质量手册英文版解析
质量手册翻译中英文对照解析
质量手册翻译中英文术语表3.1.1 质量 quality3.1.2 要求 requirement3.1.3 等级 grade3.1.4 顾客满意 customer satisfaction3.1.5 能力 capability3.2.1 体系(系统) system3.2.2 管理体系 management system3.2.3 质量管理体系 quality management system 3.2.4 质量方针 quality policy3.2.5 质量目标 quality objective3.2.6 管理 management3.2.7 最高管理者 top management3.2.8 质量管理 quality management3.2.9 质量策划 quality planning3.2.10 质量控制 quality control3.2.11 质量保证 quality assurance3.2.12 质量改进 quality improvement3.2.13 持续改进 continual improvement3.2.14 有效性 effectiveness3.2.15 效率 efficiency3.3.1 组织 organization3.3.2 组织结构 organizational structure3.3.3 基础设施 infrastructure3.3.4 工作环境 '77ork environment 3.3.5 顾客 customer3.3.6 供方 supplier3.3.7 相关方 interested party3.4.1 过程 process3.4.2 产品 product3.4.3 项目 project3.4.4 设计和开发 design and development 3.4.5 程序 procedure3.5.1 特性 characteristic3.5.2 质量特性 quality characteristic 3.5.3 可信性 dependability3.5.4 可追溯性 traceability3.6.1 合格（符合） conformity3.6.2 不合格（不符合） nonconformity 3.6.3 缺陷 defect3.6.4 预防措施 preventive action3.6.5 纠正措施 corrective action3.6.6 纠正 correction3.6.7 返工 rework3.6.8 降级 regrade3.6.9 返修 repair3.6.10 报废 scrap3.6.11 让步 concession3.6.12 偏离许可 deviation permit3.6.13 放行 release3.7.1 信息 information3.7.2 文件 document3.7.3 规范 specification3.7.4 质量手册 quality manual3.7.5 质量计划 quality plan3.7.6 记录 record3.8.1 客观证据 objective evidence3.8.3 试验 test3.8.4 验证 verification3.8.5 确认 validation3.8.6 鉴定过程 qualification process3.8.7 评审 review3.9.1 审核 audit3.9.2 审核方案 audit programme3． 9．3 审核准则audit criteria3．9．4 审核证据 audit evidence3．9．5 审核发现 audit findings3．9．6 审核结论 audit conclusion3．9．7 审核委托方 audit client3． 9．8 受审核方 auditee3．9．9 审核员 auditor3．9．10 审核组 audit team3．9．11 技术专家 technical expert3．9．12 能力 competence3.10.1 测量控制体系 measurement control system 3.10.2 测量过程 measurement process3.10.3 计量确认 metrological confirmation3.10.4 测量设备 measuring equipment3.10.5 计量特性metrological characteristic 3.10.6 计量职能 metrological function Aaudit 3.9.1 审计audit client 3.9.7 客户审计audit conclusion 3.9.6 审计结论audit criteria 3.9.3 审计标准audit evidence 3.9.4 审计证据audit findings 3.9.5audit programme 3.9.2 审计大纲audit team 3.9.10 审计团队auditee 3.9.8auditor 3.9.9Ccapability 3.1.5characteristic 3.5.1concession 3.6.11conformity 3.6.1continual improvement 3.2.13 correction 3.6.6corrective action 3.6.5customer 3.3.5customer satisfaction 3.1.4 competence 3.9.12Ddefect 3.6.3dependability 3.5.3design and development 3.4.4 deviation permit 3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency 3.2.15Ggrade 3.1.3Iinformation 3.7.1infrastructure 3.3.3inspection 3.8.2interested party 3.3.7Mmanagement 3.2.6management system 3.2.2 measurement control system 3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic 3.10.5 metrological confirmation 3.10.3 metrological function 3.10.6Nnonconformity 3.6.2Oobjective evidence 3.8.1 客观证据organization 3.3.1 organizational structure 3.3.2 Ppreventive action 3.6.4 procedure 3.4.5process 3.4.1product 3.4.2project 3.4.3Qqualification process 3.8.6 quality 3.1.1quality assurance 3.2.11quality characteristic 3.5.2 quality control 3.2.10quality improvement 3.2.12 quality management 3.2.8quality management system 3.2.3 quality manual 3.7.4quality objective 3.2.5quality plan 3.7.5quality planning 3.2.9 质量计划quality policy 3.2.4Rrecord 3.7.6 记录regrade 3.6.8release 3.6.13 放行repair 3.6.9requirement 3.1.2review 3.8.7rework 3.6.7 返工Sscrap 3.6.10specification 3.7.3supplier 3.3.6 供应商system 3.2.1 系统Ttechnical expert <audit> 3.9.11 技术出口test 3.8.3 测试top management 3.2.7 高层管理traceability 3.5.4 可塑性Vvalidation 3.8.5verification 3.8.4 验证Wwork environment 3.3.4 工作环境质量管理体系基础和术语 Quality management syst ems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分: GB/T 19001、GB /T 19002和GB/T 19003实施通用指南 Quality manag ement and quality assurance standards－－Part 2: Generic guidelines for the application of GB /T 19001、GB/T 19002 and GB/T 19003质量管理和质量保证标准第3部分: GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南 Qual ity management and quality assurance standards －－Part 3: Guidelines for the application of G B/T 19001 to the development, supply, installat ion and maintenance of computer software质量管理和质量保证标准第4部分:可信性大纲管理指南 Quality management and quality assurance s tandards－－Part 4: Guide to dependability prog ramme management质量管理体系要求 Quality management systems－－Requirements质量管理体系业绩改进指南 Quality management sy stems－－Guidelines for performance improvement s质量管理和质量体系要素第2部分: 服务指南 Quali ty management and quality system elements－－Pa rt 2: Guidelines for services质量管理和质量体系要素第3部分: 流程性材料指南 Quality management and quality system elements －－Guidelines for processed materials质量管理和质量体系要素第4部分: 质量改进指南 Q uality management and quality system elements－－Guidelines for quality improvement质量管理质量计划指南 Quality management－－Gui delines for quality plans质量管理项目管理质量指南 Quality management－－Guidelines to quality in project management质量管理技术状态管理指南 Quality management－－Guidelines for configuration management质量体系审核指南审核 Guidelines for auditing q uality systems－－Part 1: Auditing质量体系审核指南质量体系审核员的评定准则 Guide lines for auditing quality systems－－Part 2: Q ualification criteria for quality systems audit ors质量体系审核指南审核工作管理 Guidelines for au diting quality systems－－Part 3: Management of audit programmes测量设备的质量保证要求第一部分: 测量设备的计量确认体系 Quality assurance requirements for mea suring equipment Part 1: Metrological confirmat ion system for measuring equipment测量设备的质量保证第2部分: 测量过程控制指南 Q uality assurance for measuring equipment－－Par t 2: Guidelines for control of measurement proc esses质量手册编制指南 Guidelines for developing qual ity manuals质量经济性管理指南 Guidelines for managing the economics of quality质量管理培训指南 Quality management－－Guideli nes for training English Chinesereceipt （入厂）接受，验收，进货handling 搬运packaging 包装storage 保存protection 保护comparison 比较identification 标识replacement of identification mark 标识标志更换maintenance of identification 标识的保持records of identification control 标识控制记录tender 标书normative document 标准文件supplemental 补充nonconforming product 不合格品control of nonconforming product 不合格品控制control procedure of nonconforming products 不合格品控制程序tendency of nonconformance 不合格倾向purchasing 采购verification of purchased product 采购的产品验证purchasing process 采购过程purchasing control procedure 采购控制程序purchasing information 采购信息reference standard 参照标准reference instructions 参照细则stockhouse 仓库measurement, analysis and improvement 测量，分析和改进measurement result 测量结果control procedure of monitoring and measuring d evices 测量设备控制程序planning 策划preservation of product 产品保护control procedure for maintenance, replacement and records of product identification 产品标识的保持, 更换和记录控制程序procedure for product identification and tracea bility 产品标识和可追溯性程序conformity of product 产品的符合性monitoring and measurement of product 产品的监督和测量product plan 产品方案control procedure for product preservation 产品防护控制程序method of product release 产品放行方法conformity of product, product conformity 产品符合性product realization 产品实现planning of product realization 产品实现策划product characteristics 产品特性input to product requirements 产品要求的输入product status 产品状态final acceptance of product 产品最后验收procedure 程序program documents 程序文件continual improvement 持续改进procedure for continual improvement of quality management system 持续改进质量体系程序adequacy 充分性storage location 存放地点agency personnel 代理人员submission of tenders 递交标书adjustment 调整，调节statutory and regulatory requirements 法律法规要求rework, vt 返工repair, vt 返修subcontractor 分承包方annex 附录improvement 改进improvement actions 改进措施on-the-job training 岗位技能培训responsibility of individual department and pos t 各部门, 各岗位职责change identification 更改标记change order number 更改单编号process sheets 工艺单process specification 工艺规程procedure(process card) 工艺规程(工艺卡) process characteristics 工艺特性Job Description Format 工种描述单work environment 工作环境impartiality 公正性functional requirements 功能要求supplier 供方supplier evaluation procedure 供方评价程序supplier provided special processes 供方提供的特殊过程verification at supplier's premises 供方现场验证supply chain 供应链criteria for supplier selection, evaluation and re-evaluation 供应商选择、评估和再评估准则communication 沟通customer 顾客customer property 顾客财产control procedure for customer property 顾客财产控制程序customer feedback 顾客反馈Customer Service Contact Form 顾客服务联系表customer communications 顾客沟通customer satisfaction 顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint 顾客投诉identification of customer requirements 顾客要求的识别management review 管理评审records from management review 管理评审记录management review control procedure 管理评审控制程序management representative 管理者代表management responsibility 管理职责specified limits of acceptability 规定的可接受界限specified use 规定的用途process 过程complexity of processes 过程的复杂性monitoring and measurement of processes 过程的监视和测量operation of process 过程的运行status of processes 过程的状态process approach 过程方法process controls 过程控制process control documents 过程控制文件process performance 过程业绩appropriateness 合适性changes to contractor 合同的更改contract review control procedure 合同评审控制程序internet sales 互联网销售environmental conditions 环境条件monogram pragram requirements 会标纲要要求type of activities 活动类型infrastructure 基础建设infrastructure 基础设施fundamentals and vocabulary 基础与词汇control of records 记录控制technical specificaion 技术规范process trace sheet 加工跟踪单monitoring and measurement 监视和测量monitoring and measuring device 监视和测量装置control of monitoring and measuring devices 监视和测量装置控制check method 检查方法frequency of checks 检查频次calibration status 检定状态inspection and test control procedure 检验和试验控制程序identification procedure for inspection and tes t status 检验和试验状态标识程序inspection witness point 检验见证点inspection hold point 检验停止点buildings 建筑物delivery 交付post-delivery activities 交付后的活动delivery activities 交付活动interface 接口acceptance of contract or orders 接受合同或定单type of medium 介质类型experience 经验correction action 纠正措施Corrective action response time 纠正措施答复时间，纠正措施响应时间management procedure for corrective actions 纠正措施管理程序corrective action response times 纠正措施响应时间development activity 开发活动traceability mark 可追溯性标志objectivity 客观性Customer Service Log 客户服务记录簿control feature 控制特性，控制细节control features 控制细则periodic assessment of stock 库存定期评估justification 理由routine 例程，惯例，常规质量职能分配表论证范围internal communication 内部沟通internal audit 内部审核internal audit procedure 内部审核程序internally controlled standard 内控标准internal audit 内审results of internal and external audits 内外部审核结果competence 能力training 培训training needs 培训需要evaluate 评价records of the results of the review 评审结果的记录review output 评审输出review input 评审输入Purchase Requisition 请购单authority 权限validation 确认concession 让步human resources 人力资源job training of personnel 人员岗位培训qualification of personnel 人员资格equipment control procedure 设备控制程序device type 设备类型order of design changes 设计更改通知单design and development control procedure 设计和开发控制程序design and development 设计开发design and development planning 设计开发策划control of design and development changes 设计开发更改控制design and development review 设计开发评审design and development validation 设计开发确认design and development outputs 设计开发输出design and development inputs 设计开发输入design and development verification 设计开发验证design validation 设计确认design documentation 设计文件编制design acceptance criteria 设计验收准则design verification 设计验证audit program 审核大纲conduct of audits 审核行为audit criteria 审核准则production process control 生产过程控制production process control procedure 生产过程控制程序production and service provision 生产和服务提供control of production and service provision 生产和服务提供的控制validation of processes for production and serv ice provision 生产和服务提供过程的确认production order 生产令identification and traceability 识别和可追溯性identification and traceability maintenance and replacement 识别和可追溯性维护与替换invalidate 使失效market survey 市场调研suitability 适宜性scope 适用范围controlled condition 受控状态terms and definitions 术语与定义analysis of data 数据分析sequence 顺序transfer of ownership 所有权转移system document 体系文件statistical technique 统计方法outsource(vt) a process 外包过程external source 外部来源documents of external origin 外来文件outsource, vt 外协unique identification 唯一的标识maintenance 维护Document Change Control 文件更改控制Request For Document Change (RDC) 文件更改需求单control of documents 文件控制documentation requirements 文件要求enquiry 问询，询价field nonconformity analysis 现场不符合分析relevance 相关性interaction 相互作用detail design 详细设计，详图设计，零件设计，施工设计sales department 销售部sales contract 销售合同checklist 校验表，一览表，检查一览表calibration 校准submission of action plans 行动计划的递交documented procedures 形成文件的程序documented statement 形成文件的声明performance requirements 性能要求licensee responsibilities 许可证持有者责任acceptance criteria 验收准则verification arrangement 验证安排verification results 验证结果customer focus 以客户为关注点，以客户为焦点awareness 意识introduction 引言，概述，介绍normative references 引用标准application 应用visit to user 用户访问review of requirements related to the product 有关产品的要求评审competent 有能力的effectiveness 有效性determination of requirements related to the pr oduct 与产品有关的要求的确定customer-related processes 与顾客有关的过程preventive action 预防措施management procedure for preventive actions 预防措施管理程序planned results 预期的结果intended use 预期的用途procedure for competence, knowledge and trainin g of personnel 员工能力, 知识和培训程序personnel training procedure 员工培训程序supporting services 支持性服务functions 职能部门responsibility 职责assignment of responsibility 职责分工workmanship 制造工艺manufacturing acceptance criteria 制造验收准则quality policy 质量方针quality programs 质量纲领quality management system 质量管理体系quality management system planning 质量管理体系策划performance of the quality management system 质量管理体系业绩quality plan 质量计划quality records 质量记录quality objectives 质量目标quality audit 质量审核quality manual 质量手册quality problem handling form 质量问题处理单quality requirements 质量要求allocation table of quality responsibilities 质量职能分配表availability of resources 资源的可获得性resource management 资源管理allocation of resources 资源配置provision of resources 资源提供general requirements 总要求，一般要求constituent part 组成部件organization 组织continual improvement of the organization 组织的持续改进size of organization 组织的规模Organizational Diagram 组织机构图final acceptance 最终验收work instructions 作业指导书11 / 11。
质量手册翻译中英文对照
质量手册翻译中英文术语表3.1.1 质量quality3.1.2 要求requirement3.1.3 等级grade3.1.4 顾客满意customer satisfaction3.1.5 能力capability3.2.1 体系(系统) system3.2.2 管理体系management system3.2.3 质量管理体系quality management system 3.2.4 质量方针quality policy3.2.5 质量目标quality objective3.2.6 管理management3.2.7 最高管理者top management3.2.8 质量管理quality management3.2.9 质量策划quality planning3.2.10 质量控制quality control3.2.11 质量保证quality assurance3.2.12 质量改进quality improvement3.2.13 持续改进continual improvement3.2.14 有效性effectiveness3.2.15 效率efficiency3.3.1 组织organization 3.3.2 组织结构organizational structure 3.3.3 基础设施infrastructure3.3.4 工作环境'77ork environment3.3.5 顾客customer3.3.6 供方supplier3.3.7 相关方interested party3.4.1 过程process3.4.2 产品product3.4.3 项目project3.4.4 设计和开发design and development 3.4.5 程序procedure3.5.1 特性characteristic3.5.2 质量特性quality characteristic3.5.3 可信性dependability3.5.4 可追溯性traceability3.6.1 合格（符合）conformity3.6.2 不合格（不符合）nonconformity 3.6.3 缺陷defect3.6.4 预防措施preventive action3.6.5 纠正措施corrective action3.6.6 纠正correction3.6.7 返工rework3.6.8 降级regrade3.6.9 返修repair3.6.10 报废scrap3.6.11 让步concession3.6.12 偏离许可deviation permit 3.6.13 放行release3.7.1 信息information3.7.2 文件document3.7.3 规范specification3.7.4 质量手册quality manual3.7.5 质量计划quality plan3.7.6 记录record3.8.1 客观证据objective evidence 3.8.3 试验test3.8.4 验证verification3.8.5 确认validation3.8.6 鉴定过程qualification process 3.8.7 评审review3.9.1 审核audit3.9.2 审核方案audit programme 3．9．3 审核准则audit criteria 3．9．4 审核证据audit evidence 3．9．5 审核发现audit findings 3．9．6 审核结论audit conclusion 3．9．7 审核委托方audit client 3．9．8 受审核方auditee 3．9．9 审核员auditor3．9．10 审核组audit team3．9．11 技术专家technical expert 3．9．12 能力competence3.10.1 测量控制体系measurement control syste m3.10.2 测量过程measurement process3.10.3 计量确认metrological confirmation3.10.4 测量设备measuring equipment3.10.5 计量特性metrological characteristic3.10.6 计量职能metrological functionAaudit 3.9.1 审计audit client 3.9.7 客户审计audit conclusion 3.9.6 审计结论audit criteria 3.9.3 审计标准audit evidence 3.9.4 审计证据audit findings 3.9.5audit programme 3.9.2 审计大纲audit team 3.9.10 审计团队auditee 3.9.8auditor 3.9.9Ccapability 3.1.5characteristic 3.5.1 concession 3.6.11 conformity 3.6.1continual improvement 3.2.13 correction 3.6.6corrective action 3.6.5 customer 3.3.5customer satisfaction 3.1.4 competence 3.9.12Ddefect 3.6.3dependability 3.5.3design and development 3.4.4 deviation permit 3.6.12 document 3.7.2Eeffectiveness 3.2.14 efficiency 3.2.15Ggrade 3.1.3Iinformation 3.7.1 infrastructure 3.3.3 inspection 3.8.2 interested party 3.3.7Mmanagement 3.2.6 management system 3.2.2 measurement control system 3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic 3.10.5 metrological confirmation 3.10.3 metrological function 3.10.6Nnonconformity 3.6.2Oobjective evidence 3.8.1 客观证据organization 3.3.1 organizational structure 3.3.2Ppreventive action 3.6.4 procedure 3.4.5process 3.4.1product 3.4.2project 3.4.3Qqualification process 3.8.6quality 3.1.1quality assurance 3.2.11quality characteristic 3.5.2 quality control 3.2.10quality improvement 3.2.12 quality management 3.2.8 quality management system 3.2.3 quality manual 3.7.4quality objective 3.2.5quality plan 3.7.5quality planning 3.2.9 质量计划quality policy 3.2.4Rrecord 3.7.6 记录regrade 3.6.8release 3.6.13 放行repair 3.6.9requirement 3.1.2review 3.8.7rework 3.6.7 返工Sscrap 3.6.10specification 3.7.3supplier 3.3.6 供应商system 3.2.1 系统Ttechnical expert <audit> 3.9.11 技术出口test 3.8.3 测试top management 3.2.7 高层管理traceability 3.5.4 可塑性Vvalidation 3.8.5verification 3.8.4 验证Wwork environment 3.3.4 工作环境质量管理体系基础和术语Quality management s ystems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分: GB/T 19001、G B/T 19002和GB/T 19003实施通用指南Quality management and quality assurance standards －－Part 2: Generic guidelines for the applicati on of GB/T 19001、GB/T 19002 and GB/T 190 03质量管理和质量保证标准第3部分: GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南Q uality management and quality assurance stan dards－－Part 3: Guidelines for the applicationof GB/T 19001 to the development, supply, i nstallation and maintenance of computer soft ware质量管理和质量保证标准第4部分:可信性大纲管理指南Quality management and quality assuranc e standards－－Part 4: Guide to dependability programme management质量管理体系要求Quality management system s－－Requirements质量管理体系业绩改进指南Quality management systems－－Guidelines for performance impro vements质量管理和质量体系要素第2部分: 服务指南Quali ty management and quality system elements－－Part 2: Guidelines for services质量管理和质量体系要素第3部分: 流程性材料指南Quality management and quality system elem ents－－Guidelines for processed materials质量管理和质量体系要素第4部分: 质量改进指南Q uality management and quality system elemen ts－－Guidelines for quality improvement质量管理质量计划指南Quality management－－Guidelines for quality