This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.


4.5 Document Control

4.5.1 Document Approval and Issue

Provide Workers Up-to-Date, Authoritative Documents

Review and obtain final approval on procedure documents before publishing them. Make sure that:

a) The people who do the work have current copies of the documents which describe the procedures they carry out;
b) out-of-date documents are removed from the work place.

Discussion:

Before issuing a controlled document, review the document with people who have knowledge of the work, and authority to stipulate a process. When a new issue of a document is distributed, destroy or mark as obsolete the prior issue document. Mark "Uncontrolled copy" on copies that are distributed to people other than those who need the document for their work. Alternatively, stamping controlled copies in red to distinguish them from uncontrolled photocopies can be effective. The scope of this requirement includes procedure documents, project documents relating to a particular product as well as organization charts and job descriptions. The single largest source of noncompliance usually occurs with this section of the Standard.

4.5.2 Document Changes/Modifications

Control Document Changes

People who are familiar with the original document should review changes to be made to that document. Provide document reviewers with the information they need to make informed decisions. It is good also to identify in writing the nature of the changes made to the revised document.

Keep a list of the current revision level of each controlled document. If the document has been changed frequently, re-issue it in its entirety, incorporating all of the various revisions in final form.

Discussion:

If the document affects product quality, then it must be controlled. Although an overall master list of titles is not required for each type of document generated, it must be easy to determine if the documents in use are the latest version.


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