Title

Amend the Equipment SOPs developed in phase 1

Why

In phase 2 new procedures were developed for equipment management. These procedures need to be described in the Equipment SOP for each piece of equipment. As the Equipment SOPs were developed in phase 1 they may not yet contain these procedures.

What

In this phase several new procedures have been developed regarding the use and maintenance of equipment that should be described in the SOPs specific for each piece of equipment. An example is the procedure for calibration and maintenance. This procedure is highly specific for each piece of equipment and should therefore be added to the Equipment SOP specific for every piece of equipment.


In phase 2 the document control system will be launched. This system ensures that all the SOPs of the laboratory are reviewed and, if necessary, revised annually. Read through the Equipment SOPs and see which SOPs need to be amended with procedures developed in phase 2. Write these procedures on a Document Revision Form (developed earlier in this phase) and place this in front of each SOP. This way the author of each SOP knows what to adapt when he must review and revise the SOP.

How & who

Equipment Officer:

  1. Determine which procedures need to be added to each SOP.
  2. List these procedures on a Document Revision Form and place this form in front of the SOP it belongs to.
  3. Inform the author of each SOP that there is a Document Revision Form filled-out for their SOP with a list of procedures that need to be added to the SOP. Explain that he/she should add these procedures at the moment the SOP needs to be reviewed and revised according to the SOP for Document Control.

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This activity belongs to the QSE Documents & Records

 

ISO15189:2007: 4.2.1 5.3.5 5.3.12
ISO15189:2012: 5.3.1.3 5.3.1.4
ISO15190:2003: