IMPAC Awarded ISO and MDD Certification; eHealth Company's Quality Initiative Culminates In ISO 9001 Certification

Business Wire, Sept 14, 2000

Business Editors/Health & Medical Writers

MOUNTAIN VIEW, Calif.--(BW HealthWire)--Sept. 14, 2000

IMPAC Medical Systems, Inc. announced today that it received ISO 9001 and EN 46001 certification for implementing and maintaining a quality system meeting those requirements. IMPAC's SEQUENCER, MLC Fit, and ViewStation products are also certified as compliant with the Medical Device Directive (MDD) for distribution within the European Union.

The IMPAC Quality System is an internal management system that provides mandatory guidelines for the design, development, testing, installation, and service of all IMPAC products. As a manufacturer of medical devices, IMPAC has always met regulatory requirements for domestic distribution of its products. For the past three years, IMPAC has intensified its efforts to continuously improve its management system to better meet the requirements and expectations of its customers and operations. The requirement to seek and implement improvements that increase the value and quality of products and services is inherent to the IMPAC Quality System.

"ISO certification and the ability to apply CE Marking to our products are monumental achievements for IMPAC," said Thom Faris, IMPAC's Director of Regulatory Affairs and Quality Assurance. "We consider this to be a significant indication of progress towards our expressed Total Quality Management system commitments: absolute customer satisfaction, inspiration and advancement of our employees, and continuous pursuit of more effective and efficient operations."

"This project required the effort and direct participation of each and every IMPAC employee. The entire organization is to be recognized for making this happen. It is only as a result of everyone's support and commitment that IMPAC has achieved ISO certification," observed Jay Hoey, Executive Vice President and COO of IMPAC.

"What we want to do now is begin to reap the benefits of our investment in the IMPAC Quality System. We have already seen improved consistency and organizational communications across the board as a result of controlled processes," reflected Joseph K. Jachinowski, IMPAC's President and CEO. "It is only through a continuous and total commitment to quality that we can hope to perpetuate our hard-earned reputation for quality and customer satisfaction."

IMPAC Medical Systems, Inc., a privately held company based in Mountain View, Calif., is the leading provider of integrated oncology management systems. Specializing in the development of practice management, electronic medical record, image management, and decision support software solutions, IMPAC has an installed customer base of over 1,100 cancer sites in 43 countries worldwide. IMPAC software manages the daily care for over 30,000 cancer patients. For more information about IMPAC Medical Systems' products and services, please contact us at 650-623-8800 or visit us as at www.impac.com.