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(1). 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.

在某些情况下，产品要求和有关过程的要求可包含在诸如技术规范、产品标准、过程标准、合同协议和法规要求中。

(2). An approach to developing and implementing a quality management system consists of several steps including the following

建立和实施质量管理体系的方法包括以下步骤

(3). Determining the needs and expectations of customers and interested parties

确定顾客和其他相关方的需求和期望

(4). This International Standard describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.

本标准表述了GB/T19000族标准中质量管理体系的基础，并确定了相关的术语。

(5). This International Standard is applicable to the following: a)organizations seeking advantage through the implementation of a quality management system

本标准适用于:通过实施质量管理体系寻求优势的组织

(6). Organizations seeking confidence from their suppliers that their product requirements will be satisfied;c)users of the products

对能满足其产品要求的供方寻求信任的组织;产品的使用者

(7). Those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators)

就质量管理方面所使用的术语需要达成共识的人们(如:供方、顾客、行政执法机构)

(8). Those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies)

评价组织的质量管理体系或依据GB/T19001的要求审核其符合性的内部或外部人员和机构[如:审核员、行政执法机构，认证(注册)机构]

(9). Those internal or external to the organization who give advice or training on the quality management system appropriate to that organization

对组织质量管理体系提出建议或提供培训的内部或外部人员

(10). Developers of related standards.

制定相关标准的人员。

(11). Quality management systems can assist organizations in enhancing customer satisfaction.

质量管理体系能够帮助组织增强顾客满意。

(12). 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.

顾客要求产品具有满足其需求和期望的特性，这些需求和期望在产品规范中表述，并集中归结为顾客要求。

(13). Customer requirements may be specified contractually by the customer or may be determined by the organization itself.

顾客要求可以由顾客以合同方式规定或由组织自己确定。

(14). In either case, the customer ultimately determines the acceptability of the product.

在任一情况下，产品是否可接受最终由顾客确定。

(15). Because customer needs and expectations are changing, and because of competitive pressures and technical advances, organizations are driven to improve continually their products and processes.

因为顾客的需求和期望是不断变化的，以及竞争的压力和技术的发展，这些都促使组织持续地改进产品和过程。

(16). 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.

质量管理体系方法鼓励组织分析顾客要求，规定相关的过程，并使其持续受控，以实现顾客能接受的产品。

(17). 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.

质量管理体系能提供持续改进的框架，以增加顾客和其他相关方满意的机会。

(18). It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.

质量管理体系还就组织能够提供持续满足要求的产品，向组织及其顾客提供信任。

(19). 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.

质量管理体系要求是通用的，适用于所有行业或经济领域，不论其提供何种类别的产品。GB/T19001本身并不规定产品要求。

(20). Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation.

产品要求可由顾客规定，或由组织通过预测顾客的要求规定，或由法规规定。

(21). Establishing the quality policy and quality objectives of the organization

建立组织的质量方针和质量目标

(22). Determining the processes and responsibilities necessary to attain the quality objectives

确定实现质量目标必需的过程和职责

(23). Establishing methods to measure the effectiveness and efficiency of each process

规定测量每个过程的有效性和效率的方法

(24). Applying these measures to determine the effectiveness and efficiency of each process

应用这些测量方法确定每个过程的有效性和效率

(25). Determining means of preventing nonconformities and eliminating their causes

确定防止不合格并消除产生原因的措施

(26). Establishing and applying a process for continual improvement of the quality management system.

建立和应用持续改进质量管理体系的过程。

(27). Such an approach is also applicable to maintaining and improving and existing quality management system.

上述方法也适用于保持和改进现有的质量管理体系。

(28). An organization that adopts the above approach creates confidence in the capability of its processes and the quality of its products, and provides a basis for continual improvement.

采用上述方法的组织能对其过程能力和产品质量树立信心，为持续改进提供基础

(29). This can lead to increased satisfaction of customers and other interested parties and to the success of the organization.

从而增进顾客和其他相关方满意并使组织成功。

(30). Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process.

任何使用资源将输入转化为输出的活动或一组活动可视为一个过程。

(31). For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes.

为使组织有效运行，必须识别和管理许多相互关联和相互作用的过程。

(32). Often, the output from one process will directly form the input into the next process.

