Chapter 12: Quality Manual Issues

12.1 Hard-Copy Manual Issues

12.1.1 Manual Control

In practice, a pure hard-copy system is the most expensive and time consuming to maintain, and it is best to limit the number of controlled manuals to essential personnel [e.g., document owner (often the site manager), ISO 9000 management representative, and the registrar].

Uncontrolled copies usually need to be released by the owner on a filtered basis for marketing and educational purposes. However, the manual should have some sort of disclaimer (e.g., "The contents of this uncontrolled manual may not be at the latest revision level"). Because the manual is usually revised on the average of about twice a year (e.g., after a surveillance assessment and after organizational changes), the currency of the document is not a big issue and uncontrolled copies are not really a concern.

12.1.2 Manual Revisions

It is important to minimize the number of times per year that changes are made to the manual to minimize printing costs. Such costs can be very significant when you consider the cost of labor and distribution control. It is best to collect minor changes and do a rewrite periodically unless, as we pointed out earlier, there has been some major action taken (e.g., reorganization, third party audit that resulted in nonconformances, merger/acquisition activities, or a business scope upgrade).

12.1.3 Manual Distribution

The creation and distribution of the manual must comply with the requirements of Element 4.2.3: Control of Documents of the Standard. A convenient checklist to be used to ensure this compliance is shown in Appendix E, entitled "Checklist for Standard Element 4.2.3: Control of Documents Quality Manual Requirements."