Imaging Sciences International earns ISO standards of quality
management
28 January 2005
Imaging Sciences International, Inc., a global leader in the development
and manufacturing of advanced dental and maxillofacial radiography products,
today announced that the ISO (International Organization for
Standardization) has awarded ISO 9001:2000 and ISO 13485:2003 certifications
to the company, reinforcing its commitment to the highest product quality
and customer satisfaction standards and elevating its presence in the
international market.
As part of the Company's aggressive expansion into the global
marketplace, ISO 9001:2000 and 13485:2003 position Imaging Sciences to
continually meet the increasing demand for quality advanced dental imaging
systems. The ISO certifications further facilitate Imaging Sciences'
accreditation to do business in the European Union and Asian markets, where
dental professionals are increasingly demanding Imaging Sciences' i-CAT(TM)
advanced 3-D imaging technology. These certifications are the latest awards
in Imaging Sciences' growing portfolio of global business and medical device
manufacturing certifications. In addition to meeting the Food and Drug
Administration's (FDA) Part 820 of the Code of Federal Regulations (21 CFR
Part 820), the Company recently earned the Canadian Medical Devices
Regulations (CMDR) and the European Union Medical Device Directive, CE-MDD
93/42/EEC, for quality assurance requirements.
ISO certification, considered the premier worldwide standard for
manufacturers, ensures that all products manufactured, including the
company's marquee imaging systems i-CAT(TM) and Panorex CMT, meet or exceed
internationally defined manufacturing and quality assurance standards for
medical devices and are supported by a dedicated customer service operation.
The ISO 9001:2000 is a global quality management standard and delivery
framework for effective business-to-business dealings. It focuses on meeting
customer quality and regulatory requirements, enhancing customer
satisfaction, and driving continual business performance improvements, from
initial contracting through delivery of service. The ISO 13485:2003
specifies a quality management system for the design, development,
production, installation, and servicing of medical devices and related
services.
Earning the certifications required Imaging Sciences to invest an
estimated $250,000 over the past year to fund comprehensive improvements to
manufacturing, purchasing, sales, and marketing processes. The result: a
streamlined, efficient, and uniform work environment that satisfies the
ISO's rigorous requirements.
For more information see:
www.imagingsciences.com/ |
|
|