【正文】
s to achieve the objectives。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 techniquesThe use of statistical techniques can help in understanding variability, and thereby can help organizations 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 focusesThe quality management system is that part of the organization’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 organization such as those related to growth, funding, profitability, the environment and occupational health and safety. The various parts of an organization’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 organization. The organization’s management system can be assessed against the organization’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 modelsThe approaches of quality management systems given in the ISO9000 family of standards and in organizational excellence models are based on mon principles. Both approaches a) enable an organization 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。 hardware (. engine mechanical part)。 the creation of ambience for the customer (. in hotels and restaurants). Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures ()Hardware is generally tangible and its amount is a countable characteristic (). Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.NOTE 3 Quality assurance () is mainly focused on intended product.projectunique process (), consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements (), including the constraints of time, cost and resourcesNOTE 1 An individual project can form part of a larger project structure.NOTE2 In some projects the objectives are refined and the product characteristics () defined progressively as the project proceeds.NOTE 3 The oute of a project may be one or several units of product ().NOTE 4 Adapted from ISO 10006:1997.design and developmentset of processes () that transforms requirements () into specified characteristics () or into the specification () of a product (), process () or system ()NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (. product design and development or process design and development). procedurespecified way to carry out an activity or a process ()NOTE1 Procedures can be documented or not.NOTE2 When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document () that contains a procedure can be called a “procedure document”. Terms relating to characteristics characteristicdistinguishing featureNOTE 1 A characteristic ca be inherent or assigned.NOTE 2 A characteristic can be qualitative or quantitative.NOTE 3 There are various classes of characteristic, such as the following: physical (. mechanical, electrical, chemical or biological characteristics)。 ergonomic (. physiological characteristic, or related to human safety)。 behavioral (. courtesy, honesty, veracity)。 an activity performed on a customersupplied intangible product (. the ine statement needed to prepare a tax return)。process is defined as “set of interrelated or interactin