ISO9001:2008质量管理体系文件的类别
ISO9001: 2008 quality management system document category
在GB／T19001—2008标准的4．2．1条款中质量管理体系文件的类别已有明确的规定，它们是；
In GB / T19001 - 2008 standard 4.2.1 in terms of the quality management system documentation categories are well defined, they are;
　　 (1)形成文件的质量方针和质量目标；
( 1) documented statements of a quality policy and quality objectives;
　　 (2)质量手册；
( 2) a quality manual;
　　 (3)本标准所要求的形成文件的程序；
( 3) the standards required by the documented procedures;
　　 (4)组织为确保其过程的有效策划、运行和控制所需的文件；
( 4) the organization to ensure the effective planning, operation and process control documents required;
　　 (5)本标准所要求的记录。
( 5) records required by this international standard.
　　其中(1)条“形成文件的质量方针和质量目标”，可以单独成文，也可以放在《质量手册》中，依据标准5．3条“质量方针”的要求进行阐述。
One (1 ) "the documented quality policy and quality objectives", can be written, can be placed in the" quality manual", according to the standard 5.3" quality policy" requirements for the.
　　 (3)条款“本标准所要求的形成文件的程序”规定了以下六个基本程序文件：
( 3 ) the terms " the standards required by the documented procedures " provisions of the following six basic procedures:
　　 a．文件控制程序；
A document control procedure;
　　 b．质量记录控制程序；
Quality record control procedures B;
　　 c．内部审核程序；
C. Internal audit procedure;
　　 d．不合格品控制程序；
D nonconforming product control procedure;
　　 e．纠正措施控制程序；
E. Corrective measures to control procedures;
　　 f．预防措施控制程序。
F. Prevention measure control procedure.
　　除了标准规定的以上六个程序文件必须编写之外，组织的其他工作是不是可以不编写程序文件了呢?并非如此。在标准4．2．1条款中的“注2”中有这样一条笼统的规定：“不同组织的质量管理体系文件的多少与详略程度取决于：a)组织的规模和活动的类型；b)过程及其相互作用的复杂程度；c)人员的能力。”
In addition to the standard stipulated in the above six program files must be written, the organization of other work is it right? Can not write a program file is not so?. In the standard 4.2.1 clause in the" 2" there is a general provisions:" different organization quality management system documents and the amount of detail depending on: a ) the size of organization and type; b ) the complexity of processes and their interactions; c ) the competence of personnel."
　　质量手册和标准中规定的六个基本程序文件是必须编写的。其他程序文件的数量和详略程度，可依据标准中规定的上述三条原则选编。但建议组织就选编的范围和内容与所选择的认证机构进行商讨后确定。
The quality manual and standards set forth in the six basic program file must be prepared. Other program file number and somewhat, can according to the standard stipulated in the above three principles. But suggested that the organization selected range and content with the choice of the certification body for discussions to determine.
　　其他质量文件，归纳起来大致可分为以下三大类：
Other quality documents, Baconian rise can be roughly divided into the following three categories:
　　 a)管理标准：各类规章制度；　　
A ) management standard: all kinds of rules and regulations;
　　 b)工作标准：部门和个人的职责；
Work standard: b ) department and individual responsibility;
　　 c)技术标准：工艺规程、检验规程、操作规程、还包括一些外来文件如国家标准、行业标准等。
C ) technical standards: procedure, test procedures, operating procedures, including some foreign documents such as the national standards, industry standards.
　　这些文件，一般组织是应该具备的，但须依据标准的要求规范化、系统化、标准化。质量记录是执行上述文件的结果，也是质量管理体系运行的证据。记录的格式应附在上述文件之后，其内容应依据文件要求设计并达到规范化、系统化的要求。
These documents, the general organization should have, but must be based on the standard standardization, systematization, standardization. Quality records is the implementation of the above-mentioned documents results, but also in quality management system of evidence. Record format should be attached in the file, its content should be based on document design requirements and to achieve standardization, systematic requirements.