Pacific Plastics & Engineering (PPE), a medical device contract manufacturer and scientific injection molder, announced it has upgraded to the new ISO 9001:2008, the most recent and rigorous requirement imposed upon manufacturers. According to Yolanda O’Grady, director of Quality & Regulatory Affairs, “When added to the quality requirements of ISO 13485 and FDA registration, these important criteria demonstrate PPE’s commitment to meet the highest quality standards for manufacturing medical devices.”
The ISO audit, conducted by LRQA, resulted in a perfect score in Pacific Plastics & Engineering’s Quality Management Systems, including Quality, Manufacturing, Purchasing, Materials Management, and overall management of the organization. This most recent success is the latest evidence of Pacific Plastics and Engineering’s on-going commitment to excellence in serving their customers.
O’Grady noted that this certification aligns PPE’s management system with ISO 13485 and FDA Quality System Regulations. Other companies that are FDA registered include PPE customers such as Johnson & Johnson, Boston Scientific, Thoratec, and Cepheid as well as medical device and life science companies within in the United States.
The ISO audit, conducted by LRQA, resulted in a perfect score in Pacific Plastics & Engineering’s Quality Management Systems, including Quality, Manufacturing, Purchasing, Materials Management, and overall management of the organization. This most recent success is the latest evidence of Pacific Plastics and Engineering’s on-going commitment to excellence in serving their customers.
O’Grady noted that this certification aligns PPE’s management system with ISO 13485 and FDA Quality System Regulations. Other companies that are FDA registered include PPE customers such as Johnson & Johnson, Boston Scientific, Thoratec, and Cepheid as well as medical device and life science companies within in the United States.