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ISO 9000: the world quality standard.

What is ISO 9000? What are its shortcomings? What can ISO 9000 registration mean for your company and its sales? How does the standard relate to other quality pursuits such as Total Quality Management (TQM) or the more specific Malcolm Baldrige Award? Finally, if you decide to pursue registration, who can you approach for assistance, education, or compliance?

First published in 1987 by the Geneva-based International Organization for Standardization, the ISO 9000 series quality standard has been accepted by more than 90 countries as their national standard, including the United States (designated as ANSI/ASQC Q90 series) and the European Community (labeled the EN 29000 series).

The series consists of five manuals that describe the elements for establishing or maintaining quality management systems:

ISO 9000. The first manual, Quality management and quality assurance standards--Guidelines for their selections and use, provides an overview of the entire standard series. It describes quality concepts and serves as a guide to which quality models to use.

ISO 9001. Model for quality assurance in design/development, production, installation, and servicing is to be used when conformance to specified requirements is to be assured by the supplier during several stages, which include design/development, production, installation, and servicing.

ISO 9002. Model for quality assurance in production and installation is used when conformance to specified requirements assured by the supplier is limited to production and installation.

ISO 9003. Model for quality assurance in final inspection and test is used when conformance to specified requirements is to be assured by the supplier solely at final inspection and test.

ISO 9004. Quality management and quality system elements--Guidelines is used for developing and implementing an internal quality system for design and manufacturing. Also provides insight into the other ISO 9000 standards.

Registration of a company's quality management system is only achieved through compliance with ISO 9001, 9002, or 9003. Reading ISO 9000 and listening to your customers can help you decide which of the three are best suited to your business needs.

What ISO 9000 is

The standards provide a comprehensive listing of basic elements essential for maintaining an effective quality management system. Because the standards are generic--not specific to any particular products--they are applicable to companies of all types and sizes in manufacturing and service industries alike.

Simply put, a company that is registered as complying with ISO 9000 standards has demonstrated (to an accredited third-party auditor) that it has documented its processes and is systematically verifying the results of those processes. The standard does not, in any way, dictate what a process should consist of or how often it should be checked.

A company already engaged in a quality program such as TQM or in pursuit of the Malcolm Baldrige Award may find it is ahead of the game in achieving ISO 9000 registration. It may simply need to document what it is already doing and demonstrate that it has a system in place to assure adherence to its own procedures. Others, who have no formal program in place, can use the ISO 9000 guidelines for establishing a quality system that is compliant with the standard. Later, the company can use its ISO 9000 registration as a foundation in pursuing loftier quality goals.

What ISO 9000 is not

Contrary to what some people have been led to believe, ISO 9000 is not a product standard. It is, quite literally, a standard for quality measurement systems. It is an organization's quality management system, not its product, that is registered to ISO 9000 standards.

The ISO 9000 standards are not, and were never intended to be, the ultimate in quality management. In fact, internationally, they are viewed as the minimum standards for quality systems. Quality award programs, such as the Malcolm Baldrige Award and the Deming Prize, and TQM programs have much more demanding requirements.

Because ISO 9000 is not a product-quality standard, there has been considerable debate as to the value of ISO 9000 registration. Opponents of the standard remind us that it's entirely possible that two ISO registered companies could provide us with products vastly different in terms of quality. For example, one manufacturer of widgets could decide its process will consist of aligning the widget machine once a year and measuring every 100th widget off the conveyor using a straight-edge scale. Another widget manufacturer might use in-process gaging on the widget machine and measure every widget off the conveyor with a CMM. There is little question as to which company has made a greater quality investment in its products, yet it's entirely conceivable that both companies could be ISO 9000 registered. Far fetched? Then consider the fact that many of the countries that have adopted ISO 9000 have not acquired the technology necessary (such as in-process gaging and CMMs) to build products with quality equal to those of the major industrial powers.

For reasons such as these, the deputy assistant secretary of defense for production resources, Nicholas M Torelli, Jr, recently told the military services and the Defense Contract Management Command (DCMC) that the ISO 9000 series of quality assurance standards "are not adequate for use without significant supplementation" and "should not be cited in DOD contracts as a substitute for MIL-Q-9858, MIL-I-45208, or the inspection for supplies clause."

