ISO9001认证中如何识别产品文件或者体系文件？
How to identify the product ISO9001 certification documents or system files?
1）产品文件。凡是规定交付给顾客产品中特性要求的文件就是产品文件。这个“产品”包括最终产品以及所用的原、材料、工艺、试验等。譬如，材料规范、材料标准、工艺标准、试验标准等。产品文件是设计开发过程的输出，其内容在产品设计定型阶段必须要确认的。产品设计和开发以及设计定型等都是质量管理活动。因此，有些单位把产品文件就叫产品设计和开发过程的记录。
1) product documentation. All specified delivery to customer product requirements document is a product file properties. The" product" including the final products and the use of raw materials, process, test, etc.. For example, material specifications, material standard, technology standard, test standard. Product design and development process, the output file, its content in the product design stage must be identified. Design and development of products and design finalizing are quality management activities. Therefore, some units of the product file called product design and development process of recording.
2）体系文件。凡是描写如何形成交付给顾客产品活动（过程）有关要求的文件就是体系文件。譬如，质量手册、质量计划等都是描述如何建立控制该产品用质量管理体系的。各种程序和作业指导书都是描述活动（过程）的。前面讲的设计和开发过程也是质量管理体系中的一部分，描述这些活动（过程）的文件就是体系文件。而这些活动（过程）的结果是产品文件。
2) file system. General description on how to form the product delivered to a customer activities ( process ) the requested file is a system file. For example, a quality manual, quality plans are described how to establish control of the product with quality management system. Various procedures and work instructions are describing activities ( process ). Speaking in front of the design and development process and quality management system part, describes these activities ( process ) file is a system file. And these activities ( process ) the result is a product file.
3）有些难于界定的文件。因为产品是过程的结果。过程又是组成体系的元素。有些和过程有关的文件就难以归属于产品文件还是体系文件。譬如，
3) some difficult to define in file. Because the product is process results. Process and system elements. Some and process related documents to belong to the product or system files files. For example,
a）标准第7.3.3.b）条规定设计和开发输出必须包含为采购、生产和服务提供相应适当的信息。这里的“适当”，在不同行业中有不同的传统处理方式。凡是包含在设计和开发输出中的文件就是产品文件，没有包括的那么，只能算体系文件了。又如，
A ) standard 7.3.3.b) provides the design and development outputs must include purchasing, production and service to provide appropriate information. Here the " appropriate", in different industries have different traditions. Usually included in the design and development output file is the file, not including the then, can only be system files. And as,
b）标准第7.3.3.c）条产品设计和开发输出中必须包含或者引用产品合格验收用的判别准则。如果包含，那就计算产品文件；如果引用，那么被引用的文件是否也算产品文件。还有
B ) standard 7.3.3.c) product design and development output must contain or reference product qualified for acceptance criterion. If included, then computes the product file; if the reference, then the referenced file is also regarded product documentation. Also
c）有人把文件分成技术文件和管理文件。当然也可以。但是，也会有些文件不容易区分。譬如，热处理作业指导书可以看作是技术性文件，但它又是描述产品形成过程（活动）的文件，应当属于体系文件比较妥当。再如，产品交付后随产品交付提供的，指导顾客如何和组织保持联系，取得售后服务的文件，显然应当算是管理性的文件，但是，由于它随同产品一起交付给顾客的，往往会归属于产品文件。
C ) someone to put files into technical file and document management. Of course, can also. However, there will be some files are not easy to distinguish between. For example, heat treatment operation instructions can be seen as a technical document, but it is described the product forming process ( activity ) file, it should belong to the system file comparison. Moreover, after the delivery of products with the product delivery, guiding customers to keep in touch and organization, made service file, obviously should be regarded as the management of the file, but, because of its accompanying product delivery to customers, often attributable to the product documentation.