveness ultimately achieves neither. A system designed to pass an audit does not output quality products, it passes audits. That is what it is designed to do. As a result, it may not be useful, and it may cost more than it should, it may confuse personnel at all organizational levels, but it passes audits. However, it won’t be long before such systems stop passing ISO 9001 audits. It’s time to abandon this errant approach.
A system designed to output quality product outputs quality product. Such systems are normally in place already, but they are often confused by ISO 9001-based system documentation. A process approach makes managing processes easier and more transparent, it provides a sound foundation for improvement, it makes quality management more effective and cost effective, and it makes passing audits easier. A process approach produces better results.
Bio:
Why wait until the 2015 standard undeniably requires it to enjoy the benefits of a well-designed quality management system? Stop expecting ISO 9001 to drive quality and put Deming in the driver’s seat. He’ll take you where you want to go.
T. D. (“Dan”) Nelson is a quality management consultant, author, and trainer specializing in the process approach, ISO 9001, and related sector schemes. Dan has roughly 20 years of experience with ISO 9000 and over 15 years’ experience with the process approach. Dan holds an MA in Business Administration from the University of Iowa. Dan can be reached at:
dan@tdnelson.com
319.210.2642