Hanna Lind

Main Content

Single Post Article

LEMO USA Achieves ISO 13485:2003 Certification

LEMO USA, Inc. (www.lemo.com), a subsidiary of LEMO SA (headquartered in Ecublens, Switzerland), a global leader in the design and manufacture of precision custom connection solutions, is proud to announce that they have achieved ISO 13485 Certification for the Design, Manufacture and Distribution of Medical Components and Cable Assembly to medical customers on June 10, 2015. These certifications are accredited by SQS, Swiss Association for Quality and Management in partnership with IQNet.

ISO 13485 establishes requirements for a comprehensive quality management system for product design and development consulting services for the medical device market. ISO 13485 is based on the ISO 9001 format with additional requirements for design, special processes, environmental control, traceability, documentation records, and regulatory actions.