ISO 9001 Opinion Piece Draws Heavy Response

Editor’s Note: We received an unprecedented number of responses to Jack Dearing’s February 2007 article, “ISO 9001: Could It Be Better,” (p. 23). Reactions were split almost equally, with about half the letters supporting Dearing’s opinion piece and half decrying it.

The following letters represent a sample of those we received. Go to our discussion board (www.asq.org/pub/qualityprogress) to find more viewpoints and to participate in the discussion.

Jack Dearing beat us to the punch with his insightful article.

ISO 9001 registration is gaining in visibility and necessity for our customers. However, as a quality professional in charge of ensuring our company stays registred to continue meeting that customer requirement, I am losing faith in the certification process and its real, significant value to a quality driven organization.

I trust the ISO 9001 registrars out there, including our own, will not take issue with Dearing’s well-thought out advice and opinion. We are struggling with the same issues he writes about—how do we reduce the burden of staying ISO 9001 registered while maintaining good quality and preserving the value and integrity of the registration process?

What has really been discouraging is that we recently learned of a competitor’s approach to ISO 9001 registration that we think vastly lacks integrity and is far behind our ap-proach in quality principles. Yet this company maintains its registration and can boast it rarely has any noncompliances from third-party audits.

We almost always have noncompliances from third-party audits. We don’t take issue with our noncompliances; we see them as opportunities for improvement. What we are shaking our heads at is the lack of value we see in ISO 9001 registration when we learn of the contrasting applications of assessments and audits.

Dearing’s article has encouraged us to look for new ways to assure our customers that we are continually improving, without the need for a certificate on the wall to say so.

BAX Global Inc.
Irvine, CA

Frankly, Jack Dearing’s article should not have been published. Readers who don’t understand the requirements of the ISO 9001 standard will use the article to justify their opposition to any quality management system (QMS) standard. You’ve allowed one individual, based on personal experience, to speak as though he’s conducted a case study.

Dearing calls audits overhead burden. This is nonsense. In my experience, organizations use third-party and internal audits as just one tool to instill the discipline necessary to effectively apply a QMS. Perhaps an organization made of strongly committed individuals could operate a QMS effectively without formal assessments. However, this system could deteriorate with employee turnover.

Dearing says the requirement of a quality manual is another unnecessary overhead burden. That depends on how the manual is developed. If it is written verbatim to the standard, replacing references to “the organization” with the company’s name, as some registrars suggest, then yes, the quality manual is useless and becomes overhead burden.

On the other hand, if the manual is developed in the practical manner in which the organization applies its policies, while staying in line with the standard, then it becomes a living, value added document.

I do agree with some of Dearing’s ideas, such as his suggestion that many Q9001 requirements be notes. But here’s my point: Many of your readers have as much, if not more, experience with applying ISO 9001 as Dearing. No one, including me, should be given a forum in a respected magazine to speak his or her opinion and make it appear as fact.

KI-USA Corp.
Berea, KY

I enjoyed Jack Dearing’s article. It is an understatement of my own skepticism toward ISO 9001 as the answer to resolving every quality problem by discipline, audits and fear.

Third-party audits take attention away from the real quality problems and redirect it to the need to fulfill static requirements of a quality system that is developed to resolve problems though standardized products and processes.

I work in healthcare, where there is no such thing as a static patient problem or solution and ISO 9001 processes can often lead to quality failure instead of quality improvement.

Ringerike hospital

I can agree with much of what Jack Dearing proposes, but he seems to be missing one law of resources and its subsequent fall-out: People will tend to do what is easiest.

I have worked at many companies that abandoned ISO 9001 third-party audits. What follows is that management sees this doesn’t immediately affect operations; in fact, they can push more material through more quickly. They let their QMS fall into disarray and see their quality labs as an extra cost that really doesn’t get them anything. They end up firing many of their quality professionals.

The quality manager (QM) is then saddled with more responsibilities, being told his or her priority is not being a QM. The QM typically loses his or her access to upper management.

When customer complaints become rampant, the company no longer has processes in place to implement corrective actions and improvements because it has gotten rid of the people who had that expertise.

I’m not saying all companies are like this, but the third-party audit does tend to hold upper management’s feet to the fire.

We can benefit from Dearing’s ideas if we have a strong relationship with upper management and it has internalized the need and see the benefit of a strong, robust QMS. If that is the case, then upper management will likely promote the behaviors a third- party audit is meant to influence.

Eastman Kodak
Penfield, NY

I couldn’t agree more with Jack Dearing. Although its creators intended ISO 9001 to be generic and thus applicable to many types of businesses, the result is a standard that imposes an administrative burden with no real value.

We dutifully maintain documents we never look at and records we don’t need just so our registrar can audit them. We spend thousands of dollars on third-party audits that drive very little improvement compared to our own internal audit process. In some cases, third-party audits have actually added unnecessary work, taking valuable resources away from us—and therefore our customers.

Creative quality managers improve QMSs in spite of ISO 9001, not be-cause of it. When designing or im-proving processes I believe will result in high quality products and services, ISO 9001 requirements always take a back seat to our real business needs.

I don’t believe the world is ready to do away with ISO 9001 and its associated third-party audit burden, but a better approach might be to have a two-tiered system: the existing standard for new companies just forming a QMS and a less burdensome standard for companies with less to prove.

