ISO 9000, not a total quality solution, but a catalyst for continuous quality improvement.

ISO is not an acronym. It's derived from the Greek word ISOS which means equal, as in isobar, isometric and isosceles. ISO 9000, published in 1987, is a series of five related standards -- numbered 9000 through 9004 -- that has been adopted by at least 60 countries, including the U.S., Japan, Canada, and twelve members of the European Community. Businessmen like the certification because it helps them avoid having to evaluate the multitude of competing quality plans, audits and awards. It's a way of benchmarking a total quality management program to a standard that can be understood. But the universality of ISO 9000, that admittedly sets norms that are attainable across a broad range of industries and cultures, raises a yellow flag. Many critics contend; ISO 9000 falls short of the quality that world-class corporations demand of themselves and their suppliers. ISO 9000 is not a quality system, but it is a catalyst for the other quality factors: training and empowerment of workers, benchmarking competitors and achieving continuous improvement.

Possible misunderstanding of ISO 9000 Standards in the U.S. suggests several crucial pitfalls, especially now that many U.S. firms, including my own, are at the height of efforts to pursue the automotive equivalent of ISO 9000 registration. The main concern is that ISO takes an extremely narrow look at quality assurance, mainly in the area of documentation.

ISO 9000 makes no demands or assurances about a company's products. The standards virtually ignore the formula of modern quality management: There is no mandate to reduce cycle time, cut inventories, speed up deliveries and increase customer satisfaction.

According to recent polls, many executives of mid-size manufacturers are still either unaware of ISO 9000 implications or think it will have no impact on their companies. Some managers mistakenly believe that ISO 9000 is a legal requirement for doing business in the European Community.

Simply put, the standards provide a framework for showing customers how products are tested, employees are trained, documentation is assured and defects are corrected. ISO 9000 is not another total quality management variant; it is a set of generally accepted accounting principles for documenting quality practices.

As a designer and manufacturer of precision molded and machined polymeric products for the automotive, heavyduty, business machine and industrial markets, Acadia Polymers has firmly entrenched total quality management programs in each of our five plants. All customers already demand the highest level of quality and verifiable documentation in order for a supplier to receive certification, preferred status, etc.

Quality is what the customer says it is; not what the supplier says it is.

Now that trade barriers are coming down, and worldwide competition is growing, OEMs need to exploit every available weapon in the quality assurance arsenal to improve their standing. Today ISO 9000 registration may be a competitive advantage. In the future, it will be a "must" to participate in the global arena.

Some customers never stop auditing, even with ISO 9000 standards in place, and believe that performance to the dictates of the standards is just a small fraction of the assurance they are looking for.

Overview

It should be understood that ISO 9000 is a for-profit, open-market program. The Geneva-based International Organization For Standardization introduced the ISO 9000 Series in 1987 and a revision in 1994. The series is comprised of subdivisions 9001, 9002, 9003 and 9004 which relate to a company's scope of activity at any particular site (table 1). Standards, necessarily quite general and flexible, are introduced throughout a company to assure consistency and awareness in all phases of operations.

Table 1 - ISO 9000 line up

ISO 9000: An introduction and overview; implementation varies from one company to another.

ISO 9001: Covers manufacturing, from design through service and installation.

ISO 9002: Covers production and installation of a product. Its content is also part of 9001.

ISO 9003: Covers quality assurance in final inspection and testing.

ISO 9004: Is different than the others in that it addresses guidance for philosophy of quality management.

Companies choose to qualify to specific standards depending on which ones most closely match their scope of operation. ISO 9001 has the broadest scope but has just seven pages of requirements. Registration proves that a company is following its own procedures inspecting production processes, updating engineering drawings, maintaining machinery, calibrating equipment, training workers and dealing with customer complaints.

The key to implementation is internal auditing and constant monitoring of all functions. Many participating companies claim certification has increased productivity, lowered incidence of accidents, and upped employee morale and communication.

