FDIS Changes to ISO 9001:2000 Requirements

The FDIS version of ISO 9001:2000 is expected to have some clause numbering changes, as well as, numerous text revisions.

For example, quality plan (5.5.5), document control (5.5.6), and record control (5.5.7) of the Management Responsibility section of the DIS version will be moved to Documentation Requirements in 4.2.2, 4.2.3, and 4.2.4, respectively. The old 5.5 Administration section will become Responsibility, Authority, and Communication.

Another numbering change is the movement of process validation from 7.5.5 in the DIS to 7.5.2 in the FDIS, along with a revised title of Validation of Special Processes.

A sampling of other expected changes include a new requirement on “outsourcing”, design output to also provide information for purchasing, and the use of “objective” and “impartial” to replace “independent” in internal auditing.