ISO22716关于文件管理的要求

17.3.2 The title, nature and purpose of documents should be stated.

文件包含标题，目的、属性

17.3.3 Documents should be:文件应该是这样的

a)written in a legible and comprehensive way;清晰，容易被理解

b)approved, signed and dated by authorized persons before being used;在使用前经过授权人员批准，签字，确定生效日期。

c)prepared, updated, withdrawn, distributed, classified;编写，更新，撤回，发放，分类。

d)referenced to ensure that obsolete documents are not used; 不能使用失效的文件。

e)accessible to appropriate personnel;所有员工都能理解。

f)removed from the job area and destroyed if they are out-dated.如果失效就要从使用区域撤回和销毁 17.3.4 Records which require the entry of handwritten data should:手写的记录要符合以下条件：

a)indicate what is to be entered;表明需要写的内容

b)be written legibly with permanent ink;用不褪色墨水清楚书写

c)be signed and dated;签字和日期

d)be corrected, if needed, leaving the original entry still readable; where appropriate, the reason for the correction should

be recorded.如果改写，原来的内容也应可读，适用时，应写明修改原因。

17.4 Revision 修订

Documents should be updated, when necessary, and the revision number indicated.

The reason for each revision should be retained.

需要时资料必须更新，更新的项目必须被标识。

17.5 Archiving 存档

17.5.1 Only original documents should be archived and only controlled copies should be used

只有原始文件可以存档，受控副本可以使用。

17.5.2 The duration of archiving original documents should be defined according to applicable legislation and regulations.

原始文档的存档期必须根据适当的法律法规来制定。

17.5.3 The storage of original documents should be properly secured

.原始数据的储存必须有保证

17.5.4 Documents may be archived as either electronic or hard-copies and their legibility should be ensured.

文件存档为电子档或者手写的，必须保证是清晰易读的。

17.5.5 Backup data should be stored at a separate and secure location at regular intervals.

备分数据应在规定的期限内单独保存、确保安全。