Documents of External Origin

ISO9000:2000 certification is site specific.  All quality management system documents must meet the standard's requirements for document control (issue, change, review, approve, and control).  All of the requirements of the Standard must be addressed by the site.  If you look at the site as an island, all of the requirements of the standard are encompassed within the island.

The organization writes, changes, reviews, approves and controls documents to ensure quality management system activities are carried out in accordance with the organization's requirements on the island.  Any document needed to ensure quality management system activities are carried out in accordance with the organization's requirements on the island that do not originate on the island are considered documents of external origin.  The organization can review, approve, and controls documents of external origin but the organization can not write or change a document of external origin.  A mechinism should be created to ensure the organization is using the correct revision.