9.5 Nonmandatory Sensible Requirements

The charge to the authors to create a reasonable volume of documents and to keep the corporate economics in mind is expressed in Par. 4.2.1: General of the Standard as note 2 and is therefore not mandatory but is to be considered a guideline ^[5]. We are alerted that QMS documentation can differ widely between organizations as a result of such characteristics as size, organizational structure, process complexity, and levels of personnel training, skills, experience, and education. The similar clause in the 1994 version was mandatory.

At issue here is the tendency to overwrite—usually a good 40% more than is necessary for an effective presentation. We all do it, and it usually takes a few years after certification to streamline the system. Typical forms of redundancy include the following:

Policy statements in the quality manual repeated in the tier II and tier III documents;
Tier III documents that repeat the same procedures as the tier II documents;
Flow charts with associated text pages that state the same information;
Master lists repeated in labeled text in procedures such as a master records list with a list of records repeated in a procedure. One or the other is sufficient as long as all the necessary record requirements are met.

There will be plenty of time available after the ISO 9001:2000 certificate hangs on the wall to optimize the documentation. Besides, the documents will most likely have a number of significant changes during the first surveillance period, so that is a good time to make the nfecessary revisions.

^[5]As with all powerful ideas, an ISO 9000 mythology has been created in spite of its short 15-year existence. One of the myths is that each tier must have a document for each mandatory, and for that matter, each implied requirement. We feel that such an approach is not only contrary to the spirit of the Standard, but the redundancy that results from such a viewpoint is counterproductive and serves to confuse the users instead of support their efforts. The new revision attempts to remedy this attitude but may have oversimplified the requirements.