A Standard for All Industries.

• Author: VAN HOUTEN, GERRY

THIS ARTICLE DISCUSSES

* How records and information managers can participate in their organizations' quality management processes

* Why he revised standard is more accessible and applicable to RIMs beyond the manufacturing industry

* What changes have been incorporated in ISO 9001:2000

ISO 9001:2000 is an internationally recognized quality management system (QMS) standard affecting thousands of organizations around the world. A new version, which is scheduled for publication in late 2000, will replace ISO 9001:1994 and will have both a new look and a new scope as its image as a purely manufacturing standard is eclipsed and it becomes more acceptable to other sectors. Late 2000 will be the start of a busy period for anyone directly involved in an organization's ISO 9001 certification activities. One of the disciplines affected will be records and information management (RIM).

Provided they take a proactive role, information management professionals will find significant new opportunities to participate more fully than ever before in their organization's quality management processes. The focus of these opportunities lies in the area of documentation of an organization's processes and its related information and records systems.

This overview of the new standard should be a call to information managers in all sectors to look carefully at the standard to begin to understand its implications for them.

The final draft of ISO 9001: 2000, Quality Management Systems -- Requirements, was issued on February 22, 1999. Its adoption will continue to have a major influence on the manufacturing industry where it has long been accepted as the benchmark of quality management. The standard's most significant change is its potential applicability to industries other than manufacturing.

This article has a dual focus. First, it outlines the main elements of the agreement reached on a new version of ISO 9001. Second, it examines the new standard's impact on information management professionals.

While some service and software industries had already adopted ISO 9001, most organizations in these industries declined in the beginning to treat ISO 9001 seriously. They justified their lack of interest on the grounds that the standard was applicable only to manufacturing quality management systems.

The more generic and expanded character of ISO 9001:2000 clearly challenges this view. The strong manufacturing bias reflected in the content and structure of both the original 1987 standard and its 1994 revised version is now a thing of the past. Service and software organizations are likely to face increasing pressure to measure the quality of their organizations against the benchmarks outlined in ISO 9001:2000.

Background and Future of ISO 9001:2000

ISO 9001 serves as the basis for benchmarking an organization's quality management system. Quality management should not be confused with terms such as quality assurance" or quality control. Quality management measures the overall management function in determining the organization's quality policy, its objectives, and its responsibilities, as well as the quality policy implementation through means such as quality assurance and quality control. Quality assurance measures all planned and systematic activities implemented within the organization's quality system. Quality control is the operational techniques and activities used to fulfil quality requirements (e.g., meeting a customer's specifications or requirements for a given product or service).

Revision of the ISO 9000 standards has been under discussion for a number of years. Soon after the 1994 revisions, ISO Technical Committee 176 began the task of overcoming the standard's manufacturing bias while, at the same time, overcoming other persistent criticisms that the standard did not adequately cover all aspects of the QMS.

The development of ISO 9001:2000 has been a particularly interesting process to behold. It is an object lesson in consensus building. ISO Technical Committee 176, with the participation of various national standards bodies, has actually managed to overcome criticisms from apparently opposite directions and written a document that appears to be acceptable to the great majority of ISO's member bodies.

The manufacturing industry criticized the older versions of ISO 9001 for its failure to include a large range of quality management requirements in the standard. Some manufacturing industries considered ISO 9001 to be so inadequate that they developed their own expanded, industry-specific versions of the ISO 9001 standard. ISO was also criticized by non-manufacturing industries for catering to the manufacturing industries. Everything about the older versions of ISO 9001 seemed overwhelmingly rooted in a manufacturing environment.

The ISO technical committee found itself in a dilemma and then found a way out. ISO 9001:2000 appears to have actually reached a satisfactory compromise in which the language is generic enough to be applicable to industries other than manufacturing yet specific enough to satisfy the particular concerns of the manufacturing industry.

ISO Technical Committee 176's objective was to overcome the apparent conflict between the manufacturing industry's specific requirements and the demand to make the standard more accessible and more clearly applicable to other industries. This objective also led to changes in the structure and organization of what used to be a series of standards and guidelines. ISO 9001:2000 will replace all three 1994 standards (9001, 9002, and 9003). Once ISO 9001:2000 is published, ISO 9002 and ISO 9003 will become obsolete.

All organizations will have to fulfill all the requirements in ISO 9001:2000. A requirement is now inapplicable only if the function or activity it describes is not performed at all. In other words, organizations that may have certified under ISO 9002 to avoid including design and development activities in the scope of their certification can no longer do so. If they perform design and development activities, these activities must be included as part of the ISO...