GB/T19001: 2016-7.5.3.2记录

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“分发、访问、检索和使用”。例如：

由文件编制者注明，并由文件控制部门统一分发,并有分发回收记录；

设置访问权限：

通过数据库检索或制作检索卡片；

防止不适当使用(比如使用错误版本的成文信息)

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Distribute, Access, Retrieve, and Use.

For example:



Marked by the document creator and uniformly distributed by the document control department;



Set access permissions:



Retrieve or create search cards through databases;



Prevent inappropriate use (such as using incorrect versions of written information)

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“存储和防护，包括保持可读性”

成文信息应被保持在合适的媒介中以确保其防护和可读性，要做好防护需要专门的档案柜和档案室 确保防火防潮防爆等

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Storage and protection, including maintaining readability



Documented information should be kept in appropriate media to ensure its protection and readability. To do a good job in protection, special Filing cabinet and filing room are required to ensure fire, moisture, explosion, etc

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“更改控制（如版本控制）”。

随着组织改进其过程及其质量管理体系，成文信息可能改变或发展。

组织应考虑版本控制，例如：确定一些方法以识别当前版本和废弃版本的成文信息，并建立控制以确保仅当前版本的成文信息被使用。

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更改记录是我们做文静更改追溯非常好的手段

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Change control (such as version control).



As organizations improve their processes and quality management systems, written information may change or develop.





Organizations should consider version control, such as identifying methods to identify the written information of current and obsolete versions, and establishing controls to ensure that only the written information of the current version is used.





Changing records is a very good means for us to trace and document changes

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“保留和处置”。

“对于组织确定的策划和运行质量管理体系所必需的来自外部的成文信息，组织应进行适当识别并予以控制”。

这可能包括来自顾客或外部供方的成文信息，例如图纸、特定的测试方法、抽样方案、标准或校准报告。

应特别关注敏感数据的控制。

“对所保留的、作为符合性证据的成文信息应予以保护，防止非预期的更改”。

对此类信息，组织应仅允许受控的访问，例如，为代表组织工作的有关人员授权的访问或受限的电子访问(比如“只读”)，视情况而定

文件和记录都需要有保留的期限，以便在产品上市期间的调查和追溯，所以最少应该是在产品寿命期后一年

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Retention and disposal.



The organization shall appropriately identify and control external written information necessary for the planning and operation of the quality management system determined by the organization.



This may include written information from customers or external suppliers, such as drawings, specific testing methods, sampling plans, standards, or calibration reports.



Special attention should be paid to the control of sensitive data.



Documented information retained as evidence of compliance should be protected to prevent unexpected changes.



For such information, the organization should only allow controlled access, such as authorized access for personnel working on behalf of the organization or restricted electronic access (such as "read-only"), as appropriate





Both documents and records need to have a retention period for investigation and traceability during the product launch period, so it should be at least one year after the product's lifespan

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