A Total Quality System
Corporate Quality at Medline consists of several distinct areas: Quality Assurance, Quality Control, Regulatory Affairs and Sterilization. Our staff of more than 300 highly trained employees oversees all quality-related functions for Medline’s 100,000-plus products. The team includes chemists, microbiologists, statisticians, RNs and engineers whose combined knowledge and experience contribute to our goal of continuous improvement. In addition, numerous technicians, inspectors, coordinators and administrative personnel perform vital functions on a daily basis to assure effective implementation of our Quality Process.
This important function guarantees that Medline products meet or exceed all relevant requirements and standards. Besides ensuring the continuous review and improvement of Medline products, QA team members conduct seminars around the world to help hospitals manage safety issues.
Quality Control is the final check prior to distribution, where we confirm that our design and validation processes have yielded products that meet our customers’ needs. Quality Control is not a substitute for creating processes that ensure good product off the line, but it acts as a safety net in case an error occurs.
It is the job of Medline’s Regulatory Affairs (RA) staff to make certain we are in substantial compliance with a complex set of requirements set by the FDA, ISO and other regulatory bodies. This area is responsible for obtaining marketing clearance for our medical devices and OTC drugs and provides similar assistance for our many suppliers and partners.
In addition to performing sterilization cycle validation, this team evaluates new products and assigns the appropriate sterilization method and cycle. Staff members continually research alternate technologies that might help reduce lead time and costs while ensuring that our products meet all sterility requirements. They also answer customer questions related to sterilization methodology and provide on-site assistance with hospital sterilization processes.