Did you know KA Imaging has a Quality Policy?
At KA Imaging, we are committed to the design and development of X-ray systems that meet the needs of our customers. Through the implementation of our quality processes, we will comply with all applicable regulatory requirements and maintain the effectiveness of
the Quality Management System. We build quality in all we do.
Therefore, at KA Imaging, quality is everybody’s business! It is a journey of continuous improvement. The question is: how do you achieve quality?
Quality is defined as Conformance to Requirements. That is, any product, service, or process that conforms to its requirements is a Quality Product, Service, or Process.
At KA Imaging, ‘Quality’ is based upon Process Management and Improvement Methodology (PM&I). It focuses upon processes and their efficiencies that produce their outcomes in a consistent and a repeatable manner. The process outcomes must meet their agreed upon requirements. The pictorial view below represents KA Imaging’s PM&I model.
For KA Imaging to function effectively, it has identified and has linked all business processes. The application of a system of processes within an organization, together with the identification and interactions of these processes and their management to produce the desired outcome, can be referred to as the “process approach”. The linking of the processes to produce outcomes is also known as inter-related processes.
KA Imaging deploys a RASUI concept in its approach towards designing and developing products. RASUI is an acronym that stands for ‘Reliability, Availability, Serviceability, Usability, and Installability’.
KA Imaging being in the business of Development and Manufacturing of medical devices such as high-end Dual-Energy X-Ray Detectors, it is crucial that it consistently meets the ISO 13485:2016 Standard and Regulatory requirements. To this end, KA Imaging engages in training all its employees in the Process based Quality Management System including Management.