Quality and Risk Management for Acoustic Pollution in Intensive Care Units

The project aims to apply the international standard ISO 9001:2015—which incorporates risk-based thinking—and ISO 31000:2018—which provides guidelines for risk management—in neonatal intensive care units where high noise levels are a risk to physical and mental health in patients and staff of the institution. The analysis is based on the values recommended by medical device standards, medical associations, and data from various health organisms obtained from scientific publications. Through the identification and evaluation of adverse incidents associated with noise, statistics will be generated to develop protocols and execute preventive actions to mitigate and minimize those effects. This analysis is complemented with information from previous own experiences in public institutions plus new data from a private health institution via new field measurements, surveys and interviews to staff. With the risk map associated, a qualitative and quantitative data analysis will be performed to identify the factors that cause a deviation in its processes and quality management system from the planned results.