质量管理术语汇编.doc

ISO 9000:2005HAFHAF003-1991HAD003/XXIAEA Safety Glossary 2007IAEA 50-C/SG-Q(1996)10 CFR 50NRC Glossary 2008ASME NQA-1-2004质量管理术语汇编2008.12质量管理术语汇编61 目录目录11“质量”相关术语41.1质量41.2要求41.3等级51.4顾客满意51.5能力52“管理”相关术语72.1体系（系统）72.2管理体系72.3质量管理体系72.4质量方针82.5质量目标82.6管理82.7最高管理者82.8质量管理82.9质量策划92.10质量控制92.11质量保证92.12质量改进102.13持续改进102.14有效性102.15效率103“组织”相关术语113.1组织113.2组织结构123.3基础设施133.4工作环境133.5顾客133.6供方133.7相关方143.8合同154“过程与产品”相关术语164.1过程164.2产品184.3项目214.4设计与开发214.5程序265“特性”相关的术语285.1特性285.2质量特性285.3可信性295.4可追溯性296“合格”（符合）相关的术语306.1合格（符合）306.2不合格（不符合）306.3缺陷306.4预防措施316.5纠正措施316.6纠正326.7返工326.8降级326.9返修326.10报废336.11让步336.12偏离许可336.13放行347“文件”相关的术语357.1信息357.2文件357.3规范357.4质量手册367.5质量计划377.6记录388“检查”相关的术语408.1客观证据408.2检验408.3试验418.4验证428.5确认438.6鉴定过程448.7评审449“监查”（审核）相关的术语469.1监查（审核）469.2审核方案（监查大纲）489.3监查准则489.4监查证据489.5监查发现（项）489.6监查结论489.7监查委托方489.8受监查方489.9监查员（审核员）499.10监查队（审核组）499.11技术专家499.12监查计划499.13监查范围499.14能力4910“测量过程的质量管理”相关的术语5010.1测量管理体系5010.2测量过程5010.3计量确认5010.4测量设备5010.5计量特性5110.6计量职能5111核安全相关术语5212其他的相关术语591 “质量”相关术语1.1 质量Quality: (ISO9000:2005) 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.质量：核电厂的物项和服务均需具有它们对安全的重要性和使用目的而规定的质量。每一物项和服务的质量是由可鉴别和可测量的特性决定的。物项的质量特性可通过性能（物理、尺寸、冶金和化学性能）、状态或条件（温度、压力和密度）或使用特性（速度、持续时间、输出、消耗、预计寿命、准确度、效率、精确度）来规定。服务的质量特性可根据特定情况进行规定。（HAD003/01-1988，2.1.1节）1.2 要求Requirement: (ISO9000:2005) need or expectation that is stated, generally implied or obligatoryNote 1 Generally implied means that it is custom or common practice for the organization, its customers and other interested parties, that the need or expectation under consideration is implied.Note 2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement.Note 3 A specified requirement is one that is stated, for example in a document.Note 4 Requirements can be generated by different interested parties.Technical Requirements: The technical requirements should be specified by reference to technical documents such as: codes, specifications, regulatory requirements, standards, design basis, drawings, process requirements and requirements for approval or qualifications of items, procedures or processes. The responsible organization may require supplier personnel to be specifically qualified in order for some technical requirements to be met, for example welding, inspection and testing, and heat treatment. It may also include: requirements for performance; requirements for fabrication, storage, handling, packaging and presentation of materials; requirements for installation; and requirements for operation. Each specified requirement should be achievable and verifiable and when met will render items or services fit for the intended purpose. (IAEA 50-SG-Q6, 1996)技术要求：（1）描述待采购物项和服务的技术规范、图纸、程序、说明书和技术条件及其修订本的技术要求；（2）试验、检查和验收要求，以及用于诸如设计、标识、加工、清洗、包装、装卸、运输和贮存等工作的专用说明和要求。（HAD003/03-1986，3.2节）质量保证要求：确定适用于所采购物项和服务的质量保证的要求。采购文件中必须列有按需要程度要求供方提供与规定的有关要求相符的质量保证大纲的条款。（HAD003/03-1986，3.2节）Acceptance Criteria: specified limits placed on the performance, results, or other characteristics of an item, process, or service defined in codes, standards, or other requirement documents. (NQA-1-2004)1.3 等级Grade: (ISO9000:2005) category 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 When establishing a quality requirement, the grade is generally specified.Graded Approach: (IAEA 2007)1. For a system of control, such as a regulatory system or a safety system, a process or method in which the stringency of the control measures and conditions to be applied is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control. An example of a graded approach in general would be a structured method by means of which the stringency of application of requirements is varied in accordance with the circumstances, the regulatory systems used, the management systems used, etc. For example, a method in which: (1) The significance and complexity of a product or service are determined; (2) The potential impacts of the product or service on health, safety, security, the environment, and the achieving of quality and the organizations objectives are determined; (3) The consequences if a product fails or if a service is carried out incorrectly are taken into account. 2. An application of safety requirements that is commensurate with the characteristics of the practice or source and with the magnitude and likelihood of the exposures. 1.4 顾客满意Customer Satisfaction: (ISO9000:2005) customers perception of the degree to which the customers requirements have been fulfilledNote 1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.Note 2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.1.5 能力Capability: (ISO9000:2005) ability 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 3534-2.Competence: (ISO9000:2005) demonstrated ability to apply knowledge and skillsNote The concept of competence is defined in a generic sense in this International Standard. The word usage can be more specific in other ISO documents.2 “管理”相关术语2.1 体系（系统）System: (ISO9000:2005) set of interrelated or interacting elements2.2 管理体系Management System: (ISO9000:2005) system to establish policy and objectives and to achieve those objectivesNote A management system of an organization can include different management systems, such as a quality management