Write an SOP on Handling of Complaints and start to follow-up complaints in a standardized way


Complaints are often seen as negative criticism on the way the laboratory works. However, the fact is that complaints are indications that clients have bad experience with a certain aspect of the services delivered by the laboratory. This is thus a perfect indication of a point for improvement: complaints are free-of-charge information on what can be improved in the laboratory. It is therefore necessary to handle complaints in the same way as nonconformities, using the plan-do-check-act cycle. This enables the laboratory to learn and to continually improve.


Handle complaints in a standardized way. Complaints should be treated the same as nonconformities. The only additional activity regarding the solving/correcting of complaints is that the complainer is informed about how his/her complaint is treated and solved. This is part of the customer focus of the laboratory.

For recording and solving complaints a complaint form is needed. In the right-hand column a template for a complaint form is given. This form consists of the following elements:

  1. A section in which the details of the complainer (name, address, telephone number, email address) need to be recorded
  2. A section in which the complaint is described, including the date
  3. A section in which the details of the laboratory staff member recording the complaint are filled-out
  4. An indication whether the laboratory is receptive to the complaint (if the complaint is not about something the laboratory can improve, it is of no use to try to handle the complaint)
  5. A section with a description of the solution to the issue of the complaint
  6. A section for the date and time on which the complainer has been informed of the resolution of the issue of the complaint. The name of the person informing the complainer also needs to be recorded here
  7. Signature and date of laboratory manager as indication that the complaint has completely been handled.

For solving/correcting a complaint the following procedure needs to be carried out:

  • When a complaint is received at the laboratory the first 4 steps (above) need to be done for filling out the complaint form
  • A nonconformity form needs to be filled out; the complaint is now translated into a nonconformity. From this point on the procedure for solving/correcting nonconformities needs to be followed (see previous activity)
  • When the complaint (i.e. nonconformity) has been solved, the laboratory has to describe what was done to solve the complaint on the complaint form (step 5 above)
  • The complainer needs to be notified and the date, time and name of the person notifying the complainer need to be filled-out on the complaint form (see step 6 above)
  • The complaint form is then given to the laboratory manager who checks completeness of the form and if the complaint was indeed appropriately handled. If so, the laboratory manager signs and dates the form and gives it to the Quality Officer for archiving.

How & who

Quality Officer:

  1. Write the SOP on Handling of Complaints according to the protocol for developing a Procedure SOP in the Master SOP and use the template Procedure SOP attached to the Master SOP. Do this together with the person assigned (earlier in phase 4) to provide advice to customers when requested.
  2. Design the complaint form; this will be an appendix to the SOP on Handling of Complaints.
  3. Review and authorize the SOP in accordance with the SOP for Document Control.
  4. Include the SOP on the Read and Understand List and indicate that all staff members must read the SOP (especially the staff members that have regular customer contact).
  5. Present the SOP in a weekly staff meeting and explain the procedure for handling complaints and why complaints need to be handled according to this procedure. Indicate that all staff members, especially those who have regular customer contact, have to read the SOP and start to record complaints as described in the SOP.
  6. Monitor if all staff members have read the SOP.
  7. Monitor if staff members start to record nonconformities on the form. If you receive no filled-out complaint forms, stress the importance of recording complaints again in a weekly staff meeting, until you start receiving filled-out forms.

Laboratory Manager:

  1. Adapt the Authorization Matrix to include the tasks and responsibilities described in the SOP on Handling of Complaint for the different positions in the laboratory.
  2. Monitor if complaints are indeed recorded and handled correctly in accordance with the SOP.

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This activity belongs to the QSE Nonconforming Event Management
ISO15189:2007: 4.8
ISO15189:2012: 4.8