Standardize the method of developing, reviewing and evaluating a contract for service delivery


Before promising something, you always have to be sure that you can fulfill the promise. This also applies to the laboratory. When a laboratory enters in a contract to perform examinations for a research project or to deliver other services, the laboratory must be sure that it can meet the demands.


Develop an SOP for Developing, Reviewing and Evaluating a Contract for Service Delivery. This SOP describes all the actions that need to be done to develop a proper contract for service delivery and reviewing and evaluating the contract.

The following procedures need to be included:

  • Investigating if the laboratory houses all the requested examinations and expertise, including:
    • Investigating if the laboratory can cope with the additional workload on top of the the standard workload of routine testing (take into account the availability of personnel, work space, expertise, et cetera).
    • Investigating if the amount of money paid by the client weighs up against the costs made.
    • In case of research projects: making appointments regarding the number of samples, when they are delivered, the turnaround time, when and how results are reported, how long data must be archived by the laboratory, when and how the payment is done, etc. Of all the meetings with the client minutes need to be made and archived together with the contract itself.
    • Formulating opt-out criteria that enable you to terminate the contract when certain requirements from your side are not met by the client.
  • The procedure for doing a contract review during the contract period. In this review you check if the appointments made in the contract are complied with. The findings of this review need to be recorded and archived together with the contract itself.
  • The procedure for making minutes when meetings are organized with the customer and the laboratory that include a description of all the appointments made during that meeting. These minutes must also be archived with the contract and the contract review findings. When the arrangements in the contract are changed or amended during the contract period, the contract must be reviewed again.
  • The procedure for evaluating a contract to see if all appointments were met by the laboratory and the client. Findings of this evaluation also need to be recorded. The protocol must also include actions to be undertaken when appointments were not met by either the laboratory or the client.
  • The procedure for if the laboratory has to deviate from the contract due to unforeseen circumstances. The client always needs to be informed before deviating from the contract. The laboratory has to try to find solutions to problems in close discussion with the client. These events need to be document and archived together with the contract.

How & who

Laboratory Manager:

  1. Write the SOP Developing, Reviewing and Evaluating a Contract for Service Delivery according to the protocol on writing a Procedure SOP in the Master SOP and the template for a Procedure SOP attached to the Master SOP. While writing the procedures, take into account your experience with participation in contracted service delivery activities in the past.
  2. Review and authorize the SOP in accordance with the procedures of the SOP for Document Control (do this in cooperation with the Quality Officer).
  3. Discuss the contents of the SOP with the relevant persons. These are the persons involved in acquisition processes.
  4. Create a new folder entitled "Contracts for Service Delivery". This folder is for storing the contracts, together with findings of contract reviews and evaluations and minutes of meetings with the contracted clients.
  5. Include the SOP in the Read and Understand List and indicate who have to read the SOP (those for whom the SOP is relevant, e.g. senior technologists, acquisition department, Financial Officer, etc.).
  6. Present the SOP to the staff members for whom the SOP is relevant; explain why it was developed and which procedures are included in the SOP. Explain that this SOP has to be followed from now on in developing new contracts.

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This activity belongs to the QSE Purchasing & Inventory


ISO15189:2007: 4.4.1 4.4.2 4.4.4 4.4.5
ISO15189:2012: 4.4.1 4.4.2