Diagnostic imaging  

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/


To top