【正文】 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)。d) documents stating remendations or suggestions。d) determining and providing the resources e) establishing methods to measure the effectiveness and efficiency of each process。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。 such documents are referred to as quality plans。process is defined as “set of interrelated or interacting activities which transforms inputs into outputs.”If the term “process” is replaced by its definition, as follows:product then bees “result of a set of interrelated or interacting activities which transforms inputs into outputs.”A concept limited to a special meaning in a particular context is indicated by designating the subject field in angle brackets, , before the definition, for example, technical expert audit (). Terms relating to quality quality degree to which a set of inherent characteristics () fulfils requirements ()NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent.NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic. requirementneed or expectation that is stated, generally implied or obligatoryNOTE1 “Generally implied” means that it is custom or mon practice for the organization (), its customers () and other interested parties (), that the need or expectation under consideration is implied:NOTE2 A qualifier can be used to denote a specific type of requirement, . product requirement, quality management requirement, customer requirement.NOTE3 A specified requirement is one which is stated, for example, in a document ().NOTE4 Requirements can be generated by different interested parties.gradecategory or rank given to different quality requirements () for products () processes () or systems () having the same functional useEXAMPLE Class of airline ticket and category of hotel in a hotel guide.NOTE 4 Requirements can be generated by different interested parties.customer satisfactioncustomer’s perception of the degree to which the customer’s requirements () have been fulfilledNOTE1 Customer plaints are a mon indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.NOTE2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction. capabilityability of an organization (), system () or process () to realize a product () that will fulfill the requirements () for that productNOTE Process capability terms in the field of statistics are defined in ISO . Terms relating to management system set of interrelated or interacting elements management system system () to establish