MONROVIA, Calif.--Roncelli Plastics recently announced that it has achieved ISO 13485:2003 registration for its Monrovia, Calif., facility, where the company provides CNC fabrication and mechanical assembly of nonmetallic components. In a July press release, the diversified manufacturer of engineered plastics said that earning ISO 13485 registration "demonstrates Roncelli Plastics' commitment to design and manufacture high quality materials to better serve the medical device community."

ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Created by the International Organization for Standardization, ISO 13485:2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact-based decision making, and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.

Roncelli Plastics' ISO 13485 registration complements the company's AS9100 and ISO 9001 quality management system registrations. The company serves a wide range of industries, such as aerospace, defense, electrical, and semiconductor, as well as medical and pharmaceutical.

"For more than 40 years, we have been committed to quality," said Riley Cole, president of Roncelli Plastics, in a statement announcing the registration. "Our goal is consistent improvement of our processes to provide the highest quality products and materials to our clients. Our ISO 13485 registration from NSF-ISR is additional proof of the success of these efforts."

In order to earn ISO 13485 registration, Roncelli Plastics (www.roncelliplastics.com) demonstrated its ability to meet customer and regulatory requirements, enhance customer satisfaction through effective application of its quality systems, and provide for continual improvement. NSF-ISR assessed Roncelli Plastics' quality management systems via a two-day comprehensive audit and found it to be in compliance with the ISO 13485 quality management system requirements.