The International Organization for Standardization, also known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. ISO 13485 is a standard that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. The Medical Device Single Audit Program (MDSAP) is to evaluate compliance with the quality management system requirements of regulatory agencies in multiple major medical device markets, including the U.S., Canada, Japan, Brazil, and Australia. The MDSAP is designed to meet the requirements of ISO 13485 plus additional processes to address specific requirements of the participating MDSAP regulatory authorities.
Art Optical was the first exclusive GP manufacturer in the United States to receive ISO registration and now is the first to achieve this with MDSAP. We have always had an outstanding quality system and achieving ISO compliance has had an additional positive impact on all areas of the company. Through the extensive audit process, the certification has standardized, enhanced our quality systems and production processes, and prepared us for global expansion in our licensing and distribution businesses.
Our focus is on complete customer satisfaction and the delivery of quality custom lenses developed in compliance with quality regulations. We will:
Comply with the requirements of MDSAP, ISO 13485, FDA’s Quality System Regulations, and other applicable regulatory requirements,
Maintain a shared quality vision and a focus on continuous improvement and understanding the customer requirements,
Thoroughly involve our associates to achieve the goal of delivery of quality products and services and maintaining effectiveness of our quality management system.