A Quality Management System (QMS) is a formalized system of processes, procedures, and responsibilities employed to achieve quality. Additionally, the quality system directs activities to meet customer, regulatory, and accreditation agency requirements. The system strives for continuous improvement in the efficiency and effectiveness of the work processes. In the laboratory environment, the total quality system is composed of everything that contributes to quality laboratory testing systems as well as the quality test results that are the desired endpoint in any laboratory operation. In addition, the system strives for continuous improvement in the efficiency and effectiveness of the work processes.
As demonstrated in the Quality System diagram, the QMS is structured with two telescoped components: quality assessment (QA) and quality control (QC). While the overall QMS is in place within the laboratory, quality assessment and quality control are the "hands-on" processes that are addressed with every laboratory test performed. Quality assessment is the part of QMS that instills confidence that all of the quality requirements will be fulfilled. The total QMS is developed to ensure that QA and QC requirements are met and maintained at all times.
Quality assessment (previously quality assurance) can be defined as "planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality." 17
Quality control can be defined as "The operational techniques and activities used to fulfill requirements for quality."
These three terms and the relationship of this terminology are diagramed in the attached image.
