© yuri arcurs dreamstime.com Electronics Production | January 08, 2019
East/West earns ISO 13485:2016 certification
EMS provider, East/West Manufacturing Enterprises (East/West), announces that it has achieved ISO 13485:2016 certification. The company also renewed its ISO 9001:2015 certification.
ISO 13485:2016 is an international standard that defines common medical regulatory concepts to provide assurance that a company meets certain quality management system expectations. The 2016 version of the international standard is a major revision of the 2003 version, with an increased focus on risk management and risk-based decision-making processes at both the quality management system and product levels. In addition to achieving ISO 13485:2016 and ISO 9001:2015 certifications, East/West experienced strong growth and improvements in 2018. "2018 has been another year of solid growth for East/West," said Andy Salo, President of East/West Manufacturing Enterprises. "We are working closely with our customers as their manufacturing arm to deliver high-quality products, while achieving reduced customer costs through our process efficiency and strong distributor relationships."