Raintree Essix, L.L.C., a manufacturer and distributor of orthodontic supplies, today announced that it has achieved ISO 13485 certification from BSI, Inc., a quality management systems registrar. The ISO 13485:2003 standards, released in July 2003 as the successor to ISO 13485:1996, is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a quality management system (QMS) embracing the activities of the company from staff training to taking the instruction from the customer, the design and development of products, the purchasing of materials and services and the delivery of the products and services, with all aspects of medical device, regulatory and industry requirements being addressed. This also includes CMDR (Canadian Medical Device Regulations) and the European MDD (Medical Device Directive).
"Raintree Essix has always been committed to providing the highest levels of service excellence" stated Dann Schwartz, Raintree Essix’s CEO. "We are proud to be certified to ISO 13485. This demonstrates that our focus remains on quality, world-class performance, and continuously monitoring our business operations to ensure that we deliver on the promises we make to our customers, employees and vendors."
"Raintree Essix employees enthusiastically embraced and assisted in the development of the QMS. The management implementation team oversaw each stage of development and insured scheduled progress was timely, efficient and effective. We are very proud to have gained certification," stated Angela Schnauder, Raintree Essix’s Quality Manager.
“By earning ISO 13485 certification, Raintree Essix is further demonstrating its commitment to quality,” said Robert Perry, President of BSI, Inc. “Raintree Essix was audited against the requirements of 13485:2003 and found to be compliant. To achieve this so soon after the standard was released is a real achievement. By formalizing their documentation and using ISO 13485:2003 as an extra set of eyes, Raintree Essix will be able to improve quality, customer responsiveness and remain at the cutting edge of their industry. The company’s employees are committed and use well organized processes – ISO 13485 certification can only serve to improve an already top-of-the-line business.”
About BSI, Inc.
BSI is the world's leading quality management systems registrar. Founded in 1901, BSI has issued more than 42,000 registration clients in over 90 countries. More than 112 'Global 500' companies have chosen BSI as their preferred ISO 9000, QS-9000, ISO 14000, TickIT, or EMAS registrar. BSI's registration experience covers virtually every industrial and commercial sector (i.e. automotive, aerospace, chemical and allied processes, IT/software, service).
About Raintree Essix, L.L.C.
Raintree Essix is the leading manufacturer and distributor of thermoforming products for orthodontic and dental appliances. Essix appliances are an aesthetic method of retaining/finishing orthodontic cases at a fraction of the cost and frustration of conventional orthodontic devices. www.essix.com.