ISO15195：2018质量手册英文版模板
ISO9001质量手册-中英文版
2. 引用标准………………………………………………………………………………….7 Normative reference
3. 术语和定义……………………………………………………………………………….7-8 Terms
4. 质量管理体系 Quality management system 4.1 总要求……………………………………………………………………………….8-9 General requirements 4.2 文件要求…………………………………………………………………………….9-11 Documentation requirements
开发部
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D&D Dept
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品质部
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QA Dept
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货仓部
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WH. Dept
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采购开发部
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Sourcing Dept
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人事 & 行政部
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HR & Admin. Dept
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Revision History 修订记录
E. 主要产品 Main products: 手袋及其它缝纫制品。
Bags and other sewing products. F. 主要生产流程 Main production processes:
开料→贴合/热压/电压/烫画→车缝→包装 Cutting→Lamination/Thermoforming/High frequency/Transfer sticker→Sewing→Packing G. 主要生产设备 Main production equipment: 裁床、贴合机、热压机、电压机、针车等. Cutting machine, lamination machine, thermoforming machine, high frequency machine, sewing machine, etc. H. 主要测试仪器 Main measuring devices: 盐雾试验机、破裂强度测试仪、卡尺、硬度计、千分尺、拉力计、推拉力计、电子天平、验 布机及及其它布料测试设备等. Salt spray test machine, broken strength tester, caliper, hardness tester, microscope, pull gage, push-pull gage, electronic weight scale, fabric inspection machine and other fabric testing equipment.
质量手册2018版
质量手册文件类别：□受控本□非受控本文件持有部门：文件发放编号：目录质量手册目录┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄１修改页┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 5批准页┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄6公司简介┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 7管理者代表任命书┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 8质量方针、质量目标┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 9各部门质量目标分解┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 10公司组织机构图┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 11质量体系组织结构图┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 12质量管理职能分配表┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 131 范围┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄１62 引用标准┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄１73 术语和定义4 质量管理体系总要求┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄２6文件要求┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄２74.2.1 总则┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄２74.2.2 质量手册┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄２84.2.3 医疗器械文档┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄２9文件控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄２9记录控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 305 管理职责管理承诺┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 32以顾客为关注焦点┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 32质量方针┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 33策划┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄335.4.1 质量目标┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄335.4.2 质量管理体系策划┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄34职责、权限和沟通┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 34┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄426 资源管理资源提供┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄45人力资源┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄45基础设施┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄46工作环境和污染控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 48工作环境┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 48污染控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 507 产品实现产品实现的策划┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄51与顾客有关的过程┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 52设计和开发┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 54总则┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 54设计和开发策划┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 54设计和开发输入┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 54┄┄┄┄┄┄┄┄┄┄ 55设计和开发评审┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 55设计和开发验证┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 56设计和开发确认┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 56设计和开发转换┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 56设计和开发更改的控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 56设计和开发文档┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 57采购┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 58生产和服务提供┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 607.5.1 生产和服务提供的控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄607.5.2 产品的清洁┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄617.5.3 安装活动┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 617.5.4 服务活动┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄617.5.5 无菌医疗器械的专用要求┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄62生产和服务提供过程的确认┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 62灭菌过程和无菌屏障系统确认的专用要求┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 63标识┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 64可追溯性┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 64顾客财产┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 65产品防护┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 66监视和测量设备的控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 678 测量、分析和改进总则┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 69监视和测量┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 698.2.1反馈┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 69抱怨处理┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 70向监管机构报告┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 71内部审核┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 73过程的监视和测量┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 74产品的监视和测量┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 74不合格品的控制┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 76数据分析┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 78改进┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 798.5.1 总则┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄798.5.2 纠正措施┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 808.5.3 预防措施┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 81修订页批准页为提高本公司产品的品质，提升产品的市场影响力，贯彻本公司的质量方针，依据《医疗器械生产质量管理规范》（以下简称《规范》）、《医疗器械生产质量管理规范附录无菌医疗器械》（以下简称《附录》）、ISO 13485：2016 idt YY/T 0287：2017《医疗器械质量管理体系用于法规要求》、ISO 9001：2015 itd GB/T 19001:2016《质量管理体系要求》及相关法律、法规、规章和标准并结合我公司的实际情况重新制订此《质量手册》。
