ISO9001:2008认证《质量手册》的编写要求
ISO9001: 2008 certification" quality manual" the writing requirements
根据GB／T 19000—2000标准的3．7．4条款，对“质量手册”所下的定义是，规定组织质量管理体系的文件。
According to GB / T 19000 - 2000 standard 3.7.4 clause, to" quality manual" the definition is provided, the organization's quality management system documents.
　　注：为了适应组织的规模和复杂程度，质量手册在其详略程度和编排格式方面可以不同。
Note: in order to adapt to the organization's size and complexity, the quality manual in detail and format can be different.
　　质量手册的基本内容在GB／T19001—2000标准的4．2．2条款中规定：
Quality manual on basic content in GB / T19001 - 2000 standard 4.2.2 provision:
　　 (1)质量管理体系的范围，包括任何删减的细节与合理性；
( 1) the scope of the quality management system, including details of and justification for any exclusions;
　　 (2)为质量管理体系编制的形成文件的程序或对其引用；
( 2) for the quality management system, the documented procedures established or reference to them;
　　 (3)质量管理体系过程之间的相互作用的表述。
( 3) the processes of the quality management system a description of the interaction between.
　　质量管理体系的范围应包括组织提供满足顾客要求和满足适用的法律法规要求的产品的能力所要求的内容。一般情况下应当覆盖标准的全部内容。如有不适用的条款需删减时，应依据本标准1．2条款“应用”的要求进行删减。
The scope of the quality management system shall include the organization to provide to meet customer requirements and meet the applicable laws and regulations require products on the ability of the requested content. Under normal circumstances should cover the entire content standard. If there is not applicable to all the terms, provisions should be based on the standard 1.2" application " requirement.
　　质量手册的范围确定之后，其具体内容的编排可以有两种方式：第一种，质量手册中包括全部程序文件的内容。1994版标准称其为《质量管理手册》。规模较小，产品简单的组织，可以采用这种质量手册。其作用是：对内可以作为质量管理体系实施的依据，不需要再单独编写程序文件。对外可以展示自身的质量管理体系，为满足标准要求提供证据，同时可以为质量管理体系审核(包括内审和外审)提供依据。
Quality manual range is determined, the specific content arrangement can be in one of two ways: first, the quality handbook includes all the program files content. The 1994 edition of the standard called" quality management manual.". A smaller scale, product simple organization, can adopt the quality manual. Its role is: to the quality management system can be used as the basis of the implementation of the program, do not need to separate files. Foreign can display their quality management system, to meet the requirements of the standard to provide evidence, at the same time for quality management system audit ( including internal and external audit ) provide a basis.
　　第二种质量手册中不包括程序文件的内容，只是依据标准的要求对质量管理体系各过程的控制作简要的描述，在描述过程中引用相关程序文件的编号、标题、或节录，其中一段关键的内容。这种质量手册在1994版标准中被称为《质量保证手册》。规模较大，产品较复杂的组织可以采用这种质量手册。其作用是对外展示和证明自身的质量管理体系。对内实施质量管理体系要依据单独编写的程序文件。
Second kinds of quality manual is not included in the program content of the document, but according to the standard requirements of the quality management system process control is briefly described, in describing the process reference document number, title, or excerpt, in which a key content. This quality manual in the 1994 version of the standard is called the" quality assurance manual". Larger scale, product more complex organizations can adopt this quality manual. Its role is foreign to show and prove its own quality management system. Implementation of internal quality management system according to the separate program file.
　　质量手册的结构和形式，有关的国际标准和国家标准中均未作统一要求。只要所提供的信息能结合组织自身的特点，又符合标准要求即可。但应强调不要完全照抄标准。
Quality manual structure and form, the relevant international standards and national standards are not unified requirements. As long as the information provided by the combination of tissue with its own characteristics, and meet the requirements of the standard. But should emphasize not simply copy standard.
　　质量手册发布前，应由各部门负责人对其进行评审。确保其清晰、准确，适用和结构合理。然后由组织的最高管理者批准发放。所有文本都应带有批准发放的标记。
Release quality manual, shall be borne by the head of its review. Ensure the clear, accurate, applicable and reasonable structure. Then by the organization's top management approval for issuing. All text should come with the payment approval mark.
　　组织应规定手册的分发范围和办法。手册应有文件编号和发放号，并设计文件发放登记表，按号发放并登记签字。
The organization shall distribute the scope and procedures manual. Manual should document number and issuance, and design documents issued registration form, press release and sign.