1. Module 8
Decoding ISO 15189™
Conducting a Management Review
A management review is a formal meeting of key members of senior management. The purpose is to
review the status and effectiveness of the quality management system. This meeting provides a venue for
management to evaluate and analyze laboratory practices for the purpose of improvement. During this
meeting, a comprehensive look back at the organization’s quality management system takes place. This
includes a review of documented policies and a review of records. Following the meeting, a list of action
plans for improvement should be produced.
The Agenda:
A detailed, timed agenda should be prepared by the quality manager. With advance preparation, most
organizations should be able to complete the meeting in a single day. However, it is critical that advance
planning is done to allow the meeting to run smoothly.
The management review agenda should include the following inputs for discussion:
1. Review of the quality policy
2. Progress towards goals and objectives
3. Results of audits from the past year, this includes internal audits and audits by external bodies
4. Customer feedback such as the results of satisfaction surveys and a summary of complaints
5. A summary of quality indicator data such a turn-around times or specimen rejection rates.
6. Review of proficiency testing performance
7. A review of nonconformites including the status of corrective actions
8. Status of the previous management review items
9. A review of resources taking into consideration any changes in the volume of work and type of
work undertaken
10. An evaluation of suppliers
For your management review, all discussion inputs should be included on the agenda along with a target
timeframe for each discussion. A review of your quality policy and objectives from the past year should
occur at the onset of the meeting.
Preparing for the Meeting:
For each agenda item, consideration should be given to the desired outcomes. It would be advantageous
to use standard templates for the preparation of briefing notes to establish continuity. In order to facilitate
a smooth meeting, it is essential to be thorough in material preparation so that the volume of information
can be managed in the time allotted. The meeting will be greatly enhanced by preparing graphical
summaries of data such as the Pareto chart shown in Figure 1.
Pareto charts and other summary tools will provide focus and direction to help pinpoint issues, monitor
progress and enable management to recognize trends. The champion—usually the quality manager—
must determine which process records will support the identified areas of measurement (i.e., quality
indicators) and ensure that they effectively assess the status of the area to be reviewed. The
management team must analyze all information to determine if the target has been realized, the action
has been adequate or if further improvement can be achieved.
© Institute for Quality Management in Healthcare Page 1 of 2

2. Module 8
Decoding ISO 15189™
Figure 1: Sample Pareto Chart
During the Meeting:
We suggest that as the meeting unfolds, the quality manager ensures that the management team
commits to an action plan to address each input. Essentially, the outputs of the management review feed
directly back into the strategic planning for the next year. The action plan should adequately identify the
issue to be resolved, assign key responsibility for follow-up, indicate timelines for completion and define a
mechanism to evaluate effectiveness, i.e., mini audits. Timelines should be adequately assigned
according to the urgency of the issue. Someone must be assigned to record the minutes of the meeting.
This will provide a record of the management review. It is imperative that each action plan is completely
documented.
Page 2 of 2 © Institute for Quality Management in Healthcare