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Volume 7 · Issue 4 · April 2002


Page 30…

ISO 9001:2000 and the Legal Implications of Document Control

James W. Kolka and Timothy J. Budacki write that if you have an effective QMS that covers all its processes, you have nothing to fear from the paper trail created by the QMS and could regret eliminating parts that might prove you made every effort to protect the customer from harm. They advise any organization to seriously consider what documentation the QMS will include beyond what is required by ISO 9001:2000 and to retain what is needed for the QMS–and organization–to operate effectively. Kolka and Budacki examine the purpose of document control in an ISO 9001:2000 QMS, the types of documents that create legal problems, the product liability case for document control and the limits of attorney-client privilege with a QMS.