East West Manufacturing, a global contract manufacturing company, is pleased to announce a milestone achievement; our wholly-owned Vietnam facility is now qualified to manufacture Class II Medical devices and certified to ISO 9001:2008 and ISO 13485: 2003 Quality Management Systems standards and guidelines. Though East West has worked with ISO certified suppliers in China, India, and Vietnam for many years, we are excited to now include our Vietnam operation as a certified ISO 13485 supplier and center of our Medical Contract Manufacturing operations..
What is ISO 9001? What is ISO 13485?
ISO 9001:2008 and 13485:2003 are a set of international standards and guidance documents for quality management and quality assurance. The standard represents an international consensus on good management practices, policies and procedures with the aim of ensuring that East West Manufacturing can time after time deliver the product or services that meet our customer’s quality requirements. Are they easy to obtain? No!
What is Medical Device Contract Manufacturing?
With ISO 13485:2003 certification, East West is qualified to manufacture plastic and metal parts and electro-mechanical assemblies for the medical device industry. Class II medical devices and medical products are a complement to our Vietnam facility which already has manufacturing processes such as metal stamping, plastic injection molding, and full box build assembly operations. Opened in 2006, our Vietnam facility has grown to three buildings, occupying over 150,000 square feet of manufacturing space.
With the recent ISO certification, our customers can be confident that East West Manufacturing is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed customer satisfaction and quality.
Click here to read more about East West's Medical Division.