BUSINESS STANDARDS
is the quarterly magazine of BSI Group, highlighting the vital role that standards play in today's business environment. Regular features include interviews with leading business figures, as well as news on the latest developments in management systems and standards.
Image Solutions focuses on quality across the organization
02 Jul 2008
Topics: Quality management, ISO 9001, USA, China
It seems that the desire to demonstrate that you are embracing quality management practices within your organization can be infectious. That certainly appears to be the case with ISI, which is headquartered in New Jersey, USA.
ISI has recently gained an ISO 9001 quality management systems certification from BSI Americas for the company's operations in San Bruno, California and Whippany, New Jersey. This follows hard on the heels of its first ISO 9001 certification, awarded late last year to the company's offices in Tianjin, China. Now ISI plans to seek certification to the quality standard for its European offices, creating a global certification.
These moves are all part of ISI's determination to establish a globally consistent high quality services' offering. In the words of Jinsoo Kim, president and chief executive officer of ISI: "ISI is committed to providing high-quality solutions on a global scale. Receiving the ISO 9001:2000 certifications for our California and New Jersey offices demonstrates ISI's commitment to quality and customer satisfaction while setting the stage for a truly global solution offering."
Market leader
ISI, which was founded by Kim in 1992, is a proven market leader in providing submissions solutions, process services and consulting to life sciences companies as a way to improve the clinical and regulatory processes that bring new medicines to market faster. The company was among the first in professional services to deliver PDF-based electronic submissions to the Life Sciences industry and has since delivered more than 1,600 electronic submissions and 900+ eCTD submissions.
Its work in developing advances in electronic submissions has won ISI a place in the Smithsonian Institution's "Innovation in Science Collection" as a pioneer in the movement toward acceptance and standardization of electronic submissions to the FDA with the first PDF-based electronic submission. Its commitment to innovation has propelled ISI to a place on Deloitte & Touche's prestigious "Technology Fast 500" programme in the United States for four years in a row. And Jinsoo Kim himself has recently been honoured as a recipient in the 2008 Outstanding Asian Americans in Business Awards - the first and largest business award programme for the Asian American business community, and a New Jersey Entrepreneur of the Year by Ernst & Young in the category of Pharmaceutical Technologies / Life Sciences.
The company provides software and services for hundreds of biopharmaceutical clients, small and large. Its extraordinarily impressive client list includes the world's top 50 pharmaceutical and biotech organizations. In addition to its pioneering regulatory software, ISI provides a wide range of regulatory services and strategic sourcing to life sciences and biotechnology companies around the world.
Guiding principles
Unsurprisingly, given the extreme technological and precise nature of the business it's operating in, ISI has a history of commitment to quality and has pursued the ISO certification to reinforce its many quality initiatives. These guiding principles served as a frame of reference for global process improvement initiatives.
ISI's new American certifications cover the regulatory operations and submission processes for life science organizations at the company's sites on both US coasts, supporting efforts in its China location. Importantly, ISI believes that third-party certification of its quality system will offer it a number of significant marketplace benefits. For one thing, the company expects the certifications to open doors into new markets for them, where certification is a requirement for doing business. ISI also expect to exploit further opportunities in existing markets that were previously out of reach to a non-certified organization. Gaining ISO 9001 may be infectious, but with good reason.
For more on ISO 9001 see: www.bsiamerica.com/en-us/Assessment-and-Certification-services/Management-systems/Standards-and-schemes/ISO-9001/
Business Standards © 2008. Editorial produced by Caspian Publishing in association with the British Standards Institution. Editorial opinions expressed on are not necessarily those of BSI Group or Caspian Publishing. Neither Caspian Publishing nor BSI Group accept responsibility for advertising or editorial content, nor for that appearing on linked third-party websites. Reproduction in whole or in part is forbidden without written permission from BSI Group or Caspian Publishing.
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