Oliver-Tolas’ facility in Feasterville, PA USA is now ISO 13485:2003 certified. ISO 13485:2003 outlines a quality management system specifically designed for organizations that provide medical devices and related services that consistently meet applicable customer requirements. The standard focuses on risk management activities during product development and guides specific requirements for verification of effectiveness of corrective and preventive actions.
All Oliver-Tolas facilities are ISO 13485 certified.