In any case, change is long overdue, and I look forward to the next revision of ISO 9001 in hopes that it will better reflect the needs of businesses in the 21st century.

Johnson Matthey Catalysts
West Deptford, NJ

With all due respect, I find it hard to believe the editor of Quality Progress and a quality manager with more than 25 years experience can be so naïve. ISO 9001 does not require third-party audits.

It is ironic that Jack Dearing writes, “This ignorance is found even among some consultants and trainers, quality professionals, auditors and others who use ISO 9001 quality systems.” Who is ignorant here?

Wouldn’t it be fair to expect Dear-ing’s statements that infer ISO 9001 requires third-party audits would be researched before publication of this article? Isn’t this what responsible journalism is all about?

Such statements include: “But we can do better if we throw out much of ISO 9001, particularly the third-party audit feature,” “The root flaw of ISO 9001 is its reliance on third-party audits,” and “Eliminate third-party audits—the proof you have a good quality system is in the quality of your products and services.”

ISO 9001 is a voluntary consensus standard. It, or any part of it, can be used any way an organization wants.

If the requirements this article discusses are wasteful, interview the automotive industry, which has defined more than 290 requirements (shalls) in its version of the standard, or the aerospace industry, which has defined more than 300 requirements. Compare these numbers to ISO 9001, which only has 136!

Or better yet, talk to organizations whose parts per million defective were more than 5,000 and are now in the low hundreds or to those whose on time delivery was 70% or less and is now 90% or more, thanks to using ISO 9001 based standards.

Criticism is healthy and generally leads to improvement, for which there is always room, but please, let’s do our research first.

Jaeger-Holland Inc.
Woodridge, IL

Author’s Response:

Thank you for your letters and discussion board posts. The complimentary ones are easy to accept. Those with different opinions are also of great value to the discussion, which I hope will continue and positively affect the next version of ISO 9001.

Most of your feedback has focused on specific ISO 9001 requirements
and not on the point of my article:
We can apply more resources to controlling and improving quality,
which is what customers need, if we are not focused on ISO 9001’s overhead requirements.

Whatever ISO 9001’s merits are, they have to be balanced against the competing need to control and improve quality. This requires us to do a critical review of the overall ISO 9001 system, including—if you want to be registered—third-party audits.

I recognize ISO 9001 has benefits and many good requirements. But it is not above reproach, and it needs to be improved. Even those who disagree with my opinion that third-party audits have more costs than benefits, often acknowledge the third-party audit system needs improvement.

In the limited space provided, I cannot begin to respond to all of your well thought-out and often passionate letters in the detail they deserve. I hope some of you will develop your thoughts into articles and submit them to Quality Progress. I would love to see articles on how to improve the third-party audit system.

I also hope our voices—both pro and con—will be heard by Technical Committee 176, the ANSI-ASQ National Accreditation Board and other interested parties. I hope that leads to a better ISO 9001 and an improved third-party audit system that together guide organizations to improved quality in a less burdensome manner.


“30,000-Foot” Full of Problems—or Paradigm Shift?

Regarding John Flaig’s comments in February’s “QP Mailbag” (“‘30,000-Foot’ Full of Problems,” p. 8), I will avoid semantic differences of opinion about common and special cause variability.

To get to the heart of the issue, let’s consider a quality practitioner who wants to create a control chart that makes a process capability/performance metric statement about wait time in grocery store checkout lines.

One of the first things to do is selecting a subgrouping frequency. Possibilities include minute, hour, day or week time periods. Using traditional control charting techniques, most practitioners would select an x and R control chart as the process tracking tool with a short sub grouping period, such as minute or hour.

Customer volume can vary by time of day and day of week, which could affect wait time in the checkout line. Let’s assume it does.

In all likelihood, the described x and R chart will be out-of-control (see my Quality Progress November 2003 column). Because of this condition, we should not report any process capability/performance metric. Be-cause the process reported is unstable, a general statement about customers’ checkout wait times can be erroneous.

As the store manager, you ask your quality practitioner about checkout wait time. He or she cannot report this because the process is out of control. How would you feel? You made what seemed like a reasonable request and are told it cannot be done.

The reason wait time would have out-of-control signals is that customer volume changes with the time of day and day of week. Across an entire year, we could expect hourly patterns to repeat each day and daily patterns to repeat each week. Except for holiday seasons, we could expect no repeatable weekly pattern.

In 30,000-foot-level reporting, weekly wait time means and standard deviations, or log standard deviations, are tracked over time in individual charts. If these charts are in control, the process can be considered predictable. Individual checkout times would then be used to estimate the process capability/performance metric. Wait time improvements would focus on what could be done differently to reduce weekly reported means and standard deviations.

For this situation, frequent sampling yields auto correlated data reporting. Traditional control charting would lead to time of day as an assignable cause, and directives state that assignable causes should be eliminated. But eliminating the time of day doesn’t make sense.

An alternative would be to use control charts to better manage the number of people in the checkout line. However, you still couldn’t react quickly enough to eliminate these assignable causes so the chart would be in control. In other words, you still might not be able to report a process capability/performance metric.

My proposed 30,000-foot-level reporting method can address these situations by providing a high-level view of all customer experiences.

Smarter Solutions
Austin, TX

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