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The ISO 15189 document control standard applies to all quality documentation, including charts, reference ranges, standard operating procedures, and posters. Eight document control processes must be applied to these documents:
- Documents must be reviewed or approved prior to use.
- A document control log must be maintained.
- Only current documents should be in use.
- Documents must be periodically reviewed, revised if necessary, and approved.
- Obsolete documents are ensured against inadvertent use.
- Archived documents are identified as such.
- If hand-edits are allowed, the procedures for doing them must be defined and controlled.
- Computerized document control systems must have defined procedures.
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