通常，一个过程的输出将直接成为下一个过程的输入。

(33). The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach.”

系统地识别和管理组织所应用的过程，特别是这些过程之间的相互作用，称为“过程方法”。

(34). The intent of this International Standard is to encourage the adoption of the process approach to manage an organization.

本标准鼓励采用过程方法管理组织。

(35). Figure 1 illustrates the process-based quality management system described the ISO 9000 family standards.

由GB/T19000族标准表述的，以过程为基础的质量管理体系模式如图1所示。

(36). This illustration shows that interested parties play a significant role in providing inputs to the organization.

该图表明在向组织提供输入方面相关方起重要作用。

(37). 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.

监视相关方满意程度需要评价有关相关方感受的信息，这种信息可以表明其需求和期望已得到满足的程度。

(38). Quality 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.

建立质量方针和质量目标为组织提供了关注的焦点。两者确定了预期的结果，并帮助组织利用其资源达到这些结果。

(39). The quality policy provides a framework for establishing and reviewing quality objectives.

质量方针为建立和评审质量目标提供了框架。

(40). The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable.

质量目标需要与质量方针和持续改进的承诺相一致，其实现需是可测量的。

(41). 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.

质量目标的实现对产品质量、运行有效性和财务业绩都有积极影响，因此对相关方的满意和信任也产生积极影响。

(42). Role of top management within the quality management system

最高管理者在质量管理体系中的作用

(43). Through leadership and actions, top management can create an environment where people are fully involved and in which a quality management system can operate effectively.

最高管理者通过其领导作用及各种措施可以创造一个员工充分参与的环境，质量管理体系能够在这种环境中有效运行。

(44). The quality management principles can be used by top management as the basis of its role, which is as follows

最高管理者可以运用质量管理原则作为发挥以下作用的基础

(45). To establish and maintain the quality policy and quality objectives of the organization

制定并保持组织的质量方针和质量目标

(46). To promote the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement

通过增强员工的意识、积极性和参与程度，在整个组织内促进质量方针和质量目标的实现

(47). To ensure focus on customer requirements throughout the organization

确保整个组织关注顾客要求

(48). To ensure that appropriate processes are implemented to enable requirements of customers and other interested parties to be fulfilled and quality objectives to be achieved

确保实施适宜的过程以满足顾客和其他相关方要求并实现质量目标

(49). To ensure that an effective and efficient quality management system is established, implemented and maintained to achieve these quality objectives

确保建立、实施和保持一个有效的质量管理体系以实现这些质量目标

(50). To ensure the availability of necessary resources

确保获得必要资源....(please sign in for more)

(51). To review the quality management system periodically;to decide on actions regarding the quality policy and quality objectives.to decide on actions for improvement of the quality management system.

定期评审质量管理体系;决定有关质量方针和质量目标的措施;决定改进质量管理体系的措施。....(please sign in for more)

(52). Documentation enables communication of intent and consistency of action. Its use contributes for achievement of conformity to customer requirements and quality improvement,provision of appropriate training.

文件能够沟通意图、统一行动，其使用有助于:满足要求和质量改进;提供适宜的培训....(please sign in for more)

(53). Repeatability and traceability, provision of objective evidence, and evaluation of the effectiveness ad continuing suitability of the quality management system.

重复性和可追溯性;提供客观证据;评价质量管理体系的有效性和持续适宜性。....(please sign in for more)

(54). Generation of documentation should not be an end in itself but should be a value-adding activity.

文件的形成本身并不是目的，它应是一项增值的活动。....(please sign in for more)

(55). The following types of document are used in quality management systems

在质量管理体系中使用下述几种类型的文件....(please sign in for more)

(56). Documents that provide consistent information, both internally and externally, about the organization’s quality management system; such documents are referred to as quality manuals

向组织内部和外部提供关于质量管理体系的一致信息的文件，这类文件称为质量手册....(please sign in for more)

(57). Documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans

表述质量管理体系如何应用于特定产品、项目或合同的文件，这类文件称为质量计划....(please sign in for more)

(58). Documents stating requirements; such documents are referred to as specifications

阐明要求的文件，这类文件称为规范....(please sign in for more)

(59). Documents stating recommendations or suggestions; such documents are referred to as guidelines

阐明推荐的方法或建议的文件，这类文件称为指南....(please sign in for more)

(60). Documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions and drawings

提供如何一致地完成活动和过程的信息的文件，这类文件包括形成文件的程序、作业指导书和图样....(please sign in for more)

(61). Documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.

