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In Quality New Zealand, New Zealand Organisation for Quality, May 1996, vol. 27, and in Proceedings of SEPG 98, Software Engineering Institute, Carnegie Mellon University, Chicago IL, 1998. 4. , International Organization for Standardization, Geneva, 1996. 5. , International Organization for Standardization, Geneva, 1996. Copyright © 2004 by Taylor & Francis Chapter 2 Terminology and Definitions The following terms and concepts are used throughout this volume. They are presented here to ensure that readers have a common understanding of terms that may be unfamiliar (such as quality management system) or ambiguous (such as ISO 9000 and should).

2 provides detailed information about one of the required documents—the quality manual. 3 contains detailed requirements for the control of all documents except records. 4 contains the detailed requirements for the control of records. 1 General contains a mixture of specific documents and types of documents. 1, which are rich in information and that verge on violating the ISO convention that notes are guidance. These notes are presented in Exhibit 4-2. The Required Documents. 1 refer to one or more specific documents the organization is required to produce and maintain in a suitable form.

The simplest way for an organization to satisfy these requirements is to require that suppliers of outsourced processes be ISO 9001:2000 registered. Although this approach is a favorite of registrars, it may limit the pool of suppliers the organization can consider, and it may result in increased costs as the supplier passes along the overhead costs associated with registration. The alternative is for the organization to assume responsibility for ensuring that the supplier’s processes satisfy the relevant requirements of ISO 9001:2000.

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