WHAT IS QUALITY?

Quality improvement has now become both the corporate and international business strategy of the 1990's. Cadillac and Milliken and Company each advertise winning the Malcolm Baldrige Award for quality. Ford Motor Company publicizes a " Quality is Job 1 " slogan, and many other companies are following suit. At the international level, interest has mushroomed in quality systems as a means of assuring the consistent conformity of products or services to a given set of standards or expectations.

There has, however, been little agreement among either corporate management or professionals in the field regarding the meaning of "quality." The International Organization for Standardization (ISO)Standard 8402 defines quality as: "the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs." However, there are problems with this definition. Whose needs does the service or product address? Who are its customers? In the testing services field, for example, totally erroneous test results may satisfy a client's needs quite well if the faulty test report can be used to allow him to sell his product, especially if an accurate test report would not. Nevertheless, such results are unlikely to satisfy the needs of the potential buyers of the product or of the agency responsible for regulating the product.

Customers for a product or service produced by a company can be located within or outside the company or both, depending on the product or service. A product or service may be provided by one company unit to another solely for the latter's use, or for subsequent delivery to a customer outside the organization. It has been said that most product or service defects (no matter where they occur in the service or manufacturing process) usually find their way to the point of interface between a company and its outside customers.

In an attempt to address this problem, ISO has added seven footnotes to its definition, including that: "in a contractual environment, needs are specified, whereas in other environments, implied needs should be identified and defined" and that " needs can change with time." Needs can be defined in terms of safety; usability; availability; versatility; compatibility with other products; reliability; maintainability; overall cost (including purchase price, maintenance costs, and product life); environmental impact; or other desired characteristics.

Even if all "needs" can be identified and adequately defined (often no easy task), what about the issue of an "acceptable quality level (AQL) " -- the maximum percentage of nonconforming products or service units that should be considered satisfactory as a process average? Stated in other words, how many (if any) mistakes can you make and still produce a " quality" product or service? A manufacturer's production system may be considered by his customers to produce a " quality" product if the AQL is 0.1%, that is only one in 1,000 products contains defects. Yet a 1 in 1,000 error rate for nurses whose job it is to hold babies (they only drop one out of a thousand) or for containers which hold highly toxic or hazardous materials (only one serious leak gets by for every 1,000 containers produced) are obviously not acceptable. There is a belief among many quality experts and their disciples that the only acceptable quality level for any manufactured product or service is 100% ("zero defects" ), and that any failure to "do it right" the first time is not tolerable. This is not a universally held opinion.

WHAT IS A QUALITY SYSTEM?

Product quality depends on many variables, such as the caliber of the components or materials used; type of equipment used in design, production, handling, installation, testing and shipping; the equipment calibration and maintenance procedures employed; the training and experience of production and supervisory personnel; the level of " workmanship;" and sometimes the environmental conditions (temperature, humidity, level of dust particles) in the area where the product is produced. The process, organizational structure, procedures, and resources that manufacturers and suppliers use to control these variables to produce a product of consistent quality which meets defined specifications is called a quality system. The ISO Standard 9000-1987 defines quality systems as: "the organization, structure, responsibilities, procedures, processes, and resources for implementing quality management. The standards that are being adopted globally for quality systems are the ISO 9000 standards.

WHY AND BY WHOM WERE THE ISO 9000 STANDARDS DEVELOPED?

The International Organization for Standardization (ISO) is a worldwide federation founded in 1946 to promote the development of international standards and related activities (including conformity assessment) to facilitate the exchange of goods and services worldwide. ISO is composed of member bodies from over 90 countries, the U.S. member body being the American National Standards Institute (ANSI).

In 1979, ISO formed Technical Committee (TC) 176 on Quality Management and Quality Assurance to address the worldwide trend towards increasingly stringent customer demands with regard to quality combined with growing confusion in international trade resulting from differing national and subnational quality system requirements.

In 1987, based on the work of TC 176, ISO published the ISO 9000 Standard Series on quality management and assurance. These standards were based on considerable input from a number of countries, especially the United States (U.S.), Canada, and the United Kingdom (U.K.). In particular, the ISO 9000 standards were based in large part on the British Standards Institution's BS 5750 Series, Quality Systems.

HOW WAS BS 5750 DEVELOPED?

In 1959, the U.S. Department of Defense (DOD) established a Quality Management Program with the designation of MIL-Q-9858. Four years later, it was revised to MIL-Q-9858A - its only revision to date. In 1968, the North Atlantic Treaty Organization (NATO) essentially adopted the provisions of MIL-Q- 9858A, Quality Program Requirements, in the form of Allied Quality Assurance Publication 1 (AQAP-l). In 1970, the U.K.'s Ministry of Defence adopted the provisions of AQAP-1 as its Management Program Defence Standard DEF/STAN 05-8. In 1979, the British Standards Institution (BSI) developed the first commercial quality management system standard, known as BS 5750. >From these predecessors, ISO created the ISO 9000 Standard Series in 1987 - essentially adopting most of the elements of BS 5750. That same year, the ISO 9000 standards were adopted in the United States as the ANSI/ASQC (American Society for Quality Control) Q90 Standard Series; and BS 5750 was revised to be identical to the ISO 9000 standards. NATO is currently revising its quality system standards to incorporate the ISO 9000 standards.