为完成的活动或达到的结果提供客观证据的文件，这类文件称为记录。....(please sign in for more)

(62). Each organization determines the extent of documentation required ad the media to be used.

每个组织确定其所需文件的多少和详略程度及使用的媒体。....(please sign in for more)

(63). This depends on factors such as the type and size of the organization, the complexity and interaction of processes, the complexity of products, customer requirements

这取决于下列因素，诸如组织的类型和规模、过程的复杂性和相互作用、产品的复杂性、顾客要求、....(please sign in for more)

(64). The applicable regulatory requirements, the demonstrated ability of personnel, and the extent to which it is necessary to demonstrate fulfillment of quality management system requirements.

适用的法规要求、经证实的人员能力以及满足质量管理体系要求所需证实的程度。....(please sign in for more)

(65). When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated.

评价质量管理体系时，应对每一个被评价的过程提出如下四个基本问题....(please sign in for more)

(66). Is the process identified and appropriately defined?Are responsibilities assigned?Are the procedures implemented and maintained?Is the process effective in achieving the required results?

过程是否已被识别并适当规定?职责是否已被分配?程序是否得到实施和保持?在实现所要求的结果方面，过程是否有效?....(please sign in for more)

(67). The collective answers to the above questions can determine the result of the evaluation.

综合上述问题的答案可以确定评价结果。....(please sign in for more)

(68). Evaluation of a quality management system can vary in scope and encompass a range of activities, such as auditing and reviewing the quality management system, and self-assessments.

质量管理体系评价，如质量管理体系审核和质量管理体系评审以及自我评定，在涉及的范围上可以有所不同，并可包括许多活动。....(please sign in for more)

(69). Audits are used to determine the extent to which the quality management system requirements are fulfilled.

审核用于确定符合质量管理体系要求的程度。....(please sign in for more)

(70). Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement.

审核发现用于评定质量管理体系的有效性和识别改进的机会。....(please sign in for more)

(71). First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization’s self-declaration of conformity.

第一方审核用于内部目的，由组织自己或以组织的名义进行，可作为组织自我合格声明的基础。....(please sign in for more)

(72). Second-party audits are conducted by customers of the organization or by other persons on behalf of the customer.

第二方审核由组织的顾客或由其他人以顾客的名义进行。....(please sign in for more)

(73). Third-party audits are conducted by external independent organizations. Such organizations, usually accredited, provide certification or registration of conformity with requirements such as those of ISO 9001.

第三方审核由外部独立的组织进行。这类组织通常是经认可的，提供符合(如:GB/T19001)要求的认证或注册。....(please sign in for more)

(74). 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.

最高管理者的任务之一是就质量方针和质量目标，有规则的、系统的评价质量管理体系的适宜性、充分性、有效性和效率。....(please sign in for more)

(75). 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.

这种评审可包括考虑修改质量方针和质量目标的需求以响应相关方需求和期望的变化。评审包括确定采取措施的需求。....(please sign in for more)

(76). Amongst other sources of information, audit reports are used for review of the quality management system.

审核报告与其他信息源一同用于质量管理体系的评审。....(please sign in for more)

(77). An organization’s self-assessment is a comprehensive and systematic review of the organization’s activities and results referenced against the quality management system or a model of excellence.

组织的自我评定是一种参照质量管理体系或优秀模式对组织的活动和结果所进行的全面和系统的评审。....(please sign in for more)

(78). Self-assessment 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.

自我评定可提供一种对组织业绩和质量管理体系成熟程度的总的看法。它还有助于识别组织中需要改进的领域并确定优先开展的事项。....(please sign in for more)

(79). 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

持续改进质量管理体系的目的在于增加顾客和其他相关方满意的机会，改进包括下述活动....(please sign in for more)

(80). Analysing and evaluating the existing situation to identify areas for improvement;establishing the objectives for improvement;searching for possible solutions to achieve the objectives

分析和评价现状，以识别改进区域;确定改进目标;寻找可能的解决方法，以实现这些目标....(please sign in for more)

(81). Evaluating these solutions and making a selection;implementing the selected solution;measuring, verifying, analyzing and evaluating results of the implementation to determine that the objectives have been met;formalizing changes.

