ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach

Chapter 4: Paragraph 4 Quality Management System

PARAGRAPH 4 is presented in two paragraphs that serve as a framework for the rest of the paragraphs in ISO 9001.

PARAGRAPH 4.1: General Requirements

As noted earlier, once the lists preceded by "shall" and the numerous "and"s are taken into consideration, PARAGRAPH 4.1 contains 23 distinct, high-level requirements. [*] PARAGRAPH 4.1 is an excellent distillation of the requirements in ISO 9001:2000. Unfortunately, although 21 of the 23 requirements are satisfied as a result of collectively satisfying requirements in other paragraphs, two of the requirements appear only in PARAGRAPH 4.1. The two requirements unique to PARAGRAPH 4.1 are

  1. Identify the application [of the processes needed for the quality management system] throughout the organization

  2. Determine the sequence of these processes.

PARAGRAPH 4.1 b also refers to interactions, which are thoroughly discussed in conjunction with PARAGRAPH 4.2.2 c.

Implementation Considerations

Although the information in PARAGRAPH 4.1 is valuable for setting expectations and attitudes, there are two challenges in implementing processes to satisfy the requirements of PARAGRAPH 4.1. The first challenge is to identify and preserve the requirements that are unique to this paragraph. The second challenge is to avoid the frustrating exercise of constructing solutions for which clear, detailed requirements are provided later. Dealing with PARAGRAPH 4.1 can be like an inefficient review of a document, in which a great deal of time and energy spent on arguing about and analyzing the first paragraphs is made unnecessary by later portions of the document.

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