The effect of implementation of the ISO 9000 on customer complaints; a 5-year follow-up study in a regional laboratory.

Although the importance of quality management in the medical laboratory has been emphasized, we are unaware of any interventional studies demonstrating benefits of implementation of recommendations of the International Standards Organization (ISO). In the following 5-year follow-up study, we implemented quality management as stipulated by the ISO, received a certificate of approval, and determined how the program affected customer complaints. From 1997 to 2001 there was only a slight decrease in the number of customer complaints, but a significant continuing downward trend in the proportion of justified complaints (chi-squared test, p<0.001). In fact in 2001 the proportion of justified complaints had decreased by nearly 80% (relative risk, 0.22; 95% confidence interval, 0.09–0.52)), to only 10.9% of the total complaints. We conclude that the use of the ISO 9000 along with good laboratory practice resulted in a significant decrease in the proportion of justified complaints.