ISO 13485:2003, medical devices

Diversified Plastics Has Been Certified ISO 13485:2003

News Release from: Diversified Plastics, Inc.
12/02/2010

Diversified Plastics, Inc. has achieved ISO 13485:2003 certification by showing it has established a quality management system to provide medical components and devices that consistently meet regulatory requirements for the medical device industry. Many medical device manufacturers are now requiring their suppliers to be ISO 13485:2003 certified. "Weʼve been ISO 9001:2000 certified for many years and this new level of certification provides us with the opportunity for producing a greater variety of products for a larger base of customers," said Joe Bourgeault, director of quality, Diversified Plastics. "This takes our quality management system to the next level."

While many ISO 13485:2003 requirements are taken directly from ISO 9001:2000, the two certifications are unique. The most important difference is that ISO 9001:2000 is a continual improvement process, where ISO 13485:2003 is medical industry-specific and emphasizes the documentation, implementation and maintenance of processes, procedures and requirements. Although the two ISO levels share some requirements, they are significantly different and certification for one cannot apply for the other.