Although much of this clause was taken from various sections of ISO 9001:1994, the new standard has many new features. The primary new feature is the area of "permissible exclusions," or where this clause-or certain sections of it-might not apply to your organization.

How do you know what applies and what doesn't? That's where it can become difficult, because it's up to you and top management to decide if something might not be applicable. Permissible exclusions are related to Clause 1.2 of ISO 9001:2000, which states:

"Where exclusions are made, claims of conformity to this international standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements."

TC 176 included the clause for permissible exclusions because of the elimination of two standards in the 1994 series-ISO 9002 and ISO 9003. Those standards were developed to achieve the minimum levels of quality or where design and development were not a function of the organization. (Some service organizations or small businesses are examples of organizations that used those standards to achieve product conformity while excluding design elements.)

With ISO 9001:2000, however, the ability to exclude design elements becomes difficult-but not impossible. Organizations must use the quality manual (Clause 4.2.2) to explain any exclusions in their system. But be sure of your decision to exclude anything. If you decide a certain clause is not applicable to your organization, auditors will check it thoroughly to ensure system conformance and, more importantly, that customer requirements are being met.