WCG, the global leader in providing solutions that measurably improve and accelerate clinical research, announced today the extension of its ISO 9001 certification to its Institutional Biosafety Committee (IBC) services by BSI. WCG has now achieved ISO 9001 certification for both its Institutional Review Board (IRB) and IBC services – reinforcing its commitment to excellence of quality management across ethical review.
“In 2010, WCG’s IRB became the only IRB in the world to have met ISO quality management standards and to have received ISO 9001 certification,” commented WCG Chief Executive Officer Sam Srivastava. “Today, we are proud to raise the bar yet again as we have set a new high standard for quality management in ethical review within our IBC.”
“WCG has been leading ethical review for decades,” added David Forster, JD, MA, CIP, Chief Compliance Officer, WCG. “We were the first to pioneer the concept of independent ethical review, and we continually seek ways to increase efficiencies within the clinical research process while maintaining the highest standards of human subject protection. Achieving ISO certification within our IBC 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.
About BSI
BSI is the business improvement and standards company that enables organizations to turn standards of best practice into habits of excellence, “inspiring trust for a more resilient world.” For over a century, BSI has driven best practice in organizations around the world. Working with over 77,500 clients across 195 countries, it is a truly global business with skills and experience across all sectors, including automotive, aerospace, built environment, food and retail and healthcare. Through its expertise in Standards and Knowledge, Assurance Services, Regulatory Services and Consulting Services, BSI helps clients to improve their performance, grow sustainably, manage risk, and ultimately become more resilient. For more information, visit: bsigroup.com
About ISO
ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards. ISO is a network of national standards bodies of 169 countries, with a Central Secretariat in Geneva, Switzerland. For more information, visit http://www.iso.org/iso/home.html.
About WCG
WCG is a global leader of solutions that measurably improve and accelerate clinical research. Biopharmaceutical and medical device companies, contract research organizations (CROs), research institutions, and sites partner with us for our unmatched expertise, data intelligence, and purpose-built technology to make informed decisions and optimize study outcomes, while maintaining the highest standards of human participant protection. WCG raises the bar by pioneering new concepts, reimagining processes, fostering compliance and safety, and empowering those who perform clinical trials to accelerate the delivery of medical therapies and devices that improve lives. For more information, please visit wcgclinical.com or follow us on LinkedIn or Twitter @WCGClinical.