Laboratory quality management system definition

A qms helps coordinate and direct an organizations activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Overview of the twelve quality system essentialsmichael mukiibi ms. Quality management systems for laboratories and external quality. However, a qa program is the backbone of the laboratory quality system. Universal access to high quality health laboratories is essential for strong health systems and crucial for improving public health. Quality production laboratory materials facilities and equipment packaging and labeling. A quality management system qms is a collection of business processes focused on consistently meeting customer requirements and enhancing their. This definition is used by the international organization for standardization iso, and by the clinical and laboratory standards institute clsi. A quality management system can be defined as coordinated activities to direct. Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. Laboratory quality management systems towards accreditation in rwanda. A quality management system can be described as a set of building blocks needed to control, assure and manage the quality of the laboratorys processes. The importance of laboratory quality world health organization. A quality management system qms is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

Quality is hard to define in a way that is appropriate for all situations. Guidance on the role of the quality manager in clinical laboratories. Quality management systems for laboratories and external. It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. A system used in this tool is the framework of 12 building blocks, called quality system essentials qses. A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. An alternative definition of a qms is through the meaning of each word separately, according to the iso 9000. Besides qa, the laboratory quality management system also includes management of. The importance of implementing a quality management system in. Laboratory information management system wikipedia. Implementing a laboratory quality management system. The features and uses of a lims have evolved over the years from simple sample.

Quality management is the act of overseeing all activities and tasks needed to maintain a desired level of excellence. Guidance on quality management in laboratories ibms. A quality system refers to the organizational resources, processes and procedures to implement quality management, which is broader than both quality assurance qa and quality control qc. This includes the determination of a quality policy, creating and. Quality system essentials structure laboratory quality. A quality management system qms is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies. A quality management system qms plans, controls, and improves the elements that impact on the achievement of the desired results by the laboratory and on the satisfaction of the users. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple. It is aligned with an organizations purpose and strategic direction. Laboratory quality management system world health organization. Laboratory quality can be defined as accuracy, reliability and timeliness of.