The business world is buzzing about the next revision of the ISO quality system standards, to be called either ISO 9000:2000 or ISO 9000:2001, depending on when it is finally released. This revision has polarized observers, with factions either condemning or supporting the draft. One side asserts that the simplicity of the current version has been convoluted by the addition of explanations, subcategories, and department-specific requirements; the other, that it is insufficient to handle the needs of their specific industries. To avoid falling victim to the adversarial mood that usually accompanies major change, you should try to objectively assess the current ISO 9000 quality standard, analyze the proposed changes, and determine the possible effect of those changes on your business or industry.

After undertaking just such an assessment, I have concluded that revising and updating the quality standard is necessary if it is to remain an integral part of the business world. Revision allows the standard to keep up with the changes in business and accommodate both new and established industries. But this process of revision will only work well if those affected by the changes submit their concerns and considerations to the committees who are now creating the document.

Industry-specific groups continue to translate the standard to provide a unique interpretation for their own needs. The automotive industry has QS 9000, the aerospace industry has AS 9000, and many other groups are seeking to customize the standard to their needs. However, these customizations have diminished the nature of ISO 9000 as a standard, forcing us to adhere to a multitude of quality standards. With each new standard comes a bureaucracy to monitor it. Companies increasingly must comply with multiple quality systems and different agencies dictating different interpretations, training, methodologies, multiple audits, higher costs, and more time. In the process, the initial focus of ISO 9000–meeting customer expectations, at the right cost, on time, the first time, and at a profit–becomes obscured.

It was with these issues in mind that the ISO technical committee (TC) 176 began to rewrite the ISO 9000:1994 standard. In March 1999, the committee released its second revision to allow all stakeholders a chance to contribute to the amendment of the standard. The stakeholders are not simply managers, quality professionals, engineers in particular industries, but everyone concerned about the quality of the goods and services they provide or receive.

The challenge set forth to stakeholders is, What should one be doing to improve the system and quality? What must be or can be accepted? What do we want in the next millennium for our quality systems? Is the number of standards getting out of control, or is it unavoidable? Is it better to have one system, or are the QS 9000, AS 9000, TE Supplement, TL 9000, TickIT, and others still under development a better choice? Can one system work for all industries? It is now up to all of us to make our interests known by reading and commenting upon the ISO 9000 draft revision.

The current working draft of ISO 9000:2000 is significantly different from the current system. While covering the same ground, the five basic documents, ISO 9000 through 9004, have been condensed into three, as follows:

The present ISO 8402 standard for the definitions of quality terms has been merged into the series, replacing the original ISO 9000 document. The instructions for the application of the 9001­9004 series of standards in the current version of 9000 will no longer be necessary.

The structure of the original series was novel and logical in its graduated structure, but it never seemed to work as intended. For some reason, the notion that ISO 9001 was better than ISO 9002, which was in turn superior to ISO 9003, prevailed. The new structure may not be as elegant as ISO 9000, but it is certainly functional and reflects how the series is really used.

The current ISO 9000 standard is excellent; it is concise and simple, and addresses the essential quality issues. It is universal enough to be applied internationally, regardless of culture, nationality, product, industry, or size. If applied correctly, with proper support, it provides an excellent model for a solid quality management system.

Given these facts, many supporters of the current standard were greatly disturbed by the proposed changes. To them, the standard is sacrosanct. But after actually reading the proposed changes, many of these die-hards have come to admit that they have been a bit reactionary. Their change of heart came after asking the following questions:

In fact, a thorough examination of the proposed revision reveals clear changes, needed improvements, aggressive moves, and perhaps some areas for concern.

An excellent example of improvements to the standard is the new structure. It applies a commonsense business approach for the organization of a well-founded quality system. The proposed structure focuses on four definitive business processes rather than the 20 discrete functional elements in the current standard. The original elements are still there; they are just organized properly into the following categories:

In addition to the original elements, these sections include some valuable improvements. For example, section 8 includes section 8.5, "Improvement," composed of the sections on "Corrective Action," "Preventive Action," and "Improvement Process" from the current version. This upgrade introduces into the standard the recognized quality tool, continuous improvement, and outlines steps to achieve it. Section 7.5 includes, along with the existing elements 4.8, "Identification and Traceability," and 4.15, "Handling, Storage, Packaging, Preservation, and Delivery," a new element on process validation.

Providing additional management controls over key business issues, section 6 on resource management adds elements 6.2, Human Resources; 6.3, Information; 6.4, Infrastructure; and 6.5, Work Environment. Where the management responsibility, quality planning, and training elements of the 1994 revision of ISO 9001 loosely address these issues, ISO 9001:2000 focuses on the competence of employees, the effectiveness of training, the benefits of improved personal performance, the infrastructure to achieve conformity of the product or service, and the work environment, including work ethics and health and safety conditions.

Similarly, although not new concepts by any means, including section 7.2 on the identification and review of customer requirements, needs, and expectations in the revision is a tremendous leap forward. Here we are reminded to shape our quality system to address not only customer requirements, but also their needs and expectations.

It is easy for proponents of revision to embrace the changes without considering their effects on auditing activities associated with the system. The programs audited under the current and previous system were simple, precise, easily defined, and measured. By contrast, some of the new concepts are more obscure and leave room for interpretation. It will be much more difficult for the average auditor to maintain objectivity when evaluating a company; many may become subjective and opinionated during the review.

For example, what is acceptable continuous improvement, and what ensures that the company has sufficiently identified the customer's expectations? This question, in turn, may lead to the issue of "official" interpretation, confusing the whole situation and requiring an appropriate agency to manage these interpretations for diverse industries. Different customers may impose varying interpretations on a company. In such circumstances, we would once again have several different quality programs and no single standard.

There are other significant concerns that may arise during the transition to ISO 9001:2000. The industry will need to address what happens with the third edition of QS 9000, or AS 9000, which both encompass the requirements of ISO 9001:1994. Companies that choose to implement ISO 9001:2000 will need to revise referencing the obsolete ISO standards, which could create timing and technical issues. Companies must also decide if they need to revise their policy manuals and procedures to address the new standard formats. The hidden costs to revise these documents and the time needed to train employees on these changes could have significant effects on profitability.

To meet the new standards, additional auditor training will be required. This will be the case not just for the company implementing the management system, but for industry training and consulting firms, registrars, and accreditation bodies. Also, as with the 1994 revisions, a "cooling period" may be needed for industry interpretations to "level off," which could confuse matters and reflect poorly on the ISO industry. There will also be such questions as what happens if a client's certificate is scheduled to expire during the transition to ISO 9001:2000. These are just a few of the issues that TC 176, the ISO industry, accreditation bodies, and registrars will need to address for this transition to be successful.

Fundamentally, ISO 9000 is your standard. Whatever your opinion of it, the standard has made significant changes and contributions to international commerce generally and to quality in North American business specifically. It will continue to have a meaningful influence well into the next millennium. Therefore, it would be prudent to reserve judgment until thoroughly reviewing the proposed revision.

Under the schedule released in the second committee draft, the draft must be returned by August 1, 1999. In September 1999, ISO TC 176 will reconvene in San Francisco. Subsequently, a draft international standard will be released for balloting. The new edition of the standard is scheduled for publication in the fourth quarter of the year 2000.

As quality assurance moves into the next millennium, it is important for the systems to evolve and grow to meet industry needs. Before condemning or praising the proposed reforms, you should examine all the elements and the effects they will have on industry. More importantly, if you see deficiencies in either the current version or the revision, you should bring them to the committee's attention, along with suggested remedies. The ultimate success of the revised standard will depend on such participation.