Title

Make an SOP covering the various support activities that are carried out such as cleaning of the laboratory and organization of work discussions

Why

In each laboratory there are many small activities that are necessary to keep the laboratory functioning, and these have to be standardized in SOPs. However, it would be too inefficient to make separate SOPs for every small procedure. Instead, it may be better to make one SOP compiling all these support procedures.

What

Develop an SOP for General Activities, covering all the smaller activities that are carried out by the laboratory. Examples of such activities are:

  • Internal communication: organization of meetings and drafting of minutes
  • Monitoring of transportation of samples (see next activity)
  • Cleaning of the containment laboratory.
  • Temperature monitoring
  • Cleaning of refrigerators, freezers, incubators, etc.

How & who

Quality Officer:

  1. Make a list of procedures that are too simple to standardize individually in separate SOPs, but that have to be standardized because they are critical for proper functioning of the laboratory.
  2. Construct the SOP following the protocol for developing a Procedure SOP in the Master SOP and using the template for a Procedure SOP attached to the Master SOP.
  3. Review and authorize the SOP according to the SOP for Document Control.
  4. When the SOP is ready determine at which locations copies of the SOP must be available and indicate this on the SOP (to facilitate efficient and correct replacement of all copies when a new version of the SOP is printed). The SOP must be coded as a Procedure SOP.
  5. Include the SOP in the Read and Understand List and indicate the persons for which this SOP is relevant and who thus have to read it.
  6. Present the SOP to the laboratory and support staff in a weekly staff meeting and explain which procedures can be found in this SOP and indicate who have to read the SOP and sign the Read and Understand List after reading.

Back to Roadmap Activity Overview
This activity belongs to the QSE Process Management

 

ISO15189:2007: 4.2.1
ISO15189:2012: 4.2.2.1
ISO15190:2003: