Procedure for documents and records

The activity of establishing and maintaining ISO 17025:2017 documents and records is a critical activity in most laboratories, as it usually involves many personnel meeting many ISO 17025 requirements. A procedure is therefore required, being defined as a “specified way to carry out an activity or a process”. (ISO 9000:2015)

Although it is noted that procedures can be either documented or not; consider that documents and records are core to meeting every ISO 17025 requirement. If a documented procedure did not exist to establish, identify, approve, review, change and control distribution of documents and records; a laboratory would risk the quality and control of many processes within the ISO 17025 management system.  As ISO 17025 requires a laboratory to consider and address risks of all activities, a documented procedure to manage documents and records is considered mandatory.