What it takes to reach ISO 9000

What it takes to reach ISO 9000

The process of achieving certification to ISO 9000 — the International Organization for Standardization`s (ISO) total quality management system — can be long, tedious and costly. But many companies who have `taken the plunge` have reaped some surprising internal benefits — increased efficiency of their existing systems, a better across-the-board understanding of processes, and a real surge in worker commitment and morale. By actually going through the process of certification (or registration), company officials have had to ask hard questions of themselves and their employees. They`ve defined and refined processes and, depending on the level of commitment, brought a higher level of consistency and quality to their operations. The ultimate result: better quality products and systems, satisfied customers, and increased sales/yields. Three suppliers of products to the cleanrooms industry have all gone through the process and have achieved ISO 9000 certification. These are the stories of the journey each took to get there.

Oak Technical Inc. (Stow, OH) is a vinyl glove manufacturer. Oak first introduced vinyl disposable gloves to the medical industry back in the 1960s. The company has received ISO 9002 certification, achieving recognition for both of its manufacturing facilities — in Tullahoma, TN, and in Traveler`s Rest, SC.

Fluoroware Inc. (Chaska, MN) supplies materials management solutions for mission-critical industries such as semiconductor manufacturing, data storage, and chemical processing, and it has been since 1966. ISO 9001 certification serves as the baseline for the company`s comprehensive quality program. Its facilities in Chaska, MN, and Bad Rappenau, Germany, are both ISO 9001 certified, and the company`s other manufacturing facilities will soon follow their lead.

Precision Clean Products, a Division of Fisher Container Corp. (Evanston, IL), has recently earned the U.S.`s first ISO 9002 certification for the manufacture and flexographic printing of cleanroom products, including Precision Clean Centerfold Film, which is designed to protect cleanrooms from particulate contamination during retrofitting or construction.

Oak Technical

Oak Technical, a vinyl glove manufacturer, is ISO 9002 certified at both of its manufacturing facilities — in Tullahoma, TN, and in Traveler`s Rest, SC. Founded in 1916, the company originally manufactured toy balloons. In the 1960s, Oak introduced the world`s first vinyl disposable gloves to the medical industry. Today, Oak Technical offers glove products to users in critical environment, microelectronics, food service, laboratory and industrial applications. The company obtained a corporate-wide ISO 9002 certification and has just passed its first ISO six-month surveillance audit. Oak`s CEO Murray Collette is proud that Oak is, to his knowledge, the first glove manufacturer in the world to be ISO certified. “We think that`s significant. Like most glove manufacturing processes, ours has probably a fair degree of difficulty to bring into compliance, just by the nature of what we do.”

Collette says he firmly believes in the benefits of ISO 9000 certification from an internal management standpoint, as well as the quality advantage from a vendor/supplier perspective. “As chief executive officer, I felt it was critically important to pursue this certification. It`s a little difficult maybe to do a return on investment, but I think there`s been a lot of benefits to the company in terms of how we operate this business that does ultimately end up as a return on investment. What it does for you internally — the accountability it brings to how you run your operation — is significant. You may already think you do a good job and you`ve got everything in place; in reality, this puts so much more structure into place, that you begin to do things significantly better,” he says.

Because of Oak Technical`s international clients, Collette says, company officials soon realized that ISO was “something that you had to do no matter what.” Instead of a trade barrier, Oak officials found that it actually opened up quality markets both overseas and at home. “It`s just the realization that this is something that top-notch quality companies are going to implement and expect, and if you`re going to be a partner with those people, then you need to do it, too. Maybe it was once viewed as a potential trade barrier or as an unnecessary expense or hassle, but it`s not now. I think eventually it`s going to be something that`s expected if you`re going to be a progressive manufacturer,” he says.

