Shenzhen, China Plant Achieves
ISO 13485 Certification

EVCO Plastics Achieves ISO 13485 Certification at Shenzhen, China Plant

EVCO Plastics, a leading custom plastics manufacturer, has reached a milestone at its Shenzhen, China plant: ISO 13485 certification. To achieve certification, EVCO demonstrated its ability to provide medical devices that consistently met customer and regulatory requirements.

EVCO implemented systems to train its staff and leadership group on the specific ISO 13485 certification protocol, conducted the necessary testing and auditing, and completed the registration requirements—a six-month process. To maintain this certification, the EVCO Shenzhen facility will need to run in complete compliance with the ISO and FDA standards, ensuring that every finished medical product is properly registered and that staff adheres to the training requirements.

“Obtaining this certification at our Shenzhen facility was paramount to show prospective customers that we are fully committed to meeting their expectations, as well as the expectations of the medical market as a whole,” offered Rich Duval, director of quality and human resources at EVCO Plastics. “To be viewed as a suitable supplier, customers look for this certification. Now we can proudly offer it to them.”

Additionally, receiving the ISO 13485 certification coincides with EVCO’s significant investments to its Chinese medical operation. Scheduled for  October 2015, EVCO will move to a new and bigger facility outside of Shenzhen. The building will include an ISO Class 8-certified, 10,000 square foot clean room, which will include 20 presses,  3 overhead cranes and a large assembly test area. The new facility will offer robust opportunities for EVCO to assume increased medical work, and to enhance the quality of products for its customers.  Paired with its ISO 9001 certification, EVCO Shenzhen is able to serve a diverse client market.

EVCO Plastics is a leading plastics manufacturing company, with nine manufacturing facilities strategically located throughout the world. With an emphasis on design for manufacturability, strategic engineering and innovative technology, EVCO is recognized as a global leader in custom plastic injection molding. EVCO was founded in 1964, EVCO employs over 900 people and operates 140 injection molding machines, ranging from 28 to 3,500 tons. For more information about EVCO, visit www.facebook.com/evcoplastics or www.twitter.com/evcoplastics.