plans质量管理项目管理质量指南Quality management －－Guidelines to quality in project manageme nt质量管理技术状态管理指南Quality management －－Guidelines for configuration management 质量体系审核指南审核Guidelines for auditing q uality systems－－Part 1: Auditing质量体系审核指南质量体系审核员的评定准则Guid elines for auditing quality systems－－Part 2: Qualification criteria for quality systems audito rs质量体系审核指南审核工作管理Guidelines for a uditing quality systems－－Part 3: Managemen t of audit programmes测量设备的质量保证要求第一部分: 测量设备的计量确认体系Quality assurance requirements for m easuring equipment Part 1: Metrological confir mation system for measuring equipment测量设备的质量保证第2部分: 测量过程控制指南Q uality assurance for measuring equipment－－Part 2: Guidelines for control of measurement processes质量手册编制指南Guidelines for developing qu ality manuals质量经济性管理指南Guidelines for managing the economics of quality质量管理培训指南Quality management－－Gui delines for trainingEnglish Chinesereceipt （入厂）接受，验收，进货handling 搬运packaging 包装storage 保存protection 保护comparison 比较identification 标识replacement of identification mark 标识标志更换maintenance of identification 标识的保持records of identification control 标识控制记录tender 标书normative document 标准文件supplemental 补充nonconforming product 不合格品control of nonconforming product 不合格品控制control procedure of nonconforming products不合格品控制程序tendency of nonconformance 不合格倾向purchasing 采购verification of purchased product 采购的产品验证purchasing process 采购过程purchasing control procedure 采购控制程序purchasing information 采购信息reference standard 参照标准reference instructions 参照细则stockhouse 仓库measurement, analysis and improvement 测量，分析和改进measurement result 测量结果control procedure of monitoring and measurin g devices 测量设备控制程序planning 策划preservation of product 产品保护control procedure for maintenance, replaceme nt and records of product identification 产品标识的保持, 更换及记录控制程序procedure for product identification and trace ability 产品标识和可追溯性程序conformity of product 产品的符合性monitoring and measurement of product 产品的监督和测量product plan 产品方案control procedure for product preservation 产品防护控制程序method of product release 产品放行方法conformity of product, product conformity 产品符合性product realization 产品实现planning of product realization 产品实现策划product characteristics 产品特性input to product requirements 产品要求的输入product status 产品状态final acceptance of product 产品最后验收procedure 程序program documents 程序文件continual improvement 持续改进procedure for continual improvement of qualit y management system 持续改进质量体系程序adequacy 充分性storage location 存放地点agency personnel 代理人员submission of tenders 递交标书adjustment 调整，调节statutory and regulatory requirements 法律法规要求rework, vt 返工repair, vt 返修subcontractor 分承包方annex 附录improvement 改进improvement actions 改进措施on-the-job training 岗位技能培训responsibility of individual department and po st 各部门, 各岗位职责change identification 更改标记change order number 更改单编号process sheets 工艺单process specification 工艺规程procedure(process card) 工艺规程(工艺卡) process characteristics 工艺特性Job Description Format 工种描述单work environment 工作环境impartiality 公正性functional requirements 功能要求supplier 供方supplier evaluation procedure 供方评价程序supplier provided special processes 供方提供的特殊过程verification at supplier's premises 供方现场验证supply chain 供应链criteria for supplier selection, evaluation and r e-evaluation 供应商选择、评估和再评估准则communication 沟通customer 顾客customer property 顾客财产control procedure for customer property 顾客财产控制程序customer feedback 顾客反馈Customer Service Contact Form 顾客服务联系表customer communications 顾客沟通customer satisfaction 顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint 顾客投诉identification of customer requirements 顾客要求的识别management review 管理评审records from management review 管理评审记录management review control procedure 管理评审控制程序management representative 管理者代表management responsibility 管理职责specified limits of acceptability 规定的可接受界限specified use 规定的用途process 过程complexity of processes 过程的复杂性monitoring and measurement of processes 过程的监视和测量operation of process 过程的运行status of processes 过程的状态process approach 过程方法process controls 过程控制process control documents 过程控制文件process performance 过程业绩appropriateness 合适性changes to contractor 合同的更改contract review control procedure 合同评审控制程序internet sales 互联网销售environmental conditions 环境条件monogram pragram requirements 会标纲要要求type of activities 活动类型infrastructure 基础建设infrastructure 基础设施fundamentals and vocabulary 基础与词汇control of records 记录控制technical specificaion 技术规范process trace sheet 加工跟踪单monitoring and measurement 监视和测量monitoring and measuring device 监视和测量装置control of monitoring and measuring devices 监视和测量装置控制check method 检查方法frequency of checks 检查频次calibration status 检定状态inspection and test control procedure 检验和试验控制程序identification procedure for inspection and tes t status 检验和试验状态标识程序inspection witness point 检验见证点inspection hold point 检验停止点buildings 建筑物delivery 交付post-delivery activities 交付后的活动delivery activities 交付活动interface 接口acceptance of contract or orders 接受合同或定单type of medium 介质类型experience 经验correction action 纠正措施Corrective action response time 纠正措施答复时间，纠正措施响应时间management procedure for corrective actions 纠正措施管理程序corrective action response times 纠正措施响应时间development activity 开发活动traceability mark 可追溯性标志objectivity 客观性Customer Service Log 客户服务记录簿control feature 控制特性，控制细节control features 控制细则periodic assessment of stock 库存定期评估justification 理由routine 例程，惯例，常规质量职能分配表论证范围internal communication 内部沟通internal audit 内部审核internal audit procedure 内部审核程序internally controlled standard 内控标准internal audit 内审results of internal and external audits 内外部审核结果competence 能力training 培训training needs 培训需要evaluate 评价records of the results of the review 评审结果的记录review output 评审输出review input 评审输入Purchase Requisition 请购单authority 权限validation 确认concession 让步human resources 人力资源job training of personnel 人员岗位培训qualification of personnel 人员资格equipment control procedure 设备控制程序device type 设备类型order of design changes 设计更改通知单design and development control procedure 设计和开发控制程序design and development 设计开发design and development planning 设计开发策划control of design and development changes 设计开发更改控制design and development review 设计开发评审design and development validation 设计开发确认design and development outputs 设计开发输出design and development inputs 设计开发输入design and development verification 设计开发验证design validation 设计确认design documentation 设计文件编制design acceptance criteria 设计验收准则design verification 设计验证audit program 审核大纲conduct of audits 审核行为audit criteria 审核准则production process control 生产过程控制production process control procedure 生产过程控制程序production and service provision 生产和服务提供control of production and service provision 生产和服务提供的控制validation of processes for production and ser vice provision 生产和服务提供过程的确认production order 生产令identification and traceability 识别和可追溯性identification and traceability maintenance and replacement 识别和可追溯性维护与替换invalidate 使失效market survey 市场调研suitability 适宜性scope 适用范围controlled condition 受控状态terms and definitions 术语与定义analysis of data 数据分析sequence 顺序transfer of ownership 所有权转移system document 体系文件statistical technique 统计方法outsource(vt) a process 外包过程external source 外部来源documents of external origin 外来文件outsource, vt 外协unique identification 唯一的标识maintenance 维护Document Change Control 文件更改控制Request For Document Change (RDC) 文件更改需求单control of documents 文件控制documentation requirements 文件要求enquiry 问询，询价field nonconformity analysis 现场不符合分析relevance 相关性interaction 相互作用detail design 详细设计，详图设计，零件设计，施工设计sales department 销售部sales contract 销售合同checklist 校验表，一览表，检查一览表calibration 校准submission of action plans 行动计划的递交documented procedures 形成文件的程序documented statement 形成文件的声明performance requirements 性能要求licensee responsibilities 许可证持有者责任acceptance criteria 验收准则verification arrangement 验证安排verification results 验证结果customer focus 以客户为关注点，以客户为焦点awareness 意识introduction 引言，概述，介绍normative references 引用标准application 应用visit to user 用户访问review of requirements related to the product 有关产品的要求评审competent 有能力的effectiveness 有效性determination of requirements related to the product 与产品有关的要求的确定customer-related processes 与顾客有关的过程preventive action 预防措施management procedure for preventive actions 预防措施管理程序planned results 预期的结果intended use 预期的用途procedure for competence, knowledge and tra ining of personnel 员工能力, 知识和培训程序personnel training procedure 员工培训程序supporting services 支持性服务functions 职能部门responsibility 职责assignment of responsibility 职责分工workmanship 制造工艺manufacturing acceptance criteria 制造验收准则quality policy 质量方针quality programs 质量纲领quality management system 质量管理体系quality management system planning 质量管理体系策划performance of the quality management syste m 质量管理体系业绩quality plan 质量计划quality records 质量记录quality objectives 质量目标quality audit 质量审核quality manual 质量手册quality problem handling form 质量问题处理单quality requirements 质量要求allocation table of quality responsibilities 质量职能分配表availability of resources 资源的可获得性resource management 资源管理allocation of resources 资源配置provision of resources 资源提供general requirements 总要求，一般要求constituent part 组成部件organization 组织continual improvement of the organization 组织的持续改进size of organization 组织的规模Organizational Diagram 组织机构图final acceptance 最终验收work instructions 作业指导书。
ISO 9001质量手册英文版(ISO 9001 Quality Manual)
ISO 9001：2000 QUALITY MANUALWOLSTENHOLME INTERNATIONAL LIMITEDCONTENTS1.0 Scope of the Quality Management System at Wolstenholme International Limited 1。
1 Statement of Quality Policy2。
0 Quality Management System Documented Procedures2.1 Document Control2。
2 Control of Quality Records2.3 Internal Quality Audits2。
4 Control of Nonconforming Product2.5 Corrective Action2.6 Preventative Action3.0 Quality Management System Processes and Interrelations3。
1 Organisation Charts3.2 Responsibilities3.3 Interrelation of Processes3.4 Processes1。
0 Scope of the Quality Management System at Wolstenholme International LimitedWolstenholme International Limited is a Company with a long—standing successful history of supplying metal powders, pastes， pellets， varnish, offset ink， flexography ink and other related products for use in a large range of applications, on a worldwide basis. The scope of the Quality Management System encompasses all activities on the Darwen Site.The Metallic Powders Operation at Darwen is responsible for the manufacture and supply of metal powders and pigments mainly in aluminium， copper and brass (bronze） based alloys， for use in printing, inks， plastics and other industrial and engineering applications.The Ink Operation at Darwen is responsible for the manufacture of a wide range and type of printing ink, 'one—pack' gold ink, varnish and related printing products。
质量手册翻译中英文对照解析
质量手册翻译中英文术语表Sscrap 3.6.10specification 3.7.3supplier 3.3.6供应商system 3.2.1系统Ttechnical expert <audit> 3.9.11 技术出口test 3.8.3测试top management 3.2.7 高层管理traceability3.5.4可塑性Vvalidation3.8.5verification3.8.4验证Wwork environment 3.3.4 工作环境质量管理体系基础和术语Quality management syst ems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分:GB/T 19001、GB /T 19002和GB/T 19003实施通用指南 Quality mana gement and quality assurance standards－－Part 2: Generic guidelines for the application of GB /T 19001、GB/T 19002 and GB/T19003质量管理和质量保证标准第3部分:GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南Quality management and quality assurance standardresponsibility职责assignment of responsibility 职责分工workmanship制造工艺manufacturing acceptance criteria 制造验收准则quality policy质量方针quality programs质量纲领quality management system 质量管理体系quality management system planning 质量管理体系策划performance of the quality management system 质量管理体系业绩quality plan质量计划quality records质量记录quality objectives质量目标quality audit质量审核quality manual质量手册quality problem handling form 质量问题处理单quality requirements 质量要求allocation table of quality responsibilities质量职能分配表availability of resources 资源的可获得性resource management 资源管理allocation of resources 资源配置provision of resources 资源提供general requirements 总要求，一般要求constituent part组成部件organization组织continual improvement of the organization 组织的持续改进size of organization 组织的规模Organizational Diagram 组织机构图final acceptance最终验收work instructions作业指导书。
质量手册(中英双语)
Quality ManagementManual质量管理手册Manual number: HZ/QM—2018手册编号：HZ/QM—2018Version number: A/0版本号：A/0Controlled state:受控状态：Issuing No.: 01分发号：01Released on January 18, 2018 Implemented on January 18, 2018 2018年1月18日发布2018年4月18日实施HZ INDUSTRIAL.CO (PRIVATE) LIMITED Release 恒泽建材有限公司发布Chapter：0.1 File No. HZ/QM—2018 章节：01 文件编号：HZ/QM—2018 Title：Editorial staff题目：编审人员Prepared by编写人：Reviewed by审核人：Approved by批准人：Chapter: 0.2 File No. HZ/QM—2018章节：0.2文件编号：HZ/QM—2018 Title : Modification and Registration题目：修改登记Chapter: 03 File No. HZ/QM—2018 章节：0.3文件编号：HZ/QM—2018 Title: Contents题目：目录章节号标题名称Chapter No. Title0.1 Editorial staff编审人员0.2 Modification and Registration修改登记0.3 Contents目录0.4 Approval批准页0.5 Quality Manual Description质量手册说明0.6 Quality policy and Objective质量方针和目标1.0 Management Representative Appointment管理者代表任命书2.0 Company Profile企业简介3.0 Organization Chart组织结构图3.1 Quality Control Function Distribution Table质量职能分配表3.2 Scope, Criteria, Terminology and Definitions范围、引用标准、术语和定义4.0 Quality Management System质量管理体系4.1General Requirements总要求4.2Document Requirements文件要求4.2.1 General Principles总则4.2.2 Quality Manual质量手册4.2.3 Document Control Procedure文件控制程序4.2.4 Record Control Procedure记录控制程序5.0 Management Activities管理活动5.1 Management Commitment管理承诺5.2 Customer Focus以顾客为关注焦点5.3 Quality Policy质量方针5.4 Planning策划5.4.1 Quality Management Objective质量管理目标5.4.2 Quality Management System Planning质量管理体系策划5.5 Responsibilities, Authority and Communication职责、权限与沟通5.5.1 Responsibility and Authority职责和权限5.5.2 Management Representative管理者代表5.5.3 Internal Communication内部沟通6.0 Product Realization产品实现6.1 Planning Control Procedures of Product Realization产品实现的策划控制程序6.2 Process Control Procedures Related to the Customer与顾客有关的过程控制程序6.4 Procurement Control Procedure采购控制程序6.5 Control Procedures of Production and ServiceProvision生产和服务提供的控制程序6.6 Control Procedures of Monitoring and MeasuringEquipment监视和测量设备的控制程序7.0 Measure, Analysis and Planning of Improvement测量、分析和改进7.1 General Principles总则7.2 Monitoring and Measure监视和测量7.2.1 Customer Satisfaction Degree顾客满意7.2.2 Control Procedures of Internal Audit内部审核控制程序7.2.3 Process Monitoring and Measure过程的监视和测量7.2.4 Control Procedures of Product Monitoring andMeasurement产品的监视和测量控制程序7.3 Control Procedures of Nonconforming Product不合格品控制程序7.4 Data Analysis Control Procedure数据分析控制程序7.5 Improvement改进7.5.1 Continual Improvement持续改进Chapter: 04 File No. HZ/QM—2018章节：0.4文件编号：HZ/QM—2018 Title: Approval题目：批准页In order to standardize quality management activities, improve corporate management, enhance market competitiveness, ensure customer satisfaction, and continuously enhance customer satisfaction, and promote the company's economic efficiency and sustainable development, the company decided to establish, implement and continuously improve the quality management system in accordance with the series of ISO standards.为规范质量管理活动，提高企业管理水平，增强市场竞争能力，确保满足顾客需求，并不断增强顾客满意，促进公司经济效益的提高和持续发展，公司决定依据ISO9000族标准，建立、实施并持续改进质量管理体系。
质量手册翻译中英文术语表
质量手册翻译中英文术语表质量 quality要求 requirement等级 grade顾客满意 customer satisfaction能力 capability体系(系统) system管理体系 management system质量管理体系 quality management system质量方针 quality policy质量目标 quality objective管理 management最高管理者 top management质量管理 quality management质量策划 quality planning组织 organization组织结构 organizational structure基础设施 infrastructure工作环境 '77ork environment顾客 customer供方 supplier相关方 interested party过程 process产品 product项目 project设计和开发 design and development 程序 procedure特性 characteristic质量特性 quality characteristic 可信性 dependability可追溯性 traceability合格（符合） conformity不合格（不符合） nonconformity缺陷 defect预防措施 preventive action纠正措施 corrective action纠正 correction返工 rework降级 regrade返修 repair信息 information文件 document规范 specification质量手册 quality manual质量计划 quality plan记录 record客观证据 objective evidence试验 test验证 verification确认 validation鉴定过程 qualification process评审 review审核 audit审核方案 audit programme3． 9．3 审核准则audit criteria 3．9．4 审核证据 audit evidence 3．9．5 审核发现 audit findings 3．9．6 审核结论 audit conclusion 3．9．7 审核委托方 audit client 3． 9．8 受审核方 auditee3．9．9 审核员 auditor3．9．10 审核组 audit team 3．9．11 技术专家 technical expert3．9．12 能力 competence测量控制体系 measurement control system 测量过程 measurement process计量确认 metrological confirmation测量设备 measuring equipment计量特性metrological characteristic计量职能 metrological functionAauditaudit clientaudit conclusionaudit criteriaaudit evidenceaudit findingsaudit programmeauditeeauditorCcapabilitycharacteristicconformitycorrectioncorrective action customercustomer satisfactionDdefectdependabilitydesign and developmentdocumentEGgradeIinformationinfrastructureinspectioninterested partyMmanagementmanagement system measurement control system measurement processmeasuring equipment metrological characteristic metrological confirmation metrological functionNnonconformityOobjective evidence organizationorganizational structurePpreventive action procedureprocessproductprojectQqualification process qualityquality characteristicquality managementquality management systemquality manual quality objective quality plan quality planning quality policyRrecordregraderepair requirement reviewreworkSspecification suppliersystemTtesttop management traceabilityVvalidationverificationWwork environment质量管理体系基础和术语 Quality management systems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分: GB/T 19001、GB/T 19002和GB/T 19003实施通用指南 Quality management and quality assurance standards－－Part 2: Generic guidelines for the applica tion of GB/T 19001、GB/T 19002 and GB/T 19003质量管理和质量保证标准第3部分: GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南 Quality management and quality assurance standards－－Part 3: Guidelines for the applic ation of GB/T 19001 to the development, supply, installation and maintenance of computer software质量管理和质量保证标准第4部分:可信性大纲管理指南 Quality management and quality assuran ce standards－－Part 4: Guide to dependability programme management质量管理体系要求 Quality management systems－－Requirements质量管理体系业绩改进指南 Quality management systems－－Guidelines for performance impro vements质量管理和质量体系要素第2部分: 服务指南 Quality management and quality system elements －－Part 2: Guidelines for services质量管理和质量体系要素第3部分: 流程性材料指南 Quality management and quality system ele ments－－Guidelines for processed materials质量管理和质量体系要素第4部分: 质量改进指南 Quality management and quality system eleme nts－－Guidelines for quality improvement质量管理质量计划指南 Quality management－－Guidelines for quality plans质量管理项目管理质量指南 Quality management－－Guidelines to quality in project managem ent质量管理技术状态管理指南 Quality management－－Guidelines for configuration management 质量体系审核指南审核 Guidelines for auditing quality systems－－Part 1: Auditing质量体系审核指南质量体系审核员的评定准则 Guidelines for auditing quality systems－－Par t 2: Qualification criteria for quality systems auditors质量体系审核指南审核工作管理 Guidelines for auditing quality systems－－Part 3: Managem ent of audit programmes测量设备的质量保证要求第一部分: 测量设备的计量确认体系 Quality assurance requirements f or measuring equipment Part 1: Metrological confirmation system for measuring equipment 测量设备的质量保证第2部分: 测量过程控制指南 Quality assurance for measuring equipment－－Part 2: Guidelines for control of measurement processes质量手册编制指南 Guidelines for developing quality manuals质量经济性管理指南 Guidelines for managing the economics of quality质量管理培训指南 Quality management－－Guidelines for training？？