ISO 13485:2003

Cokeva received ISO 13485:2003 certification. This certification is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

This independent certification validates Cokeva’s long-standing commitment to quality, meeting the stringent requirements of customers in the medical device market. It also serves as a strong foundation for its medical device initiatives. The scope of Cokeva’s certification include repair and refurbishment, process and test, engineering support and logistics management services to medical device customers.

Although Cokeva originally sought this certification to enable support of medical device companies, other non-medical customers received benefits from this standard. Included are specific requirements for inspection and traceability which are very helpful to all customers using a repair partner.

Between the two powerful ISO quality standards (9001:2008 & 13485:2003), customers are provided with complete assurance of operations at the highest quality standards. Additionally, 13485 assures all regulatory and compliance requirements are met for products and services.