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document control (Compliance adds requirements that transform document management into a document control issue. Document control is a regulatory requirement within accounting (e.g., 8th EU Directive, Sarbanes–Oxley Act), food safety (e.g., Food Safety Modernization Act), ISO (mentioned above), medical device manufacturing (FDA), manufacture of blood, human cells, and tissue products (FDA), Healthcare (JCAHO), and Information technology (ITIL).[9][10] Your documents – procedures, work instructions, policy statements, etc. – provide evidence of documents under control. Failing to comply could cause fines, the loss of business, or damage to your business reputation. The basic requirement for document control require that you establish and document a procedure for: Reviewing and approving documents prior to release Reviews and approvals Ensuring changes and revisions are clearly identified Ensuring that relevant versions of applicable documents are available at their "points of use" Ensuring that documents remain legible and identifiable Ensuring that external documents like customer supplied documents or supplier manuals are identified and controlled Preventing "unintended" use of obsolete documents. WAD Leonid Dzhepko) |
