GB/T19001: 2016-7.5成文信息总则

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组织所确定的、为确保质量管理体系有效性所需的成文信息”。

例如：组织所确定的、为确保质量管理体系有效性所需的记录、规范、质量计划、程序文件、作业指导书、图样、报告、标准等

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Documented information determined by the organization to ensure the effectiveness of the quality management system.
For example, records, specifications, quality plans, procedural documents, work instructions, drawings, reports, standards, etc.

determined by the organization to ensure the effectiveness of the quality management system

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组织的规模，以及活动、过程、产品和服务的类型”。

例如：与有非常特殊的顾客和法律法规要求的汽车零件制造商相比，小面包店所需的成文信息将更简单、范围更小。

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The size of the organization, as well as the types of activities, processes, products, and services.
For example, compared to car parts manufacturers with very special customers and legal and regulatory requirements, the written information required by small bakeries will be simpler and smaller in scope.

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过程及其相互作用的复杂程度”

。质量管理体系的过程及其相互作用越复杂，质量管理体系所需的成文信息就可能越多与越详细

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The complexity of processes and their interactions.
The more complex the process and interaction of the quality management system, the more and more detailed the written information required for the quality management system may be

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人员的能力”。

例如：完成相同的工作，能力弱的人员可能需要作业指导书，而能力强的人员可能不需要作业指导书。

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The ability of personnel.
For example, to complete the same task, personnel with weak abilities may need work instructions, while personnel with strong abilities may not need work instructions.