English Chinesereceipt （入厂）接受，验收，进货handling 搬运packaging 包装storage 保存protection 保护comparison 比较identification 标识replacement of identification mark 标识标志更换maintenance of identification 标识的保持records of identification control 标识控制记录tender 标书normative document 标准文件supplemental 补充nonconforming product 不合格品control of nonconforming product 不合格品控制control procedure of nonconforming products 不合格品控制程序tendency of nonconformance 不合格倾向purchasing 采购verification of purchased product 采购的产品验证purchasing process 采购过程purchasing control procedure 采购控制程序purchasing information 采购信息reference standard 参照标准reference instructions 参照细则stockhouse 仓库measurement, analysis and improvement 测量，分析和改进measurement result 测量结果control procedure of monitoring and measuring devices 测量设备控制程序planning 策划preservation of product 产品保护control procedure for maintenance, replacement and records of product identification 产品标识的保持, 更换及记录控制程序procedure for product identification and traceability 产品标识和可追溯性程序conformity of product 产品的符合性monitoring and measurement of product 产品的监督和测量product plan 产品方案control procedure for product preservation 产品防护控制程序method of product release 产品放行方法conformity of product, product conformity 产品符合性product realization 产品实现planning of product realization 产品实现策划product characteristics 产品特性input to product requirements 产品要求的输入product status 产品状态final acceptance of product 产品最后验收procedure 程序program documents 程序文件continual improvement 持续改进procedure for continual improvement of quality management system 持续改进质量体系程序adequacy 充分性storage location 存放地点agency personnel 代理人员submission of tenders 递交标书adjustment 调整，调节statutory and regulatory requirements 法律法规要求rework, vt 返工repair, vt 返修subcontractor 分承包方annex 附录improvement 改进improvement actions 改进措施on-the-job training 岗位技能培训responsibility of individual department and post 各部门, 各岗位职责change identification 更改标记change order number 更改单编号process sheets 工艺单process specification 工艺规程procedure(process card) 工艺规程(工艺卡)process characteristics 工艺特性Job Description Format 工种描述单work environment 工作环境impartiality 公正性functional requirements 功能要求supplier 供方supplier evaluation procedure 供方评价程序supplier provided special processes 供方提供的特殊过程verification at supplier's premises 供方现场验证supply chain 供应链criteria for supplier selection, evaluation and re-evaluation 供应商选择、评估和再评估准则communication 沟通customer 顾客customer property 顾客财产control procedure for customer property 顾客财产控制程序customer feedback 顾客反馈Customer Service Contact Form 顾客服务联系表customer communications 顾客沟通customer satisfaction 顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint 顾客投诉identification of customer requirements 顾客要求的识别management review 管理评审records from management review 管理评审记录management review control procedure 管理评审控制程序management representative 管理者代表management responsibility 管理职责specified limits of acceptability 规定的可接受界限specified use 规定的用途process 过程complexity of processes 过程的复杂性monitoring and measurement of processes 过程的监视和测量operation of process 过程的运行status of processes 过程的状态process approach 过程方法process controls 过程控制process control documents 过程控制文件process performance 过程业绩appropriateness 合适性changes to contractor 合同的更改contract review control procedure 合同评审控制程序internet sales 互联网销售environmental conditions 环境条件monogram pragram requirements 会标纲要要求type of activities 活动类型infrastructure 基础建设infrastructure 基础设施fundamentals and vocabulary 基础与词汇control of records 记录控制technical specificaion 技术规范process trace sheet 加工跟踪单monitoring and measurement 监视和测量monitoring and measuring device 监视和测量装置control of monitoring and measuring devices 监视和测量装置控制check method 检查方法frequency of checks 检查频次calibration status 检定状态inspection and test control procedure 检验和试验控制程序identification procedure for inspection and test status 检验和试验状态标识程序inspection witness point 检验见证点inspection hold point 检验停止点buildings 建筑物delivery 交付post-delivery activities 交付后的活动delivery activities 交付活动interface 接口acceptance of contract or orders 接受合同或定单type of medium 介质类型experience 经验correction action 纠正措施Corrective action response time 纠正措施答复时间，纠正措施响应时间management procedure for corrective actions 纠正措施管理程序corrective action response times 纠正措施响应时间development activity 开发活动traceability mark 可追溯性标志objectivity 客观性Customer Service Log 客户服务记录簿control feature 控制特性，控制细节control features 控制细则periodic assessment of stock 库存定期评估justification 理由routine 例程，惯例，常规质量职能分配表论证范围internal communication 内部沟通internal audit 内部审核internal audit procedure 内部审核程序internally controlled standard 内控标准internal audit 内审results of internal and external audits 内外部审核结果competence 能力training 培训training needs 培训需要evaluate 评价records of the results of the review 评审结果的记录review output 评审输出review input 评审输入Purchase Requisition 请购单authority 权限validation 确认concession 让步human resources 人力资源job training of personnel 人员岗位培训qualification of personnel 人员资格equipment control procedure 设备控制程序device type 设备类型order of design changes 设计更改通知单design and development control procedure 设计和开发控制程序design and development 设计开发design and development planning 设计开发策划control of design and development changes 设计开发更改控制design and development review 设计开发评审design and development validation 设计开发确认design and development outputs 设计开发输出design and development inputs 设计开发输入design and development verification 设计开发验证design validation 设计确认design documentation 设计文件编制design acceptance criteria 设计验收准则design verification 设计验证audit program 审核大纲conduct of audits 审核行为audit criteria 审核准则production process control 生产过程控制production process control procedure 生产过程控制程序production and service provision 生产和服务提供control of production and service provision 生产和服务提供的控制validation of processes for production and service provision 生产和服务提供过程的确认production order 生产令identification and traceability 识别和可追溯性identification and traceability maintenance and replacement 识别和可追溯性维护与替换invalidate 使失效market survey 市场调研suitability 适宜性scope 适用范围controlled condition 受控状态terms and definitions 术语与定义analysis of data 数据分析sequence 顺序transfer of ownership 所有权转移system document 体系文件statistical technique 统计方法outsource(vt) a process 外包过程external source 外部来源documents of external origin 外来文件outsource, vt 外协unique identification 唯一的标识maintenance 维护Document Change Control 文件更改控制Request For Document Change (RDC) 文件更改需求单control of documents 文件控制documentation requirements 文件要求enquiry 问询，询价field nonconformity analysis 现场不符合分析relevance 相关性interaction 相互作用detail design 详细设计，详图设计，零件设计，施工设计sales department 销售部sales contract 销售合同checklist 校验表，一览表，检查一览表calibration 校准submission of action plans 行动计划的递交documented procedures 形成文件的程序documented statement 形成文件的声明performance requirements 性能要求licensee responsibilities 许可证持有者责任acceptance criteria 验收准则verification arrangement 验证安排verification results 验证结果customer focus 以客户为关注点，以客户为焦点awareness 意识introduction 引言，概述，介绍normative references 引用标准application 应用visit to user 用户访问review of requirements related to the product 有关产品的要求评审competent 有能力的effectiveness 有效性determination of requirements related to the product 与产品有关的要求的确定customer-related processes 与顾客有关的过程preventive action 预防措施management procedure for preventive actions 预防措施管理程序planned results 预期的结果intended use 预期的用途procedure for competence, knowledge and training of personnel 员工能力, 知识和培训程序personnel training procedure 员工培训程序supporting services 支持性服务functions 职能部门responsibility 职责assignment of responsibility 职责分工workmanship 制造工艺。
ISO9001质量手册英文版
ISO9001质量手册英文版WOLSTENHOLME INTERNATIONAL LIMITEDCONTENTS1.0 Scope of the Quality Management System at Wolstenholme Internatio nal Limited1.1 Statement of Quality Policy2.0 Quality Management System Documented Procedures2.1 Document Control2.2 Control of Quality Records2.3 Internal Quality Audits2.4 Control of Nonconforming Product2.5 Corrective Action2.6 Preventative Action3.0 Quality Management System Processes and Interrelations 3.1 Organisation Charts3.2 Responsibilities3.3 Interrelation of Processes3.4 Processes1.0 Scope of the Quality Management System at Wolstenholme International LimitedWolstenholme International Limited is a Company with a long-standing succe ssful history of supplying metal powders, pastes, pellets, varnish, offset ink, flexog raphy ink and other related products for use in a large range of applications, on a w orldwide basis. The scope of the Quality Management System encompasses all acti vities on the Darwen Site.The Metallic Powders Operation at Darwen is responsible for the manufacture and supply of metal powders and pigments mainly in aluminium, copper and brass (bronze) based alloys, for use in printing, inks, plastics and other industrial and eng ineering applications.The Ink Operation at Darwen is responsible for the manufacture of a wide ran ge and type of printing ink, 'one-pack' gold ink, varnish and related printing produc ts.All production processes at Darwen are validated before leaving the site and a s such sub-clause 7.5.2 is excluded.The overall operation at Darwen is controlled by the Ink & Print business unit and the Industrial business unit.Technical Service and Research and Development are vital to the future devel opment of the Company, together with understanding and developing new products and applications for our customers.The manufacturing, technical and administration functions of the Company ar e based in Darwen, Lancashire, England and employ some 210 staff at that locatio n.Through the application of Quality Management Systems and Company wide t raining programmes, Wolstenholme International Ltd. is committed to ensuring con tinuous improvements to both its processes and product technology.WOLSTENHOLME INTERNATIONAL LTD.QUALITY POLICYWolstenholme International Limited is committed to the provision of customer satisfaction. Quality in everything we do is the central ingredient in the above com mitment. Our commitment goes beyond maintaining a quality system which fully c omplies with the requirements of BS-EN-ISO 9001. We are committed to achievin g, maintaining and improving overall organisational performance and capabilities b y the application of the principles outlined in BS-EN-ISO 9004:2000We will maintain and continuously improve our quality management system b y the setting of measurable quality objectives throughout the organisation and vigo rous internal audits. We will review our performance at regular management review s. Additional inputs to these reviews will also include customer feedback, process p erformance and product conformance. The prime output of the review will be to ens ure continuing customer satisfaction and improvement of products.As part of this commitment we will identify and meet the training needs of our employees, so ensuring that the needs of our customers are met. This Policy will b e made available throughout our organisation to ensure that the commitment to our customers is clear and widely understood.Chris Ravenscroft Managing DirectorControl of Quality RecordsAll quality records will be maintained and controlled. The records will be legi ble and stored in such a manner as to protect them from damage, loss and deteriorat ion. Quality records will also be stored and clearly located in such a manner as to fa cilitate easy retrieval of information.REF: Control of Quality/ Environmental Records - WIQSP.22.3 Internal Quality AuditsInternal audits will be carried out in accordance with Company procedures and will be conducted for any of the following reasons:-(i) On a scheduled basis.(ii)2.5 Corrective Actiontomers have cause to complain or following in-progress/ final inspection. Correctiv e action requests may also be raised in an effort to improve current working practis es. Corrective actions and customer complaints will be reviewed at Management R eview Meetings.When non-conforming products or services are identified, the root cause of the problem will be investigated, corrective action taken and preventative measures ini tiated to preclude a recurrence.REF: Corrective Action - WIQSP.52.6 Preventative ActionCorrective action is taken as a result of Product or process nonconformity. It is hence a reactive measure and does not necessarily prevent further non conformancThe SARA Manager (MR) has the primary responsibility to structure the qual ity system which will involve all sections and also to ensure compliance with all qu ality system requirements.Specifically, the Management Representative is involved in areas such as:-- Drafting the policy on quality assurance of the Company along with th e Operations Director.- Setting the quality management objectives of the Company.- Reporting on the performance of the Quality System at Management Review Meetings.- Determining and reporting the principle causes of quality system non-c onformances.- Monitoring the quality system to determine where improvements are needed and monitoring the necessary corrective action.- Maintain contact with the external Registration Body on matters relating to t he operation of the Quality System.SARA Manager is responsible to the Operations Director for the upkeep and maintenance of all the ISO Systems and the Company Health and Safety Policy. Th e SARA Manager is also responsible for driving the E,H&S policies within the Co mpany.Technical DirectorsThe Technical Directors for pigments and inks are responsible to the Managin g Director .. and ink and print Director respectively for ensuring that processes and equipment are designed and developed such that product of the highest attainable q uality is produced consistently and efficiently.Human Resources and Administration ManagerThe Human Resources and Administration Manager reports to the Managing Director and is responsible for managing all aspects of the personnel function, whic h includes the facilitating, co-ordinating, recording personnel issues and training, w ithin Wolstenholme International Ltd.Ink Manufacturing ManagerThe Ink Manufacturing Manager is responsible to the Operations Director for t he control of stocks, manpower and the process necessary to produce products to th e correct specification within a given time.Sales DirectorsThe Sales Directors are responsible to the Managing Director for ensuring that customers' requirements for the sale of printing/ industrial powders, pastes, pellets, inks, varnishes and related Company products are taken, reviewed and dealt with e fficiently.UK Financial Controller and Purchasing Manager.The UK Financial Controller & Purchasing Manager is responsible to the Fina ncial Director for the effective control and reporting of manufacturing costs incurre d by the manufacturing facility at the Darwen site.There is also a responsibility to the Financial Director for the effective and eco nomic procurement of raw materials and consumables used in the business of the C ompany.Research and Development ManagersResearch and Development Managers are responsible to Technical Directors f or managing Research and Development projects, maintaining customer contact du ring the project development stages and the general running of research laboratorie s.Bronze Manufacturing Manager / Offset Ink R&D ManagerThe Bronze Manufacturing Manager and Offset Ink R&D Manager (ink operat ions) are responsible to the Technical Directors for the agreement of specifications with the customer, and ensuring that there is a facility to continuously monitor and i nspect the product to ensure that all such requirements are met.Customer Services ManagerThe Customer Services Manager is responsible to the Operations Director for t he operation of Customer Services together with a team of administrators.Production Supervision。
质量手册英文版
5-1 5-2 5-3 5-6 5-8
LG(71) 공통 005 A4 모 (950301)
L G 전 자
VACUUM CLEANER Div
LG(71)-A-1501
Revised :
PAGE :
3
Contents
Section 6. Monitoring and Measurement of Processes Internal Audit Monitoring and Measurement of Process Measurement and Monitoring of Product Control of Nonconformity Product Data Analysis Improvement and Preventive Action 7. Addendum Addendum 7-1 6-1 6-3 6-4 6-7 6-8 6-9 Page Rev. No Rev. Date Remarks
LG(71) 공통 005 A4 모 (950301)
L G 전 자
VACUUM CLEANER division
LG(71)-A-1502
Revised :
PAGE : 4
Environmental Management/Quality Assurance Manual Ⅰ General 1.1 Scope and Purpose Quality Assurance manual is a standard that describes systematically the quality policy being observed by the Vacuum Cleaner division and basic matters related to quality and environment. It establishes and implements a system to prevent defects in advance, through quality assurance activity. This manual has Korean version and English version. This manual applies to all activities related to quality at all stages from design/development of Vacuum Cleaner division product through to servicing. And, all the activity related to environmental management shall be controlled by the description of the Environmental management manual (LG(69)-A-2001). The application purpose of this manual is to manage more efficiently and systematically the quality system applied in order to prevent the quality defects of products being produced in Vacuum Cleaner division in advance, and to meet customer requirements. This manual consists of 7 requirements from Quality Management through to Measurement, analysis and improvement in accordance with international standard ISO 9000 with updated 2002 Version. Among products being produced in the Vacuum Cleaner division the products approved by ISO-9000 from UL Korea are Vacuum Cleaner . Hence, other products shall be excluded from the range of the approval. This manual shall be controlled as described in Standard control procedures (LG(71)-A-2503), and when any difference exists between Korean version and English version, Korean version has higher priority.
