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The standards require documentation to be current, so clearly it must be reviewed regularly to ensure currency.

Changes of practice need to be accompanied by simultaneous review of the relevant parts of the QMS documentation. It is still, however, easy for documents to become out of date. They therefore need to be reviewed on a regular basis by appropriate members of staff.

The frequency of review should be specified in the QMS documentation; it need not be the same for all documents.

The Quality Manager is responsible for ensuring that review takes place as planned, but is not personally responsible for the review of all documents.

ISO/IEC 17025 clause states:

  • Where practicable, the altered or new text shall be identified in the document or the appropriate attachments.
  • This makes it easier for staff to see quickly what changes have been made in a new version. How this is achieved depends on the system of document control used. In hard copies, for example, new or altered text could be highlighted by printing in bold and italic script.