Oak was already no stranger to quality standards and procedures for its processes. Its medical exam glove was manufactured under very specific FDA regulations and GMPs. But ISO certification raised the bar, Collette says. In terms of real savings, he points out, quality is always a good investment. “If you can make it right the first time at the quality level that you want it to be and reduce your reject rate, that`s going to be a savings. Because the dollars you committed to raw materials, to labor, the overhead dollars are being used efficiently to put into the warehouse a good high-quality product at a high percentage of what you`ve done. So that`s a significant savings. It`s a hard number to quantify, but it happens.”

Oak employees decided to do as much of the program as they could on their own in preparation for ISO certification. “One thing that we did was to educate ourselves,” explains Collette. “We decided that from an internal perspective, we would become as knowledgeable and as expert as we could. Our people attended various seminars on ISO. Eventually, we also did get a consultant and had a pre-audit.” He says anyone can go out and hire a consultant, “but ultimately, you`re the one who`s going to have to administer the program and follow the procedures.”

Darrell Alford, technical services manager at Oak`s Travelers Rest, SC, facility, was appointed to initiate and implement the ISO 9000 project at all three company facilities. He became a certified internal auditor during the process.

Alford says the company already had a quality system in place that was modeled on parts of ISO 9000. Many of the procedures, especially in the quality area, were essentially but unofficially ISO 9003. Ultimately, the decision was made to obtain ISO 9002. The first step was to rewrite and standardize the existing procedures into ISO 9000 format, which involved everyone from the top down, says Alford. The first step was to establish a sense of “ownership” on the part of all the employees, which meant getting them to write the procedures for their own jobs.

“At first, people didn`t necessarily buy it; but after a while,” says Alford, “it wasn`t too long before the plant managers and the supervisors bought in because it was making their job simpler, and we could see improvements — we weren`t doing seat-of-the-pants stuff. And even though we had a system, it wasn`t as good as this one.

“We`ve always had a consistent product in terms of cleanliness, but I think, if anything, it`s helped our consistency even more, because we do it the same way. We have a rule that says, `you have to wear this; you have to do it this way.` So if we`re doing it wrong, it`s going to be consistently dirty! But at least it`s consistent.”

Oak performs packaging and checking operations on its gloves in Class 100 clean areas, which Alford says, operate closer to between Class 10 and Class 1. “We`ve done some enclosures of some larger clean areas. We believe that`s going to be cleaner, too. It`s just part of our continuing process to improve the product we`re making, and it becomes part of ISO.”

As processes become even cleaner at Oak, Alford says he is convinced ISO procedures will lead the way. He predicts that with cleaner spaces now being built, glove cleanliness levels will accelerate to Class 1. “We`re probably eventually going to come out with gloves that are orders of magnitude cleaner than what we have now. We`re sowing the seeds now, and it`ll take a year or so before we`re maybe Class 1 or 10, but it`s going to happen because we`re getting there now.”


Fluoroware is a supplier of process and transport carriers, storage boxes and critical fluid management components and subsystems, which are used in cleanrooms in the semiconductor industry. One of the company`s major core competencies is molding high purity specialty plastics to tight tolerances. Currently, it is aggressively developing a complete family of 300 mm wafer handling solutions in anticipation of the upcoming transition to 12-inch wafers. (See “Products for 300 mm manufacturing cropping up”, p.1)

The philosophy of quality has been with Fluoroware since its inception, articulated by president and CEO Stan Geyer as, “just a part of what we do.” It was a desire for a better “baseline quality system,” specifically in manufacturing, that proved to be the driver for Fluoroware`s seeking ISO certification. Says Geyer, “I think we realized that we still needed a better baseline quality system that covered more parts of the organization than just operations. And our customers were really telling us more about ISO. That`s when we started looking into it.”

