KNIGHT LLC, Mexico facility achieves ISO 13485 certification
Ciudad Juarez, Mexico – December 23, 2014 – Tecma Group client company, Lake Forest, California-based Knight LLC, recently earned an International Standards Organization (ISO) quality certification for the Ciudad Juarez maquiladora facility operated by Tecma.
The plant recently passed the external audit required to be recognized as a medical manufacturer under ISO 13485 in Mexico. The ISO 13485 standard was established and published in 2003, and is applicable to manufacturing quality systems that guide the design and manufacture of medical devices. In addition to requiring that certified companies establish and maintain systems ensuring the quality of their design and manufacturing operations, ISO 13485 mandates that holders of the certification establish, maintain and update:
- controls in order to ensure that manufactured products are inspected and safe for use;
- management awareness of regulatory issues related to the item (s) being produced;
- a system for preventing and correction errors that negatively impact product quality.
The products that Tecma will manufacture for Knight at the Ciudad Juarez maquiladora facility under ISO 13485 in Mexico include chemical dispensing systems that have a medical application in instrument pre-cleaning.
According to company president, George Noa, Jr., “We consider the achievement of certification in ISO 13485 to be essential to our future direction. The certification is a critical component of successfully meeting the challenges related to competing in a highly competitive medical industry market segment. Our manufacturing know-how, the quality of the systems in place at the Ciudad Juarez maquiladora facility to build a world-class product, and the support that we receive from the Tecma Group of Companies will ensure that our company is well-positioned going forward to build a world-class product.”
ABOUT KNIGHT LLC
Knight LLC has been successfully dedicated to the challenge of developing innovative chemical delivery systems and first-rate customer support for their users since 1972. Since that time, Knight has led the way with new greater value-added and efficient technologies. The company’s team of highly experienced and dedicated leaders has directed its vision and insight toward creating an environment of growth in a constantly changing market. Knight’s engineering teams use the latest design techniques to develop chemical delivery systems that control end user costs, while maintaining an uncompromising standard of quality.
ABOUT THE TECMA GROUP OF COMPANIES
The Tecma Group of Companies, Inc., headquartered in El Paso, Texas provides services that have enabled firms from a wide range of industries to establish and maintain manufacturing in Mexico for almost three decades. Under its Mexico Shelter Manufacturing Partnership (MSMP) companies control and focus on their core, value-added manufacturing functions, while Tecma tends to their human resource, payroll, accounting, logistics, and other needs that, although important, are not part of the production process.
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