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。
质量手册英文版
1 Control program of (management) document and dataXLC/QP07.01-02 Page 1 Total: 2 pages 1.1 Aims and applicable scopeIn charge of documents and data about quality system and guarantee the related Dept. use the available edition.1.2 Obligations1.2.1 Quality Dept. is responsible for the delivering and controlling of quality manual and program file.1.2.2 Every functional Dept. is in charge of the delivering and controlling of each files and dada.1.3 Working Procedures1.3.1 Classification and serial numbers of files and data1.3.1.1 Controlled and uncontrolled files are divided into. Quality manual and programmed filethe responsible belong to the controlled. “Controlled files checking list” should be proposed by people in related Dept and then checked by the director in that Dept. Finally, representative supervisor approve that. The controlled files should be marked with ID, numbers, whereas, the unrolled files on the contrary.1.3.1.2 Quality Dept. makes “document number regulation” (without technical files) and that canbe carried out after obtaining the approval of the representative supervisor.1.3.2 Composing, examining, approving and delivering of documents1.3.2.1 The representative supervisors organize the composing of the quality manual and programmed files and the functional departments are responsible of composing each document.1.3.2.2 The representative supervisor check the quality manual and the General Manage approve it;every functional manages make a joint checkup for programmed files and directors approve thosefiles; the other files should be checked by each functional supervisors according to sufficiency and adaptation.1.3.2.3 Quality manual and programmed files will be delivered by Quality Dept. and alsoby the data administrators “Borrowing files registration form”. The other files should be deliveredin each functional department in the certain range.1.3.2.4 “Inner Notice” as the main form of XLC inner management document will be delivered in certain scope which is approved by examiner and the getters will sign on the original files and then get the copy one.1.3.3 Altering and cancellation1.3.3.1 The representative supervisor organizes the altering of quality manual and programmed files. After altering of the documentation, the altering marks and valid time will be given. The original files will be taken back document administrator in Quality Dept and the obvious markswill be stamped on.1XLC/QP07.01-02 Page 2 Total: 2 pages1.3.3.2 The other altering files will be carried out by each department and then checked by thedirector of each department after altering. Serial numbers and valid time should be marked. Eachdocument administrator take bake all the files and destroy them completely. Then new files can begiven out. Meanwhile, the altering reasons and contents should be told to representativesupervisors in the form of Inner Notice. “The controlled files checking list” of each Dept. should also be changed when it is necessary.1.3.4 Files management1.3.4.1 The document administer in every department is responsible the files management.1.3.4.2 The document should be easily recognized and referred to.1.3.4.3 When the user?s files seriously damaged, the document administrator should be informedimmediately for altering and reissuing.1.3.4.4 The document administrator should check the efficiency of the files regularly and change“controlled files check list” in time.1.3.5 Controlling the external filesDirect use the external files should be approved by the director of document management department. Marks should be added and fill in the check list and control delivering.1.4Relevant Documents1.4.1 “Quality Manual”ty Records Controlling Program1.4.2 “QualiProcessing methods about internal files in Company”1.4.3 “1.4 Quality Records1.4.1 Files Using Registration Form1.4.2 Inner Notice1.4.3 Controlling data checking list22 (technical) documents and data control procedureXLC/QP07.02-02 Page 1 Total: 2 pages 2.1 Aims and applicable scopeControl the technical files related to quality system and guarantee the valid versions of those documents.It can be applied to the controlling technical data about quality system.2.2 ObligationsDocument controller is responsible for delivering, controlling and supervising technical files. Thetechnical department is in charge of making, changing and controlling drawings and part lists (Inthe form of Product BOM).2.3 Working Procedures2.3.1Files under control (included the electronic document)Drawings and part lists, technical process sheet, modification notice.2.3.2examining and approving of documents2.3.2.1Technical Department make drawings and part lists and enter Product BOM(part list) in toERP system.2.3.2.2Technical director examines and approves drawings and part lists.2.3.3documents management2.3.3.1 Document controller provides drawings and part lists according to part list(BOM) and delivery to the relevant departments.2.3.3.2The technical files under control can be delivered in a certain range made by document maker after the approving of technical manager. For the altered production drawings or part lists,the document administer delivery files in the approved range which written in the applying list forchanging. At the same time, cancel and destroy the returned drawings.2.3.4Altering of filesThe applicant gives the ID Numbers and changing conditions for the damaged drawings and partlists. The document administrator changes them according to “Managing Regulations of drawings and part lists”. The drawing only can be printed but no copying.2.3.5 Altering of files2.3.5.1 The applicant who wants to change the files should fill in a form (that?s