Does ISO 9001 require controlled processes for improvement? By now, I think most users would agree that it does. The requirements for that controlled process are simple to describe. They start with planning.
To meet the minimal requirements of ISO 9001, an organization must have thought through, planned, and implemented its processes for improvement. However, ISO 9001, even when we refer to the definition of “continual improvement” in ISO 9000, doesn’t provide us with a complete understanding of the concept. ISO 9000--”Quality management systems--Fundamentals and vocabulary” defines continual improvement as:
“Continual improvement--recurring activity to increase the ability to fulfill requirements.
“NOTE: The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews (3.8.7) or other means and generally leads to corrective action or preventive action.”
(Source: ANSI/ISO/ASQ Q9000-2005)
It’s interesting that the note following the definition describes some, but not all, of the improvement requirements of ISO 9001. For example, the quality- policy and top-management focus that is present in ISO 9001 is missing in the definition. The basic requirement of ISO 9001 may appear to be somewhat narrow because it only addresses “effectiveness of the quality management system,” but that narrow wording is intentional. For example, ISO 9001 doesn’t intend to require improvement of process efficiency.
This is all well and good, but there’s much more to it. Quality management, as in life, is a roller coaster--a series of ups and downs. Nothing improves all the time, but we should shoot for a stable system that is improving. The trick to quality--also like life--is to make the right decisions when you face a quality crisis. Recognize that, to some extent, it was the organization’s past decisions that caused downturns in quality performance. This is often true even if those past decisions seemed right at the time. They may have been driven by a misunderstanding of external situations. What’s important is to understand why the downturn happened, and make system adjustments to return to the upward curve. This isn’t easy because:
• Even knowing that you have a quality problem requires constant attention to important performance measures.
• Causes are often separated from symptoms by time and distance.
• The organization may not have total (or any) control over many causative factors.
• Dealing with a downturn in quality is difficult unless the organization has established a culture of continual improvement during times when quality is good.
On the other hand, if improvement becomes a controlled process in its own right, it can be a natural result of everyday work. That’s the notion embedded in ISO 9001, and there’s hope if you heed the last bulleted item. Improvement isn’t just a set of ISO 9001 requirements; it’s a business imperative. If your organization enjoys great quality and high customer satisfaction, now is the time to institutionalize a culture of continual improvement. It’s very likely that you will need it.
ISO 9001’s continual improvement requirements are simple and narrowly focused. For any organization committed to developing a culture of continual improvement, a broader understanding is necessary. With the definition in ISO 9000, improvement depends on the requirements. If there’s a requirement for a better or less expensive product, then the continual improvement concept might be applied. If there’s a requirement for improving the organization’s overall performance, then continual improvement of performance would be an organizational objective.
By clearly linking the organization’s continual improvement efforts to important business needs, the process becomes an integral part of the fabric of the organization’s behavior.
This column was developed in part from material in Chapter 6 of Unlocking the Power of Your QMS: Keys to Business Performance Improvement, by Charles A. Cianfrani and me. (ASQ Quality Press, 2004.)
Editor’s note: This is Jack West’s last column. His Standards Approach column first appeared in Quality Digest in August 2004. The staff at Quality Digest sincerely thanks Jack for his dedicated contribution to our magazine.
From 1997 through 2005 John E. (Jack) West was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176.
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