ISI Receives International Quality Certification
ISO 9001:2000 Certification Recognizes ISI’s Quality Management Processes
Whippany, NJ (September 19, 2007) – Image Solutions, Inc. (ISI), a leader in providing software and services to streamline the drug development and regulatory approval process, today announced that its Tianjin, China office was granted ISO 9001:2000 certification by the International Organization for Standardization (ISO) for meeting exacting Quality Management Systems standards in all areas of operation, including electronic document processing services. The audit was conducted by the British Standards Institute, a leading global provider of management systems assessment and certification solutions.
“ISI is committed to providing high-quality solutions and exploring new ways to continually improve our existing product and service offerings, in-line with the ISO’s requirements for 9001:2000 certification,” said Jinsoo Kim, president and chief executive officer of ISI. “Receiving recognition for our quality management processes from an organization with such stringent standards as ISO verifies ISI’s strong commitment to our customers.”
ISI has a history of commitment to quality and has long followed the guidelines set by an internal quality policy that details meeting customer expectations and improving internal processes year after year. These guiding principals not only made the ISO 9001:2000 certification easier, but they make implementing the ISO framework seamless. The ISO certification will provide ISI with numerous benefits, including access to new markets that require ISO certification and new opportunities in existing markets that require a company to have the 9001:2000 designation.
In addition to its pioneering regulatory software, ISI provides medical writing, regulatory consulting, implementation/IT services, electronic submission outsourcing and education services for life sciences and biotechnology companies around the world. ISI’s Tianjin, China office, which opened in May 2007, is dedicated to Case Report Form (CRF) processing and will handle electronic Common Technical Document (eCTD) processing in the near future. More than five million CRF pages are processed each week, making this task the most paper and time-intensive. Since the company’s inception in 1992, ISI has processed more than 50 million CRFs.
“CRF processing has been a vital part of ISI’s services since we began in 1998,” said Kim. “CRF services are part of ISI’s broad portfolio of business process outsourcing services developed to help companies reduce the time and cost associated with compiling electronic submissions, managing data and preparing scientific documents. Our Tianjin office is vital to assisting our clients as they manage multiple national regulatory standards in an increasingly global life sciences market.”