Business considerations

Regardless of whether you view the ISO 9000 standards as an opportunity to establish a quality system, improve your existing system, or merely as a means of documenting your existing system, you have to consider what compliance will mean to marketing your company's products in today's global economy.

At present, the standards are considered voluntary because no country is required to adopt them and no customers have to recognize them. However, compliance with the standards may be required by any customer at any time without it being considered a restraint of trade under the General Agreement on Tariffs and Trade (GATT). Thus, any efforts our government is making in opening up trade in European and Asian markets may be ineffectual if customers in those countries require ISO 9000 registration and US manufacturers are unable to demonstrate compliance.

Remaining competitive seems to be at the top of the motivation list for most companies contemplating or actively pursuing ISO 9000. Dr Kurt Nordlund, director of marketing, and Ms Debbie Svennevik, manager of quality engineering, Carboloy, stated that while their company is already certified under Ford, GM, and Chrysler quality programs, they still see ISO 9000 certification as the only certain way of remaining competitive in the world marketplace. "Our European plants are seeing more and more of their customers inquiring about the kinds of certification they have and who the certifying body was... where this wasn't even mentioned a couple of years ago," says Dr Nordlund.

Even if your company has no intention of selling abroad, some of your customers may. Dave Redding project manager of the ISO 9000 program at Cincinnati Milacron's Electronics Div, told us that more than a year ago many of its contract manufacturing customers in the United States "were telling us that we should establish a high priority on becoming ISO 9000 certified."

If the company you are selling to is ISO registered, there is a good chance that it will require its suppliers to be ISO registered. One of the quality system elements in the ISO 9001 and 9002 standards is quality in purchasing. A company seeking certification under these standards must be able to demonstrate it has a procedure for procuring "defect-free" components. One way to demonstrate conformity is to require that all suppliers be certified. Obviously, if your company is not certified, it will be at a disadvantage when bidding against a competitor who is certified. "Where a company has had a long standing relationship with a supplier, they are probably not going to just cut the supplier off," says Ms Svennevik, "but you can be sure they will be urging their supplier to obtain certification as soon as possible."

Selecting a registrar

If your company decides to pursue ISO 9000 certification, one of the first things it should do is decide on a registrar. During the pre-assessment phase, the registrar can provide you with a checklist that explains how your company will be evaluated, the kinds of things that will be audited, and the kinds of things the auditor will be looking for in your system. While the registrar cannot help you set up your program or assist you with implementing it, the auditor can provide a list of companies that provide training and certification program assistance.

Unfortunately, at present, the task of selecting a registrar is not as simple as merely flipping through the "R" section of the yellow pages. Being fully versed in the requirements of ISO 9000 and being a certified registrar is not enough. The registrar your company selects should also understand the needs of your industry and companies your industry serves. Without a working knowledge of your industry, the registrar will have no way of judging whether or not your written procedures are adequate.

Also, the registrar should be recognized by the companies you do business with. Without this latter assurance, it is possible that a company could become ISO 9000 certified and still not be acceptable to its customers. There is a perception among many of the companies we spoke with that unless your registrar has Memorandums of Understanding (MOU) with an established European certifying bureau, your certification may not be acceptable to some European companies.

Who the registrar was certified by was certainly a major consideration in Cincinnati Milacron's selection of Quality Management Institute (QMI), Toronto, Canada as its registrar. QMI has MOUs with several European agencies such as British Standards Institute. And though its registrar is QMI, Cincinnati Milacron is requesting dual certification with BSI.

Traceability to a European standards bureau was also an important consideration for Allen-Bradley. With 21 of its facilities already registered, Allen-Bradley has dealt with several registrars in the United States, Canada, and the United Kingdom. All of the registrars were certified by or had MOUs with European standards organizations. Before finally deciding on a registrar, a company would be wise to ask its customers which ISO 9000 facility registration certificates they will accept.

ISO costs

The costs associated with ISO 9000 are sizable both in terms of time and money. "It's every bit as large in scope as launching a new product line," says Dick Bowler, national service manager, Marposs. "Our parent company in Italy has just completed its ISO registration program and is awaiting its final audit scheduled for June." Like many of the companies we spoke with, Marposs reported that 18 months from inception to certification is pretty common.

