Timothy Macenroe

Controlling External Quality Manual Documents in your ISO9001:2000 Quality Management System

Does your organization use externally generated documents as part of your quality manual?    Do you wonder if you have to control these, and how to control these?

Do you use external documents in your quality manual?  External documents are those generated and (usually) updated by organizations outside your company.  Documents such as:

• Government Standards
• MIL-SPEC Documents
• Federal Aviation Regulations
• Drawings created by your Customers or Vendors
• etc.

If you don’t want to, or are not allowed to control external documents, you must specifically state in your quality manual, and on the documents themselves, that they are “For Reference Only” and are not updated.

External documents that you depend on, and that are updated occasionally, must be controlled in your quality management system. Revision is usually controlled by the publisher. You are responsible to ensure that you have a means to receive updates from the publisher (such as a current subscription) and that you periodically check to make sure that you have the latest revisions.

As part of your quality manual's document control, you must also devise a way to withdraw the obsolete documents and prevent their accidental use, and also issue the new updated documents to the necessary personnel in your organization.

Whatever process you use to make sure you have the latest revisions, you must document this in your quality manual.

Article Tags: Quality Management System, Quality Manual, Quality Management, Management System

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