The British Standards Institution completed a Continuing Assessment Visit at Jaltek in November. The assessment evaluated Jaltek’s ability to meet the requirements of the ISO13485 standard which looks at the Quality Management Systems required for the production of Medical Devices.
The successful completion of this assessment confirms and reinforces Jaltek’s capability to continue to reliably and consistently manufacture Medical Devices under their established ISO13485 Quality Management System. Jaltek has held certification to the Medical Standard and has been manufacturing Medical Devices since early 2010. This certification complements Jaltek’s other qualifications which include BSI certification to AS9100 (Aviation, Space and Defence) and the Kitemark to IPC-A-610 Class 3.
Neil Stanton, Quality and Training Manager, commented on the successful assessment saying; “The assessment was as thorough as ever. BSI auditors challenge all aspects of our controls and systems, so it’s always satisfying to find that we continue to meet and exceed the requirements of the Standard”.