Certification Follows a Major Expansion Aimed at Meeting Demands of Medical Industry
MANCHESTER, Conn.—Vision Technical Molding, a manufacturer of precision injection molded components, has achieved certification under the medical quality management systems standard, ISO 13485: 2003. According to the company, the achievement is “the latest in a series of company milestones aimed at providing the highest-quality and most technologically sophisticated molding and post-molding operations for the medical device industry.” Vision has also updated its ISO 9001 certification to the 2008 standard, and recently added a 10,000-square-foot, certified ISO Class 8 clean room that includes space for secondary operations. Registration to both ISO standards was performed by QMI-SAI Global, a leading North American registrar.
“We proactively pursued ISO 13485 certification to demonstrate Vision’s strong and continuing commitment to the medical device sector and our customers,” said Vision Technical Molding President Steven Arnold, in a statement released by the company. “As we grow, we are focused on understanding and anticipating the changing needs of the industry, particularly regarding quality and consistency. To support manufacturers, we achieved ISO 9001 registration for general quality management, and now have attained the key ISO certification for the [medical] device industry. We will continue to be forward thinking in our approach to attaining certifications that benefit our customers in the healthcare industry.”
Vision Technical Molding, which has reportedly achieved double-digit growth during each of the last four years, recently announced a major 27,000-square-foot facility expansion that increases its capacity and capabilities for serving the medical device industry. Aimed at meeting increasing customer demand for the rapid turnaround of complex medical devices, which often require post-molding operations, the expansion brings the total area of the facility to 57,000 square feet. The upgraded facility, currently in full operation 24 hours a day, seven days a week, includes a new ISO Class 8 clean room; a new material drying and conveying system; additional quality control lab space; a dedicated metrology department, and a full-service toolroom.
“The demand for high-quality, injection molded single and multi-use medical devices is increasing,” said Arnold. “To meet this growing need, we invested in a significantly larger and more comprehensive state-of-the-art facility. Our customers will benefit from the latest technologies and value-added operations, as well as our enhanced ability to handle multi-component molding and assembly. This project further underscores our commitment to the medical industry.”
The new 10,000-square-foot, ISO certified Class 8 (FED STD 209E equivalent, 100,000) clean room was designed to meet the current and future quality demands of medical device manufacturing. It boosts Vision Technical Molding’s clean room space by 150 percent and includes traditional and two-shot injection molding and a customized material drying and conveying system. Part of the expansion is dedicated to special transition (positive pressure) areas where clean room staff and non-gowned employees can meet to help optimize information flow and project management. It also includes ISO certified Class 8 clean room space dedicated to secondary operations, such as pad printing, labeling, and ultrasonic welding. The company reportedly has plans to create automated and manual work cells comprising adjacent clusters of equipment in order to streamline manufacturing.
Vision Technical Molding (www.visionmolding.com) specializes in molding difficult parts that demand high precision under closely monitored processes, primarily for the medical device industry. In addition to traditional and two-shot injection molding of specialty and commodity plastics, the company provides a range of value-added operations that include automated or manual assembly, automated packaging, ultrasonic welding, pad printing, and custom labeling.
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