"A 50-employee shop could be registered in nine months, but this would require a large amount of management time. A more typical schedule is 18 months," says Ralph J Teetor, president of Foundry Quality Systems, a company that offers consulting services to help companies meet ISO 9000 requirements.

Writing for the November, 1992 issue of INCAST, Mr Teetor presented a very thorough analysis of the internal and external costs associated with ISO 9000 preparation and registration. In the article, Mr Teetor takes a typical 100-employee plant and itemizes expenses such as QA manager's time, training, manual review, travel expenses, etc. His analysis reveals that the 100-employee plant will spend at least $36,050 and as much as $206,098. Of course, larger plants and companies with multiple plants will spend proportionately more.

Where to get help

ISO 9000 is a hot topic in quality circles these days. As a result, it's easy to find sources of information and training on ISO 9000 ranging from books, videos, computer programs, and seminars, to courses at you local community college.

To start, you can contact ANSI or ASQC (see "Standards information" sidebar) for copies of the standard, a list of accredited registrars, and a variety of brochures and pamphlets created to help you understand the requirements of ISO 9000 and plot a course of action.

More than once while conducting interviews for this article, people recommended Quality System Update by CEEM Information Services, 10521 Braddock Rd, Fairfax, Va 22032-2236. The newsletter lists companies that are registered, who the registered certification companies were, and a range of useful information relative to quality standards.

Most major trade associations (see "Standards information" sidebar) conduct seminars on ISO 9000 and offer a variety of publications dealing with the standard. Many of the publications include a list of accredited registrars, training providers, and other sources of information.

Magazines such as our sister publication, Quality In Manufacturing, carry a variety of articles on ISO 9000. Also, you'll find many ads dealing with ISO 9000--books, videos, computer software, consulting services, and training providers.

Many colleges and junior colleges offer training on ISO 9000 orientation and implementation. Typical of what junior colleges have to offer can be found at Lakeland Community College, Mentor, OH. The college offers a low cost, week long program that trains participants in all facets of ISO 9000. Upon completing the course, participants are fully knowledgeable about the standard, have learned internal auditing techniques, are competent to audit subcontractors and suppliers, are able to prepare their organizations for ISO 9000 certification, and understand the economic advantages of the ISO quality management systems.

Steps to registration

In its series of satellite broadcasts last fall, Allen Bradley outlined a multi-step program for achieving ISO 9000 registration. Regardless of the type or size of a company, the following activities are typically required to successfully achieve registration:

Obtain management commitment. The key to success is management's belief in the value of registration to ISO 9000 standards and its resolve to devote the time and resources necessary to achieve it.

Designate a steering committee. These employees will have the responsibility and authority to develop a detailed plan of action and will manage it to completion.

Train personnel. A core group of employees must be well-trained in the auditing techniques appropriate for the selected ISO 9000 standard.

Select an accredited registrar. Registration is obtained only through third-party assessments done by organizations accredited as qualified to evaluate a company's quality system.

Schedule final audit date. Because the final audit will be very comprehensive, adequate time should be allowed for full preparation.

Educate entire staff. Conduct awareness sessions with all personnel to explain ISO 9000, what it is, why it's important to the company, how it will affect each person's work, and what the benefits will be.

Analyze current situation. Document existing policies and procedures, compare them with ISO 9000 requirements, and identify all deviations and deficiencies.

Create a quality plan. Determine and implement all measures necessary to eliminate differences between current procedures and ISO 9000 guidelines.

Simulate an ISO 9000 audit. Check effectiveness of new procedures by having staff members conduct a formal audit according to ISO 9000 guidelines.

Correct problems. Implement adjustments needed to eliminate any deficiencies revealed by the pre-audit.

Have registrar conduct pre-audit (optional). A preliminary audit determines readiness for the final audit and can help clarify specific requirements.

Correct problems. Implement adjustments needed to eliminate any deficiencies revealed by the pre-audit.

Have registrar conduct final audit. Third party auditors conduct an on-site assessment of your quality system.
COPYRIGHT 1993 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

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Title Annotation:includes related articles
Author:Stovicek, Donald R.
Publication:Tooling & Production
Article Type:Cover Story
Date:Apr 1, 1993
Words:2532
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