【正文】 ation of conformity with requirements such as those of ISO 9001.ISO 19011 provides guidance on auditing. Reviewing the quality management systemOne 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. SelfassessmentAn organization’s selfassessment is a prehensive and systematic review of the organization’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 organization and the degree of maturity of the quality management system. It can also help to identify areas requiring improvement in the organization and to determine priorities. Continual ImprovementThe 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 are referred to as quality plans。c) to ensure focus on customer requirements throughout the organization。g) developers of related standards.2 Fundamentals of quality management systems Rationale for quality management systemsQuality management systems can assist organizations in enhancing customer satisfaction.Customers require products with characteristics that satisfy their needs and expectations. These needs and expectations are expressed in product specifications and collectively referred to as customer requirements. Customer requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately determines the acceptability of the product. Because customer needs and expectations are changing, and because of petitive pressures and technical advances, organizations are driven to improve continually their products and processes.The quality management system approach encourages organizations to analyse customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements. Requirements of quality management systems and requirements for productsThe ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements. Quality management systems approachAn approach to developing and implementing a quality management system consists of several steps including the following:a) determining the needs and expectations of customers and interested parties。b) organizations seeking confidence from their suppliers that their product requirements will be satisfied。d) determining and providing the resources e) establishing methods to measure the effectiveness and efficiency of each process。f) to ensure the availability of necessary resources。d) documents stating remendations or suggestions。d) evaluating these solutions and making a selection。 processed materials (. lubricant).Many products prise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product “automobile” consists of hardware (. tyres), processed materials (. fuel, cooling liquid), software (. engine control software, driver’s manual), and service (. operating explanations given by the salesman).NOTE 2 Service is the result of at least one activity necessarily performed at the interface between the supplier () and customer () and is generally intangible. Provision of a service can involve, for example, the following: an activity performed on a customersupplied tangible product (. automobile to be repaired)。 functional (. maximum speed of an aircraft).quality characteristicinherent characteristic () of a product (), process () or system () related to a requirement ().NOTE 1 Inherent means existing in something, especially as a permanent characteristic.NOTE 2 A characteristic assigned to a product, process or system (. the price of a product, the owner of a product) is not a quality characteristic of that product, process or system. dependabilitycollective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance NOTE Dependability is used only for general descript