Syntec, OFS ISO certifications aim to reassure buyers of polymer optics, optical components for medical devices

July 27, 2009
Two optics component suppliers--Syntec Optics (Pavilion, NY) and OFS, Specialty Photonics Division (Avon, CT)--report ISO certification compliance achievements, which reinforce their credentials as high-precision manufacturers of custom polymer optics and medical device components, respectively.

Two optics component suppliers--Syntec Optics (Pavilion, NY) and OFS, Specialty Photonics Division (Avon, CT)--report ISO certification compliance achievements, which reinforce their credentials as high-precision manufacturers of custom polymer optics and medical device components, respectively.

Syntec Optics has been certified to be in compliance with ISO 9001:2000 through an audit conducted by the Bureau Veritas Group. The quality management system certification strengthens Syntec's position as a supplier of injection molded polymer optics and opto-electronic assemblies. Syntec plans to leverage this qualification to expand its reach to other markets worldwide that are characterized by cost constraints and tight schedule demands which require strict process control.

"We have long pursued continual improvement of our quality management system and wanted to take it to the next level," said Lori Steffenilla, Syntec's VP of Manufacturing Operations, adding that the accreditation "affirms that Syntec values and strives for customer satisfaction and operational excellence." According to Rick Arndt, Vice President and General Manager for Syntec, "This ISO accreditation further demonstrates our ability to contribute to the global polymer optics field," noting that the move "grants us access to customers who can be assured of the strength and quality of our processes."

OFS, Specialty Photonics Division's Avon, CT facility won certification to standard ISO 13485--also verified by Bureau Veritas. All OFS Specialty Photonics Division facilities have maintained ISO 9001 certification to help ensure the quality and repeatability of product manufacturing; the Avon facility took this additional step because of its focus on component manufacturing for the medical industry. Medical components manufactured in Avon include both disposable and reusable probes, fibers, and assemblies, which it supplies to OEMs and which are used in surgery and office outpatient procedures.

"We maintain very close relationships with our customers, and found that they would find it much easier to do business with us if we had the additional (ISO 13485) certification. So we made the business decision to implement the systems, documentation, and auditing processes necessary to help ensure the level of quality our customers required," said Mike Winslow, Quality Manager for OFS, Specialty Photonics Division.

"More and more, medical device manufacturers are asking their suppliers to be 13485 certified. Being certified allows us to further satisfy our key medical customers and create new opportunities," added Steve Allen, OFS's Medical Market Manager. Mr. Allen went on to say, "…with 25 years of experience designing and manufacturing optical fibers and fiber based products, medical OEMS can rely on us to meet their customers' critical specifications and help get to market faster."

For more information on Syntec Optics see the company's website.

For more information about OFS, Specialty Photonics Division, please visit the Specialty Photonics website. There you can download a brochure detailing OFS's medical manufacturing capabilities and their products, such as HCXtreme optical fibers for transmitting high laser powers through tight bends.

About the Author

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.

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