Southington Tool & Mfg. Corp. announced a milestone achievement of becoming registered to the ISO 13485:2003 standard. In addition to the new certification awarded by American Systems Registrar on October 9th, Southington Tool & Mfg. Corp continues to maintain its ISO 9001:2008 certification, demonstrating a commitment to quality and customer goals and expectations.
ISO 13485 is an internationally recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet the specific customer and regulatory requirements applicable to medical equipment.
“As a leader in manufacturing medical component products, Southington Tool & Mfg. Corp. recognizes the benefit of aligning our quality system to the needs of our customers,” said Lynette Nadeau, President.
Krzysztof Lipinski, Quality Manager and ISO representative had this to add: “Achieving the ISO 13485 registration is not only one of our initiatives to provide our customers with the highest quality products and services, but is also a representation of who we are and what we are after. The strength of Southington Tool lies in our employees and their powerful approach; how things were done yesterday, today they have to be done better while maintaining the stability of our quality system, along with conformance to customer requirements and regulatory requirements.” Lipinski continued, “Registration of ISO 13485 is just one of the progressive steps for Southington Tool to be valuable and attractive to our customers, to our employees, and to our community.”