a pplying list for changing) and describe changing reasons, contents and delivering range. The related changing technical data should be enclosed on. It can be changed after the approving of technical manager.3XLC/QP07.02-02 Page 2 Total: 2 pages2.3.5.2 After modifying the technical documents, the modifying condition marks must be noted.files modification 2.3.5.3 After modifying documents, the document controller delivery” Technicalin relevant delivering scope.notice”2.3.6 Management of technical files2.3.6.1 In daily time, technical documents are often charged by document administrator. The technical drawings will be recorded in the tapes as copies from working net by technical managerwho is responsible for controlling the technical drawings.2.3.6.2 The technical department is responsible for entering new data in XLC management system(ERP) and preserves them. The using rights shall be guaranteed by microcomputer managementsystem.2.3.7 The controlling of external technical filesThe external technical files such as standard, drawings offered by customers, technical dada supplied by sub-contractor should be kept by technical Dept. Technical Manager?s approval should be obtained when they will be used.2.4 Relevant Documents2.4.1“Technical documents serial numbers regulations”2.4.2“Drawings and part lists managing rules”2.5 Quality Records2.5.1 Document modification notice43 Quality records control programXLC/QP07.03-02 Page 1 Total: 2 pages 3.1 Aims and applicable scopeEfficiently control and manage the quality records, which can demonstrate the products quality meeting certification and quality system running efficiently.Quality Systems are suitable for all related records.3.2 ObligationsQualities Dept. is responsible for making program document and supervises the controlling condition of every department towards quality records.Every functional department is in charge of each quality records.3.3 Working Procedures3.3.1 Quality records are the true records of forming product quality. They prove that products have reached the quality requirement level and demonstrate the proof of our company quality system running efficiently.3.3.2 The range of quality records:Every department work out each quality records checking list and hand in to Quality Dept.3.3.3 Intermediary form of quality records:Quality records can be taken down in the forms of tables, reports, documents and E-media.3.3.4 The filling requirements of quality records:Fill in the quality records carefully and clearly for easy recognizing and meanwhile guarantee thecorrection of whole contents. Faking fillings are not allowed. The signature confirmation by quality recording personnel has to be obtained when necessary.3.3.5 Collection of quality records, labels and conservation:Every functional department collect quality records according to the range of quality record checking list and make on each quality records for easy looking for. The quality records have to bekept well. The suitable environment which can prevent for damp and damage has to be offered byeach functional department for keeping quality records well.3.3.6 File and sort out the quality recordsFor easy management controlling, quality recorder should file the quality records. After filing, every functional department sort out and mark the quality records according to certain standard.5XLC/QP07.03-02 Page 2 Total: 2 pages3.3.7Quality records should be provided to customers for referring to when there isrequirement in contracts.3.3.8Conservation terms and dealing methods of quality records:The keeping period of Quality records should not be less than three years (except the products files).When there is a changing on quality records, the quality recorder propose aapplying in the form of inner notice and give it to each department director to approve.Casual changing is not allowed on quality records. The people who change the recordsshould sign on the changing place and mark on the exact changing time. When destroythe quality records, the quality recorder make a checking list and hand in to every functional director for approving.Products files should be preserved for all the time. The products files which have beenkept more than 3 years will be conserved in the form of E-media.(CD, Disk saving).3.4Relevant Documents(Management) documents and data controlling program3.5 Quality Records3.5.1 Quality records checking lists64 Quality management system planned programXLC/QP07.04-02 Page 1 Total: 3 pages 4.1 Aims and applicable scopeQuality management plan aims for realizing our company?s quality policy and aim.Identify and plan the processes and resources which are applicable for ensuring realizing qualitypolicy and process and resource of aims.4.2 Obligations4.2.1 General Manager is responsible for approving the quality planned outputs documents whichare made by the related departments according to our company?s quality policy, aims and the necessary resources.4.2.2 Management representative is responsible for reviewing the related documents which are made for quality management plan.4.2.3Quality department is responsible for organizing each department to manage and plan and make the corresponding planned documents. Supervising and checking shall be implemented.4.2.4 The managing people of each department shall be responsible for quality plan of their departments.4.3Working Procedures4.3.1 Quality aims4.3.1.1 In order to realize the quality policy of organizations, the general quality object of organization is:(1) finished products delivering pass percent is 100℅for one time(2) Components and parts(3) customer?s satisfaction rate shall be no less than 90％(4)the feedback rate of malfunction is less than 5％in early time (3 months)(5)20％has been increased ( product market expanding rate)(6) Explore the new products successfully at the first time4.3.1.2 Each department which related to quality shall divide the whole object of the organizationinto several small exact objects. In order to reach the quality goal successfully, the correspondingquality plan shall be implemented.4.3.2 The appropriate opportunity for making quality planQuality