system, a financial management system or an environmental management system.Management System: A set of interrelated or interacting elements (system) for establishing policies and objectives and enabling the objectives to be achieved in an efficient and effective manner. (IAEA 2007)l The component parts of the management system include the organizational structure, resources and organizational processes. Management is defined (in ISO 9000) as coordinated activities to direct and control an organization. l The management system integrates all elements of an organization into one coherent system to enable all of the organizations objectives to be achieved. These elements include the organizational structure, resources and processes. Personnel, equipment and organizational culture as well as the documented policies and processes are parts of the management system. The organizations processes have to address the totality of the requirements on the organization as established in, for example, IAEA safety standards and other international codes and standards.Integrated Management System (for facilities and activities): A single coherent management system in which all the component parts of an organization are integrated to enable the organizations objectives to be achieved. (IAEA 2007)l These component parts include the organizational structure, resources and organizational processes. l Personnel, equipment and organizational culture, as well as the documented policies and processes, form parts of the management system. l The organizational processes have to address the totality of the requirements on the organization, as established by or in, for example, interested parties, IAEA safety standards and other international codes and standards.2.3 质量管理体系Quality Management System: (ISO9000:2005) management system to direct and control an organization with regard to quality 质量保证大纲：为保证质量而规定的和要完成的全部工作，这些工作包括两种类型：管理性工作和技术性工作。（HAD003/01-1988，2.1.3节）QA Program In some Member States the quality assurance program is referred to as the quality assurance system or the quality system. (IAEA 50-SG-Q1, 1996)2.4 质量方针Quality Policy: (ISO9000:2005) overall intentions and direction of an organization related to quality as formally expressed by top managementNote 1 Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives.Note 2 Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy.2.5 质量目标Quality Objective: (ISO9000:2005) something sought, or aimed for, related to qualityNote 1 Quality objectives are generally based on the organizations quality policy.Note 2 Quality objectives are generally specified for relevant functions and levels in the organization.2.6 管理Management: (ISO9000:2005) coordinated activities to direct and control an organizationNote In English, the term management sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When management is used in this sense, it should always be used with some form of qualifier to avoid confusion with the concept management defined above. For example, management shall is deprecated whereas top management (3.2.7) shall is acceptable.2.7 最高管理者Top Management: (ISO9000:2005) person or group of people who directs and controls an organization at the highest level2.8 质量管理Quality Management: (ISO9000:2005) coordinated activities to direct and control an organization with regard to qualityNote Direction and control with regard to quality generally includes establishment of the quality policy and quality objectives, quality planning, quality control, quality assurance and quality improvement.2.9 质量策划Quality Planning: (ISO9000:2005) part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectivesNote Establishing quality plans can be part of quality planning.2.10 质量控制Quality Control: (ISO9000:2005) part of quality management focused on fulfilling quality requirements质量控制：按规定要求为控制和测量某一物项、工艺和装置的性能提供手段的所有质量保证活动。（HAD003/01-1988）Quality Control (QC): Part of quality assurance intended to verify that structures, systems and components correspond to predetermined requirements. (IAEA 2007)This definition is taken from ISO 921:1997 (Nuclear Energy: Vocabulary) 7. A more general definition of quality control and definitions of related terms can be found in ISO 8402:1994 35.2.11 质量保证Quality Assurance: (ISO9000:2005) part of quality management focused on providing confidence that quality requirements will be fulfilled质量保证：为使物项或服务与规定的质量要求相符合并提供足够的置信度所必需的一系列有计划的系统化的活动。（HAF003-1991）置信度：以样本估计值推论总体实际值大小时，正确估计的概率。Quality Assurance (QA): all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. (NQA-1-2004)Quality Assurance (QA): (IAEA 2007) 1. The function of a management system that provides confidence that specified requirements will be fulfilled. l The IAEA is revising the requirements and guidance in the subject area of quality assurance for new safety standards on management systems for the safety of nuclear facilities and activities involving the use of ionizing radiation. The term management system has been adopted in the revised standards instead of the terms quality assurance and quality assurance program. l Planned and systematic actions are necessary to provide adequate confidence that an item, process or service will satisfy given requirements for quality; for example, those specified in the license. This statement is slightly modified from that in ISO 921:1997 (Nuclear Energy: Vocabulary) 7 to say an item, process or service instead of a product or service and to add the example. A more general definition of quality assurance and definitions of related terms can be found in ISO 8402:1994 35. 