This clause makes the "top 5 list" of new changes in ISO 9001:2000.

To begin, the phrase "top management" is used in ISO 9001:2000 instead of the old phrase, "executive management." The change occurred for two reasons: First, "executive management" didn't translate well into other languages, such as French and Russian. Second, and perhaps more important, there is a much stronger emphasis concerning the involvement of an organization's top leaders as active participants to ensure the PDCA Cycle works properly.

Of course, there's still room for interpretation concerning how "top management" is defined in your organization-and that's up to you (and top management) to decide.

In ISO 9000:2000, top management is defined simply as a "person or group of people who directs and controls an organization at the highest level." That could mean the person or group might be located across the hall from you or they might be at headquarters on the other side of the world. However you define it, this must be established early in your journey for your organization to have success with implementation and registration.

Another major change with ISO 9001:2000 appears in Clause 5.1.a, which states that top management must communicate to the organization "the importance of meeting customer as well as statutory and regulatory requirements." Although the standard says little to explain what that means, this is very important to the business and the management system from every perspective.

Think of it this way: Your company makes automotive parts for all of the major manufacturers, and you've just discovered that your products (which were shipped to the client last Thursday) failed to meet the industry's baseline safety standards. Additionally, you just found out that while manufacturing these products, your company violated 11 national and state regulations, which range from violations concerning the environment to transportation and distribution statutes in four states.

This situation is obviously not good for anyone. Your company has violated laws and failed industry standards, which will cost the organization significantly in areas such as fines and penalties, lost product, bad value for the long term and bad press-not to mention that nasty shareholder meeting the CEO is going to have to deal with next quarter.

All of this might have been avoided, however, if top management had communicated those regulations and standards effectively throughout the organization. At the end of each day, a company needs to make sure it's following all applicable laws so that potential infractions don't prevent it from doing business.