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ISO13485認證輔導---ISO13485-2016中英文對照 測量、分析和改進(8.1)
8 Measurement, analysis and improvement 8 測量、分析和改進 8.1 General總則 The organizationshall plan and implement the monitoring, measurement, analysis and improvement processesneeded to: 組織應當策劃和實施監(jiān)控、測量、分析和改進程序以便: a) demonstrateconformity of product; 證明產(chǎn)品的一致性; b) ensureconformity of the quality management system; 保證質量管理體系的符合性; c) maintain theeffectiveness of the quality management system. 保持質量管理體系的有效性。 This shallinclude determination of appropriate methods, including statistical techniques,and the extent of their use. 這些程序包括確定的適宜的方法,包括分析技術以及使用的范圍。
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