Government
regulations require that companies working in certain industries control their
documents. These industries include 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).
Particular industries are also held to a higher level of documentation control,
for privacy, warranty and insurance purposes. For example, in the construction
industry, it is common that project documentation is held on record and
adequately controlled for warranty periods ranging on average for 5-10 years.
Documents
stored in a document management system — such as procedures, work instructions,
and policy statements—provide evidence of documents under control. Failing to
comply could cause fines, the loss of business, or damage to a business's
reputation.
The
following are important aspects of document control:
- 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
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