ISO 9000: A Guide to world-class quality standards

ISO 9000: A guide to world-class quality standards Hospital Materiel Management Quarterly; Rockville; Feb 1997; Stephen F Tambolas , Vol. 18, Issue 3, pp’s 62-68. ISSN 01922262, Aspen Publishing

NO TOPIC IN THE 1990s, outside of managed care contracting, has generated more interest and activity among health care providers than quality: quality control, quality assurance, continuous quality improvement, total quality management, quality systems, Joint Commission on the Accreditation of Healthcare Organizations quality standards, etc., etc. The focus of quality management has quickly evolved to the engineering of continuous quality improvement throughout all processes (quality systems) measured by consistent and predictable outcomes. While this started in clinical areas, support functions, including materiels management, are feeling the pressure to keep pace. This is because it is impossible to embark on a path of continuous quality improvement without moving up the chain to all internal and external support systems and vendors. Health care providers are now finding their quality programs being scrutinized by someone else, usually managed care providers, who view them as vendors. While this may all appear to be quite a revolution in quality management, health care is simply following another well-established industrial paradigm. Just ask Ford Motors or General Motors (or any other well known industrial company), where formal supplier certification, including reviews of quality management, is an established routine of doing business.

The process of supplier certification by health care organizations has, up to now, been superficial, haphazard, or outright neglected. The foremost reason for this being the unique existence of government [Food and Drug Administration (FDA)] regulations concerning medical products fitness for use and/or consumption. These regulations were viewed somewhat as a guarantee of product quality, leaving providers free to choose products based upon other factors such as price and usage characteristics. However, documented failures of products whose prototypes and designs received pre-market FDA approval are rather common. Product failures demonstrate that government regulations alone do not guarantee consistent manufacturing quality. Nor do they guarantee that manufacturers will ever improve upon the minimum standards that allow a product initial entry into a medical market.

Health care providers today are seeking suppliers genuinely committed to the concept of continuous quality improvement for all aspects of a product's life cycle, including end use by the customer. Obviously, by picking these companies as suppliers a company can better assure that its own quality level will improve. The idea is simple enough: find and partner with suppliers dedicated to improving their product(s). But, how does a company find out which suppliers are really doing their best to improve quality? How does it find out which suppliers are engineering continuous quality improvement into all of their processes? It seems that when a vendor is asked if they're committed to quality the answer is always a yes.
Fortunately, we don't have to take their word for it. And we don't have to create complex vendor quality questionnaires, site visits, or other certification activities surrounding quality. Someone else has already done the work. ISO 9000, a broad series of standards made up of many quality system elements, provides a company with the tools necessary to design, document, and implement a quality system that, once implemented, is certifiable by independent auditors and recognized throughout the world. A company certified in one or more ISO 9000 standards has been audited, registered, and provided with documentation assuring its level of commitment to quality improvement. Understanding the full ISO 9000 process, which is already widely adopted in Europe, Asia, and the U.S., can greatly benefit anyone working to improve supply chain quality. In fact, ISO 9000 certification is a requirement to market some regulated products in the European community.

THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

Since 1946, ninety member countries have run the International Organization for Standardization (ISO) in Geneva, Switzerland. The United States is represented in this body by the well-known American National Standards Institute. ISO establishes, publishes, and maintains international standards for manufacturing, trade, and communications. Among these are the broad series of quality standards referred to collectively as ISO 9000, first published in 1987.

To obtain ISO 9000 certification, a company is required to: (1) document their quality processes in quality manuals, policies, procedures, work instructions, and records; (2) actually do what the documentation says; (3) keep records of what happens; (4) look at what happens and measure it against expectations; and (5) take action when performance doesn't meet expectations. Companies then prove that they actually do these by being audited and certified by a quality system registrar, an independent company whose function in quality management is analogous to a financial auditor in matters of accounting.

THE 9000 SERIES

ISO 9000 is actually five separate series of standards, which are further divided into two categories: guidance and conformance. The guidance standards, 9000-1 and 9004-1, are sometimes referred to as the road maps to the conformance standards. That's because they are informational guides to help a company accomplish the implementation of the conformance standards: 9001, 9002, and 9003. Companies certify to the conformance standards, but not to the guidance standards. If a company wished to begin the process of certification, a good place to start would be obtaining a copy of one or both of the guidance standards. These provide written outlines and details of the conformance standards to assist a company in deciding which of the conformance standards apply to its particular market(s) or product(s).

