iso9000：2000质量管理体系基础和术语英文版

iso9000：2000质量管理体系基础和术语英文版内容摘要：

rm 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。 b) establishing the objectives for improvement。 c) searching for possible solutions to achieve the objectives。 d) evaluating these solutions and making a selection。 e) implementing the selected solution。 f) measuring, verifying, analyzing and evaluating results of the implementation to determine that the objectives have been met。 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 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。 evaluation of quality management systems determines fulfillment of those requirements. The excellence models contain criteria that enable parative evaluation of anizational performance and this is applicable to all activities and all interested parties of an anization. Assessment criteria in excellence models provide a basis for an ISO9000:2020(E) 7 anization to pare its pe。