FDA Approved Assemblies & Facilities
Rapid advances in life sciences are driving the growing demand for specialized equipment from certified design centers and factories. The ISO 13485 certification is a requirement for factories that manufacture FDA approved assemblies. This stringent quality certification requires detailed design and manufacturing processes that provide customers the assurance of highly uniform manufacturing processes. Our new product introduction (NPI) engineering teams can provide full optical, mechanical and electrical system support from design to volume manufacturing of FDA approved biomedical assemblies.
ISO 13485 Factories: Dallas
II-VI’s ISO 13485 certification at its Dallas site marks the successful implementation of a comprehensive quality management system to support the design and manufacture of medical devices and systems for FDA approved equipment.
II-VI’s broad portfolio of materials, components and subsystems enable a wide range of biomedical equipment including PCR systems, blood analyzers, reagent chillers, as well as injury treatment and dental systems.
II-VI provides optimum thermal management solutions for applications in life sciences, including genetic analysis, immunoassay, pharmaceutical development, clinical diagnostics, food analysis, agricultural development, environmental analysis, industrial hygiene and identification of bio-threats. II-VI’s broad array of thermal management solutions includes precision systems for thermal cycling, temperature stabilization, as well as air and fluid temperature control.
Quality & Environmental Management
Our customers agree that “quality” serves as the primary distinction of II-VI in the field of thermoelectric technology. At II-VI, quality is our operating business philosophy. For every product or service II-VI provides, we seek to meet or exceed our customers’ expectations, without exception. To reinforce this commitment, each employee takes a personal, daily pledge to do their job “right today, better tomorrow,” with priority given to the customer’s interest and requirements.
The failure analysis capability includes reinspection and retesting to the customer drawing and internal specifications. II-VI’s analysis capabilities include X-ray fluorescence, scanning electron microscope with energy dispersive spectroscopy, metallographic scope with 1000x magnification, CMM for measuring dimensions and an optical scope with photographic capability. The failure analysis report and conclusions are reviewed by manufacturing, engineering, sales/marketing and quality. This team determines root cause and corrective actions, then the engineer or sales representative reports the findings to the customer.
Malcolm Baldrige National Quality Award Winner (1991)
The Baldrige Award is given by the President of the United States to businesses – manufacturing and service, small and large – and to education and health care organizations that apply and are judged to be outstanding in seven areas: leadership, strategic planning, customer and market focus, information and analysis, human resource focus, process management and business results.
Congress established the award program in 1987 to recognize U.S. organizations for their achievements in quality and performance and to raise awareness about the importance of quality and performance excellence as a competitive edge. The award is not given for specific products or services. Three awards may be given annually in each of these categories: manufacturing, service, small business and, starting in 1999, education and health care.
II-VI has established, implemented and maintained an environmental management system (EMS) that demonstrates our commitment to environmental excellence. The system consists of an environmental system manual, an environmental policy, environmental objectives and associated procedures, forms and records.