The most comprehensive conformance series is 9001. An outline of the 9001 requirements is contained in the Appendix. These requirements cover every aspect of a product starting with management responsibility, to product design, through aftermarket service, statistical techniques, and the contracting processes used with customers. Companies certifying to 9001 have touched on quality at every level of a product's development, sales, and service. Manufacturing and some service companies would normally select 9001.

Almost as comprehensive is the 9002 series. However, these ignore product design. Often, plants or companies that choose 9002 build to specifications developed elsewhere. An example is companies that subcontract to build assemblies and parts used in another company's product. Or, a company with multiple plants may certify one plant to 9002 and another to 9001 depending upon the particular location's activities. One central location will likely carry on all design activities, while production may be worldwide. Another example, very pertinent to health care, is the refurbishment, sometimes referred to as remanufacturing, of high-tech equipment. Firms involved in this area often perform every aspect of equipment manufacturing and servicing except the original design. Hence, the need to certify product design processes is not always present. When buying equipment, informed buyers should know where and when design processes occurred as well as manufacturing.

Least comprehensive is 9003, which deals with problems found during final inspection and testing. It is sometimes referred to as a good, old fashioned quality-control program. Companies that do not make anything, such as distributors, can use 9003. These firms' services can be less complex and thus rated using inspection and testing.

THE AUDIT PROCESS

Once a company has implemented the entire series for a particular standard, they are audited by a third party company called a registrar. Firms begin dealing with their registrar as soon as they decide to embark on obtaining 9000 certification. The registrar can assist them with pre-certification audits that reveal how far they need to go to achieve their goal. It has been estimated that it takes a firm, on average, a little over one year to prepare for their first audit. However, some companies are able to do this in as little as six months. The difference is the strength of their existing quality systems prior to embarking on the 9000 path.

Registrars audit a firm on every applicable standard and issue certificates of approval to companies that meet or exceed all standards. Firms may receive a conditional approval for minor deficiencies, but quality systems that do not meet all of a standard's elements are not approved. Typically, companies are registered for a period of three years, though this can be changed with different registrars. If minor problems exist that need attention, but do not warrant disapproval, the registrar may conduct periodic surveillance audits to monitor and assure progress. Once certified companies can copy registration certificates and provide them to customers and other interested parties. Thus, an objective proof of a defined quality process is obtainable.

Just as faith in the integrity and capabilities of a financial auditor is required to believe his or her evaluation of a client's financial statements, so is the need for faith in the quality system registrar's ability to ascertain a company's adherence to a particular ISO 9000 standard(s). The key to the system is confidence in the audit firm. The reliance on ISO 9000 by many of the world's leading firms is possible due to an accreditation process to which the audit firms themselves are subject. Not all audit firms are accredited, however, and it is a caveat emptor, buyer beware, world. In the United States the accreditation body, also called the authoritative body, is known as the Registrar Accreditation Board. In Europe, several other reputable boards exist, including RvC (Dutch abbreviation for the Dutch Council for Certification) and the National Accreditation Council for Certification Bodies (NACCB). While this writer is not familiar with any specific examples of registrars falsely or carelessly certifying poor quality programs, it is still recommended that the authoritative body of a company's registrar be known prior to accepting his or her certification as proof of compliance with series 9000 requirements.

The entire world is moving on a path that leads to ongoing improvements in quality. The need to communicate and verify a company's quality activities has led to worldwide standards that are verifiable by independent third parties. No doubt, even these standards will improve over time. Purchasers of equipment and supplies owe it to their companies to learn more about the ISO 9000 process. Dun & Bradstreet has been found to be a good source. In fact, several of their publications are listed as Suggested Reading in this article. In addition, they can provide a current database of every company in North America with ISO 9000 certification. However, the best information will come when specific questions concerning a company's commitment to quality are found in every request for proposal.

SUGGESTED READINGS

The Road to Quality . . An Orientation Guide to ISO 9000 (lst ed.). Fairfax, Va.: Irwin Professional Publishing, 1995.
ISO 9000 Information Guides, Series 1, CEEM Information Services. Fairfax, Va.: Dun & Bradstreet Information Services.
ISO 9000 Information Guides, Series 2, CEEM Information Services. Fairfax, Va.: Dun & Bradstreet Information Services.
ISO 9002 Certification and Reconditioned Medical Equipment, Wayne Tschirn, MED Medical Electronics, December, 1995.

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