ISO 9001:2000 Explained
ISO (1) See ISO speed.
(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001:2000 Explained. By CA. Cianfrani, JJ. Tsiakals & J.E. West. ASQ ASQ American Society for Quality
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From the beginning, ISO 9000 has been confusing to many. Under the ISO umbrella were five standards: ISO 9000 itself, a guideline guideline Medtalk A series of recommendations by a body of experts in a particular discipline. See Cancer screening guidelines, Cardiac profile guidelines, Gatekeeper guidelines, Harvard guidelines, Transfusion guidelines. for selection and use of the other four; 9001, the overall quality standard governing a product or service from development through maintenance; 9002 dealing with product manufacture and installation; 9003 on final inspection, text, and distribution of product; and 9004, a guide to design and use of quality systems.
The 2000 revision eliminated ISO 9002 and 9003 (the first was for use by organizations not performing product design, and the second was meant only to expose nonconformance), and 9001 now provides for compliance with customer and regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. .
This book describes fully what ISO 9001 requires, and what's behind the changes since 1994. The authors all served on the ISO Technical Committee TC- 176 responsible for the 2000 revision.
A preface summarizes the approach to the revision: less emphasis on detailed documentation; more on "developing effective processes," setting objectives, and measuring performance. One goal was "the use of wording that is more easily understood." Another was a more specific requirement for "continual improvement Continual Improvement (also called incremental improvement or staircase improvement) is a process or productivity improvement tool intended to have a stable and consistent growth and improvement of all the segments of a process or processes. " in quality management.
The 12 chapters contain the complete ISO 9001-2000 as adopted in the U.S., interspersed with background and explanatory text. Four key symbols identify new provisions or changes from the 1 994 edition, definitions of important terms, typical items checked in a compliance audit, and "considerations for documentation."
Chapter 3 on "Management Responsibility," one of the book's longest, stresses the latest standard's emphasis on the need for top management commitment to a quality management system. Evidence of such commitment must now be provided. At the other end of the process, commitment to meeting customer needs is also paramount. Some in industry have contended that "ISO 9000 has little to do with quality and everything to do with bureaucracy."
Even defenders of the standard conceded that ISO 9000 doesn't necessarily make a product better suited to its intended use. In response, the TC- 176 position is that the revision provides "closer alignment of the quality management system with the dayto-day running of the organisation." Still, as the authors make clear, the ISO documents are minimum standards that do not dictate a specific level of quality, or relate to specific products.
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