As illustrated in Exhibit 3-1, ISO 9001:2000 contains five first-level paragraphs that contain requirements. The 138 "shall"s in ISO 9001 are distributed among 23 second-level paragraphs (e.g., PARAGRAPH 4.1 and PARAGRAPH 7.3). However, to state that there are 138 requirements is misleading. Although ISO 9001 is an excellent standard, particularly notable for its brevity, it is like many succinct market and customer requirements definitions and statements, written by a committee.

Exhibit 3-1: The first- and second-level headings.

• There are compound statements a single "shall" precedes a list of discrete activities. For example, PARAGRAPH 4.1 contains five "shall"s and 23 distinct requirements.

• There is redundancy the requirements in one paragraph duplicate or are decomposed into requirements in another paragraph. For example, PARAGRAPH 7.1 requires that all product realization activities be planned; PARAGRAPH 7.3 requires that design and development activities (which are part of product realization) be planned. As a second example, of the 23 requirements in PARAGRAPH 4.1, only two are not completely addressed in other paragraphs.

• There is factoring the requirements in one paragraph apply to any solution for the requirements in one or more other paragraphs. Factoring streamlines the requirements but challenges implementers to ensure that the global requirement is addressed in all the instances to which it applies. For example, the document control requirements in PARAGRAPH 4.2.3 are implicitly repeated each time a documented procedure (or plan or other work product) is referenced in the quality management system.

• There are misplaced requirements. PARAGRAPH 7.5 is titled production and service provision, which...