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See also:
You, Your Customers and ISO 9000 -- Part Two
You, Your Customers and ISO 9000 -- Part Three
The International Organization for Standardization (Organisation internationale de normalisation -- ISO) based in Geneva is a worldwide federation of national standards bodies from over 110 nations, one from each nation. This body has developed over 10,000 voluntary, consensus-based International Standards covering just about every field of industrial, economic, scientific and technological activity. ISO sprang from a meeting in London in 1946 to establish a new international association "the object of which would be to facilitate the international coordination and unification of industrial standards." ISO officially opened its doors on February 23, 1947, and the first ISO standard was published in 1951 ("Standard reference temperature for industrial length measurement").The mission of ISO -- a non-governmental body -- is to foster the development of standardization and related activities in the world with a view to facilitating the transnational exchange of goods and services, and to enhancing cooperation in the spheres of intellectual, scientific, technological and economic activity. Industry-wide standardization is a condition existing within a particular industrial sector when the large majority of products or services conform to the same standards. For example, the format for credit cards, telephone cards, and "smart" cards that are now commonplace is derived from an ISO International Standard. Adhering to this standard, which defines such features as an optimal thickness (0.76 mm), enables these cards to be used worldwide.
International standardization results from consensus agreements reached between all economic players in that industrial sector -- suppliers, users, and often governments. They agree on the technical specifications and other precise criteria to be applied consistently as rules, guidelines or definitions of characteristics to ensure that materials, products, processes and services are fit for their purposes. The objective is to facilitate trade, exchange and technology transfer through:
- enhanced product quality and reliability at a reasonable price,
- improved health, safety and environmental protection, and reduction of waste,
- greater compatibility and interoperability of goods and services,
- simplification for improved usability,
- reduction in the number of models, and thus reduction in costs, and
- increased distribution efficiency, and ease of maintenance.
Users place more confidence in products and services that conform to International Standards. Assurance of conformance can be provided by manufacturer’s declarations, or by audits carried out by independent bodies.
The ISO 9000 Standards Series, first issued in 1987 and revised in 1994, describe the elements necessary for organizations to establish and maintain quality management systems. In fact, ISO 9000 is a series of five international standards (9000 through 9004) designed to pilot companies in establishing total quality assurance systems and maintaining product integrity. (These standards are comparable to the Q-9000 through Q-9004 standards promulgated by the American National Standards Institute.) ISO has also released ISO 10011 establishing basic auditing principles as well as general guidelines for establishing, planning, implementing and documenting audits of quality systems. Today, ISO is focusing on the promulgation of the ISO 14000 Standards Series, Environmental Management Standardization (14001,14010, 14011, and 14012).
The ISO is a standards-setting body; it does not have powers of governance or enforcement. Its 110+ member nations (more than 80 of which have adopted the ISO 9000 series as national standards) are significantly less than the full membership of the United Nations. Although in no sense mandatory, its published standards are becoming widely accepted as the common quality management standards of transnational commerce -- an increasingly important consideration in transcending the plethora of local rules and regulations throughout the world.
Briefly, ISO 9000 requires all procedures for total quality management to be fully documented and to be fully understood by all responsible personnel. This includes procedures for identifying, recording and rectifying variances and deviations from standards. It encompasses the procedures for training, upgrading and testing the proficiency for all quality management personnel. The procedures for initiating, testing, documenting and communicating all processing and manufacturing changes and revisions are critical. Of course, the core of quality management is effective internal auditing and timely management action in response to these audits. Equipment calibration and verification is a crucial component of any quality management system. Each responsible quality management employee is to be tested to assure full familiarity with all relevant procedures.
The continued examination of the ISO 9000 registration process will be the focus of subsequent columns.
Your comments and suggestions for these pages are most welcomed!
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Revised: June 3, 1999 TAF
© Copyright 1997, 1999 Thomas A. Faulhaber, All Rights Reserved
