ISSYS Achieves ISO 9001:2000 Certification

(ISSYS) Achieves ISO 9001:2000 Certification
YPSILANTI, Mich. – Integrated Sensing Systems, Inc. (ISSYS) has met the standards and
requirements of the ISO 9001:2000 certification program and has been registered as an ISO
9001:2000 compliant company. This registration was made through BSI Management Systems,
the world’s first national standards body and founding member of the International Organization
for Standardization (ISO). This achievement represents ISSYS’ commitment to manufacturing
excellence and to continuous quality improvement. Achieving ISO 9001:2000 certification
required ISSYS to conform to high quality standards, including: a focus on providing and
measuring customer satisfaction; adherence to a process model closely aligned to business
practices; and a process for continual improvement.
ISO certification is a key step for ISSYS towards marketing its first medical device in the drug
delivery field. Doug Sparks, executive vice president of operations, said, “Additionally, ISSYS is
currently running its manufacturing infrastructure according to ISO-13485 and FDA GMP
compliant manufacturing. We expect certification for these standards to be awarded shortly after
the sales of ISSYS’ first medical products (drug delivery systems).”
Drug administration errors are responsible for tens of thousands of injuries and deaths in the
United States each year, according to ISSYS. Earlier this year, ISSYS completed development of
its lead medical device that monitors the flow of intravenous drug infusion systems, and that may
help to reduce a significant portion of those injuries and deaths. ISSYS plans to seek FDA
approval to market this first medical device in the first quarter of 2005.

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