In this International Standard, the term entity (1.1) includes the term product, but extends further to cover, for example, activity, process (1.2), organization (1.7) or person. Confusion has arisen in understanding the terms quality control (3.4), quality assurance (3.5), quality management (3. 2) and total quality management (3.7). This International Standard is intended to clarify these concepts. In simplified terms, quality control concerns the operational means to fulfill the quality requirements, while quality assurance aim sat providing confidence in this fulfillment, both within the organization and externally to customers (1.9) and authorities. Within International Standards, the English terms "ensure" and "assure" are used in the following sense: "ensure" means to make sure or certain, "assure" means to give confidence to oneself or to others. Quality management includes both quality control and quality assurance, as well as the additional concepts of quality policy (3.1), quality planning (3.3) and quality improvement (3.8). Quality management operates throughout the quality system (3.6). These concepts can be extended to all parts of an organization. Total quality management brings to these concepts along-term global management strategy and the participation of all members of the organization for the benefit of the organization itself, its members, its customers and society as a whole. All concepts addressed in this International Standard have both economic and time implications. This should be recognized in the interpretation of all definitions in this International Standard even though it has not been explicitly stated in each definition. The distinction made in this International Standard between the terms defect (2.11)and nonconformity (2.10) is crucial as it has legal connotations, particularly those associated with product liability (2.12) issues. Consequently, the term defect should be used with extreme care. The terms defined in this International Standard have direct application to the International Standards on quality given in annex A. Other pertinent standards are listed in annex A. Special attention should be paid to vocabulary standards in the statistics field: parts 1 to 3 of ISO 3534