Title

Design a Document Revision Form

Why

In this phase a document control system needs to be developed and implemented. In this system all the SOPs and quality manual chapters (to be developed in phase 3) will be reviewed and, when necessary, revised on a regular basis. Sometimes errors and inconsistencies in SOPs or quality manual chapters will be noticed during their use. However, if these do not directly influence the outcome of the procedure/examination it is not necessary to go through the hassle of directly correcting these errors and reprinting the documents. In this case the correction of the errors can wait until scheduled review and revision of the documents.

What

Develop a Document Revision Form. When a minor error is identified in a specific document this form must be used for recording this error so that the error will be corrected during scheduled review and revision of the document. This means that the Document Revision Form should have room for filling-out the code of the document to which the form applies. See the template added in the right-hand column for an example of what the Document Revision Form could look like.

How & who

Quality Officer:

  1. Develop the Document Revision Form. You could use the template Document Revision Form provided in the right hand column.
  2. Print a number of copies of the form and place this at a location that is accessible to all laboratory personnel.
  3. Present this form to all the staff members in the laboratory. Explain that soon a lot of SOPs will be developed and that if they detect an error in one of the SOPs after it has been authorized and distributed for use, they have to fill out this form and hand it over to you. Explain that you will subsequently determine if the SOP needs to be revised right-away or that this can wait until scheduled revision which is done annually. Explain that this is the best way to keep track of errors in documentation of the laboratory. Explain where to find copies of the form.

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This activity belongs to the QSE Documents & Records
ISO15189:2007: 4.3.2
ISO15189:2012: 4.3
ISO15190:2003: