【正文】 may result from such variability, and to promote continual improvement. Guidance on statistical techniques in a quality management system is given in ISO/TR 10017. Quality management systems and other management system focuses The quality management system is that part of the anization’s management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate. The quality objectives plement other objectives of the anization such as those related to growth, funding, profitability, the environment and occupational health and safety. The various parts of an anization’s management system might be integrated, together with the quality management system, into a single management system using mon elements. This can facilitate planning, allocation of resources, definition of plementary objectives and evaluation of the overall effectiveness of the anization. The anization’s management system can be assessed against the anization’s management system requirements. The management system can also be audited against the requirements of International Standards such as ISO9001 and ISO 14001:1996. These management system audits can be carried out separately or in bination. Relationship between quality management systems and excellence models The approaches of quality management systems given in the ISO9000 family of standards and in anizational excellence models are based on mon principles. Both approaches a) enable an anization to identify its strengths and weaknesses, b) contain provision for evaluation against generic models, c) provide a basis for continual improvement, and d) contain provision for external recognition. The difference between the approaches of the quality management systems in the ISO9000 family and the excellence models lies in their scope of application. The ISO 9000 family of standards provides requirements for quality management systems and guidance for performance improvement。 e) implementing the selected solution。 c) searching for possible solutions to achieve the objectives。 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 excellence. Selfassessment can provide an overall view of the performance of the anization and the degree of maturity of the quality management system. It can also help to identify areas requiring improvement in the anization and to determine priorities. Continual Improvement The aim of continual improvement of a quality management system is to increase the probability of enhancing the satisfaction of customers and other interested parties. Actions for improvement include the following: a) analysing and evaluating the existing situation to identify areas for improvement。 such documents can include documented procedures, work instructions and drawings。 such documents are referred to as guidelines。 such documents are referred to as specifications。 such documents are referred to as quality plans。 such documents are referred to as quality manuals。 g) to review the quality management sys