plan shall be carried out when company is in the following situations:a)Quality management system shall be established and improved according to qualitymanagement standard.7b)Important changes of company?s quality policy, quality aim and company?s organization.c)Important changes of company?s resource arrangement and market situation.d)The present document of system can?t cover the special items.e) 4.3.3 Quality planned contentsThe General Manager should identify and plan the necessary resources which ensure realizing thequality aim. Quality planned contents shall include:a)Quality aim and corresponding quality management processes; inputs, outputs and activitiesof processes and make regulations.b)Identify the established resources arrangement of processes which are required for realizingquality aim.c)Review rules regularly for realizing the whole quality aim and phrase or partial quality aim.The improvement of processes and activities shall be focused on in review processes.d)Find the distance of quality aim according to review results and ensure improvingcontinuously for enhancing the efficiency and effectiveness of quality management system.e)The planned results shall be filed (includes changing) such as quality manual, programmeddocuments and so on.4.3.4 The principle of making quality planned outputs documents and the following principlesshall be complied with:a) Complying with company?s aim, the exact practice of product and process shall be madeaccording to GB/T19001-2000quality management system for satisfying operability.b) The character and scope shall comply with the requirements of law and rules and the otherrelated requirements and expectation of customers, and that shall be applicable for company forsatisfying applicability and efficiency.4.3.5 Making, audition and delivering of quality planned outputs documents4.3.5.1 Quality department is responsible for organizing each department to make quality planneddocuments according to XLC-QP07.01-02 “Management documents and data control program”．4.3.5.2 Name, serial numbers, organizer, auditor, approval and issuing data shall be written on thecovers of quality planned outputs documents.4.3.6 Implementation of quality plan, supervising and changing4.3.6.1 In the process of implementation, each department shall control according to the stipulatedcontents, schedule and requirements of quality planned results. The feedback of existed problemsand present situations shall be informed to quality department.4.3.6.2 Quality department shall inspect and check the present situations of quality plan.84.3.6.3Quality planned changea) The changing of quality planned output documents shall be carried out in the controlledcondition and the related department issue “Internal Notice” and finally it shall be implemented according to “Management documents and data control program”b) Keep the quality management system running completely in changing period, e.g. thecorresponding changing shall be done through organization adjustment4.3.6.4 The related documents resulted form quality plan shall be turned to quality department andthen file them.4.4Relevant Documents4.4.1 “Management documents and data control program”4.4.2 “Planned control program of realizing process”4.5 Quality Records4.5.1 Quality planner of each department output documents95 Management review procedureXLC/QP07.05-02 Page 1 Total: 3 pages 5.1 Aims and applicable scopeGeneral Manager assess regularly to the present situation of company?s quality system, adaptability and efficiency, which guarantees that is suitable for company?s policy and aim.This program is applicable for management review.5.2 Obligations5.2.1General manager is in charge of managing review5.2.2 Management representative is responsible for reporting the quality system running situationto General Manager and5.2.3 Director of each department shall be responsible for preparing the demanded and related datafor reviewing and raising corrective and preventative measures for implementation in review.5.3Working Procedures5.3.1 Management review shall be carried out per 12 months.5.3.2 When some important unusual situations about company?s quality system happening, the related personnel shall be called in for management review if General Manager thinks it?s necessary.5.3.3 Management representative organizes making management review plan and report to General Manager. Then general manager approve for issuing and implementing.5.3.4 The review plan shall be delivered to company?s leaders and each department director in tendays before.5.3.5 Management representative organizes every director of each department to collect and prepare the necessary materials for reviewing according to the review plans.5.3.6 Review contents include:a) Review results include internal quality system audition, the third party?s audition of customer?sreview and the results of product quality audition. The quality department provides the related data.b) Customer?s feedback includes the measuring results of customer?s satisfaction or dissatisfactionand customer?s complaints. The after-sales department offers the related data.c) Process outstanding achievement and product conformity, which include the results of process,product measurement and monitoring results. Each department offers the related data.10d) Improving, preventive and corrective measures. Every department offers the related data.e) Implementation and efficiency of the tracking measures to management review in the past.Quality department offers records and the comprehensible report.f) All various changes include inner and outside environment, law and rules, new technology, newtechniques, new equipment exploration and so on, which perhaps influence quality managementsystem. Every department offers the related data.g) The running situation of quality management system, which include the applicability andefficiency of quality policy and objectives.5.3.7 There are many forms of management review such as meeting and local reviews can beadopted. The general manager appoints some special personnel to make the exact review recordsin review process.5.3.8 