Cost was a factor that had been studied right from the beginning, says Ross Hanson, who was put in charge of implementing ISO from its inception in March 1992. In addition to about $50,000 in external costs to consultants, internal costs on time spent for generating and preparing documentation, changing systems and conducting meetings was estimated at an average wage rate of about $450,000, making a grand total of about $500,000. However, Geyer adds, even before ISO, the company had been tracking cost of quality in two categories: `cost of conformance` vs. `cost of non-conformance.` “We were well aware that lack of quality was costing us millions of dollars per year. So although it was a big number, the biggest number was when we did things wrong and then did them over wrong.”

Training processes included organization-wide meetings. Also, a core team representing people from various areas of the company, including production, operations, engineering, senior management and the vice president of operations, was created. Members divided the ISO standards up among themselves and then formed subcommittees and subgroups to document the quality system. Training for internal auditing was provided to the documentation and documentation control groups. After the bulk of the documentation was complete, the entire company went through a series of training sessions. Instead of offering resistance, says Hanson, the rank-and-file employees actually welcomed the documentation and training.

From a cleanrooms perspective, Hanson says, the ISO control system provides a baseline from which cleanroom operation can be improved. Documentation and the quality system, as well as the continuing audits performed on the company`s manufacturing cleanrooms, are a big part of the overall control. “It drove us to clear and concise operations documents — manuals for our cleanrooms to assure that they are certified and operating as designed. Through the ISO process, we`re provided with a template — a way in which we can think about our processes. And in that evaluation of our processes, we`re able to address the details of control, which are so critical to a cleanroom operation,” Hanson says. “That enables us to assure repetition of our process, to detect changes or trends in cleanroom operation, and to make corrections. And it`s so important to customers. It provides us with the assurance that we`ll have data to provide them with. Customers more and more ask for information. They say, `Bring the numbers!`”

Calibration was also something ISO forced the company to look at. “There`s a tremendous amount of measurement equipment that`s used to evaluate our products dimensionally and functionally. Prior to ISO, we had calibration; however, we really weren`t following through on gathering the information that would help us evaluate improvements in our calibration. So we moved from a calibration system where we were perhaps looking at a couple hundred instruments each year to now upwards of about 1,200 instruments. So it enabled us to take a single requirement for calibration and move it into a whole attitude about the level of professionalism and accuracy our company wants to deliver to our customers,” says Hanson.

Over the course of three years, Fluoroware has undergone a total of six surveillance audits and two recertification audits, during which the auditor reviews each of the twenty ISO standards. Fraud is a virtual impossibility, says Geyer, because there are so many elements which absolutely require and insist on the buy-in and participation and the involvement of not just senior management but all levels of management. “These auditors are very skilled. They have seen systems that have been there just as a facade, and they can see through it pretty quickly,” he says.

As the CEO of a company that considers itself a major player in the semiconductor industry, Geyer sees the industry working toward one common audit standard. “Sematech has been working for two or three years and has successfully come up with a uniform audit standard that encompasses ISO 9000 but goes beyond it, addressing some of the business performance elements of the successful company. We are afforded the opportunity to refer customers to this large-scale audit that`s been performed by a collective team of representatives from the semiconductor industry. It enables us to minimize and reduce the number of full-scale audits performed by our customers.”

The company has found that even with ISO certification, there is still a great deal of interest on the part of customers in knowing how its quality system is being run, says Hanson. “What we do find though is that there`s less time spent on some of the basics of quality, and that we can use our time with customers more effectively to dig right into some of the key issues that are specific to them and to us. So we don`t have to talk about calibration, because we know we`ve got a system that`s compliant to ISO 9000; we can dig right into a particular functional test that they`re very interested in.”

Commitment to the company`s “quality policy” under ISO reflects its primary motivator, says Hanson, and that is customer satisfaction. The company makes a point of letting every employee know that it`s not just our quality assurance department, or senior management that`s responsible for quality: everyone has a stake in it. “Continuous improvement” may not be a concept contained in the ISO standard as it stands today, says Hanson, but it is another key part of Fluoroware`s quality system. “The ISO standard as it is written today does not compel one to practice continuous improvement. It talks a lot about corrective action. I say that cautiously, because I think it`s going to change — they will be incorporating more continuous improvement. But that`s a key part of our quality system.”

