Document control: 8 requirements of ISO 15189


CAP Today




July 2009
Feature Story

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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