【正文】 nt () shall …” is acceptable. top management person or group of people who direct and controls and anization () at the highest level quality management ISO9000:2020(E) 9 coordinated activities to direct and control an anization () with regard to quality () NOTE Direction and control with regard to quality generally includes establishment of the quality policy () and quality objectives (), quality planning () quality control (), quality assurance () and quality improvement (). quality planning part of quality management () focused on setting quality objectives () and specifying necessary operational processes () and related resources to fulfill the quality objectives NOTE Establishing quality plans () can be part of quality planning. quality control part of quality management () focused on fulfilling quality requirements () quality assurance part of quality management () focused on providing confidence that quality requirements () will be fulfilled quality improvement part of quality management () focused on increasing the ability to fulfill quality requirements () NOTE The requirements can be related to any aspect such as effectiveness (), efficiency (...15) or traceability (). continual improvement recurring activity to increase the ability to fulfill requirements () NOTE The process () of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings () and audit conclusions (), analysis of data, management reviews () or other means and generally leads to corrective action () or preventive action (). effectiveness extent to which planned activities are realized and planned results achieved efficiency relationship between the result achieved and the resources used Terms relating to anization anization group of people and facilities with an arrangement of responsibilities, authorities and relationships EXAMLE Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or bination thereof. NOTE 1 The arrangement is generally orderly. NOTE 2 An anization can be public or private. NOTE 3 This definition is valid for the purposes of quality management system () standards. The term “anization” is defined differently in ISO/IEC Guide 2. anizational structure ISO9000:2020(E) 10 arrangement of responsibilities, authorities and relationships between people NOTE 1 The arrangement is generally orderly. NOTE 2 A formal expression of the anizational structure is often provided in a quality manual () or a quality plan () for a project (). NOTE 3 The scope of an anizational structure ca include relevant interfaces to external anizations (). infrastructure anization system of facilities, equipment and services needed for the operation of an anization () work environment set of conditions under which work is performed NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric position). customer anization () or person that receives a product () EXAMPLE Consumer, client, enduser, retailer, beneficiary and purchaser. NOTE A customer can be internal or external to the anization. supplier anization () or person that provides a product () EXAMPLE Producer, distributor, retailer or vendor of a product, or provider of a service or information. NOTE 1 A supplier can be internal or external to the anization. NOTE 2 In a contractual situation a supplier is sometimes called “contractor.” interested party person or group having an interest in the performance or success of an anization () EXAMPLE Customers (), owners, people in an anization, suppliers (), bankers, unions, partners or society. NOTE A group can prise an anization, a part thereof, or more than one anization. Terms relating to process and product process set of interrelated or interacting activities which transforms inputs into outputs NOTE 1 Inputs to a process are generally outputs of other processes. NOTE 2 Processes in an anization () are generally planned and carried out under controlled conditions to add value. NOTE 3 A process where the conformity () of the resulting product () cannot be readily or economically verified is frequently referred to as a “special process.” product result of a process () NOTE1 There are four generic product categories, as follows: ISO9000:2020(E) 11 services (. transport)。 ISO9000:2020(E) 6 g) formalizing changes. Results are reviewed, as necessary, to determine further opportunities for improvement. In this way, improvement is a continual activity. Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement. Role of statistical techniques The use of statistical techniques can help in understanding variability, and thereby can help anizations to solve problems and improve effectiveness and efficiency. These techniques also facilitate better use of available data to assist in decision making. Variability can be observed I the behaviour and oute of many activities, even under conditions of apparent stability. Such variability can be observed in measurable characteristics of products ad processes, and may be seen to exist at various stages over the life cycle of products from market research to customer service ad final disposal. Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of the nature, extent and causes of variability, thus helping to solve ad even prevent problems that