质量手册包括为质量管理体系编制的形成文件的程序或对其引用。
Develop procedures to review, approve, and manage all of your quality system documents and data.
应编制形成文件的程序以规定评审所采取的预防措施等方面的要求。
A documented procedure shall BE established to define requirements for reviewing preventive action taken.
编制形成文件的程序控制应规定必要时对文件进行评审与更新并再次批准。
A documented procedure shall be established to define the controls needed to review and update as necessary and re-approve documents.
策划和实施审核以及报告结果和保持记录的职责和要求，应在形成文件的程序中作出规定。
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure.
注：1、本标准出现“形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。
NOTE 1 Where the term "documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
策划和实施审核以及报告结果和保持记录(见4.2.4)的职责和要求应在形成文件的程序中作出规定。
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
小型组织可以采用一份简单的质量手册就能用来描述他们整个质量管理体系，其中包括标准规定必须要有的形成文件的各个程序。
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
小型组织可以采用一份简单的质量手册就能用来描述他们整个质量管理体系，其中包括标准规定必须要有的形成文件的各个程序。
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
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