WHAT ARE THE ISO 9000, ANSI/ASQC Q 90, AND CEN/CENELEC EN 29000 STANDARDS?

In 1987, the ISO published a series of five international standards (ISO 9000, 9001, 9002, 9003, and 9004), developed by ISO Technical Committee (TC) 176 on quality systems. This series, together with the terminology and definitions contained in ISO Standard 8402, provides guidance on the selection of an appropriate quality management program (system) for a supplier's operations.

The ISO 9000 standards were intended to be advisory in nature and were developed primarily for use in two-party contractual situations or for internal auditing. However, the standards are currently being applied under a much broader range of conditions and circumstances. In some cases, compliance with one of the ISO 9000 standards (or their equivalent) has been or will be mandated by a U.S., foreign national, or regional government body. Conformance to ISO 9000 standards is also being required in purchasing specifications with increasing frequency.

The ISO 9000 Standard Series has been adopted in the United States as the ANSI/American Society for Quality Control (ASQC) Q 90 Series (soon to be changed to the ANSI/ASQC Q 9000 series). In Europe, it has been adopted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) as the European Norm (EN) 29000 Series. According to a recent survey by ISO, forty-eight (48) countries have national standards that are identical or equivalent to the ISO 9000 Standard Series. Additional countries are considering their adoption.

DOES THE ANSI/ASQC Q90 STANDARD SERIES DIFFER FROM THE ISO 9000 STANDARD SERIES?

ISO 9000-9004 and ANSI/ASQC Q90-94 are technically equivalent. However, the ANSI/ASQC Q90 Series has been modified to incorporate customary American language usage and spelling. Some supplementary guidance on sampling and other statistical methods and product liability and user safety has also been included in the appendices to ANSI/ASQC Q94. ASQC is planning to renumber the ANSI/ASQC Q90 Series as the ANSI/ASQC Q9000 series to clearly indicate their equivalency to the ISO 9000 Series.

WHAT STANDARDS MAKE UP THE ISO 9000 FAMILY?

The ISO 9000 Standard Series is generic in scope. Each standard addresses a different aspect of quality assurance, depending on the needs of the user.

ISO 9001, 9002 and 9003 describe three distinct quality system models of varying stringency for use in different applications. Common elements in ISO 9001, 9002, and 9003 include the need for: an effective quality system; ensuring that measurements are valid, that measuring and testing equipment is calibrated regularly; the use of appropriate statistical techniques; having a product identification and traceability system; maintaining an adequate record keeping system; having an adequate product handling, storage, packaging and delivery system; having an adequate inspection and testing system as well as a process for dealing with nonconforming items; and ensuring adequate personnel training and experience.

ISO 9000-1: 1994 Quality management and quality assurance standards-Part 1: Guidelines for selection and use.

ISO 9000-2:1993 Quality management and quality assurance standards-Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003.

ISO 9000-3:1991 Quality management and quality assurance standards-Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software.

ISO 9000-4:1993 Quality management and quality assurance standards -- Part 4: Guide to dependability program management

ISO 9001:1994 Quality system-model for quality assurance in design, development, production, installation and servicing.

ISO 9002:1994 Quality system-model for quality assurance in production, installation and servicing.

ISO 9003:1993 Quality Systems-Model for quality assurance in final inspection and test.

ISO 10011-1: 1990 Guidelines for auditing quality systems. Part 1: Auditing.

ISO 10011-2: 1991 Guidelines for auditing quality systems. Part 2: Qualification criteria for quality systems auditors.

ISO 10011-3: 1991 Guidelines of auditing quality systems. Part 3: Management of audit programs.

ISO 10012-1: 1992 Quality assurance requirements for measuring equipment-Part 1: Metrological confirmation system for measuring equipment.

ISO 10013 Guidelines for developing quality manuals.

ISO/TR 13425 Guidelines for the selection of statistical methods in standardization and specification.

ISO 8402:1994 Quality management and quality assurance-Vocabulary

WHAT IS QUALITY SYSTEM REGISTRATION?

Quality system registration or approval (sometimes misnamed "quality system certification ") involves the assessment and periodic audit of the adequacy of a supplier's quality system by a third party, known as a quality system registrar. When a supplier's system conforms to the registrar's interpretation of an ISO 9000 standard, the registrar issues the supplier a "certificate of registration." Interpretations of an ISO 9000 standard may not be consistent from one registrar to another.

Note that the supplier's quality system is registered, not an individual product. Consequently, quality system registration does not imply product conformity to any given set of requirements. Registration programs can be conducted in conjunction with or independently from a certification program. Registrars may or may not concurrently operate a product certification program.

WHO EVALUATES QUALITY SYSTEMS?

A manufacturer may choose to evaluate his own quality system. Such self-audits are usually major components of the quality system itself. Such self-audits can increase the confidence of management in its production system and demonstrate to its personnel that the firm is committed to quality management.

"Second party" evaluations are also common. In these cases, it is usually the buyer who requires and conducts quality system evaluations of his suppliers. These evaluations are mandatory only for companies wishing to become suppliers to that buyer.

"Third party" quality system evaluations and registrations may be voluntary or mandatory and are conducted by persons or organizations independent of both the supplier and the buyer. According to a recent ISO survey, 31 countries reported the existence of one or more third party registration schemes in their countries.