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ISO 9001 Document Control Considerations

It is critical to control your documents to ensure good communication and consistent process execution.

ISO 9001 requires that you maintain Control of Documents (4.2.3), which can be a binder of papers or an enterprise-wide document management system.

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The key is that any document critical to the delivery of your products and/or services is controlled. This ensures that everyone in your organization is using the most recent (and correct) instructions, keeping the correct records, understanding the policies and procedures that allow you to operate.

Here are some items to consider about document control:

  • Location - Where will documents be stored? Options include:
  • Creation - How are documents created?
  • Distribution - Who is responsible for Distribution to appropriate parties?
  • Document Life - How long should documents be kept, i.e. retained?
  • Filing - How will documents be filed for easy retrieval?
  • Filing - How will documents be filed for easy retrieval?
  • Permissions - Who decides the hierarchy?
  • Protection - How can documents be recovered in case of destruction?
  • Retrieval - How will users find the documents they need?
  • Security - How do you keep documents and assure secure revisions?
  • Validation - How do you determine the document's authenticity?
  • Version Control - How can you tell whether you have the current revision?