质量手册(中英双语)
Quality ManagementManual质量管理手册Manual number: HZ/QM—2018手册编号：HZ/QM—2018Version number: A/0版本号：A/0Controlled state:受控状态：Issuing No.: 01分发号：01Released on January 18, 2018 Implemented on January 18, 2018 2018年1月18日发布2018年4月18日实施HZ INDUSTRIAL.CO (PRIVATE) LIMITED Release 恒泽建材有限公司发布Chapter：0.1 File No. HZ/QM—2018 章节：01 文件编号：HZ/QM—2018 Title：Editorial staff题目：编审人员Prepared by编写人：Reviewed by审核人：Approved by批准人：Chapter: 0.2 File No. HZ/QM—2018章节：0.2文件编号：HZ/QM—2018 Title : Modification and Registration题目：修改登记Chapter: 03 File No. HZ/QM—2018 章节：0.3文件编号：HZ/QM—2018 Title: Contents题目：目录章节号标题名称Chapter No. Title0.1 Editorial staff编审人员0.2 Modification and Registration修改登记0.3 Contents目录0.4 Approval批准页0.5 Quality Manual Description质量手册说明0.6 Quality policy and Objective质量方针和目标1.0 Management Representative Appointment管理者代表任命书2.0 Company Profile企业简介3.0 Organization Chart组织结构图3.1 Quality Control Function Distribution Table质量职能分配表3.2 Scope, Criteria, Terminology and Definitions范围、引用标准、术语和定义4.0 Quality Management System质量管理体系4.1General Requirements总要求4.2Document Requirements文件要求4.2.1 General Principles总则4.2.2 Quality Manual质量手册4.2.3 Document Control Procedure文件控制程序4.2.4 Record Control Procedure记录控制程序5.0 Management Activities管理活动5.1 Management Commitment管理承诺5.2 Customer Focus以顾客为关注焦点5.3 Quality Policy质量方针5.4 Planning策划5.4.1 Quality Management Objective质量管理目标5.4.2 Quality Management System Planning质量管理体系策划5.5 Responsibilities, Authority and Communication职责、权限与沟通5.5.1 Responsibility and Authority职责和权限5.5.2 Management Representative管理者代表5.5.3 Internal Communication内部沟通6.0 Product Realization产品实现6.1 Planning Control Procedures of Product Realization产品实现的策划控制程序6.2 Process Control Procedures Related to the Customer与顾客有关的过程控制程序6.4 Procurement Control Procedure采购控制程序6.5 Control Procedures of Production and ServiceProvision生产和服务提供的控制程序6.6 Control Procedures of Monitoring and MeasuringEquipment监视和测量设备的控制程序7.0 Measure, Analysis and Planning of Improvement测量、分析和改进7.1 General Principles总则7.2 Monitoring and Measure监视和测量7.2.1 Customer Satisfaction Degree顾客满意7.2.2 Control Procedures of Internal Audit内部审核控制程序7.2.3 Process Monitoring and Measure过程的监视和测量7.2.4 Control Procedures of Product Monitoring andMeasurement产品的监视和测量控制程序7.3 Control Procedures of Nonconforming Product不合格品控制程序7.4 Data Analysis Control Procedure数据分析控制程序7.5 Improvement改进7.5.1 Continual Improvement持续改进Chapter: 04 File No. HZ/QM—2018章节：0.4文件编号：HZ/QM—2018 Title: Approval题目：批准页In order to standardize quality management activities, improve corporate management, enhance market competitiveness, ensure customer satisfaction, and continuously enhance customer satisfaction, and promote the company's economic efficiency and sustainable development, the company decided to establish, implement and continuously improve the quality management system in accordance with the series of ISO standards.为规范质量管理活动，提高企业管理水平，增强市场竞争能力，确保满足顾客需求，并不断增强顾客满意，促进公司经济效益的提高和持续发展，公司决定依据ISO9000族标准，建立、实施并持续改进质量管理体系。
中英质量手册
xx皮手套厂有限公司质量手册QM 001BCHAPTER TABLE / 目录:1.PRESENTATION OF XXX SAFETY LTD AND XXX TANNERY介绍XXX手套厂有限公司和XX皮厂 (2)2.DECLARATION OF THE BOARD董事会宣言 (4)3.QUALITY POLICY质量政策 (6)4.PURPOSE, SCOPE AND MANAGEMENT OF THE QUALITY MANUAL质量手册的目的、范围和管理 (9)5.DEFINITIONS定义 (10)6.QUALITY MANAGEMENT SYSTEM质量管理体系 (11)7.DESCRIPTIONS OF THE INTERACTIONS BETWEEN THE PROCESSES过程之间相互作用的表述 (13)8.DESCRIPTION OF THE PROCESSES程序描述 (16)ANNEX DOCUMENT / 附件:1.PRESENTATION OF XXX SAFETY LTD AND XXX TANNERY 介绍XX皮手套厂有限公司和XX皮厂1.1.General informations / 总说明1.2.Activities / 行为Xxx Tannery ensures the design and manufacturing of safety leathers and Xxx Safety Ltd of PPE (Personal Protective Equipment). All the products are made according to the current specifications and standards.确保xxx皮厂设计和生产的皮革和xxx皮手套厂有限公司设计和生产的个人防护用品都是依照当前的规范和标准制造的。
1.3.Staff and general organization on the 2006 / 03 / 01 职员和总体组织For details, refer to“Xxx Safety Ltd. and Xxx tannery organization chart” (HFO 002).详细资料, 参照“xxx皮手套厂、xxx皮厂组织图” (HFO 002)1.4.History / 历史Our business commercial relations between Europe and China have started in February 1975. 自从1975年2月开始，我们就建立了欧洲与中国的商业伙伴关系。
质量手册翻译中英文术语表
质量手册翻译中英文术语表3.1.1 质量 quality3.1.2 要求 requirement3.1.3 等级 grade3.1.4 顾客满意 customer satisfaction3.1.5 能力 capability3.2.1 体系(系统) system3.2.2 管理体系 management system3.2.3 质量管理体系 quality management system 3.2.4 质量方针 quality policy3.2.5 质量目标 quality objective3.2.6 管理 management3.2.7 最高管理者 top management3.2.8 质量管理 quality management3.2.9 质量策划 quality planning3.2.10 质量控制 quality control3.2.11 质量保证 quality assurance3.2.12 质量改进 quality improvement3.2.13 持续改进 continual improvement3.2.14 有效性 effectiveness3.2.15 效率 efficiency3.3.1 组织 organization3.3.2 组织结构 organizational structure3.3.3 基础设施 infrastructure3.3.4 工作环境 '77ork environment 3.3.5 顾客 customer3.3.6 供方 supplier3.3.7 相关方 interested party3.4.1 过程 process3.4.2 产品 product3.4.3 项目 project3.4.4 设计和开发 design and development 3.4.5 程序 procedure3.5.1 特性 characteristic3.5.2 质量特性 quality characteristic 3.5.3 可信性 dependability3.5.4 可追溯性 traceability3.6.1 合格（符合） conformity3.6.2 不合格（不符合） nonconformity 3.6.3 缺陷 defect3.6.4 预防措施 preventive action3.6.5 纠正措施 corrective action3.6.6 纠正 correction3.6.7 返工 rework3.6.8 降级 regrade3.6.9 返修 repair3.6.10 报废 scrap3.6.11 让步 concession3.6.12 偏离许可 deviation permit3.6.13 放行 release3.7.1 信息 information3.7.2 文件 document3.7.3 规范 specification3.7.4 质量手册 quality manual3.7.5 质量计划 quality plan3.7.6 记录 record3.8.1 客观证据 objective evidence3.8.3 试验 test3.8.4 验证 verification3.8.5 确认 validation3.8.6 鉴定过程 qualification process3.8.7 评审 review3.9.1 审核 audit3.9.2 审核方案 audit programme3． 9．3 审核准则audit criteria3．9．4 审核证据 audit evidence3．9．5 审核发现 audit findings3．9．6 审核结论 audit conclusion3．9．7 审核委托方 audit client3． 9．8 受审核方 auditee3．9．9 审核员 auditor3．9．10 审核组 audit team3．9．11 技术专家 technical expert3．9．12 能力 competence3.10.1 测量控制体系 measurement control system 3.10.2 测量过程 measurement process3.10.3 计量确认 metrological confirmation3.10.4 测量设备 measuring equipment3.10.5 计量特性metrological characteristic 3.10.6 计量职能 metrological function Aaudit 3.9.1audit client 3.9.7audit conclusion 3.9.6audit criteria 3.9.3audit evidence 3.9.4audit findings 3.9.5audit programme 3.9.2audit team 3.9.10auditee 3.9.8auditor 3.9.9Ccapability 3.1.5characteristic 3.5.1concession 3.6.11conformity 3.6.1continual improvement 3.2.13 correction 3.6.6corrective action 3.6.5customer 3.3.5customer satisfaction 3.1.4 competence 3.9.12Ddefect 3.6.3dependability 3.5.3design and development 3.4.4deviation permit 3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency 3.2.15Ggrade 3.1.3Iinformation 3.7.1infrastructure 3.3.3inspection 3.8.2interested party 3.3.7Mmanagement 3.2.6management system 3.2.2 measurement control system 3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic 3.10.5 metrological confirmation 3.10.3 metrological function 3.10.6Nnonconformity 3.6.2Oobjective evidence 3.8.1 organization 3.3.1organizational structure 3.3.2 Ppreventive action 3.6.4 procedure 3.4.5process 3.4.1product 3.4.2project 3.4.3Qqualification process 3.8.6 quality 3.1.1quality assurance 3.2.11quality characteristic 3.5.2 quality control 3.2.10quality improvement 3.2.12 quality management 3.2.8quality management system 3.2.3 quality manual 3.7.4quality objective 3.2.5quality plan 3.7.5quality planning 3.2.9quality policy 3.2.4Rrecord 3.7.6regrade 3.6.8release 3.6.13repair 3.6.9requirement 3.1.2review 3.8.7rework 3.6.7Sscrap 3.6.10specification 3.7.3supplier 3.3.6system 3.2.1Ttechnical expert <audit> 3.9.11test 3.8.3top management 3.2.7traceability 3.5.4Vvalidation 3.8.5verification 3.8.4Wwork environment 3.3.4质量管理体系基础和术语 Quality management syst ems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分: GB/T 19001、GB /T 19002和GB/T 19003实施通用指南 Quality manag ement and quality assurance standards－－Part 2: Generic guidelines for the application of GB /T 19001、GB/T 19002 and GB/T 19003质量管理和质量保证标准第3部分: GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南 Qual ity management and quality assurance standards －－Part 3: Guidelines for the application of G B/T 19001 to the development, supply, installat ion and maintenance of computer software质量管理和质量保证标准第4部分:可信性大纲管理指南 Quality management and quality assurance s tandards－－Part 4: Guide to dependability prog ramme management质量管理体系要求 Quality management systems－－Requirements质量管理体系业绩改进指南 Quality management sy stems－－Guidelines for performance improvement s质量管理和质量体系要素第2部分: 服务指南 Quali ty management and quality system elements－－Pa rt 2: Guidelines for services质量管理和质量体系要素第3部分: 流程性材料指南 Quality management and quality system elements －－Guidelines for processed materials质量管理和质量体系要素第4部分: 质量改进指南 Q uality management and quality system elements－－Guidelines for quality improvement质量管理质量计划指南 Quality management－－Gui delines for quality plans质量管理项目管理质量指南 Quality management－－Guidelines to quality in project management 质量管理技术状态管理指南 Quality management－－Guidelines for configuration management质量体系审核指南审核 Guidelines for auditing q uality systems－－Part 1: Auditing质量体系审核指南质量体系审核员的评定准则 Guide lines for auditing quality systems－－Part 2: Q ualification criteria for quality systems audit ors质量体系审核指南审核工作管理 Guidelines for au diting quality systems－－Part 3: Management of audit programmes测量设备的质量保证要求第一部分: 测量设备的计量确认体系 Quality assurance requirements for mea suring equipment Part 1: Metrological confirmat ion system for measuring equipment测量设备的质量保证第2部分: 测量过程控制指南 Q uality assurance for measuring equipment－－Par t 2: Guidelines for control of measurement proc esses质量手册编制指南 Guidelines for developing qual ity manuals质量经济性管理指南 Guidelines for managing the economics of quality质量管理培训指南 Quality management－－Guideli nes for trainingEnglish Chinesereceipt （入厂）接受，验收，进货handling 搬运packaging 包装storage 保存protection 保护comparison 比较identification 标识replacement of identification mark 标识标志更换maintenance of identification 标识的保持records of identification control 标识控制记录tender 标书normative document 标准文件supplemental 补充nonconforming product 不合格品control of nonconforming product 不合格品控制control procedure of nonconforming products 不合格品控制程序tendency of nonconformance 不合格倾向purchasing 采购verification of purchased product 采购的产品验证purchasing process 采购过程purchasing control procedure 采购控制程序purchasing information 采购信息reference standard 参照标准reference instructions 参照细则stockhouse 仓库measurement, analysis and improvement 测量，分析和改进measurement result 测量结果control procedure of monitoring and measuring d evices 测量设备控制程序planning 策划preservation of product 产品保护control procedure for maintenance, replacement and records of product identification 产品标识的保持, 更换及记录控制程序procedure for product identification and tracea bility 产品标识和可追溯性程序conformity of product 产品的符合性monitoring and measurement of product 产品的监督和测量product plan 产品方案control procedure for product preservation 产品防护控制程序method of product release 产品放行方法conformity of product, product conformity 产品符合性product realization 产品实现planning of product realization 产品实现策划product characteristics 产品特性input to product requirements 产品要求的输入product status 产品状态final acceptance of product 产品最后验收procedure 程序program documents 程序文件continual improvement 持续改进procedure for continual improvement of quality management system 持续改进质量体系程序adequacy 充分性storage location 存放地点agency personnel 代理人员submission of tenders 递交标书adjustment 调整，调节statutory and regulatory requirements 法律法规要求rework, vt 返工repair, vt 返修subcontractor 分承包方annex 附录improvement 改进improvement actions 改进措施on-the-job training 岗位技能培训responsibility of individual department and pos t 各部门, 各岗位职责change identification 更改标记change order number 更改单编号process sheets 工艺单process specification 工艺规程procedure(process card) 工艺规程(工艺卡) process characteristics 工艺特性Job Description Format 工种描述单work environment 工作环境impartiality 公正性functional requirements 功能要求supplier 供方supplier evaluation procedure 供方评价程序supplier provided special processes 供方提供的特殊过程verification at supplier's premises 供方现场验证supply chain 供应链criteria for supplier selection, evaluation and re-evaluation 供应商选择、评估和再评估准则communication 沟通customer 顾客customer property 顾客财产control procedure for customer property 顾客财产控制程序customer feedback 顾客反馈Customer Service Contact Form 顾客服务联系表customer communications 顾客沟通customer satisfaction 顾客满意statistical analysis of customer satisfaction 顾客满意度统计分析customer complaint 顾客投诉identification of customer requirements 顾客要求的识别management review 管理评审records from management review 管理评审记录management review control procedure 管理评审控制程序management representative 管理者代表management responsibility 管理职责specified limits of acceptability 规定的可接受界限specified use 规定的用途process 过程complexity of processes 过程的复杂性monitoring and measurement of processes 过程的监视和测量operation of process 过程的运行status of processes 过程的状态process approach 过程方法process controls 过程控制process control documents 过程控制文件process performance 过程业绩appropriateness 合适性changes to contractor 合同的更改contract review control procedure 合同评审控制程序internet sales 互联网销售environmental conditions 环境条件monogram pragram requirements 会标纲要要求type of activities 活动类型infrastructure 基础建设infrastructure 基础设施fundamentals and vocabulary 基础与词汇control of records 记录控制technical specificaion 技术规范process trace sheet 加工跟踪单monitoring and measurement 监视和测量monitoring and measuring device 监视和测量装置control of monitoring and measuring devices 监视和测量装置控制check method 检查方法frequency of checks 检查频次calibration status 检定状态inspection and test control procedure 检验和试验控制程序identification procedure for inspection and tes t status 检验和试验状态标识程序inspection witness point 检验见证点inspection hold point 检验停止点buildings 建筑物delivery 交付post-delivery activities 交付后的活动delivery activities 交付活动interface 接口acceptance of contract or orders 接受合同或定单type of medium 介质类型experience 经验correction action 纠正措施Corrective action response time 纠正措施答复时间，纠正措施响应时间management procedure for corrective actions 纠正措施管理程序corrective action response times 纠正措施响应时间development activity 开发活动traceability mark 可追溯性标志objectivity 客观性Customer Service Log 客户服务记录簿control feature 控制特性，控制细节control features 控制细则periodic assessment of stock 库存定期评估justification 理由routine 例程，惯例，常规质量职能分配表论证范围internal communication 内部沟通internal audit 内部审核internal audit procedure 内部审核程序internally controlled standard 内控标准internal audit 内审results of internal and external audits 内外部审核结果competence 能力training 培训training needs 培训需要evaluate 评价records of the results of the review 评审结果的记录review output 评审输出review input 评审输入Purchase Requisition 请购单authority 权限validation 确认concession 让步human resources 人力资源job training of personnel 人员岗位培训qualification of personnel 人员资格equipment control procedure 设备控制程序device type 设备类型order of design changes 设计更改通知单design and development control procedure 设计和开发控制程序design and development 设计开发design and development planning 设计开发策划control of design and development changes 设计开发更改控制design and development review 设计开发评审design and development validation 设计开发确认design and development outputs 设计开发输出design and development inputs 设计开发输入design and development verification 设计开发验证design validation 设计确认design documentation 设计文件编制design acceptance criteria 设计验收准则design verification 设计验证audit program 审核大纲conduct of audits 审核行为audit criteria 审核准则production process control 生产过程控制production process control procedure 生产过程控制程序production and service provision 生产和服务提供control of production and service provision 生产和服务提供的控制validation of processes for production and serv ice provision 生产和服务提供过程的确认production order 生产令identification and traceability 识别和可追溯性identification and traceability maintenance and replacement 识别和可追溯性维护与替换invalidate 使失效market survey 市场调研suitability 适宜性scope 适用范围controlled condition 受控状态terms and definitions 术语与定义analysis of data 数据分析sequence 顺序transfer of ownership 所有权转移system document 体系文件statistical technique 统计方法outsource(vt) a process 外包过程external source 外部来源documents of external origin 外来文件outsource, vt 外协unique identification 唯一的标识maintenance 维护Document Change Control 文件更改控制Request For Document Change (RDC) 文件更改需求单control of documents 文件控制documentation requirements 文件要求enquiry 问询，询价field nonconformity analysis 现场不符合分析relevance 相关性interaction 相互作用detail design 详细设计，详图设计，零件设计，施工设计sales department 销售部sales contract 销售合同checklist 校验表，一览表，检查一览表calibration 校准submission of action plans 行动计划的递交documented procedures 形成文件的程序documented statement 形成文件的声明performance requirements 性能要求licensee responsibilities 许可证持有者责任acceptance criteria 验收准则verification arrangement 验证安排verification results 验证结果customer focus 以客户为关注点，以客户为焦点awareness 意识introduction 引言，概述，介绍normative references 引用标准application 应用visit to user 用户访问review of requirements related to the product 有关产品的要求评审competent 有能力的effectiveness 有效性determination of requirements related to the pr oduct 与产品有关的要求的确定customer-related processes 与顾客有关的过程preventive action 预防措施management procedure for preventive actions 预防措施管理程序planned results 预期的结果intended use 预期的用途procedure for competence, knowledge and trainin g of personnel 员工能力, 知识和培训程序personnel training procedure 员工培训程序supporting services 支持性服务functions 职能部门responsibility 职责assignment of responsibility 职责分工workmanship 制造工艺manufacturing acceptance criteria 制造验收准则quality policy 质量方针quality programs 质量纲领quality management system 质量管理体系quality management system planning 质量管理体系策划performance of the quality management system 质量管理体系业绩quality plan 质量计划quality records 质量记录quality objectives 质量目标quality audit 质量审核quality manual 质量手册quality problem handling form 质量问题处理单quality requirements 质量要求allocation table of quality responsibilities 质量职能分配表availability of resources 资源的可获得性resource management 资源管理allocation of resources 资源配置provision of resources 资源提供general requirements 总要求，一般要求constituent part 组成部件organization 组织continual improvement of the organization 组织的持续改进size of organization 组织的规模Organizational Diagram 组织机构图final acceptance 最终验收work instructions 作业指导书。
质量手册-中英文对照
PREFACE
This quality manual is based on ISO9001:2008 Quality Management Systems Requirements and defines the Quality Management System of ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITED (“SUNMING”).
