Leominster, Massachusetts – Albright Technologies, a silicone prototype and low-volume production molder, is pleased to announce that it has passed its ISO 13485:2003 mid-term surveillance audit. Meeting the requirements of the surveillance audit reflects Albright's continued focus of maintaining a world-class quality system and producing superior products. ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system.
Albright's notified body ISO auditor conducted an intensive two day, company-wide audit in which the quality system was thoroughly evaluated against ISO standards. Albright's processes and commitment to continuous improvement were recognized as being up to standard during the surveillance audit.
"We are very pleased to see the assigned notified body auditor recognize the effectiveness of our quality system," said Matt Bont, Quality Manager at Albright Technologies. "Passing the ISO 13485 surveillance audit paves the way for us to continue to meet our certification renewal in 2015," he added. Jeffrey Thumm, President, noted that Albright had also passed three customer audits in the past year. Mr. Thumm stated “I have great confidence in our Quality staff and their work. Matt deserves a lot of credit for his insight and for his guidance of our Quality Management System.”
About Albright Technologies, Inc.
Albright Technologies is a global leader in manufacturing prototype and low volume production silicone components for Medical, Pharmaceutical, Aerospace, Military, Industrial and Consumer applications. Albright Technologies has extensive silicone molding experience and can provide silicone material selection, prototyping and design for manufacturability and scalable molding methods. The company is ISO 13485 certified and molds components for medical related industries in its ISO 7 controlled environment room.