Inside Look

Abstract

With 77 offices across the Unites States, Universal Hospital Services (UHS) is a medical equipment lifecycle management company. UHS counts hospitals and device manufacturers among the clients to which it provides support and technical services. Ralph Dacut, national director for manufacturer services, discusses with BI&T UHS' recent accomplishment of achieving certification in ISO 9001:2000, Quality management systems-Requirements, and in ISO 13485:2003, Medical devices-Quality management systems-Requirements for regulatory purposes.BI&T: How did the idea of achieving ISO certification come about?Ralph Dacut: There is a stringent qualification process that a supplier like UHS must go through to acquire a client. Essentially, potential clients want to be sure that you have a robust quality management system (QMS) in place. While not having ISO certification did not prevent us from getting business, it was a limiting factor. Before allowing you to service their equipment, for example, a manufacturer will ask if your facilities are certified. If you are not certified, you're forced to follow that manufacturer's specific QMS and to follow their guidelines for working with equipment. And the qualification process itself generally becomes lengthier.BI&T: What have the certifications meant for UHS?Dacut: The certifications have been tremendous for us. Our business processes are smoother. Everyone on staff always knows the status of all of our equipment. We are more streamlined and efficient overall. Intangibly, it has given our technicians a greater sense of pride in our quality and a boost in morale.BI&T: How did the ISO audit work?Dacut: Perhaps the best comparison I could draw would be with a JCAHO inspection of a hospital. They reviewed our documents and processes, and made sure that each of our operations was adhering to the same process. They visited four facilities across the country and passed in our first attempt.BI&T: Do you have words of wisdom for others who manage medical equipment who may be interested in obtaining ISO certification?Dacut: There is a cost involved with doing anything. As with everything, you have to do a cost/benefit analysis and a return-on-investment (ROI) analysis. We have achieved a healthy ROI through becoming certified. For us, the downside of not being certified far outweighed the cost of becoming certified.