CeramOptec's ISO certification supports plan to expand in specialty medical, OEM markets
CeramOptec Industries (East Longmeadow, MA) manufacturer of specialty optical fibers, bundles and assemblies, reports that it has achieved certification of compliance with the ISO 9001:2000 quality management standard. This standard details the requirements that an organization must meet to create a robust quality management system for product development and manufacture.
The achievement supports the company's plan to expand its development of specialty medical and OEM products at its East Longmeadow facility. The facility is already fully compliant with the U.S. Food and Drug Administration's (FDA's) good manufacturing practice (GMP) requirements. Earlier this year the company introduced what it called the "world's first" ultraviolet non-solarizing (UVNS) optical fiber, the all-silica Optran UVNS, targeted to applications including medical diagnostics, laser delivery, photodynamic therapy as well as treatments such as UV psoriasis treatment.
"CeramOptec Industries has always adhered to the most stringent quality practices in its product development for the medical, scientific, military, industrial and scientific markets," said Kevin Bakhshpour, Director of Sales of CeramOptec, commenting on the ISO 9001:2000 certification achievement. "This certification confirms that qualified management and assurance practices are in place."
The ISO 9001:2000 standard is actually a family of related documents that describe the practices and procedures that a company needs to have in place in order to provide comprehensive product quality management during all stages of design and fabrication. The standards include requirements for monitoring and optimizing all of a company's related tasks and activities with involvement at the upper executive level, to ensure a corporate culture of continual process improvement. This includes regular review and auditing of performance to determine the effectiveness of quality management and identify opportunities for improvement.
Barbara Gefvert | Editor-in-Chief, BioOptics World (2008-2020)
Barbara G. Gefvert has been a science and technology editor and writer since 1987, and served as editor in chief on multiple publications, including Sensors magazine for nearly a decade.