GM10001 A00
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1.0 INTRODUCTION 介绍
This Quality Manual is a policy document of SUNMING about quality management system based from ISO9001:2008. It describes all the elements of implementing quality management system and responsibilities of related departments. 本《质量手册》是根据 ISO9001：2008 的原则编制的，是 SUNMING 质量体系的纲领性文件，描 述了实施质量管理体系各个要素及相关责任部门。
whatsoever, without the prior written consent of Zhongshan Sunming Optical Technologies Limited.
©2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITED
ALL RIGHTS RESERVED
TITLE : QUALITY MANUAL 质量手册
Document No.: GM10001
制药质量手册-英文
Good Manufacturing Practice (cGMP) Pharmaceutical Inspectorate For Medicinal ProductsControl of PharmaceuticalsPage 1 of 34SOP no. QM-01/02Supersedes version - 01Institute for Standardization and Control of PharmaceuticalsQuality ManualGood Manufacturing Practice (cGMP) Pharmaceutical InspectorateFor Medicinal ProductsSignatureDateJob FunctionNameDirector, Institute forStandardization and Control ofPharmaceuticalsMimi KaplanPh.D.Head ofGMP InspectorateRami Kariv,Ph.D.Quality Assurance ManagerSarah CovrigaroGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal Products Control of PharmaceuticalsPage 2 of 34SOP no. QM-01/02Supersedes version - 01Table of ContentsNo. Section Page(i) General 3(ii) References 41. Scope 52. Definitions 63. Administrative Requirements 74. Independence, Impartiality, Integrity 85. Confidentiality 96. Organization and Management 107. Quality System 158. Personnel Training and Qualification 189. Facilities and Equipment 2010. Inspection Methods and Procedures 2111. Handling Inspection Samples 2312. Records, Documents and Data Controls 2413. Inspection Reports, Issue, Withdrawal of Licenses, GMP Certificates2514. Sub-contracting 2715. Quality Improvement & Corrective and Preventive Action (CAPA)2816. Quality Audits 2917. Complaints and Appeals 3018. Periodic Review, Quality Indicators and Statistical Techniques3119. Liaison with the Institute Laboratories 3220. Co-operation 3221. Handling Suspected Quality Defects and Rapid Alert System3322. Publications 34Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 3 of 34SOP no. QM-01/02Supersedes version - 01(i) GeneralThe numbering of this quality manual is designed to address each of the sections in the document EN 45004, General Criteria for the Operation of Various Types of Bodies Performing Inspection, as well as integrating the body of the content of the PIC/S document “Recommendation on Quality System Requirements for Pharmaceutical Inspectorates” PI 002-3, September 2007.This manual documents the Israeli Ministry of Health GMP Inspectorate's Quality System. The manual is intended to demonstrate that the GMP Inspectorate has the ability, integrity and resources to perform those activities required of it, as defined in the manual. The manual also addresses procedures for maintaining the quality system, including audits and periodic, formal review of quality indicators.The activity described in this manual is covered by approved Standard Operating Procedures (SOPs) that provide precise instructions on how to perform anddocument the relevant activity.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 4 of 34SOP no. QM-01/02Supersedes version - 01(ii) ReferencesThis Quality Manual is based on the following normative standards and references. The content of the manual is intended to comply with the spirit and current understanding and interpretation of the referenced documents.1. EN 45004: 1995, European StandardGeneral Criteria for the operation of various types of bodiesperforming inspection2. PIC/S, Pharmaceutical Inspection Co-operation SchemeRecommendation on Quality System Requirements for PharmaceuticalInspectorates, PI 002-3, September 2007.3. Compilation of Community Procedures on Inspection and Exchange of InformationEC/EMEA 2006Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 5 of 34SOP no. QM-01/02Supersedes version - 011. ScopeThe scope of this Quality Manual covers all those activities that fall under the responsibility of the GMP Inspectorate at the Ministry.The Pharmaceutical Division of The Ministry is responsible for ensuring the safety, efficacy and quality of therapeutic goods supplied in Israel. The Pharmaceutical Division regulates finished pharmaceuticals (pharmaceutical products) and Active Pharmaceutical Ingredients (APIs) for human, biological and veterinary drugs. The authority for these activities is enacted in the legislation of the Pharmacists ordinance [New Version] 1981, Pharmacists Regulations (Medical Products) 1986, Pharmacists Regulations [Good Manufacturing Practice], 2008.The scope of activities covered by the inspectorate includes:•Human Pharmaceutical Drug Products•Biological Pharmaceutical Products•Plasma Products•Veterinary Drug Products•Active Pharmaceutical Ingredients (APIs)•Pre-market approval for a new drug (innovative or generic) where it is determined that there is a need for inspection•Approval for initiation of manufacturing of any of the above products in a new facility or site•Approval for manufacture of Investigational Medical Products (Phase III)The GMP inspectorate has at its disposal at any time, an up to date list of approved manufacturers inspected periodically by the inspectorate.Good Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsControl of PharmaceuticalsPage 6 of 34SOP no. QM-01/02Supersedes version - 012. DefinitionsQuality System The sum of all that is necessary to implement an organization’squality policy and meet quality objectives. It includesorganizational structure, responsibilities, procedures, systems,processes and resources.Quality Indicators Selected data intended to be periodically observed to assist inassessing trends in performance.Israeli GMP Inspectorate The national body responsible for co-ordinating and carrying out pharmaceutical GMP inspections of pharmaceutical manufacturers, issue or withdrawal of Manufacturer's authorization and GMP certificates, providing advice and handling suspected quality defects.Authorization For the purposes of this document, an authorization is defined as"Manufacturer's authorization" issued by the Ministry of Healthaccording to Pharmacists Regulation (Good ManufacturingPractice) 2008 that provides authorization to manufacturemedicinal products .Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 7 of 34SOP no. QM-01/02Supersedes version - 013. Administrative RequirementsThe Institute for Standardization and Control of Pharmaceuticals (here and after referred to as "The Institute") is a part of The Pharmaceutical Division of the Israeli Ministry of Health and is responsible for enforcement of current Good Manufacturing Practice (cGMP) regulations in Israel. The General Director of the Israeli Ministry of Health confers the legal authority for supervision of pharmaceutical facilities and issuing certificates of compliance with cGMP upon the Director of the Institute for Standardization and Control of Pharmaceuticals. This is administered through application of the General Director's directive 15/03. The GMP Inspectorate (The Inspectorate) is an independent unit functioning within the Institute and reporting to the Institute Director.The Inspectorate's activities and guidelines as how to implement these functions are documented together with a detailed description of the scope of activity for which it is competent in approved Standard Operation Procedures (SOPs). The Quality Manual is available to the general public on the Ministry of Health's website. The precise scope of each inspection or related activity is determined by the nature of the work involved and is determined in writing prior to initiation of the inspection based on review of relevant documentation.The Inspectorate's liability is assumed by the State of Israel in accordance with national laws. The Inspectorate is part of the Ministry of Health and as such provides inspection services to the Ministry of Health. As such reporting requirements and work assignments are governed by applications made by companies to the Ministry of Health and / or ongoing GMP compliance activities in accordance with the Inspectorate’s Standard Operating Procedures.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 8 of 34SOP no. QM-01/02Supersedes version - 014. Independence, Impartiality and IntegrityEvery effort shall be made to ensure that activities of the Israeli cGMP Compliance Inspectorate are not compromised by conflict of interest or improper influence. The Inspectorate is an independent organization with no financial dependence on those institutions that are inspected by the Inspectorate.Inspectorate personnel shall be free from any commercial, financial or other pressures, which may affect their judgment. Procedures shall be in place to ensure that persons, companies or organizations external to the Inspectorate cannot influence the results of the inspections carried out by the Inspectorate.The Inspectorate shall be impartial when performing an assessment of suitability for GMP requirement. In this regard, Inspectorate personnel are required to comply with the official conduct requirements of the Public Service Act. The decision on whether or not to issue a manufacturer's authorization and/or GMP certificate shall be based solely on documented, professional considerations resulting from observations and / or other evidence collected during the performance of the suitability assessment.The cGMP Inspectorate may not provide consulting services to GMP authorized/approved clients, or to clients seeking GMP authorization/approval. Likewise, the cGMP Inspectorate may not make recommendations regarding particular vendors, consultants or other service providers beyond a general statement that they consider a company may require the assistance of a certain type of provider.The Inspectorate may participate in regular meetings with various industryrepresentative groups. Such meetings shall be open to all representatives of theparticular group and shall preclude any influence on the issue of GMP or quality certification. Such meetings may be held in order to obtain industry input prior to policy making. However, at the end of the day the policy will be determined based on the Inspectorate's professional judgment and after a survey of current industry andregulatory practice.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 9 of 34SOP no. QM-01/02Supersedes version - 015. ConfidentialityThe confidentiality of commercial information shall be respected at all times. The Inspectorate shall ensure the confidentiality of information obtained in the course if its inspection activities and related duties. Proprietary rights and intellectual property rights shall be protected and respected.Where appropriate access to commercial information shall be restricted to those persons within the Inspectorate that require said information for the performance of their professional duties. Such information shall be stored in restricted access areas. Likewise, personnel will make every effort to protect information stored in electronic format or on magnetic media or in any other computerized format.Every public servant is required to sign on a confidentiality agreement as a condition for entering public service. This agreement requires them to maintain confidentiality of any information that comes to their knowledge in fulfillment of their public duties.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 10 of 34SOP no. QM-01/02Supersedes version - 016. Organization and Management (Management Responsibility)OrganizationThe organizational chart of the inspectorate is provided below. The Head of the GMP Inspectorate reports directly to the Director of the Institute. Inspectors report directly to the Head of the Inspectorate. Expert inspectors are usually managers in other units of the Institute, reporting to the Institute Director. When participating in an inspection team they report directly to the Head of GMP Inspectorate.GMP Inspectorate Organization ChartControl of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 11 of 34SOP no. QM-01/02Supersedes version - 01Management ResponsibilityThe Director of the Institute is responsible for the overall management of the GMP Inspection program and as such, for the overall management of the GMP Inspectorate.The Head of GMP Inspectorate is directly responsible for management of the Inspectorate. If absent from the office for an extended period of time, responsibility for the management of the Inspection shall be delegated to another suitably qualified member of the Inspectorate. The authority for such delegation will be documented in the person's job description. In such an event, the Acting Head, GMP Inspectorate will be responsible for all inspection related activities for which the Head is normally responsible.Based on his / her professional discretion, the Head, GMP Inspectorate, may delegate responsibility for specified activities to other Inspectorate personnel. The responsibility for making certain decisions may be delegated to specific review panels, the composition of which is determined by on an ad hoc basis. When a responsible person is absent from work and responsibility for a particular activity has not been formally delegated, delegation shall automatically be upwards, i.e. to the person's supervisor etc.The Director of the Institute is reporting to The Director of the Pharmaceutical Division, who in turn reports to the Deputy General Director of the Ministry.The responsibilities and authority of Inspectorate personnel are described in written job descriptions for each position in the Inspectorate. Job descriptions are signed by the staff member and by the Director of the Institute, indicating that they are both aware and agree to the scope of activities described therein. Job descriptions are filed in each staff member's personal file held by the Institute's personnel department.Inspectorate personnel must have appropriate educational qualification, training and experience or suitable combination of these factors to enable them to perform their duties. Generally minimum educational requirements are for an academic degree in a life science (e.g. biology, microbiology, immunology etc.), pharmacy or chemistry. Practical experience in the pharmaceutical or related industry at a management level is considered an advantage although is not necessarily a pre-requisite for employment in the Inspectorate.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 12 of 34SOP no. QM-01/02Supersedes version - 01The inspectorate is currently staffed by the Head of GMP Inspectorate, GMP Inspector, 5 part time experts, QA Manager and supported by administrative staff of the Institute. The Inspectorate is located in the Givat Shaul neighbourhood close to the entrance to Jerusalem.The responsibilities of the Director include but are not necessarily limited to:- Overall management of the GMP Compliance Inspectorate- Serving as the management representative for the Quality System- Ensuring the availability of adequate resources for implementation and maintenance of the Quality System- Intervening and assisting in resolving ongoing compliance issues where resolution between the Inspectorate and industry has not reached an acceptable conclusion- Setting Policy for the requirement from the industry and standards of the Inspectorate - Liaison with other regulatory and certification bodies, including PIC/S- Liaison with industry representatives and bodies where appropriate- Ensuring availability of adequate resources such that the inspectorate can conduct their activities in a professional and orderly manner- Decision on deferral or rejection of Quality Certificates of medicinal product, Manufacturer's authorizations or GMP Certificates.The responsibilities of the Head, GMP Inspectorate include but are not necessarily limited to: - Setting policy for, ensuring and overseeing Quality Assurance of all activities performed by the GMP Compliance Inspectorate- Ensuring the existence of and implementation of an annual training schedule as well as evaluating requests for training- Arranging, planning and conducting inspections in Israel and, where required, abroad - documenting inspections- Approval of authorizations and certificates: recommending the issue, deferral or rejection of manufacturer's authorizations or GMP Certificates.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 13 of 34SOP no. QM-01/02Supersedes version - 01- Ensuring impartiality of the inspection group such that the outcome of audits is not compromised by conflict of interest or improper influence.- Handling complaints.- Review and approval of SOPs and other documentation related to the activities of the Inspectorate as appropriate.- Ensuring the performance of management reviews and providing solutions to ongoing or recurrent problems presented in said reviews.- Providing limited advice to industry, and advice to other departments in the Ministry of Health.- Participating in internal audits, for cause inspections etc.- Participating on committees or panels as necessary.- Assessing evidence of GMP for overseas manufacturers.The responsibilities of the Quality Assurance Manager shall include:- Establishing and maintaining the Inspectorate's Quality System.- Establishing and maintaining an internal audit program.- Establishing and monitoring Quality metrics regarding the effectiveness of the Quality System to The Institute's management review and as a basis for continuousimprovement.- Establishing, maintaining and monitoring correction of items entered into the Quality System CAPA program.