WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software, has announced Western Institutional Review Board (WIRB) has been certified to ISO 9001:2008 by BSI, confirming it operates an excellent quality management system.
“WIRB and its sister IRB, Copernicus Group, are the only two IRBs to have met ISO quality management standards and to have received ISO 9001:2008 certification,” said Donald A. Deieso, Ph.D., WCG chairman and CEO.
“At WCG, we always are looking for ways to increase efficiencies within the clinical research process while—most importantly—maintaining the highest standards of human subject protection,” said David Forster, JD, MA, CIP, WCG chief compliance officer. “Achieving ISO certification is a powerful indicator of our commitment to continuous improvement in all aspects of our operations.”
All ISO 9000 standards are based on a series of quality management principles. They require company leaders to establish clear goals and objectives for their quality management system and endeavor to get all their employees involved. Participating companies adopt a strong customer focus with employees aiming not just to meet customer expectations but to exceed them. They also take both a process- and systems-based management approach, and strive for continual improvement in their company’s overall performance, using internal audits to track progress.
ISO 9001:2008 is implemented by more than one million companies and organizations in more than 170 countries, according to ISO.