TABLE OF CONTENTS A quality manual is a document that specifies an organization's QMS [1]. The Standard further specifies that the quality manual is to include the following [2]:
The scope of the QMS and details and justification for exclusions;
The documented procedures or reference to them;
A description of the interaction between the processes.
And that's it a broad umbrella requirement and only three specific conditions. Exclusions refers to a statement of nonapplicability for a particular clause. The most common exclusion is Clause 7.3 Design and Development (e.g., a machine shop that manufactures parts based on the customer's design would exclude Section 7.3).
The manual stands as a colossus above the ISO 9000 documentation hierarchy and sources the flow of the QMS. Accordingly, this chapter describes the design of a fully compliant ISO 9001:2000 Manual. However, although it is always best to keep the sections of documentation as small as possible, because of the approximately 40 specific areas of interrogation (i.e., distinct portions in the Standard with specific requirements), this is not possible. For example, Section 7 of the Standard has approximately 12 such distinct categories (i.e., 7.1, 7.2.1, 7.2.2, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3, 7.5.4, 7.5.5, and 7.6).
As a result, we require an increased level of complexity beyond what we would normally consider. In fact, this book's longest text concerns the design of the manual. Such complexity requires increased employee training in documentation structure and usage. We will assume that...
