MODULE TWO - WRITERS AND ISO 9000 IMPLEMENTATION

When is Enough Documentation, Enough? (continued)

"As well, there is a reference in clause 7.1, Planning of Product Realization, item (b) which states, "the need to establish processes and documentation, and provide resources and facilities specific to the product".

The shortage of specific requirements for documented procedures coupled with general statements alluding to the need for documentation in clause 4.2.1 of the standard, is bound to create confusion between auditors and their clients. As a quality professional, I suggest that the level of specified documentation is insufficient to support a robust quality management system.