【正文】 amily standards. This illustration shows that interested parties play a significant role in providing inputs to the organization. Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to the extent to which their needs and expectations have been met. The model shown in Figure 1 does not show processes at a detailed level. Quality policy and quality objectivesQuality policy and quality objectives are established to provide a focus to direct the organization. Both determine the desired results and assist the organization to apply its resources to achieve these results. The quality policy provides a framework for establishing and reviewing quality objectives. The quality objectives need to be consistent with the quality policy and the mitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties.NOTE Statements in parentheses do not apply to ISO 9001.Figure 1 – Model of a processbased quality management system Role of top management within the quality management systemThrough leadership and actions, top management can create an environment where people are fully involved and in which a quality management system can operate effectively. The quality management principles (see ) can be used by top management as the basis of its role, which is as follows:a) to establish and maintain the quality policy and quality objectives of the organization。 such documents are referred to as quality manuals。 such documents can include documented procedures, work instructions and drawings。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。 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