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.
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