There is a concern that ISO 9000 is too vague to be of significant value to high-tech industries. For example, Ford, Chrysler and General Motors have agreed to include the complete ISO 9000 Standard in their supplier quality system requirements, but have expanded many sections. Third party ISO 9000 registration is not required in North America; the Big Three want suppliers only to meet Big Three standards.

Another concern to manufacturers is the cost of certification; base costs of registration fees may run over $50,000. However, expenses for consultants, employee time and documentation can drive total cost to over $200,000.

ISO 9000 implementation is not oriented toward improving a manufacturer's bottom line. However, good up front organization and planning, as well as employee involvement, are the key to savings in any quality program.

Big Three mandates

In mid-1994, Ford, Chrysler and GM, acting jointly through the Automotive Industry Action Group (AIAG), issued QS-9000 Quality System Requirements (QSR) and Quality System Assessment (QSA) manuals. The intent was to help eliminate overlapping, redundant, and in some cases, conflicting requirements, so that quality and productivity would improve throughout the supply chain.

Ford's communique to suppliers at that time advised that the QSR manual would include ISO 9000 verbatim, to align Ford's requirements with the widely-recognized standard, but there was no requirement for third party registration in North America.

The QS-9000 documents replace Ford's Q-101 and Quality System Standards for Q-101 and the related documents including the system survey. Their suppliers, that have already obtained third party registration to the ISO 9000 Standard, must also verify that QS-9000 requirements (which go beyond ISO 9000) are effectively incorporated in the supplier's existing quality system. Registration may reduce the number of periodic system surveys, but Ford customer contacts, such as Quality Operating System (QOS) assessments, advanced quality planning and concern resolution, will not be affected.

The Big Three's stance is interpreted as total acceptance of ISO 9000 documentation standards, but in their supplier quality guidelines they insist there is a need to continuously supplement the guidelines' content with requirements that go far beyond ISO 9000. The crucial factors of quality, design, manufacturing and delivery must be in place, with or without ISO 9000.

Supplier benefits

There are bottom line benefits promised by attaining ISO 9000 registration. ISO 9000 certification can help a business run more efficiently, identify skills of employees, clarify operating manuals, and brings engineering and production drawings up to date. Supervisors can also better assess the capabilities of their production people and non-value added functions are eliminated.

ISO 9000 Standards as a common quality system should have a strong appeal to both buyer and seller if the standards are comprehensible to both parties. As previously stated, the standards are not the only quality solution; but they are a catalyst that can further continuous quality improvement programs.

RELATED ARTICLE: Documentation dilemma

The ISO series of Quality Management Standards, often referred to as the "Constitution for Quality" does not provide for a guarantee of product quality, but the series does dictate a minimum system of documentation elements for quality management. The dilemma encountered in industry is that just a single significant, non-conformance with any of the 20 sections of the ISO 9001 Standard may be sufficient to fail an audit.

A failure may mean considerable loss of time, additional conformance expense, and the possible loss of a contract. Analysis of audit failure statistics, published by ISO headquarters and registrars in Europe and North America reveal a starting fact. Deficiencies, directly or indirectly related to documentation problems, cause an overwhelming number of audit failures.

Examples of failure are:

* Nonexistent documentation for a specific decision making process.

* Outdated documentation or documentation not available at relevant employee locations.

* Non-falsifiable documentation that assures procedures and manuals are followed at all times.

* Documentation that outdated engineering drawings are taken out of circulation.

* No adequate proof of the date when product modifications and developments took place.

* Insufficient documentation regarding criteria for the purchasing process.

* Insufficient documentation of the training, decision making ability, etc., that are needed for vendor qualification programs.

* Insufficient documentation of incoming product inspection, conformity; even the inspection criteria used.

The long list of insufficient documentation goes on to include such things as: maintenance of tools and fixtures, environmental controls, investigation of non-conformity and corrective action, plus many other factors of production.

The intent of the documentation requirement is to mandate greater internal traceability of all decision-making processes and to provide verifiable proof that certain records were compiled on the date and at the time indicated by qualified and authorized personnel. The short fall is that ISO Standards do not make demands or assurances on the quality of products or the modern quality management goal of continuous improvement.