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:
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.
Activities related to Phase 4 - Organization
Standardize the procedure on doing a management review in an SOP. Include this in the file with all other SOPs of the laboratory and introduce it in the document control system.
Make sure that this SOP is read by all relevant personnel members.