Management review outputsapproved by General Manager is treated as the review5.3.8.1 “Management review report” outputs. Quality management system improving requirements, product improving requirements,and resources arrangement requirements shall be included in the report as the corrective andpreventive action for improving continuously.a) Improvement of quality management system and processes, which include the assessment toquality policy, quality aim, organization structure, process control and so on.b) the improvement of products which is required by customers; assessment to present productconformity include whether product process review is needed or the related contents about reviewcontents.c) Resources requirements and so on.5.3.8.2 Quality department conclude and then make “Management review report” according to management review outputs after ending the meeting. The management representative audits thereport and turn to General Manager for approving and then delivery to the related departments formonitoring and implementing. The outputs of management review in this time can be taken as theinputs of next management review.5.3.9 Implementation and verification of improving, corrective and preventative measures.Quality department tracks and verifies the implementation effects of improving, corrective and preventative measures according to the rules in “Improved control program”．5.3.10 Management of managing review documentsAll the documents and data of management review belong to controlled documents and managethem according to “Management documents and data control program”. All records and review results shall be controlled according to “Quality record control program”．115.4Relevant Documents5.4.1 “Management documents and data control program”5.4.2 “Quality record control program”5.4.3 “Internal quality system review program”5.4.4 “Improved control program”5.5 Quality Records5.5.1 Management review plan5.5.2 Management review notice5.5.3 Management audition report5.5.4 Corrective and preventative measures processes list126 Conscious, ability and training control programXLC/QP07.07-02 Page 1 Total: 3 pages 6.1 Aims and applicable scopeTo make the persons being trained be up to the regulations and requirements of related jobs.It is applied to educate and train all kinds of persons who work in and are related with quality jobs,including the supplier if necessary.6.2 Obligations6.2.1 Personnel Dept. is a vital ministry in a company to control human resources, and it is responsible to regulate and specify job responsibilities, to plan, identify and control the human resource demand of all departments, to organize, coordinate, implement and evaluate all kinds oftraining activities, as well as to make an overall assessment regularly.6.2.2 Engineering Dept. should cooperate with Personnel Dept. to implement technique training,safety education and special working procedure training.6.2.3 Quality Dept. should cooperate with Personnel Dept. to implement the training on workers? consciousness and management knowledge of quality.6.2.4 All departments should assist Personnel Dept. with their own professional technique training,to put forward training demand and keep employee training records, as well as to make humanresource plan and employee?s training, demand, assessment and ect on quality.6.2.5 Personnel Dept. is responsible to make job assessment standard ( including job description, qualification and technique standard ) and work responsibility.6.3Working Procedures6.3.1 Identification of ability and consciousnessIdentify ability requirements of all workers related with quality activities and make different job responsibilities and training according to different working positions, such as new workers, old workers, all kinds of professional workers, special technique workers, assessor and so on.6.3.1.1 Workers responsible for quality management system regulation should have capabilities,which are estimated by education, training, technique and experience.6.3.1.2 Every department is responsible to compile its own ,position responsibilities?, which is submitted to personnel dept. for collection and carried out with company leaders? approval.6.3.2 Training136.3.2.1Training PlanPersonnel department make and carry out training plan which base on the wide suggestions fromrelated departments and further investigation. From the practical situations of our company, the training contents, aims and checking system should be identified.6.3.2.2Training formsVarious forms of staff training can be adopted such as off-job-training, day releasing, off-hours and outgoing and short-term temporary arrangement.6.3.2.3Training contentsStaff training contents can be divided into quality conscience, quality management training; professional knowledge, skills training; safety educational training before work; special processing traininga ) training to leadersTo all directors in company?s departments, the training will be given according to GB/T19001-IS09001 combing with the quality manual and programmed files which made out form the quality system. All the leaders will know more about the quality system and every element in that system. From the training, they can use the methods, technical and efficient evaluation in the quality system.b) Technical and managing staff trainingThe technicians and managing staff included designer, technique people, purchasing, and qualitystaff should be given training from professional knowledge and quality management. Then theycan know our company?s quality system contents and obtain managing ways, technique, and requirements of their work.c) Training to production section supervisors and operatorsWorking skills and quality management basic knowledge training will be given to section supervisors and operators. This can make them know how to use equipment, tools, tolling, apparatus and instrument and testing equipment. Meanwhile, they are able to maintain those equipment well. Through learning our company?s quality manual, related procedure and guidancebooks and discussing each quality responsibility, people can record rightly and analyze the