Quality Management Systems (QMS) & Healthcare

OFF THE RADAR SCREEN OF THE LABORATORY INDUSTRY is an evolving management approach that gives unity to the mishmash of quality improvement tools that carry a variety of names, but have several common attributes.

Soon lab directors and pathologists will be quite familiar with the concept of the “quality management system” (QMS). Wikipedia describes it thusly:

Quality Management System (QMS) can be defined as a set of policies, processes and procedures required for planning and execution (production / development / service) in the core business area of an organization. QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.

Over recent decades, industry has developed the concept of “quality management systems” as a way to allow all business, organizational, and operational functions within the enterprise to utilize the basic management principles identified by W. Edwards Deming, Joseph Juran, Taiichi Ohno, and others, including Henry Ford. These principles are rooted in such shared management precepts as “system of prevention,” continuous improvement, “only the customer defines quality,” and use of statistical process control (SPC) to improve quality and reduce variation.

QMS is just now reaching healthcare. Within the laboratory industry, it is well known to the in vitro diagnostics (IVD) manufacturers and the QA/QC professionals inside clinical laboratories. I predict that soon many labs will have a QMS. Since early in this decade, THE DARK REPORT has been consistently early, if not the first voice in the lab profession, to alert laboratory leaders as to how and why calls for improved patient safety, reduced medical errors and greater use of evidence-based medicine (EBM) will require their laboratories to adopt different management philosophies and methods. So it is with QMS.

ISO 15189:2007 Medical Laboratories is a quality management system. In this issue of THE DARK REPORT, you have the only public interviews by the nation’s first two laboratories to adopt ISO 15189:2007. It marks another milestone on the quality management journey of the laboratory profession, and once again, THE DARK REPORT is giving you a front row seat to watch events unfold and position your laboratory for success with QMS!


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