Module 8 Decoding ISO 15189™

© Institute for Quality Management in Healthcare Page 1 of 2

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.

Module 8 Decoding ISO 15189™

Page 2 of 2 © Institute for Quality Management in Healthcare

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.