qualitysituation in production.d ) Train to new staffsSafety production training, working skills training should be given to new staffs. Basic concept ofquality management should be mentioned.e ) Special trainingSpecial training included welder, forklift truck driver, inspector, designer and so on). After specialtraining, the workers can start their work after obtaining the certificates.6.3.2.1evaluate the efficiency of offered training14Though theory examining, operation testing, working evaluation, the trainer will be judged whether they are capable of doing the work. In the end, staff training files will be established and preserved.6.3.3Worker?s daily working performance will be evaluated through personnel department organization. Spot-checking can be carried out to the staff in each department. To the unqualifiedpeople, train, test or change work position which can make the people are suitable for their abilities.6.4Relevant Documents6.4.1 “Quality Manual”6.4.2 “Management files and data control program”6.4.3 “Quality records controlling program”6.4.4 “Procedures of controlling program”6.5Relevant Documents6.5.1Staff temporary training applying6.5.2The theory and operation examining records of special workers6.5.3Yearly training applying form6.5.4Statistics form of special workers6.5.5Training attendance book157 Infrastructure and work environmentXLC/QP07.07-02 Page 1 Total: 2 pages7.1 Aims and applicable scopeIn order to realize meeting standard requirements of products continuously, identify and managethe factors of people and things in work environment for achieving conformity to product requirements.This program is applicable for the infrastructure needed to achieve conformity to product requirements. Infrastructure includes workspace, hardware and software, tools and equipment,supporting service such as communication or control of transporting facility and so on. Controlfactors of people and things in work environment.7.2 Obligations7.2.1 The maintenance section in Production Dept. is responsible for monitoring the neededfacilities which achieve conformity to product requirements.7.2.2 Personnel Dept. assists Production Dept. to monitor the needed work environment whichachieve conformity to product requirements.7.3Working Procedures7.3.1Identify and manage producing infrastructure.7.3.1.1 Identify infrastructureThe needed infrastructure which achieve product conformity include: work space (workshop,offices and so on), equipment and tools (includes working, clamp apparatus, measuring tools),software (computer net), supporting service (water, electricity, gas supplying), communicationfacilities, transporting facilities.7.3.2Infrastructure management7.3.2.1Every section director in Production Dept. makes the infrastructure investment plan fornext year in October. The investment plan will be reported to production manager. The PurchasingDept. purchases those facilities after obtaining leader?s approval.7.3.2.2The departments which use apply for self-making infrastructure, and technical departmentdesigns the drawings. After production manager approving, maintenance section organizes implementation.7.3.2.3For the purchasing and self-making infrastructure, maintenance section in Production Dept.organizes department which use to fix and adjust. After confirmation, both sides sign for checkingand accepting on “Infrastructure receiving report” and establish the basic information registration of producing equipment. For the working, clamp and measuring tools of low value and easydamage, the using departments should check by themselves16。
最新三体系手册（9001+14001+45001）-英文版
最新三体系⼿册（9001+14001+45001）-英⽂版Quality Manual ISO9001:2015 + ISO14001:2015 + ISO45001:2018ContentsContext of the Organisation (4)Company Overview (4)External and Internal Issues (4)Interested Parties (4)Vision, Mission and Values (5)SWOT Analysis (5)Key Business Strategies (6)Scope (6)Management Representative (7)IMS Structure (7)Process Flow (9)Leadership (10)Leadership and Commitment (10)Quality Policy (11)Environmental Policy (11)Health and Safety Policy (12)Organisation Roles, Responsibilities and Authorities (13)Planning (15)Actions to Address Risks and Opportunities (15)Legal and Other Requirements (16)Objectives, Targets and Plans (18)Support (19)Resources and Infrastructure (19)Training, Competency and Knowledge Management (20)Communication, Consultation and Awareness (22)Documented Information and Control of Documents (23)Operations – Marketing (25)Marketing - How to Publish a Blog (25)How to Manage Webinars (26)How to Publish Release Notes (26)Reporting End of Month Marketing Lead Performance (26)Operations – Sales and Partnering (27)Sales (27)Partner Process (27)Operations - Development (28)Developers Documentation (28)Development Requests and Bugs (28)Mango Application (29)Operations – Support and Testing (30)Mango Testing (30)Communication of Releases (30)Support (31)Implementation (31)Operations - Supplier Evaluation and Control (32)Operations – Health and Safety (33)Hazard Identification, Assessment and Control (33)Accidents / Incidents (36)Employee Participation (38)Emergency Planning – Health and Safety (40)Operations – Environmental (40)Aspects and Impacts Identification, Assessment and Control (40)Environmental Incident Reporting, Recording and Investigations (41)Environmental Emergency Planning (42)Performance Evaluation (43)Monitoring, Measurement and Evaluation (43)Internal Audit (44)Management Review (44)Improvement (45)Improvement and Corrective Actions (45)Context of the OrganisationCompany OverviewThe company enables its customers to meet their compliance requirements be they ISO 9001, ISO 14001, ISO 45001, local and government legislation and regulations.External and Internal IssuesThe company determines the external and internal issues that are relevant to its purposeand strategic direction and that affect its ability to achieve the intended results of the XXX. Consideration is given to the: Positive and negative factors or conditions.External context and issues, such as legal, regulatory, technological, competitive, cultural, social, political and