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要使质量体系有效运行,必须编制质量体系文件,使质量体系文件化,促进文件化质量体系的高效运行。 1 文件的作用 这里的文件,主要指的是质量体系文件。质量体系文件,是对质量体系进行设计的结果,实质上是对质量体系的规划和描述。质量体系文件集中于质量手册、程序文件及其支持性的质量计划、作业指导书等,一旦经企业领导签发颁布,就是企业的“法”,就是建立、保持质量体系正常运转的依据。
To make the quality system work effectively, a quality system document must be prepared to document the quality system and promote the efficient operation of the documented quality system. 1 The role of the document The documents here mainly refer to the quality system documentation. The quality system document is the result of the design of the quality system and is essentially the planning and description of the quality system. Quality system documentation focuses on quality manuals, program documentation, and supporting quality plans, work instructions, etc. Once issued and issued by business leaders, the company’s “law” is the basis for establishing and maintaining the normal operation of the quality system.