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Introduction 0.1 General i ISO 9001:2008, Quality management systems — Requirements Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by its organizational environment, changes in that environment, and the risks associated with that environment, b) its varying needs, c) its particular objectives, d) the products it provides, e) the processes it employs, f) its size and organizational structure.
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