Jaltek holds certification to ISO 13485:2012 and 2003 issued by our certification body; BSI. Jaltek was awarded this certification in 2010 and continues to actively maintain it and satisfy the stringent requirements relating to Medical Devices.
In January Jaltek underwent and successfully passed the latest surveillance assessment carried out by BSI’s specialist Medical Assessors.
This certification allows us to demonstrate continuing support to our customers in the manufacture of medical devices. It gives customers in all sectors the confidence that we continue to carry out the manufacturing process in a fully controlled manner meeting the requirements of the Medical Directive, including the appropriate Quality and traceability controls.
Jaltek has also recently implemented the Aegis Manufacturing Execution System which facilitates the control of product build, in line with the Medical industries requirements. This system includes; Bill of Materials and placement program verification, the presentation of clear work instructions to the operator, controlled routing, full traceability, live yield data and analysis. It allows full transparency of operations and facilitates quick, clear feedback to the customer with regards traceability and detailed build analysis.
Neil Stanton, Jaltek’s Quality and Training Manager commenting on the certification said, “The ISO 13485 compliments Jaltek’s other certificates (AS9100 and IPC-A-610 Kitemark) to give our customers confidence that we maintain the highest standards and demonstrate that we can consistently manufacture product to the most exacting requirements of the Medical Industry.”