Formulate the Quality Policy


Up to now the Vision, Mission, and Long Term Goals of the laboratory have been formulated. These are all at the basis of the Quality Policy of the laboratory. The Quality Policy is the description of the intention, means, and how to reach the long-term goals. This is needed for being able to develop realistic and relevant Quality Year Plans.


The Quality Policy provides the most concrete direction to the yearly planning of the laboratory. It describes the strategy the laboratory will use in reaching the Long Term Goals. Take into account that the policy shouldn't become a huge document with endless descriptions; keep it concise, covering a maximum of 4 pages. For an example refer to the Example Quality Policy in the right-hand column. This is the quality policy of the National Tuberculosis Reference Laboratory of Uganda.

ISO 15189:2012 sums up the elements that should be covered by the Quality Policy:

  • The scope of the services of the laboratory
  • A statement of the management in which it describes its commitment to establishing and maintaining the quality management system and continually improving its effectiveness
  • The objectives of the quality management system (the Long Term Goals) and what the laboratory will do to achieve this
  • The requirement that all staff must be aware of the policies and procedures of the laboratory and implement these
  • A statement describing the commitment of the whole laboratory to provide good professional practice, quality examinations in compliance with the ISO 15189 quality management system

How & who

Laboratory Manager:

  1. Write the Quality Policy based on the Vision, Mission, Core Values and Long Term Goals.
  2. Print the Quality Policy and sign and date this.
  3. Make and print a Read and Understanding List for the Quality Manual. Up to now only the Quality Policy will be indicated as essential reading material in this list. However, later in phase 3 the quality manual will be written and should be read by all laboratory staff. When chapters are finished they can be added to this list.
  4. Distribute copies of the Quality Policy among laboratory staff and discuss the policy in a weekly staff meeting.
  5. Explain to staff members that they must familiarize themselves with the policy; include it in the Read and Understand List and indicate that all staff members have to read it. Explain that they have to sign the Read and Understand List when they have read the Quality Policy.
  6. Check after 4 weeks (= SMART) that all staff members have read the Quality Policy.
  7. Store the original, signed Quality Policy in the folder Organization.

Back to Roadmap Activity Overview
This activity belongs to the QSE Organization
ISO15189:2007: 4.1.5 4.2.1 4.2.3