【正文】 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)。 e) implementing the selected solution。 such documents are referred to as records. Each anization determines the extent of documentation required ad the media to be used. This depends on factors such as the type and size of the anization, the plexity and interaction of processes, the plexity of products, customer requirements, the applicable regulatory requirements, the demonstrated ability of personnel, and the extent to which it is necessary to demonstrate fulfillment of quality management system requirements. Evaluating quality management systems Evaluating processes within the quality management system When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated. a) Is the process identified and appropriately defined? b) Are responsibilities assigned? ISO9000:2020(E) 5 c) Are the procedures implemented and maintained? d) Is the process effective in achieving the required results? The collective answers to the above questions can determine the result of the evaluation. Evaluation of a quality management system can vary in scope and enpass a range of activities, such as auditing and reviewing the quality management system, and selfassessments. Auditing the quality management system Audits are used to determine the extent to which the quality management system requirements are fulfilled. Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement. Firstparty audits are conducted by, or on behalf of, the anization itself for internal purposes and can form the basis for an anization’s selfdeclaration of conformity. Secondparty audits are conducted by customers of the anization or by other persons on behalf of the customer. Thirdparty audits are conducted by external independent anizations. Such anizations, usually accredited, provide certification or registration of conformity with requirements such as those of ISO 9001. ISO 19011 provides guidance on auditing. Reviewing the quality management system One role of top management is to carry out regular systematic evaluations of the suitability, effectiveness and efficiency of the quality management system with respect to the quality policy and quality objectives. This review can include consideration of the end to adapt the quality policy and objectives in response to changing needs and expectations of interested parties. The review includes determination of the need for actions. Amongst other sources of information, audit reports are used for review of the quality management system. Selfassessment An anization’s selfassessment is a prehensive and systematic review of the anization’s activities and results referenced against the quality management system or a model of excellen