- Ensuring that pre-approval and ongoing compliance inspections are performed in a timely manner.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 14 of 34SOP no. QM-01/02Supersedes version - 01Any decisions relating to rejection of an authorization application or the suspension of an authorization shall be made by the Director of the Institute.Inspections that require a specialized knowledge shall be restricted to inspectors with that knowledge, or specialists, e.g. persons from the Institute laboratories may be included in inspection teams to provide professional advice.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 15 of 34SOP no. QM-01/02Supersedes version - 017. Quality SystemThe primary purpose of the Quality System is to ensure that adequate quality standards are maintained in all of the Inspectorate's functions and duties. The Quality System requirements for the Israeli GMP Inspectorate should include and address all activities involved in the GMP inspection process.The GMP Inspectorate has a quality policy that defines and documents the objectives and commitment to quality. The quality policy is used as an educational resource and must be understood and followed by all personnel working under the Inspectorate's authority.7.1. Quality PolicyThe quality policy of the GMP inspectorate is as follows:The Inspectorate is committed to maintaining high performance standards, meeting the expectations of the Ministry and the general public in safeguarding public health byensuring the uninterrupted supply of safe and efficacious medicinal products.The Institute's GMP Inspectorate is committed to operating an effective quality system that complies with the PIC/S recommendations (PI 002-3, September 2007). Thesystem shall be such that it enables the Inspectorate to maintain the capability toperform its technical functions satisfactorily.The Inspectorate will do all in its power to meet its quality goals and to protect and be deserving of its respected national and international reputation.The Inspectorate will define and document their responsibilities and reporting structure in written approved standard operating procedures.The Inspectorate understands, is familiar with and is committed to the principle of continuous improvement in all areas of activity and has procedures in place to ensure that areas of weakness are systematically identified and acted upon in a timelymanner.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 16 of 34SOP no. QM-01/02Supersedes version - 01Inspectorate personnel should be familiar with the Quality Policy and committed to the following principles that are to be complied with in performance of any and all of their duties: The Quality Policy of the GMP Inspectorate is as follow:M aintain integrity and impartiality.Be consistent in decisions and assessments.Be polite, respectful, firm, fair and just.Respect the rights of all persons with whom they have contact during the performance of their duties.Maintain strict confidentiality of privileged information.Undertake continuous professional development, ensure that they are updated and aware of changes in standards, current practices and technologies and participate in appropriatetraining so as to ensure that inspectional standards are state-of-the art.7.2. Documentation SystemThe quality system is documented in a comprehensive set of Standard Operating Procedures (SOPs), of which, this quality manual forms an integral part.One of the main procedures in the quality system is the Documentation and Change Control policy. This SOP ensures that only current, approved copies of controlled documents are available to all relevant personnel. Changes in controlled documents are reviewed and approved by relevant functions within the organization and result in re-issue of the document to all concerned persons with appropriate re-training. Where changes are made in a document there is a method for identifying changes from the previous version where such exists. The master copy of any superseded document is archived for a pre-determined period and all other copies are withdrawn from use in a timely and controlled manner.As part of the documentation policy, there is a procedure for maintaining records relating to the activities of the GMP Inspectorate. The system should include any relevant documents including those received from authorization applicants and authorization holders where appropriate. A system to ensure the confidentiality of commercial information and intellectual property must be implemented and strictly maintained. Where required, records will be shared under the exchange of information procedures and arrangements between NationalControl of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 17 of 34SOP no. QM-01/02Supersedes version - 01Pharmaceutical Inspectorates and Mutual Recognition Partners, bearing in mind that the confidentiality requirements are incumbent on such partners and arrangements. Records must be handled in a manner that ensures they can be retained for a pre-determined period of time, consistent with any legal requirements and in such a manner as to provide prevent any damage or loss.7.3. Internal auditAs part of the quality system internal audits are routinely performed in accordance with an approved procedure to verify compliance with this manual, with the Ministry's Inspection Manual and with the Inspectorate's SOPs. Internal audits are intended to verify the effectiveness of the quality system and may be performed by the Quality Assurance representative or by an appropriately qualified, independent, external auditor, in which case the auditor's credentials will be maintained on file.Where discrepancies or deviations in the quality system or performance of inspection are identified, either as the result of internal audits, complaints from the public or any other source, a Corrective and Preventive Actions (CAPA) procedure is in place to ensure that the non-conformity is registered, appropriate actions taken and follow-up performed to ensure that the actions are implemented and to measure their effectiveness.7.4 Management ReviewManagement review is performed at least annually to review the quality system and ensure its continuing suitability and effectiveness. The results of the reviews are documented and followed up, including the setting of quality goals for the immediate future. Subsequent reviews address the implementation or failure thereof, of the goals determined at the previous review.Control of PharmaceuticalsGood Manufacturing Practice (cGMP)Pharmaceutical InspectorateFor Medicinal ProductsPage 18 of 34SOP no. QM-01/02Supersedes version - 018. Personnel Training and QualificationThe GMP Inspectorate has a sufficient number of permanent personnel with the necessary expertise to carry out the volume and range of work demanded by its defined functions and duties. Personnel responsible for inspection must have appropriate qualifications, training, experience and knowledge of cGMP requirements, guidelines and expectations to enable them to perform the inspection and review functions required of them. This includes knowledge of the technologies used for manufacturing pharmaceutical products, of the methods of use of the products and of problems that may arise, including injury or harming of public health as a result of failure to meet the regulations. Personnel must understand and be fully conversant with the consequences of deviations that occur or may occur during the production, distribution or use of these products.The authority for supervision of pharmaceutical facilities and issuing certificates of compliance with cGMP is conferred upon the Director of the Institute by the General Director of the Ministry of Health. The GMP Inspectorate is a part of the Institute reporting to the Director.A pre-requisite for joining the GMP inspection team is a scientific background. Allinspectors have a relevant academic degree as a minimum requirement.Staff responsible for inspection must have, apart from the above mentionedqualifications, the training and experience, as well as a satisfactory knowledge of thecGMP regulations and requirements for the inspections to be conducted. This includes understanding current interpretation of the requirements as they pertain to specificoperations and product types. Personnel are expected to have the ability to make professional judgments as to conformity with the requirements based on inspectionalfindings and to prepare detailed reports based on those findings.Inspectors are provided with on-the-job training including participating in training courses provided by foreign inspectorates as well as training courses provided by industryexperts. As part of their training experience, inspectors may participate, as observers inGMP inspections conducted by FDA and European agencies in Israeli facilities. All。
质量手册翻译中英文对照解析
质量手册翻译中英文对照解析质量手册翻译中英文术语表Sscrap 3.6.10specification 3.7.3supplier 3.3.6供应商system 3.2.1系统Ttechnical expert 3.9.11 技术出口test 3.8.3测试top management 3.2.7 高层管理traceability3.5.4可塑性Vvalidation3.8.5verification3.8.4验证Wwork environment 3.3.4 工作环境质量管理体系基础和术语Quality management syst ems－－Fundamentals and vocabulary质量管理和质量保证标准第2部分:GB/T 19001、GB /T 19002和GB/T 19003实施通用指南Quality mana gement and quality assurance standards－－Part 2: Generic guidelines for the application of GB /T 19001、GB/T 19002 and GB/T19003 质量管理和质量保证标准第3部分:GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南Quality management and quality assurance standardresponsibility职责assignment of responsibility 职责分工workmanship制造工艺manufacturing acceptance criteria 制造验收准则quality policy 质量方针quality programs质量纲领quality management system 质量管理体系quality management system planning 质量管理体系策划performance of the quality management system 质量管理体系业绩quality plan质量计划quality records质量记录quality objectives质量目标quality audit质量审核quality manual质量手册quality problem handling form 质量问题处理单quality requirements 质量要求allocation table of quality responsibilities质量职能分配表availability of resources 资源的可获得性resource management 资源管理allocation of resources 资源配置provision of resources 资源提供general requirements 总要求，一般要求constituent part组成部件organization组织continual improvement of the organization 组织的持续改进size of organization 组织的规模Organizational Diagram 组织机构图final acceptance最终验收work instructions作业指导书。
质量手册翻译中英文对照
3.3.5顾客customer 质量手册翻译中英文术语表3.1.1质量quality 3.3.6供方supplier3.3.7相关方interested party 3.4.1过程process3.1.2要求requirement3.4.2产品product3.1.3等级grade3.4.3项目project3.1.4顾客满意customer satisfaction3.4.4设计和开发design and development 3.1.5能力capability3.4.5程序procedure3.2.1体系(系统) system3.5.1特性characteristic3.2.2管理体系management system3.5.2质量特性quality characteristic3.2.3质量管理体系quality management system3.5.3可信性dependability3.2.4质量方针quality policy3.5.4可追溯性traceability3.2.5质量目标quality objective3.6.1合格（符合）conformity3.2.6管理management3.6.2不合格（不符合）nonconformity 3.2.7最高管理者top management3.6.3缺陷defect3.2.8质量管理quality management3.6.4预防措施preventive action3.2.9质量策划quality planning3.6.5纠正措施corrective action3.2.10质量控制quality control3.6.6纠正correction3.2.11质量保证quality assurance3.6.7返工rework3.2.12质量改进quality improvement3.6.8降级regrade3.2.13持续改进continual improvement3.6.9返修repair3.2.14有效性effectiveness 3.6.10报废scrap3.2.15效率efficiency3.6.11让步concession3.3.1组织organization3.6.12偏离许可deviation permit 3.3.2组织结构organizational structure3.6.13放行release3.3.3基础设施infrastructure3.7.1信息information3.3.4工作环境'77ork environment3.7.2文件document3.7.3规范 specification 3.10.6 计量职能 metrological function3.7.4质量手册 quality manualA3.7.5质量计划 quality planaudit 3.9.1审计3.7.6记录 recordaudit client 3.9.7客户审计3.8.1客观证据 objective evidenceaudit conclusion 3.9.6审计结论3.8.3试验 testaudit criteria 3.9.3审计标准3.8.4验证 verificationaudit evidence 3.9.4审计证据3.8.5确认 validationaudit findings 3.9.53.8.6鉴定过程 qualification processaudit programme 3.9.2审计大纲3.8.7评审 reviewaudit team 3.9.10审计团队3.9.1审核 auditauditee 3.9.83.9.2审核方案 audit programmeauditor 3.9.93． 9 ． 3 审核准则 audit criteriaC3． 9． 4 审核证据 audit evidencecapability 3.1.53． 9． 5 审核发现 audit findingscharacteristic 3.5.13． 9． 6 审核结论 audit conclusionconcession 3.6.113． 9． 7 审核委托方 audit clientconformity 3.6.13． 9 ． 8 受审核方 auditeecontinual improvement 3.2.133． 9． 9 审核员 auditorcorrection 3.6.63． 9． 10 审核组 audit teamcorrective action 3.6.53． 9． 11 技术专家 technical expertcustomer 3.3.53． 9． 12 能力 competencecustomer satisfaction 3.1.43.10.1测量控制体系 measurement control systemcompetence 3.9.123.10.2测量过程 measurement processD3.10.3计量确认 metrological confirmationdefect 3.6.33.10.4测量设备 measuring equipmentdependability 3.5.33.10.5计量特性 metrological characteristicdesign and development 3.4.4deviation permit 3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency 3.2.15Ggrade 3.1.3Iinformation 3.7.1infrastructure 3.3.3inspection 3.8.2interested party 3.3.7Mmanagement 3.2.6management system 3.2.2 measurement control system 3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic 3.10.5 metrological confirmation 3.10.3 metrological function 3.10.6Nnonconformity 3.6.2Oobjective evidence 3.8.1客观证据organization 3.3.1organizational structure 3.3.2Ppreventive action 3.6.4procedure 3.4.5process 3.4.1product 3.4.2project 3.4.3Qqualification process 3.8.6quality 3.1.1quality assurance 3.2.11quality characteristic 3.5.2quality control 3.2.10quality improvement 3.2.12quality management 3.2.8quality management system 3.2.3 quality manual 3.7.4quality objective 3.2.5quality plan 3.7.5quality planning 3.2.9质量计划quality policy 3.2.4Rrecord 3.7.6记录regrade 3.6.8release 3.6.13放行repair 3.6.9requirement 3.1.2review 3.8.7rework 3.6.7返工Sscrap 3.6.10specification 3.7.3supplier 3.3.6供应商system 3.2.1系统Ttechnical expert <audit> 3.9.11技术出口test 3.8.3测试top management 3.2.7高层管理traceability 3.5.4可塑性Vvalidation 3.8.5verification 3.8.4验证Wwork environment 3.3.4工作环境质量管理体系基础和术语Quality management syst ems－－ Fundamentals and vocabulary质量管理和质量保证标准第 2 部分 : GB/T 19001 、 GB /T 19002 和 GB/T 19003 实施通用指南Quality manag ement and quality assurance standards－－Part2:Generic guidelines for the application ofGB /T 19001 、 GB/T 19002 and GB/T 19003质量管理和质量保证标准第 3 部分 : GB/T 19001在计算机软件开发、供应、安装和维护中的使用指南Qual ity management and quality assurance standards －－Part 3: Guidelines for the application of GB/T 19001 to the development, supply, installation and maintenance of computer software质量管理和质量保证标准第 4 部分 : 可信性大纲管理指南 Quality management and quality assurance s tandards －－ Part 4: Guide to dependability programme management质量管理体系要求 Quality management systems－－Requirements质量管理体系业绩改进指南Quality management sy stems－－ Guidelines for performance improvements质量管理和质量体系要素第 2 部分 :服务指南Quali ty management and quality system elements－－Pa rt 2: Guidelines for services质量管理和质量体系要素第 3 部分 :流程性材料指南Quality management and quality system elements－－Guidelines for processed materials质量管理和质量体系要素第 4 部分 :质量改进指南Q uality management and quality system elements－－Guidelines for quality improvement质量管理质量计划指南Quality management－－Gui delines for quality plans质量管理项目管理质量指南Quality management－－Guidelines to quality in project management质量管理技术状态管理指南Quality management－－Guidelines for configuration management质量体系审核指南审核 Guidelines for auditing q handling搬运uality systems －－ Part 1: Auditing packaging包装质量体系审核指南质量体系审核员的评定准则Guide storage 保存lines for auditing quality systems－－ Part 2: Q protection保护ualification criteria for quality systems audit comparison比较ors identification标识质量体系审核指南审核工作管理 Guidelines for au replacement of identification mark标识标志更换diting quality systems－－Part 3: Management of maintenance of identification标识的保持audit programmes records of identification control标识控制记录测量设备的质量保证要求第一部分 :测量设备的计量tender 标书确认体系 Quality assurance requirements for mea normative document标准文件suring equipment Part 1: Metrological confirmat supplemental补充ion system for measuring equipment nonconforming product不合格品测量设备的质量保证第 2部分 : 测量过程控制指南 Q control of nonconforming product不合格品控制uality assurance for measuring equipment－－ Par control procedure of nonconforming products不t 2: Guidelines for control of measurement proc合格品控制程序esses tendency of nonconformance不合格倾向质量手册编制指南 Guidelines for developing qual purchasing采购ity manuals verification of purchased product采购的产品验质量经济性管理指南 Guidelines for managing the证economics of quality purchasing process采购过程质量管理培训指南 Quality management －－ Guideli purchasing control procedure采购控制程序nes for training purchasing information采购信息reference standard参照标准reference instructions参照细则English Chinese stockhouse仓库measurement, analysis and improvement测量，分析receipt （入厂）接受，验收，进货和改进program documents程序文件measurement result测量结果continual improvement持续改进control procedure of monitoring and measuring d procedure for continual improvement of qualityevices测量设备控制程序management system持续改进质量体系程序planning策划adequacy 充分性preservation of product产品保护storage location存放地点control procedure for maintenance, replacement agency personnel代理人员and records of product identification产品标识submission of tenders递交标书的保持 ,更换及记录控制程序adjustment调整，调节procedure for product identification and tracea statutory and regulatory requirements法律法规bility产品标识和可追溯性程序要求conformity of product产品的符合性rework, vt返工monitoring and measurement of product产品的监repair, vt返修督和测量subcontractor分承包方product plan产品方案annex 附录control procedure for product preservation产品improvement改进防护控制程序improvement actions改进措施method of product release产品放行方法on-the-job training岗位技能培训conformity of product, product conformity产品responsibility of individual department and pos符合性t 各部门 , 各岗位职责product realization产品实现change identification更改标记planning of product realization产品实现策划change order number更改单编号product characteristics产品特性process sheets 工艺单input to product requirements产品要求的输入process specification工艺规程product status产品状态procedure(process card)工艺规程 ( 工艺卡 )final acceptance of product产品最后验收process characteristics工艺特性procedure程序Job Description Format工种描述单work environment 工作环境records from management review管理评审记录impartiality公正性management review control procedure管理评审控functional