Activities related to Phase 4 - Organization

Since phase 3 management reviews need to be done annually at the end of each year. Many different indicator/monitoring systems serve as input to the management review. However, in phase 3 not all of these systems were yet established (such as an internal audit system). The ISO 15189 standard includes a longer list of input sources for management review than was given in phase 3 under the activity requiring execution of yearly management review. Now, in phase 4, most monitoring systems are in place and fully functioning. Therefore, a new list of input sources for management review is given in compliance with the full ISO 15189 requirement regarding management review.

Indicator/monitoring systems that should be taken into account while performing a management review:

• Follow-up of previous management reviews
• Reports from managerial and supervisory personnel
• Feedback, including complaints and other relevant factors, from clinicians, patients and other parties
• Nonconformities
• Any changes in the volume and type of work undertaken
• Results of continuous improvement processes
• The outcome of recent internal audits
• Monitoring of turnaround time
• Quality indicators for monitoring the laboratory’s contribution to patient care
• Evaluation of suppliers
• Assessment by external bodies
• The outcome of external quality assessment and other forms of interlaboratory comparison
• Status of corrective actions taken and required preventive action

The procedure for doing the management stays the same as described in phase 3, only the range of available indicators and monitoring systems has expanded.

 Management Review Example