It takes both flesh and bones to make up an entire body. So is it with the ISO 9000: 2000 standard released last December by the International Organization for Standardization (ISO).

In a sense, experts say, the "requirements" spelled out in the standard's ISO 9001 document can form the skeleton for companies that want to implement and operate effective quality management systems. But it is the ISO 9004 document--commonly referred to as the second half of the "consistent pair"--that provides the "guidelines," or the meat, that companies need to flesh out those quality management systems, sources agree.

"ISO 9004 is an excellent business management tool to use when companies want to go above and beyond the foundational elements of 9001," says Kathy Roberts, president of Sunrise Consulting Inc. (Raleigh, NC), and a member of the U.S. Technical Advisory Group to Technical Committee 176, the body responsible for developing the ISO 9000: 2000 standard.

The 2000 family of standards consists of three documents: ISO 9000: 2000, Quality Management Systems--Fundamentals and Vocabulary; ISO 9001: 2000, Quality Management Systems--Requirements; and ISO 9004: 2000, Quality Management Systems--Guidelines for Performance Improvement. Used together, the components make up an effective quality management system to facilitate mutual understanding in national and international trade.

Because the 2000 family of standards goes a major step beyond the 1994 standard that it replaces, many organizations so far have been concentrating on interpreting and implementing the requirements of 9001, leaving the 9004 guidelines on the shelf collecting dust. "I think at this point, 9004 is a new document and people are focused on 9001, the basic requirements, and they haven't gotten to the guidance document yet," explains Arlen Chapman, quality systems director of NQA USA (Acton, MA), a registrar.

Making it clear
But some experts note that the 9001 and 9004 documents were specifically developed as a consistent pair, intended to be used in conjunction with each other. And there is much to be gained by that approach, proponents say. 9004 is a comprehensive document that includes information from worldwide award criteria systems, such as the Malcolm Baldrige National Quality Award and Japanese and European quality awards, Roberts points out. Further, she notes, the document provides clear, concise, detailed information on how to improve business processes. "It's a business management continual improvement tool; it is not a reference tool," Roberts explains.

Unlike the 9001 standard, 9004 is not another document to which companies get registered. "It was created to assist companies in understanding performance improvement and understanding what 9001 is looking for by giving some advice, counsel, suggestions and information," says Mike Delpha, vice president of consulting services for Prism eSolutions (Blue Bell, PA), a provider of process improvement tools and solutions.

One of the first things a company can do in relation to 9004 is use the self assessment in the annex portion of the document to determine where the organization is in relation to the guidelines that 9004 suggest, says Roberts. "Depending on how they score themselves, they can use the components of 9004 to make improvements based on where their gaps are," she says.

Roger Davis, vice president of audit operations for DQS Inc., (Wilmette, IL), a registrar, notes that the self-assessment can be used to bring a company's management team together to help ensure that each area of the company is working.

9004 takes the clauses of the 9001 requirements and blows them up to give ideas and examples of how things in 9001 can be applied to an organization. Davis says that once a company is ISO 9001 certified, 9004 could be used to improve the business because it uses a common sense approach.

Most experts agree that 9004 is easy to read and user friendly and breaks down the 9001 requirements. For example, ISO 9001 says that an organization must provide a work environment that achieves conformity to product requirements. 9004 goes the next step and states what things might contribute to such a work environment, such as safety rules, ergonomics, location of the work place and social interaction.

Continual improvement?
One of the big questions arising out of the 9001 standard is exactly what is meant by the term, "continual improvement." ISO 9004 can help. "9004 provides suggestions for sources of information to look at when considering continual improvement. It provides a list," says Delpha. "There are 10 examples of sources of information for people to research to drive continual improvement into the company. So it takes it from an amorphous phrase and breaks it down into practical sources of actions to consider."

Another area in which 9004 provides direction is management responsibility. ISO 9001: 2000 is much harder on management than the 1994 version, and 9004 makes clear some of the practical issues that management might undertake, consider and act on to satisfy the requirements, says Delpha.

For example, 9001: 2000 says that management must review the quality management system periodically. And 9004 provides 13 specific things that management might consider as part of the agenda when conducting such a review. The list includes results of audits and self-assessment of the organization, results from benchmarking activities, performance of suppliers and new opportunities for improvement.

Hey, wake up
Despite all of its potential advantages, 9004 is still getting significantly less attention than its 9001 counterpart, sources confirm. "I strongly encourage all of my clients to get 9004 and use it, but so far they don't seem to be taking that advice," says Delpha. "We've been working with clients for six to seven months on the 2000 standard. Of the companies we're working with, they all have 9004 in their libraries, but my sense is that there are only a handful of them that recognize its value."

Chapman suggests that one reason companies fail to see the benefits of 9004 is because they're looking for a guidance document that they can apply specifically to their own companies. "We all know that rarely occurs. The standard is a generic document that can be applied to thousands of different companies in a thousand different industries."

The intent of ISO 9004: 1994 was almost 100% to help an organization succeed at registration, Delpha says. "In other words, the old one basically said, 'ISO says this, so do this.' This document doesn't do that. It's not meant to help you get registered. It's meant to point out a variety of things that can be done to be a better company. The intent and the content are vastly different."

Not all industry sources are enamoured of the 9004 standard, however. One who is less enthu-siastic is Paul Vragel, president of 4 A Better Business (Skokie, IL). "We really don't focus on 9004 because it confuses people. If you sit down and read it, you get overwhelmed. How could you ever do all of that stuff? You don't have to do it all," Vragel says.

Vragel, whose company helps clients focus on process-based systems, even before it became a requirement of the 2000 standard, suggests that the most important step for companies to undertake is a thorough analysis of their processes to understand how they actually work. "Not how they think they work or how they wished they worked, but how they actually work," Vragel stresses. "If you don't know how your processes work, how can you know what to do to make it better in order to fix the problem?"

Once the process understanding is in place, then some of the many ideas and solutions spelled out in the 9004 standard may be useful, Vragel says. "Some of it works, but only if you know how your system works and how it gets you where you want to go," Vragel declares. "These standards are not a substitute for critical thinking."

Still, most around the industry expect to see a growing role for ISO 9004: 2000, as companies look to boost process performance. "I tell my clients that even if they're not interested in registering to 9001, they should look at 9004 for ways to improve their businesses," says Roberts.

Indeed, although 9004 was created and designed to pair with 9001, some see its value extending beyond the intended purpose. ISO 9004 may not only help companies add flesh to the bones as a way to improve their manufacturing pro-cesses, but for those who use it correctly, proponents say, it may help them build new muscle as well.