economicenvironments.Internal context and issues, such as values, culture, organisation structure, knowledge and performance of the business. Determination and requirements of the needs and expectations of interested parties relevant to the XXX.Authority and ability to exercise control and influence.Activities, products and services relevant to the business.Documented information is retained as evidence to support that the context of the organisation has been taken into account in the XXX.Vision, Mission and ValuesVision: “Gets everyone involved and participating in QHSE”Mission: Makes compliance enjoyable.Values: Our customers’ are successful in complianceScopeThe XXX describes how the company requirements are to be addressed throughout its operations and addresses the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.Management RepresentativeThe Operations Manager is the currently appointed Management Representative and has responsibility and authority for:1.Ensuring that the:a.XXX is established, implemented and maintained in accordance with therequirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.b.XXX processes are delivering their intended outputs.c.Promotion of customer focus throughout the company.d.Integrity of the IMS is maintained when changes to the XXX are planned andimplemented.2.Reporting on the performance of the XXX to top management for review and as a basis forimprovement.IMS StructureInteraction of Processes in the XXThe company’s XX complies with:ISO 9001:2015,ISO 14001:2015ISO 45001:2018The XXX consists of the following levels of documented information:Policies: Policies are documents that demonstrate the overall commitment to improving quality performance and are authorised by the Management Team.System procedures: high-level procedures that define the activities that are to be fulfilled to ensure that the XXX that complies with standards.Module workflows, operational procedures and work instructions. Control and operational procedures:o Meet customers’ requirements.o Provide supplementary guidance and instructions to support the intent of the XXX.o Ensure that the requirements of the XXX will be adequately addressed within the organisation.Forms, registers and records are evidence to prove the XXX is operational.A diagram of the structure of the XXX structure is presented below.Mango compliance software solution:Provides automated workflows for the effective and efficient operation of the XXX.Underpins the XXX and serves as the main retention application for all documented information.Workflows and modules replace written procedures and forms associated with the process. They include the following:Process FlowPurpose and ScopeTo describe the interaction of process through the customer journey. ProcedureLeadershipLeadership and CommitmentPurpose and ScopeTo define how the company demonstrates leadership and commitment to its XXX.Procedure1.Top management will take responsibility for the effectiveness of the IMS and willdemonstrate their commitment to the xxx by:a.Defining roles, allocating responsibilities and accountabilities, and delegatingauthorities, to facilitate effective xxx management.b.Roles and Responsibilities are documented in Leadership - Organisation Roles,Responsibilities and Authorities and through position descriptions, and xxxprocedures where applicable. Ensuring:i.That relevant policies and objectives are established for the xxx and thatthese are aligned with the context and strategic direction.ii.The integration of the xxx requirements into the organisation's businessprocesses.iii.That resources needed for the xxx are available.iv.The IMS achieves its intended results.v.The process approach and risk based thinking is promoted. Communicating the importance of effective xxx management and of conforming to the IMSrequirements.vi.Engaging, directing and supporting personnel to contribute to theeffectiveness of the xxx.vii.Improvement is promoted.viii.Other relevant management roles are supported to demonstrate theirleadership as it applies to their areas of responsibility.2.Top management is committed to our customers and enhancing customer satisfaction. Thiscommitment is demonstrated by:a.Ensuring that applicable customer and statutory requirements are determined,understood and met throughout the business.b.Ensuring the risks and opportunities that can affect conformity of products andservices and the ability to enhance customer satisfaction are determined andaddressed.c.Exercising due care with our customer's property (data) whilst it is under the controlof the company.d.Monitoring customer's perceptions of the degree to which their needs andexpectations have been fulfilled.3.The key aspects of the customer information and data generated through the effectiveimplementation of the IMS processes are collected and collated by the ManagementRepresentative and presented at each Management meeting.Quality PolicyThe company is committed to providing and delivering the customer great product, great support and great marketing to make the management of our customer's compliance an easy and enjoyable experience.We are committed to:Meeting legal requirements.Continually improving our xxx.Meeting the needs and expectations of interested parties.To achieve this we will:Provide our customers with a quality product for the management of their compliance needs.Provide our customers with free content, information and industry insight to improve their compliance knowledge.Provide timely and accurate support to our customersListen to our customers when developing and enhancing the product.Provide an environment where staff can grow and learn new skills.Provide a return to shareholdersWe will measure our progress through:Setting objectivesDocumenting plansReviewing performanceWe will enable this by:Training our employeesTraining our PartnersImproving MangoInvesting in resourcesInvestigating new technologiesEnvironmental PolicyThe organisation has identified environmental management as one of its highest corporate priorities. The organisation has established policies, programmes and practices to reduce risk to the environment