评价这些解决办法并作出选择;实施选定的解决办法;测量、验证、分析和评价实施的结果，以确定这些目标已经实现;正式采纳更改。....(please sign in for more)

(82). Results are reviewed, as necessary, to determine further opportunities for improvement. In this way, improvement is a continual activity.

必要时，对结果进行评审，以确定进一步改进的机会。从这种意义上说，改进是一种持续的活动。....(please sign in for more)

(83). Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement.

顾客和其他相关方的反馈以及质量管理体系的审核和评审均能用于识别改进的机会。....(please sign in for more)

(84). The use of statistical techniques can help in understanding variability, and thereby can help organizations to solve problems and improve effectiveness and efficiency.

应用统计技术可帮助组织了解变异，从而有助于组织解决问题并提高有效性和效率。....(please sign in for more)

(85). These techniques also facilitate better use of available data to assist in decision making.

这些技术也有助于更好地利用可获得的数据进行决策。....(please sign in for more)

(86). Variability can be observed I the behaviour and outcome of many activities, even under conditions of apparent stability.

在许多活动的状态和结果中，甚至是在明显的稳定条件下，均可观察到变异。....(please sign in for more)

(87). 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 and final disposal.

这种变异可通过产品和过程可测量的特性观察到，并且在产品的整个寿命周期(从市场调研到顾客服务和最终处置)的各个阶段，均可看到其存在。....(please sign in for more)

(88). Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a relatively limited amount of data.

统计技术有助于对这类变异进行测量、描述、分析、解释和建立模型，甚至在数据相对有限的情况下也可实现。....(please sign in for more)

(89). 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.

这种数据的统计分析能对更好地理解变异的性质、程度和原因提供帮助。从而有助于解决，甚至防止由变异引起的问题，并促进持续改进。....(please sign in for more)

(90). Guidance on statistical techniques in a quality management system is given in ISO/TR 10017.

GB/Z19027给出了统计技术在质量管理体系中的指南。....(please sign in for more)

(91). Quality management systems and other management system focuses

质量管理体系与其他管理体系的关注点....(please sign in for more)

(92). The 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

质量管理体系是组织的管理体系的一部分，它致力于使与质量目标有关的结果适当地满足相关方的需求、期望和要求。....(please sign in for more)

(93). The quality objectives complement other objectives of the organization such as those related to growth, funding, profitability, the environment and occupational health and safety.

组织的质量目标与其他目标，如增长、资金、利润、环境及职业卫生与安全等目标相辅相成。....(please sign in for more)

(94). The various parts of an organization’s management system might be integrated, together with the quality management system, into a single management system using common elements.

一个组织的管理体系的各个部分，连同质量管理体系可以合成一个整体，从而形成使用共有要素的单一的管理体系。....(please sign in for more)

(95). This can facilitate planning, allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of the organization.

这将有利于策划、资源配置、确定互补的目标并评价组织的整体有效性。....(please sign in for more)

(96). The organization’s management system can be assessed against the organization’s management system requirements.

组织的管理体系可以对照其要求进行评价....(please sign in for more)

(97). 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 combination.

也可以对照国家标准如GB/T19001和GB/T24001-1996的要求进行审核，这些审核可分开进行，也可合并进行。....(please sign in for more)

(98). Relationship between quality management systems and excellence models

质量管理体系与优秀模式之间的关系....(please sign in for more)

(99). Both approaches enable an organization to identify its strengths and weaknesses,contain provision for evaluation against generic models,provide a basis for continual improvement, and contain provision for external recognition.

它们两者均:使组织能够识别它的强项和弱项;包含对照通用模式进行评价的规定;为持续改进提供基础;包含外部承认的规定。....(please sign in for more)

(100). The excellence models contain criteria that enable comparative evaluation of organizational performance and this is applicable to all activities and all interested parties of an organization.

优秀模式包含能够对组织业绩进行比较评价的准则，并能适用于组织的全部活动和所有相关方。....(please sign in for more)