requirements功能要求制程序supplier 供方management representative管理者代表supplier evaluation procedure供方评价程序management responsibility管理职责supplier provided special processes供方提供的specified limits of acceptability规定的可接受特殊过程界限verification at supplier's premises供方现场验specified use规定的用途证process 过程supply chain供应链complexity of processes过程的复杂性criteria for supplier selection, evaluation and monitoring and measurement of processes过程的re-evaluation供应商选择、评估和再评估准则监视和测量communication沟通operation of process过程的运行customer 顾客status of processes过程的状态customer property顾客财产process approach 过程方法control procedure for customer property顾客财process controls过程控制产控制程序process control documents过程控制文件customer feedback顾客反馈process performance过程业绩Customer Service Contact Form顾客服务联系表appropriateness合适性customer communications顾客沟通changes to contractor合同的更改customer satisfaction顾客满意contract review control procedure合同评审控制statistical analysis of customer satisfaction程序顾客满意度统计分析internet sales互联网销售customer complaint顾客投诉environmental conditions环境条件identification of customer requirements顾客要monogram pragram requirements 会标纲要要求求的识别type of activities活动类型management review管理评审infrastructure基础建设infrastructure基础设施Corrective action response time纠正措施答复时fundamentals and vocabulary基础与词汇间，纠正措施响应时间control of records记录控制management procedure for corrective actions纠technical specificaion技术规范正措施管理程序process trace sheet加工跟踪单corrective action response times纠正措施响应时monitoring and measurement监视和测量间monitoring and measuring device监视和测量装置development activity开发活动control of monitoring and measuring devices监traceability mark可追溯性标志视和测量装置控制objectivity客观性check method检查方法Customer Service Log客户服务记录簿frequency of checks检查频次control feature控制特性，控制细节calibration status检定状态control features控制细则inspection and test control procedure检验和试periodic assessment of stock库存定期评估验控制程序justification理由identification procedure for inspection and tes routine例程，惯例，常规t status检验和试验状态标识程序质量职能分配表论证范围inspection witness point检验见证点internal communication内部沟通inspection hold point检验停止点internal audit内部审核buildings建筑物internal audit procedure内部审核程序delivery交付internally controlled standard内控标准post-delivery activities交付后的活动internal audit内审delivery activities交付活动results of internal and external audits内外部interface接口审核结果acceptance of contract or orders接受合同或定单competence 能力type of medium介质类型training培训experience经验training needs培训需要correction action纠正措施evaluate评价records of the results of the review评审结果的design documentation设计文件编制记录design acceptance criteria设计验收准则review output评审输出design verification设计验证review input评审输入audit program审核大纲Purchase Requisition请购单conduct of audits审核行为authority权限audit criteria审核准则validation确认production process control生产过程控制concession让步production process control procedure生产过程控human resources人力资源制程序job training of personnel人员岗位培训production and service provision生产和服务提供qualification of personnel人员资格control of production and service provision生equipment control procedure设备控制程序产和服务提供的控制device type设备类型validation of processes for production and servorder of design changes设计更改通知单ice provision生产和服务提供过程的确认design and development control procedure设计和production order生产令开发控制程序identification and traceability识别和可追溯性design and development设计开发identification and traceability maintenance anddesign and development planning设计开发策划replacement识别和可追溯性维护与替换control of design and development changes设计invalidate使失效开发更改控制market survey 市场调研design and development review设计开发评审suitability适宜性design and development validation设计开发确认scope 适用范围design and development outputs设计开发输出controlled condition受控状态design and development inputs设计开发输入terms and definitions术语与定义design and development verification设计开发验analysis of data数据分析证sequence 顺序design validation设计确认transfer of ownership所有权转移system document体系文件licensee responsibilities许可证持有者责任statistical technique统计方法acceptance criteria验收准则outsource(vt) a process外包过程verification arrangement验证安排external source外部来源verification results验证结果documents of external origin外来文件customer focus以客户为关注点，以客户为焦点outsource, vt外协awareness意识unique identification唯一的标识introduction引言，概述，介绍maintenance维护normative references引用标准Document Change Control文件更改控制application应用Request For Document Change (RDC)文件更改需visit to user用户访问求单review of requirements related to the productcontrol of documents文件控制有关产品的要求评审documentation requirements文件要求competent有能力的enquiry问询，询价effectiveness有效性field nonconformity analysis现场不符合分析determination of requirements related to the pr relevance相关性oduct 与产品有关的要求的确定interaction相互作用customer-related processes与顾客有关的过程detail design详细设计，详图设计，零件设计，施工preventive action预防措施设计management procedure for preventive actions预sales department销售部防措施管理程序sales contract销售合同planned results预期的结果checklist校验表，一览表，检查一览表intended use预期的用途calibration校准procedure for competence, knowledge and trainin submission of action plans行动计划的递交g of personnel员工能力 ,知识和培训程序documented procedures形成文件的程序personnel training procedure员工培训程序documented statement形成文件的声明supporting services支持性服务performance requirements性能要求functions职能部门responsibility职责organization 组织assignment of responsibility职责分工continual improvement of the organization组织workmanship 制造工艺的持续改进manufacturing acceptance criteria制造验收准则size of organization组织的规模quality policy质量方针Organizational Diagram组织机构图quality programs质量纲领final acceptance最终验收quality management system质量管理体系work instructions作业指导书quality management system planning质量管理体系策划performance of the quality management system质量管理体系业绩quality plan质量计划quality records质量记录quality objectives质量目标quality audit质量审核quality manual质量手册quality problem handling form质量问题处理单quality requirements质量要求allocation table of quality responsibilities质量职能分配表availability of resources资源的可获得性resource management资源管理allocation of resources资源配置provision of resources资源提供general requirements总要求，一般要求constituent part组成部件。
Quality-Manual-质量手册
4.2 文件要求 Documentation Requirements
5.1/5.2 管理职责 Management Responsibility
5.3 质量方针 Quality Policy
5.4 体系策划 System Planning
5.5.1/5.5.2 职责、权限 Responsibility and Authority
is continuously collecting the feedback from customers, and try to do our products better with various of new technologies. Completely satisfy the customers is our mission. Under the cutthroat competition of marketing environment, Nu Air try to perfect it’s quality management system and use a flexible strategy of business. Taking the opportunity of ISO9001 system audit, we are establishing the documentational quality management system according to the ISO9001:2000 standard, and implement it strictly, to make an overall and systemic quality control on product, continuously improve our quality and do it better.
质量手册翻译中英文术语表
P
preventive action 3.6.4
procedure 3.4.5
process 3.4.1
product 3.4.2
project 3.4.3
Q
qualification process 3.8.6
quality 3.1.1
quality assurance 3.2.11
3.2.9 质量策划 quality planning
3.2.10 质量控制 quality control
3.2.11 质量保证 quality assurance
3.2.12 质量改进 quality improvement
3.2.13 持续改进 continual improvement
3.2.14 有效性 effectiveness
inspection 3.8.2
interested party 3.3.7
M
management 3.2.6
management system 3.2.2
measurement control system 3.10.1
measurement process 3.10.2
measuring equipment 3.10.4
3.2.15 效率 efficiency
3.3.1 组织 organization
3.3.2 组织结构 organizational structure
3.3.3 基础设施 infrastructure
3.3.4 工作环境 '77ork environment
3.3.5 顾客 customer
3.3.6 供方 supplier
中英质量手册
中英质量手册CHAPTER TABLE / 名目:1.PRESENTATION OF XXX SAFETY LTD AND XXX TANNERY介绍XXX手套厂有限公司和XX皮厂 (2)2.DECLARATION OF THE BOARD董事会宣言 (4)3.QUALITY POLICY质量政策 (6)4.PURPOSE, SCOPE AND MANAGEMENT OF THE QUALITY MANUAL质量手册的目的、范畴和治理 (9)5.DEFINITIONS定义 (10)6.QUALITY MANAGEMENT SYSTEM质量治理体系 (11)7.DESCRIPTIONS OF THE INTERACTIONS BETWEEN THE PROCESSES过程之间相互作用的表述 (13)8.DESCRIPTION OF THE PROCESSES程序描述 (16)ANNEX DOCUMENT / 附件:Creation Date: 2005/11/28 1/381.PRESENTATION OF XXX SAFETY LTD AND XXX TANNERY 介绍XX皮手套厂有限公司和XX皮厂1.1.General informations / 总讲明Name 名字xx Safety Ltdxx皮手套厂有限公司xx Tanneryxx皮厂Address 地址Telephone 电话Fax 传真Business license N°注册号Registration Place 注册地Company creation date 公司成立时刻Validity limits time 有效期Board 董事1.2.Activities / 行为Xxx Tannery ensures the design and manufacturing of safety leathers and Xxx Safety Ltd of PPE (Personal Protective Equipment). All the products are made according to the current specifications and standards.确保xxx皮厂设计和生产的皮革和xxx皮手套厂有限公司设计和生产的个人防护用品差不多上依照当前的规范和标准制造的。
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ContentsClause No. Description0Contents1Foreword2The management of quality assurance manual3Terms4Quality assurance system requirements4.1Management responsibility4.2Quality system4.3Contract review4.4Design control4.5Document and data control4.6Purchasing4.7Control of Employer-supplied product4.8Product identification and traceability4.9Process control4.10Inspection and testing4.11Control of inspection, measuring and test equipment4.12Inspection and test status4.13Control of nonconforming product4.14Corrective and preventive action4.15Handling, storage, packaging, preservation and delivery 4.16Control of quality records4.17Internal quality audits4.18Training4.19Servicing4.20Statistical techniquesChart Organization structure of quality assurance system of the Company Attachment No.1: Quality system requirements and quality responsibility Attachment No.2: List of documented procedures1Foreword1.1Brief Introduction of the CompanyCSCEC Construction Co. LTD is a construction enterprise invested byhis holding company, China State Construction EngineeringCorporation (CSCEC) offering mainly services of general projectmanagement in engineering construction projects contracting business.The company was established and registered in China in 1993 and itwas ratified as a state-level construction contracting enterprise by theMinistry of Construction of PRC.The project of Beijing Lufthansa Center (a national project) contractedby the predecessor of the company was executed and managedseverely in accordance with FIDIC contract conditions and wascompleted on time with good quality. The project was awarded “LuBan Prize ”, the designation of good qualit y project by the Ministry ofConstruction of PRC, and the National Prize for Good Quality Project.The company have enjoyed the high social prestige and obtained theeconomic effect. Since the establishment of the Company, theCompany has contracted or completed in succession the major projects,such as the New German Embassy in Beijing, the NORINCO Building,Beijing Sunflower Tower, Bayer Pharmaceutical Plant and Head OfficeBuilding of Bank of China, etc.The Company strictly implements the contract, and puts quality first inits contracted projects. The Company always satisfies the Employersby offering the quality services that conform to the internationalquality standards.The Company, soon after its establishment, formulated the qualityassurance system in accordance with the requirement of GB/T 19000--- ISO 9000 and was given formal recognition and certificate ofquality system certification for ISO 9002.The Company possesses a group of excellent engineering technicalpersonnel with the knowledge of the international contract conditionsand the sound contract management, and with rich practicalexperiences in this field both in China and abroad. The Company alsoposses abundant capital and stable network for purchasing thematerials, machinery and equipment for construction projects both inChina and abroad. The Company may undertake all kinds of Works ofcivil Engineering construction, including industrial and civil buildingprojects.The Company may offer consultant service for project constructionand project consultant, and project design, and the service for importand export trade of building materials, etc.1.2Introduction of the Quality Assurance ManualThis Quality Assurance Manual has described and defined the qualitysystem, the quantity policy and the quality objectives of the Company.The manual shall be a guide document concerning the quality systemof the Company.The manual shall be applied to all kinds of Works of Civil EngineeringConstruction contracted by the Company, including industrial and civilbuilding projects.The manual shall be a top secrete document controlled by theCompany.The manual shall be prepared by the Quality Assurance Division andreviewed by the Management Representative. The manual shall comeinto force from the date of approval by the Managing Director of theCompany.2.The Control and Management of Quality Assurance Manual2.1Approval2.1.1Before the manual is officially issued, the Quality Assurance ManualShall be reviewed by Managing Director, Management Representative,Managers of Project Division and Division managers in order toguarantee its clear and accurate meanings, its suitability and itsreasonable structure.2.1.2The manual shall come into force beginning from the date of approvalby the Managing Director of the Company and shall be carried intoeffect beginning from the approved date of implementation.2.2Issue2.2.1The original and the copies of the Manual: The approval page of theoriginal of the Quality Assurance Manual shall be put by the ManagingDirector’s own signature, and the rest page s of the originalManual shall be signed by those responsible for preparing,reviewing and approving the document.The copies of the Manual shall mean the copies of the original of theQuality Assurance Manual. The original of the Quality AssuranceManual shall remain in the sole custody of the Quality AssuranceDivision and the copies of the Manual shall be issued to all the holdersof the Manual.2.2.2The holders of the manual shall include the Company’s leaders,Management Representative, managers of Project Divisions, divisionmanagers, project managers and other approved holders. The details ofthe manual holders will be prepared by the Quality Assurance Divisionand will be submitted to the Management Representative for approval.2.2.3The Quality Assurance Division shall in unified way, distribute theManual. The seal of controlled documents shall be attached to theQuality Assurance Manual distributed by the Quality AssuranceDivision. The Manual shall be numbered for the control purpose. TheQuality Assurance Division shall fill out a register of controlleddocuments.2.2.4When the above mentioned holders of the Manual leave their relevantoffices, they shall immediately return the Quality Assurance Manualwhich they hold, and the Quality Assurance Division shall write offtheir registrations.2.3Amendment2.3.1 Any amendments to the Manual shall be made by the QualityAssurance Division and shall be approved by the ManagingDirector of the Company. Any amendments without an officialamendment notice shall be deemed to be null and void.2.3.2The Quality Assurance Division shall be responsible for sending theamendment notice to the holders of the Manual and shall require all theholders to be responsible for making amendments. The QualityAssurance Division shall keep the records of any amendments on theAmendment Sheets of Quality Assurance Manual. The amendmentsheets shall, together with the contents of amendments, be sent to allthe holders of the Manual.2.4Use and Custody2.4.1When the holders of the Manual receive the amendment sheets of thequality manual, the holders shall sequentially attach the amendmentsheets to the front of the Manual in order to find out the case ofamendments to the Manual.2.4.2The holders of the Manual shall be responsible for implementation ofthe provisions of the Quality Assurance Manual.2.4.3The holders of the Manual shall be responsible for the custody of theManual which they hold, and shall prevent the Manual from anydamage, loss and alterations to the Manual. When the Manual is founddamaged and lost, the holders of the Manual shall immediately reportthe matter in question to the Quality Assurance Division.2.5uncontrolled Copies2.5.1 For the purposes of Employer and quality audit body off-site usageand other distribution of the Manual where change control is notintended, all such distributed manuals shall be clearly identified asuncontrolled copies.2.5.2 When any Divisions and Projects need uncontrolled copies of theManual, they shall, in written form, apply to the ManagementRepresentative for approval. The applicant shall, in his application,state the reasons for uncontrolled copies of the Manual and its holder.2.5.3 The Quality Assurance Division shall be responsible for distribution ofuncontrolled copies of the Manual. The seal of controlled copies shallnot be attached to the cover of the uncontrolled Manual. The QualityAssurance Division shall fill out a register of distributing uncontrolledcopies.3Definitions3.1General TermsFor the purposes of this Quality Assurance Manual, The definitionsgiven in ISO8402 apply.3.2Definitions related to this ManualTerms DefinitionsEmployer m eans the legal person or natural person whoowns a construction project and decides toaward the project to the Company by the formof signing and concluding a Contract or anAgreement.The Employer in the Manual alsorefers to his holding company. (It is calledcustomer in International Standard ISO 9002).Company means CSCEC Construction Co. LTD.Company Leaders m eans Managing Director, Deputy GeneralManager, Chief Economist, Chief Accountant,Chief Engineer, and ManagementRepresentative of the Company.Management Representative means the person from the Company’smanagement appointed by the ManagingDirector. He shall be responsible for thequality system of the Company.Manager of Project Division M eans the person appointed by the ManagingDirector to act as Manager of Project Divisionwho shall be responsible for the managementof all the projects in the project division.Project m eans the management organization whoShall execute and manage the constructionproject (works) contracted by the Company.Subcontractor means the legal person or the natural person towhom some parts of the Works issubcontracted by singing and concluded theSubcontract between the Company and theSubcontractor. Such