Mountain View, CA, September 12, 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. is the leading provider of integrated
clinical and administrative management systems for cancer
specialists. Specializing in the development of practice
management, electronic medical record, image management and
decision support software, IMPAC offers practical solutions that
help healthcare providers better manage the process of delivering
care. IMPAC is privately held and is based in Mountain View,
Calif. Founded in 1990; IMPAC systems are utilized by over 20,000
clinicians to manage the daily care of more than 50,000 cancer
patients. For more information about IMPAC Medical Systems’
products and services, please call 650-623-8800 or visit
http://www.impac.com. |
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Marketing Communications:
Michelle Arnold
IMPAC Medical Systems, Inc.
650-623-8883
pr@impac.com
http://www.impac.com
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