Documentation

Documents or other media which describe process or establish criteria shall be adequately prepared, reviewed, approved, issued, distributed, authorized and, as required, validated.

In the same way, records reflecting the fulfilment of quality requirements shall be specified, prepared, reviewed, approved and maintained in good condition for an established period of time. Both documents and records should be adequately stored for predefined periods of time.

21.1.3 Work management

Work shall be planned and performed in accordance with established requirements and administrative controls, and using approved documents that are periodically reviewed.

Important elements to be considered in a work management process are the following: [112]