ISO9001:2008中文件要求的理解与实施
ISO9001: 2008 document understanding and Implementation
除质量手册、形成文件的程序外，组织的质量方针和目标也应形成文件。
In addition to the quality manual, procedures, organization of a quality policy and quality objectives should also form file.
通观整篇标准，只有六处要求形成文件的程序。除此之外，每个组织可以自由地决定"确保其过程有效策划、运作和控制所需的文件"，其依据的是组织的规模、活动的类型、产品及过程的复杂程度以及人员的能力。
According to the standard requirements, only six documented procedures. In addition, each organization can freely decide" to ensure the effective planning, operation and control of the process required to file", which is based on the organization's size, the type of activity, product and process complexity and the competence of personnel.
它们可以是标准中规定的文件形式，也可以是正在使用的现行有效文件（如表格或流程图等），标准并不介意它们的名称和形式。
They can be provided in the standard file format, can also is being used by the current document ( such as a form or flow chart), the standard does not mind their names and forms.
程序也并不一定需要文件化，如果所有相关人员都能说明并证实用同样的方法做同一件事，就证明了程序的客观存在，不一定必须有书面文件。
The procedures are not necessarily documented, if all relevant personnel can be described and practical way to do the same thing, as evidenced by the program 's objective existence, do not necessarily require a written document.
质量手册中必须包括质量管理体系的范围，如果产品实现过程中的某些要求不适用，组织可以将其删减，但必须充分地说明理由。
The quality manual must include the scope of the quality management system, if the product realization process in certain requirements do not apply, the organization can be deleted, but must be fully justified.
标准对质量手册没有任何格式要求，鼓励组织按自己习惯的方式编写质量手册，反对照抄标准。程序可以包括在手册中，也可只在手册中引用，可视组织的规模及产品的复杂程度而定。
Standard of quality manual no format requirements, to encourage the organization according to their own habits and prepare quality manual, opposed to mechanically standard. Procedures can be included in the manual, also can only in the manual reference, visual organization's scale and the complexity of the products and decide.
文件包括了记录，两者都必须有形成文件的控制程序，但各自的目的和控制要求不同。
File including records, both must have formed the document control procedure, but their purposes and control requirements of different.
文件控制的目的是保证使用的文件是有效的，控制的方法可根据组织的实际情况确定。发放单、盖章、签收是一类有效的控制方法，但可以有其他方法。
File control is designed to ensure the use of the file is valid, the control method can be organized according to the actual situation to determine. Leaflets, seal, sign is a kind of effective control method, but there can be other ways.
由于标准关注的是文件的有效性，文件在使用一段时间后应作评审，发现不适用就必须修订。
Because the standard is concerned the validity of the document, the file is in use after a period of time should be reviewed, found not to apply to have revised.
记录是产品符合要求和体系有效运行的证据，应保持清晰、易于识别和检索，但证据不一定必须是记录。
Record products conform to requirements and the effective operation of the system of evidence, shall remain legible, readily identifiable and retrieval, but the evidence is not necessarily records.
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