As an experienced medical Laboratory Technologist with nearly 40 years front line and management experience, I firmly believe that there is a real need for the laboratory to improve Quality Management Systems and to be able to increase efficiencies and effectiveness within their businesses quality processes and programs in order to grow and thrive. The way to do that is through an effective Quality Management System (QMS).
A QMS is a roadmap, or a business plan, towards better quality. Fundamentally it is how an organization or business should operate, it is the basic foundation for being successful.
A QMS for laboratories plans, controls, and improves the elements that impact results and consistently meets customer requirements, enhancing their satisfaction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it.
Within the laboratory environment, the QMS is made up of twelve quality system essentials (QSEs). These are: organization, customer focus, facilities and safety, personnel, purchasing and inventory, equipment, process management, documents and records, information management, nonconforming event management, assessments, and process/continual improvement. Different accrediting bodies (e.g. ISO 13845) may have QSEs differing in number or in name but will still cover the fundamental aspects of quality.
Think of it like the structure of a house, where the QMS is the roof which is supported by twelve supporting beams. If one (or more) of the beams is weak or broken, the entire structure is at risk of having problems.
Where I can assist in the development of, improvement of or implementation of a QMS:
Skills I bring to you:
My Background includes:
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