A simple formula for a Management Review report "template":
1. Create headings for each of the review inputs from the standard (ISO 13485:2016, 5.6.2)
2. Under each heading, have the following subheadings and content:
a. Data - Present the available data in a suitable format
b. Objectives - How does the data relate to established objectives? Are they being met? If not, why? Is the objective(s) still suitable?
c. Trends - Are there any relevant trends to be gleaned from the data? What is the impact (risk assessment) of such trends?
d. Resources - Any indication that resource needs are lacking? Any problems with facilities, equipment, personnel (incl. training), etc.?
e. Conclusions / Actions:
- Overall, how is the process functioning (adequacy of process/objectives, management, resources, training, meeting customer requirements, etc.)
- Are any investigations and/or corrective or preventive actions necessary?
- Are there any opportunities for improvement / changes warranted? (also consider in light of any other changes - regulatory, risk, product, etc.)
Good Luck!
MM