Imaging Sciences International, Inc., a global leader in the development and manufacturing of advanced dental and maxillofacial radiography products, has announced that the ISO (International Organization for Standardization) has awarded ISO 9001:2000 and ISO 13485:2003 certifications to the company.
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™ 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.
"With these ISO-standard measures and processes in place, Imaging Sciences can continue to produce the highest-quality dental imaging machines that provide dentists and specialist the most complete views of anatomical information for more predictable treatment outcomes worldwide," says Dave Cowan, Vice President of Engineering, Quality Assurance and Government Compliance for Imaging Sciences.
"Through our company-wide preparation for ISO certification, we've ensured that our processes are more efficient, more productive, and most important, more scaleable¿so we know our product quality will be maintained as we continue our rapid growth. The ISO certifications ensure consistency in everything we do, so our clients feel confident they're using the best 3-D dental imaging products on the market."
ISO certification, considered the premier worldwide standard for manufacturers, ensures that all products manufactured, including the company's marquee imaging systems i-CAT™ 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.
"ISO 9001 allows companies to grow and expand by creating a unified system," says Ed Marandola, Vice President and General Manager of Imaging Sciences.
"We're confident that this process has prepared us not only for the next level of expansion, but for staying power in this industry. Now that Imaging Sciences has devoted its resources to quality assurance and product development systems, we're ensuring a successful, consistent product and workplace as we continue to bring state-of-the-art 3-D dental imaging technology to dental professionals worldwide."