Geyer sums it up: “Companies who are leaders in their industry need to take the responsibility to work on quality programs or processes, or technical development. They can`t always wait for customers to demand them. Leaders have to lead, and in the realm of quality and product development or whatever it is, they have to make those hard investments that don`t automatically pay back tomorrow. I think the ISO system has set something up for the future that`s going to keep us in a position of leadership. And that`s where we want to be.”

Precision Clean Products

Precision Clean Products, a Division of Fisher Container Corp., (Evanston, IL), has recently earned the U.S.`s first ISO 9002 certification for the manufacture and flexographic printing of cleanroom products, company officials claim.

Fisher Container`s Precision Clean Division was begun in 1985 to provide low-particulate packaging materials for use in contamination-controlled environments, including semiconductor, aerospace, pharmaceutical, biotech and cleanroom glove, apparel and consumables. Precision Clean Products are manufactured in Fisher Container`s Class 10 cleanroom and shipped to customers through the U.S., the Far East, Europe and Mexico.

Fisher Container president Mike Fisher is an enthusiastic advocate of the ISO 9000 process. His company is approaching its first six-month audit. The company philosophy, he says, is very much in sync with the ideals of quality and consistency underlying ISO 9000.

“Even if I never wrote an additional piece of business from obtaining ISO, that would be fine with me, because of what it did for my company internally. For the first time in the history of my company, every single person really had a very strong understanding of and respect for everybody else`s position, because during the process of us all sitting together — from the person that sits on the bag machine to the vice president — we really got to learn what everybody does, how they are doing it, and how difficult their jobs are. To me that was one of the greatest benefits.”

Very early on, the company made the decision to implement ISO internally, even though hiring consultants would have been considerably quicker, Fisher admits. The entire process took three years. To head up the ISO 9000 effort, Fisher appointed a former colonel in the Indian army who had commanded 30,000 men in the engineering division. He brought “some pretty strict and strong quality programs,” says Fisher, as well as familiarity with their implementation on a grand scale. To help employees write their own procedures, a “template” borrowed from another ISO-certified cleanroom company, located in Australia, was distributed as a test. “We sat down and made a peanut butter and jelly sandwich. We decided amongst the team of us how we would make it — how much jelly, how much peanut butter, white bread. We don`t cut off the crusts, we leave them on, make an angle cut, how to open the jar. After writing this test, we brought in people from all of the divisions and said, `By reading this, would you please follow the instructions.`”

Fisher says after the initial “havoc and mayhem,” everyone jumped on the bandwagon. After evaluating progress after six months, Fisher says, he found that the company had experienced a strong move forward. For over a year now, its suppliers have been asked to move toward ISO compliance, as well. An important benefit was that ISO procedures helped in training employees on the industrial side of the plant to work on the cleanroom side. Fisher says he was “thrilled” when so many people came forward and admitted their newfound respect for the employees who work in the company`s cleanroom. “It is an honor to work in our cleanroom; it is specifically a move up in our company, and we pay higher scales for those who are in the cleanroom because they`ve learned more about our business and industry.”

ISO certification has affected all the other divisions of the company, spawning similar programs in shipping, purchasing, printing, industrial, food and retail. “We obtained the certification for the cleanroom division, which is Precision Clean Products, but the other divisions of my company — because all aspects of ISO touched every single one of them — were running as if they were certified. And that`s an extension of the ISO 9002 we didn`t really contemplate. We`re not going to say, `if it`s a cleanroom shipment, do it this way; if it`s a food shipment, then do it that way.` We`ve said, `Wait, this is all about consistency, so let`s do it all the same way.` It`s much easier in the long run.” He describes the experience as very interesting, educational, and a process that has taken the company to a higher level of performance and accountability.


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