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Extra resources for Encyclopedia of Nanoscience and Nanotechnology. Biomedical Applications Tissue Engineering, Therapeutic Devi

Example text

A software development organization employs an independent, Webbased service to deliver its products electronically. The software organization has reviewed and is satisfied with the service provider’s procedures for the protection of the integrity of the product and for updating the deliverable product. An organization sells a system that includes developed software and off-the-shelf hardware components. The organization employs a sheet-metal shop to fabricate custom enclosures according to a specification provided by the organization.

Each of the subsequent chapters explores the requirements of the corresponding paragraph of ISO 9001:2000: • • • • • Chapter Chapter Chapter Chapter Chapter 4 5 6 7 8 covers covers covers covers covers the the the the the requirements requirements requirements requirements requirements of of of of of PARAGRAPH PARAGRAPH PARAGRAPH PARAGRAPH PARAGRAPH 4 5 6 7 8. In this section, the paragraphs of ISO 9001 are examined in the order in which they appear in the standard. As noted above, because the paragraphs do not stand alone, paragraphs are introduced where they fit logically to simplify and improve the efficiency of the implementation.

With may, it can do something, but it does not have to. 2). By convention, notes in ISO standards represent suggestions. 2, which states that, GRAPHS NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. This note does not contain shall, but the authors of ISO 9001 clearly intended that it be treated as a requirement. Finally, ISO 9001 contains phrases that include appropriate and suitable.

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