The business world is buzzing about the next revision of the ISO quality systems standards, called ISO 9000:2000. This issue has polarized the business world, with factions either condemning or supporting the draft. One side asserts that the simplicity of ISO 9000:1987 has been convoluted by the addition of explanations, subcategories and department-specific requirements, while the other claims that the current standard is insufficient to handle the needs of "their" specific industry. However, before falling victim to the "for us or against us" syndrome which usually accompanies any change, one must assess the current ISO 9000 quality standard and proposed changes, and determine the affect on one's business or industry.
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. More importantly, those affected by the changes need to 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; aerospace has AS9000; telecom has TL-9000; and many other groups are seeking adaptations to customize ISO 9000 for their needs. However, with these customi-zations ISO 9000 becomes less of a "standard," forcing us to adhere to a multitude of quality standards. With each new standard, there is bureaucracy to control it. It will require companies to comply with multiple quality systems and different agencies dictating different interpretations, training, methodologies, multiple audits, higher costs, more time and so on. Thus, the initial focus of ISO 9000—providing the customers with what they expect, at the right cost, on time, the first time and at a profit—is lost.
It was with these issues in mind that the International Standardization Organization technical committee 176 (TC 176) began to rewrite the ISO 9000:1994 standard. In March 1999, the second committee draft of the new ISO 9000 standard was circulated to allow all stakeholders a chance to contribute to the reformation of the standard. In September 1999 the committee approved the draft international standard (DIS) ISO 9000:2000 for release this month (November, 1999). This puts the final draft on schedule for its release in November 2000.
The current working draft of the ISO 9000:2000 quality standards is significantly different from the current system. The five basic documents have been condensed into three, yet this new structure covers the same ground. The present ISO 8402 standard for the definitions of quality terms has been merged into the series, replacing the original ISO 9000 standard. Moreover, the present ISO 9000 provides instructions for the application of the series. With the new proposed structure, however, this will no longer be necessary. This new series is proposed to be:
- ISO 9000:2000, Quality Management Systems_Fundamentals and Vocabulary
- ISO 9001:2000, Quality Management Systems_Requirements
- ISO 9004:2000, Quality Management Systems_Guidelines For Performance Improvement
The structure of the original series was novel and logical in its graduated structure, but it never seemed to work the way it was intended. For some reason, the notion that ISO 9001 was somehow better than ISO 9002, which was superior to ISO 9003, prevailed. This new structure may not be as clever as ISO 9000, but it is certainly functional and reflects the reality of the way the series is used in the real business world.
The basic document, the collection of applied standards ISO 9001-9003 (1987 & 1994), is excellent. It is concise and simple and addresses the necessary quality issues. This document is universal enough to be applied internationally, regardless of culture, nationality, product, industry or size. If applied correctly and with proper support, the ISO 9000 standard provides an excellent model for a solid quality management system.
Upon hearing about some of the recommended changes, many supporters of the current standard were greatly disturbed. They hold the current system in such high regard that they believe no one should "mess with the standard." But after actually reading the proposed changes, some have to admit they have been a bit reactionary. They needed to stop and consider the basic message of the new standard and ask the following questions:
- Was it significantly different?
- Did it contradict or damage the work already accomplished by companies working with the standard?
- Would it require a lot of additional work or time to modify systems in place?
A thorough examination of the proposed revision may reveal some very nice changes, serious improvements, gutsy moves, and maybe some concerns.
An excellent representation of improvements to the standard is the new structure. It applies a common sense business approach for the organization of a well-founded quality system. This proposed structure focuses on four definitive business processes rather than the present 20 discrete functional elements. The original elements are still there; they are just properly organized and presented under the following categories:
- Section 5.0—Management Responsibility
- Section 6.0—Resource Management
- Section 7.0—Produce and/or Service Realization
- Section 8.0—Measurement, Analysis and Improvement
Within these basic processes are the original elements and serious improvements. For example, Section 8.0 Measurement, Analysis and Improvement houses the intriguingly titled sub-process 8.5 Improvement. This new section is composed of the current element 4.14 Corrective Action, Preventive Action, and Improvement Process. This upgrade introduces into the standard the recognized quality tool—continual improvement—and outlines steps to achieve it.
With The Old Comes The New
5.3 Quality Policy continual improvement
quality objectives and targets
6.2.2 Training competency
evaluation of the effectiveness of training
benefits of improved personal performance
7.3.2 & 3 Design performance requirements from the market
8.2.1 Customer Satisfaction and Internal Audits audits for opportunities to improve
measurement of customer satisfaction
In Section 7.0 Product and/or Service Realization, there is sub-process 7.5 Production and Service Operations. Within this sector we find some of our seasoned favorites from today's ISO 9000:1994—element 4.8 Identification And Tractability and 4.15 Handling, Storage, Packaging, Preservation and Delivery. But also added to these is a new improvement—Process Validation. This blending of the old and proven with the new and exciting means the new standard will serve the needs of industries better.
Other examples of innovative changes to the standard include:
- 6.0 Resource Management—ISO 9001:2000 has added requirements 6.0 Resource Management, 6.2 Human Resources, 6.3 Information, 6.4 Infrastructure and 6.5 Work Environment, which provide additional management controls over key business issues. Where the Management Responsibility, Quality Planning and Training elements of the 1994 revision of ISO 9001 or 9002 loosely address these issues, ISO 9001:2000 focuses on competence of employees, evaluates the effectiveness of training performed, the benefits of improved personal performance, the infrastructure to achieve conformity of the product and/or service, and the work environment including work ethics and health and safety conditions.
7.2 Customer—Also, 7.2.1 & 7.2.2 address the identification and review of customer requirements, needs and expectations. Here we are reminded to shape our quality system to address not only customer requirements, but also their needs and expectations.
These are not new concepts by any means, but to specify them in the ISO 9000 standard itself is a tremendous leap forward and certainly a bold action.
It Will Impact You
It is easy for proponents of reformation to embrace the changes without considering the effects of these changes on auditing activities associated with the system. The programs audited under the current and previous system were simple, precise, easily defined and measured. However, some of these new concepts are much 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, in turn, may lead to the issue of "official" interpretation, confusing the whole situation, and then an appropriate agency must be established to manage these interpretations for diverse industries. Different customers may impose these varying interpretations on a company. With all this, we are back to several different quality programs and no "STANDARD."
There are other significant impacts that may arise during the transition to ISO 9000:2000. The industry will need to address what happens with the third edition of QS-9000 or AS9000, which both envelope the requirements of ISO 9000:1994. Companies who chose to implement ISO 9000:2000 will need to transition contracts away from 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 profit and loss affects.
Additional auditor training on the new standards and requirements will be required. This will include the company implementing the management system, any 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 compound matters and create a negative reflection on the ISO industry. There may also be issues if a client's certificate is scheduled to expire during the transition to ISO 9000:2000.
Fundamentally, the ISO 9000 quality standard is our standard. Whatever your opinion of the standard, it has made significant changes and contributions to international commerce in general and North American quality, specifically. It will continue to have meaningful influence well in to the next millennium. It would be prudent to reserve judgment until thoroughly reviewing the proposed revision.
With TC-176 approval of the DIS in September 1999 for release in November 1999, it becomes even more prudent to order the standard to assess its impact. The committee has yet to decide the time lines for conversion to ISO 9000:2000 and how companies currently registered or working toward registrations will be reassessed.
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, one should examine all of the elements and the affect they will have on the industry.
About The Author—Lee Bravener is Vice President of National Quality Assurance (Acton, Massachusetts), a registrar of management systems that has registered over 14,000 clients worldwide and that has been performing ISO registrations since 1987.