Subcontractor also meansone of the Subcontractors defined in theStandards.Supplier means the legal person or the natural personwho provides products and materials to theCompany by signing and concluding aContract for supplying goods. Such Supplieralso means one of the Subcontractors definedin the Standards.Employer’s Contract means the Contract for the constructionproject (works) signed and concluded by andbetween the Employer and the Company, ormeans all the requirements (hereinafter alsocalled the Contract) agreed and communicatedby any means between the Employer and thecompany.Subcontract means the Subcontract for part of thecontraction works signed and concluded byand between the Company and theSubcontractor.Products means all raw materials, semi-finishedproducts, structural components andmachinery and equipment for incorporation inthe permanent works.Division / Project means the short form for all the Divisionand/or the Project.4Quality Assurance System Requirements4.1Management Responsibility4.1.1Quality Policy4.1.1.1The quality policy of the Company shall be as follows:We believe in the principle of winning our Employers’ trust withexcellence in the quality of our products and services.4.1.1.2The policy reflects what we require of our entire staff: devotion andtrustworthiness. Translated into action, this means continuous drive toraise the efficiency of management and update our expertise withconcerted effort. Such improvement is seen in the quality of ourproducts and services and in our unfailing effort to meet all therequirements of our Employers.4.1.1.3The quality objectives of the Company shall be as follows:Strict procedures for the best possible management, high levelexpertise, first class quality guaranteed for all the contracted Works,projects meeting all requirements for their immediately acceptance byEmployers upon completion (immediately acceptance ratio up to100%), good quality ratio up to 80 percent per unit of works, workseligible for “Excellence in Quality” and “Luban Prize” awards of theMunicipality and the Ministry, guaranteed satisfaction andzero-complaints from Employers.4.1.1.4The Personnel Division shall be responsible for training courses of thequality policy and the quality objectives. The Personnel Division shallensure that all the Company staff shall be familiar with and master thequality policy and the quality objectives.4.1.1.5In order to implement the quality policy and the quality objectives inall the projects, each construction project shall work out the qualityplanning prior to the commencement of the works, and shall define thequality objectives and the management measures of the project.4.1.2Organization4.1.2.1Responsibility and AuthorityA.Establishment of Organization StructureThe Company Leaders are responsible for establishing and adjustingthe Company Organization structures, defining the responsibility,authority and the Company Leaders shall define interrelation of thepersonnel who engage in the work affecting the quality. Theorganizational structures related to the Company’s quality assurancesystem and functions related to the quality assurance system areannexed to this Manual (See Attachment No.1)B.Description of Quality Responsibilitya.The Managing Director of the Company shall--- control and manage the overall work concerning the quality system of the Company;--- be responsible for working out the quality policy and the quality objectives of the Company, and approve the Quality AssuranceManual.--- establish and adjust the organization of the Company and define the responsibility and authority of the divisions of the Company.--- be responsible for the management review of the quality system and appoint the Management Representative.b.Deputy General Manager of the Company shall--- assist the Managing Director in the management of the quality system;--- participate in working out an d implementing the Company’s quality policy and the quality objectives, and assist the ManagingDirector in the management work;--- be authorized by the Managing Director to be responsible for the function divisions of the Company;--- Control and manage the plan and objectives of the work that he shall be i n charge of , and supervise the implementation of the planand the objectives of the work;--- be responsible for the quality assurance and the quality improvement that he shall be in charge of.c. Management Representative shall--- ensure that the Co mpany’s quality system shall be established, implemented and maintained;--- participate in working out and implementing the quality policy and the quality objectives of the Company;--- be responsible for approving the documented procedures and the Project Quality Plan;--- be responsible for supervising the internal quality system audits of the Company;--- assist the Managing Director in management reviews;--- report the results of the operations of the quality system of the Company to the Managing Director;--- arranging the quality system audits of Subcontractor;--- on behalf of the Company, deal with and coordinate all the work concerning quality management and the quality assurance betweenthe Contractor and the Employer, and be responsible for the workrelating to the quality system certification.d. Three Chiefs shall--- participate in working out and implementing the quality policy and the quality objectives of the Company, and assist the ManagingDirector in t he Company’s work;--- be authorized by the Managing Director to be responsible for the divisions of the Company;--- control and manage the plan and objectives of the work that he shall be in charge of, and implement the plan and the objectives ofthe work in question;--- be responsible for the quality assurance and quality improvement of the work he shall be in charge of.e.Manager of Project Division shall--- Participate in working out and implementing the quality policy and the quality objectives of the Company;--- be authorized by the Managing Director to be responsible for the projects in the project division, and shall, on behalf of theCompany, accept the Works and guide the execution of the Works;--- carry out the following work: Contract review, tendering, signing the Contract, the Project Quality Planning, the completion of theWorks and remedying defects in the Works;--- be responsible for the quality assurance and the quality improvement of the projects in the project division that he shall bein charge of.--- be responsible for approving the Project Quality Plan prepared by the Project.f.Quality Assurance Division shall--- assist the Management Representative in promoting and implementing the ISO9000 family;--- assist the Manager Director in preparing the quality policy and the quality objectives of the Company.--- be responsible for the work relating to preparation, issue, amendment and version change of the Quality Assurance Manualand documented procedures;--- assist the Management Representative in carrying out the internal quality system audits of the Company, and promoting andimplementing the Internal Quality Audits Procedures;--- be responsible for reviewing the “Project Quality Plan”. and responsible for reviewing the Project Quality planning;--- implement the laws and regulations of the safety and prepare the detailed rules and regulations for implementation, and beresponsible for reporting, analyzing and dealing with the incidentsand educating the relevant personnel;--- promote and implement the Process Control Procedures, theControl of Nonconforming Product Procedures and theCorrective and Preventive Action Procedures;--- be responsible for preparing the training plan for all personnel performing activities affecting the quality system and the personnelperforming specific assigned tasks, and implement the training plantogether with the Personnel Division;--- pay a return visit to the completed works and deal with the claims from the Employer, and shall supervise and implement theServicing Procedures;--- be responsible for supervising the application of the statistical techniques, and for implementing the Statistical TechniquesProcedures.g.Planning Division shall--- assist the Managing Director in adjusting the Company organization structure, and defining the responsibility and authorityof all personnel of the Company.h.Administration Division shall--- be responsible for the management and control of the Company’s documents, and shall supervise and implement the Document andData Control Procedures ;--- be responsible for the management and control of the Company’s files, and shall supervise and implement the Control of QualityRecords Procedures.i.Personnel Division shall--- prepare the training plan for all personnel of the Company, and shall supervise and implement the Training Procedures;--- provide all personnel relating to the quality management and other personnel of the management, and shall assess their assigned tasks;--- be responsible for training all personnel performing specific assigned tasks and shall ensure that all staff members are theholders of the professional qualification certificate.j.Estimation Division shall--- prepare the tender documents, guide and participate in the Contract evaluation, and shall promote and implement the Contract ReviewProcedures;--- be responsible for evaluating the Subcontractor, assist the Project Divisions in selecting the Subcontractor, and shall supervise andimplement the Subcontractor Select Procedures;--- prepare the training plan for the personnel relating to the tendering and other business management and shall implement the trainingplan together with the Personnel Division.k.Financial Division shall--- review the relevant Sub-clauses concerning financial matters in the Contract (by and between the Employer and the Company), theSub-Contract (by and between the Company and Subcontractor)and the purchase Contract (by and between the Company and theSupplier);--- participate in reviewing the qualification and selection of Sub-contractor and the Suppliers, and shall be responsible foranalysis and evaluation of the financial position and thepayment ability of the Subcontractor and the Suppliers.l.Legal Division shall--- be responsible for reviewing the legal documents of the Contract;--- ensure that the original copy of the Contract shall be in his custody. m.Purchase and Supply Division shall--- be responsible for the evaluation of the Suppliers, the purchase of the materials and the verification the purchased product, and shallsupervise and implement the Product Purchasing Procedures ;--- supervise and implement the Product Identification and Traceability Procedures, and the Handling, Storage, Packaging,Preservation and Delivery procedures;--- be responsible for purchasing machinery and equipment for the contracted construction works including the correspondingservicing;--- prepare the training plan for the personnel relating to purchase and supply of the materials, and shall implement the training plantogether with the Personnel Division.n.Technical Supply Division shall--- be responsible for the technical specifications of the Works and the standards management, and shall define the standards ofworkmanship and the construction methods, and shall superviseand implement the Inspection and Testing Procedures and theInspection and Test Status Procedures;--- participate in the tendering of the project, and shall prepare the construction plan;--- assist the Project in preparing the Construction organization, design and the major construction plan;--- be responsible for the development and the promotion of new technology, new workmanship and new construction materials;--- be responsible for the control of inspection, measuring and test equipment and the quantity measurement, and shall supervise andimplement the Control of Inspection, Measuring and TestEquipment Procedures;--- be responsible for preparing the corrective and preventive action on the nonconforming products of the project;--- prepare the training plan for the personnel in the technical system, and shall implement the training plan together with the PersonnelDivision.o.Mechanism and Electricity Division shall--- be responsible for the evaluation of the Supplier of mechanical and electrical equipment, and the procurement of the mechanical andelectrical equipment;--- be responsible for the second design of the mechanical and electrical installation project, and shall prepare the constructionplan for the mechanical and electrical installation project;--- assist the Project in the implementation of the mechanical and electrical installation project.p.Finishing and Decoration Division shall--- be responsible for the second design for the finishing and decoration project, and shall prepare the construction plan for thefinishing and decoration project;--- assist the Project in the supervision and the implementation of the finishing and decoration project.q.Project shall--- prepare the Project Quality Plan, and shall supervise and implement the Project Quality Plan;--- prepare the construction yearly, quarterly and monthly plan of the project ;--- prepare the guidelines for the operation, the operation procedures, and shall tell the details of the technical specifications andstandards to the Subcontractor;--- prepare the plan of the project construction products;--- fill in the form for the evaluation to the Subcontractor and the Supplier;--- collect and take care of the quality records for the construction works.4.1.2.2ResourcesThe Company shall provide the necessary resources to satisfy theimplementation of the quality policy and the quality objectives. Thesuitability of the resources shall be evaluated by the managementreview. When the case of the non-suitability, the Managing Directorshall deal with the matter in question. The resources for incorporationin the works shall, in accordance with the provisions of the Contract,the character of the Works and the quality objectives, be defined whenthe project quality is planned, and shall be guaranteed and coordinatedby the CompanyThe Company shall take appropriate measures to assign the trainedpersonnel to verify and audit the quality system. The verification shallcover the whole process of the Work such as, the inspection, testingand supervising of the design, execution, installation and technicalservices, etc, and the inspection, testing and supervising of thecompleted works. All quality audits activity shall be carried out by thepersonnel independent of those having direct responsibility for theactivity being audited.4.1.2.3Management RepresentativeThe Managing Director shall appoint a member of the Company’smanagement as the Management Representative. The ManagementRepresentative shall arrange and supervise the implementation of thequality system. The Quality Assurance Division shall assist theManagement Representative in the implementation of the qualitysystem. For the detailed responsibility of the ManagementRepresentative, please see Sub-Clause 4.1.2.1 c of this Manual.4.1.3Management Reviewa.The Managing Director shall be responsible for supervising and implementingthe management review. The management review shall, in general, beimplemented once every interval of 12 months, usually at the end ofthe year, that is the Month of December each year. The ManagingDirector shall decide to increase the intervals of the managementreviewing when the organizing structure, the quality system, themarket situation or rules and regulations have been Changed greatly.b.The Management Representative shall convene the meetings of themanagement review. The Company leaders, the manger of ProjectDivisions and the managers of Division shall attend the meetings.c.Contents of Management Review--- to analyze the conformity of the quality system;--- to analyze the effectiveness of the quality system;--- to analyze the suitability of the quality system;--- other important matters relating to the management review .d. The management review shall be carried out in accordance with theManagement Review Procedures. The records of management reviewshall be maintained and stored in accordance with the provisionsdefined in Sub-Clause 4.16 of this Manual.e. The Management Representative shall be responsible for supervisingand implementing the spirit and the requirements decided in themeeting of management review, and all the tasks put forward bythe meetings.f. The Quality Assurance Division shall assist the Managing Director andthe Management Representative in dealing with the day to day work ofthe management review.4.2Quality System4.2.1GeneralThe Company shall, in accordance with the standards and requirementsof ISO9002 1994, establish and document the quality assurancesystem.The documents of the quality system of the Company shall include thefour level documents as follows:--- quality assurance manual--- documented procedures--- supported documents--- quality records4.2.2Quality System ProceduresThe Company shall prepare documented procedures and shalleffectively implement the quality assurance system in the wholeconstruction processes. For the details of documented procedures,please see Attachment No.2.The documented procedures shall be established as a managementsystem in connection with the requirements by all elements of thequality system, and shall also be deemed to be the way defined for theimplementation of a quality activity.4.2.3Quality Planning4.2.3.1The quality system of the Company and its relevant documents shallapply to all the projects contracted by the Company. To guaranteeeffectively the performance of the quality assurance system in eachconstruction project, the Project Division shall, in accordance with theprovisions specified in the contract, prepare the Project Quality Planbefore the commencement date of the Works.。