2. A systematic program of controls and inspections applied by any organization or body involved in the transport of radioactive material which is aimed at providing adequate confidence that the standard of safety prescribed in the Transport Regulations is achieved in practice. (From Ref. 2.) 3. All those planned and systematic actions necessary to provide confidence that a structure, system or component will perform satisfactorily in service. (From Ref. 35.) 2.12 质量改进Quality Improvement: (ISO9000:2005) part of quality management focused on increasing the ability to fulfill quality requirementsNote The requirements can be related to any aspect such as effectiveness, efficiency or traceability.2.13 持续改进Continual Improvement: (ISO9000:2005) recurring activity to increase the ability to fulfill requirements Note The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means and generally leads to corrective action or preventive action.2.14 有效性Effectiveness: (ISO9000:2005) extent to which planned activities are realized and planned results achieved2.15 效率Efficiency: (ISO9000:2005) relationship between the result achieved and the resources usedEfficiency, plant (NRC glossary 2008) The percentage of the total energy content of a power plants fuel that is converted into electricity. The remaining energy is lost to the environment as heat. 3 “组织”相关术语3.1 组织Organization: (ISO9000:2005) group of people and facilities with an arrangement of responsibilities, authorities and relationshipsEXAMPLE Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combination thereof.Note 1 The arrangement is generally orderly.Note 2 An organization can be public or private.Note 3 This definition is valid for the purposes of quality management system standards. The term organization is defined differently in ISO/IEC Guide 2.国家核安全部门：国家核安全局及其地方监督站系统。（HAF001/02实施细则之二1995） 核设施主管部门：是指对核设施营运单位负有领导责任的国务院和省、自治区、直辖市人民政府的有关行政机关。（HAF001-1986）营运单位：持有国家核安全部门（颁发的）许可证（执照），负责经营和运行核电厂的单位。（HAF003-1991）营运单位：是指申请或持有核设施许可证，可以经营和运行核设施的组织。（HAF001-1986）Owner: the organization legally responsible for the construction and/or operation of a nuclear facility including but not limited to one who has applied for, or who has been granted, a construction permit or operating license by the regulatory authority having lawful jurisdiction. (NQA-1-2004)核电厂运行管理者：由核电厂营运单位（或其主管部门）委任的负责指挥核电厂运行，并承担直接安全责任的人员（或组织）。（HAF003-1991）合格人员：符合特定要求、具备一定条件、而且被正式指定执行规定任务和承担责任的人员。（HAF003-1991）质量保证部门：（HAD003/02-1989，2.2节）必须在组织机构内确定行使下列质量保证职能的负责人及其工作人员：（1）保证制定和有效地实施适当的质量保证大纲；（2）验证各种工作是否正确地按规定进行。他们可以处于一个单一的部门或几个部门内（每个部门负责不同的质量保证职能）。对于本导则来说，行使质量保证职能的所有人员（不管他们处于一个部门，还是处于几个部门内）下文中都统称为“质量保证部门”。质量保证部门可以行使下列职能并从事下列活动：（1）计划、设计和制定质量保证大纲，包括它的实施办法、程序和技术。这种职能也可以包括把大纲编写成计划、概述、程序或其他适当形式的文件等有关活动，以及质量保证记录的管理。（2）通过验证工作确定和评价质量是否已达到验收标准。这种职能可以包括为验收物项和服务的检查和试验以及确定和验证质量保证大纲是否已有效地实施的监查。（3）对不符合项进行管理，查明和消除严重有损于质量的情况。（4）人员资格考核、培训、质量教育和颁发证书等有关工作。Facilities and Activities: A general term encompassing nuclear facilities, uses of all sources of ionizing radiation, all radioactive waste management activities, transport of radioactive material and any other practice or circumstances in which people may be exposed to radiation from naturally occurring or artificial sources. (IAEA 2007) l Facilities includes: nuclear facilities; irradiation installations; some mining and raw material processing facilities such as uranium mines; radioactive waste management facilities; and any other places where radioactive material is produced, processed, used, handled, stored or disposed ofor where radiation generators are installedon such a scale that consideration of protection and safety is required. l Activities includes: the production, use, import and export of radiation sources for industrial, research and medical purposes; the transport of radioactive material; the decommissioning of facilities; radioactive waste management activities such as the discharge of effluents; and some aspects of the remediation of sites affected by residues from past activities. l This term is intended to provide an alternative to the terminology of sources and practices (or intervention) to refer to general categories of situations. For example, a practice may involve many different facilities and/or activities, whereas the general definition (1) of source is too broad in some cases: a facility or activity might constitute a source, or might involve the use of many sources, depending upon the interpretation used. l The term facilities and activities is very general, and includes those for which little or no regulatory control may be necessary or achievable: the more specific terms authorized facility and authorized activity should be used to distinguish those facilities and activities for which any form of authorization has been given. l In the Fundamental Safety Principles (Safety Fundamentals), the term facilities and activitiesexisting and newutilized for peaceful purposes is abbr