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Procedure for Control of Document

Title

Procedure for Control of Document

Category

QMS

Reference

ISO 13485 : 2016

Procedure for Control of Document

Documents are a crucial component of the organization, serving as documented evidence for process completion and as a reference for executing any process. They are essential for compliance, training, work reference, and audit purposes.


To manage these documents, a document control procedure is essential for correctly executing the process and ensuring ISO compliance.


The key features for document controls must adhere to the following points:

  1. Define good documentation practices.

  2. Specify the document requirements within the organization and identify which documents need to be controlled.

  3. Outline document specifications such as font type, size, spacing, indenting, page layout, language type, etc.

  4. Define the contents of the documents. For example, for an SOP, the contents include:

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