and the organisation and conduct business activities in an environmentally sound manner.The organisation is committed to environmental management and will:Integrate its environmental policies and procedures fully into all business activities as a critical element,Comply with all environmental legislation, standards and contract requirements that are applicable to the company’s operation,Continually improve its environmental performance and prevention of environment impact and taking into account current best practice, technological advances, current scientificunderstanding, customer and community needs, educate, train and promote employees to work in an environmentally responsible manner,Complete environmental assessments for aspects and impacts of all new activities that the company may undertake, promote, develop and design services, facilities, equipment andwork practices that have the least environmental impact, taking into account the efficientuse of energy and materials, the sustainable use of renewable resources and the responsible disposal of waste, thereby minimising any serious or irreversible environmental degradation,?Promote and encourage the adoption of these principals by suppliers and contractors acting on behalf of the organisation,Develop, implement and maintain emergency preparedness plans,Foster openness and dialogue with both employees and the public, encouraging them to respond with their concerns or improvement ideas within the scope of the organisation’soperations and maintain a set of environmental objectives and targets that are monitoredthrough the management review process to ensure effectiveness.Health and Safety PolicyThe company is committed to a safe and healthy working environment for everyone using the premises as a place of work or visiting on business.Management will:Set health and safety objectives and performance criteria for all managers and work areas Annually review health and safety objectives and managers’ performance ?Encourage accurate and timely reporting and recording of all incidents and injuriesInvestigate all reported incidents and injuries to identify all contributing factors and, where appropriate, formulate plans for corrective actionActively encourage the early reporting of any pain or discomfortProvide treatment and rehabilitation plans that ensure a safe, early and durable return to workIdentify all existing and new hazards and take all practicable steps to eliminate or minimise the exposure to any hazards Ensure that all employees are made aware of the hazards in their work areas and are adequately trained so they can carry out their duties in a safe mannerEncourage employee consultation and participation in all health and safety matters Enable employees to elect health and safety representativesEnsure that all contractors and subcontractors are actively managing health and safety for themselves and their employees Promote a system of continuous improvement, including annual reviews of policies and proceduresMeet legal obligations as specified in the legislation, codes of practice and any relevant standards or guidelines.Every manager, supervisor or foreperson is accountable to the employer for the health and safety of employees working under their direction.Each employee is expected to help maintain a safe and healthy workplace through:Share in the commitment to health and safety.Following all safe work procedures, rules and instructionsProperly using all safety equipment and clothing providedReporting early any pain or discomfortTaking an active role in the company’s treatment and rehabilitation plan, for their ‘early and durable return to work’Reporting all incidents, injuries and hazards to the appropriate person.The Health and Safety Committee includes representatives from senior management and union and elected health and safety representatives. The Committee is responsible for implementing, monitoring, reviewing and planning health and safety policies, systems and practices.Organisation Roles, Responsibilities and AuthoritiesPurpose and ScopeTo describe the responsibilities and authorities for the xxx and to define the organisation structure for the effective operation of the xxx.Associated DocumentsJob/Position Descriptions.Employee Contracts.Human Resources Module.Access Rights Sub-Module.Procedure1.The responsibility, accountability and authority of all personnel involved in the xxx is to be defined, documented and communicated in order to facilitate effective xxx. This is to include any responsibilities and accountability that is imposed by legislation.2.Responsibilities, accountabilities and authorities are documented in position descriptions and throughout the xxx.3.Where suppliers are involved, their responsibilities and accountabilities are to be clarified and documented by the responsible employee with authority.4.All employees and Suppliers will comply with their responsibilities.The Management Team are to:1.Ensure organisation-wide compliance to the xxx.2.Appoint the xxx Management Representative.3.Ensure that the assigned roles, responsibilities and authorities are communicated and understood./doc/2915976688.htmlmunicate the importance of meeting customer, statutory and regulatory requirements.5.Establish appropriate policies that include a commitment to continual improvement of the xxx.6.Establish IMS objectives.7.Ensure that all employees are aware of:a.Policies.。
【最新2018】质量保证书 英文版-范文模板 (6页)
本文部分内容来自网络整理所得，本司不为其真实性负责，如有异议或侵权请及时联系，本司将立即予以删除！== 本文为word格式，下载后可方便编辑修改文字！ ==质量保证书英文版质量保证书英文版【1】CERTIFICATE OF QUALITY, HEALTH, PURITY AND ANALYSISSANITARY AND VETERINARY CERTIFICATETO WHOM IT MAY CONCERNThe undersigned Lapinla commune veterinarian certifies that the milk products described herein are manufactured from sound raw materials and the manufacturing is carried out under sanitary conditions. The products are at the time of shipment sound, wholesome and fit for human consumption. The products are produced in Valo Edible Fats and ingredients, products is permitted anywhere in Finland. The product is free from B.S.E.EU-Registration number: 60220Exporter:Valo Edible Fats and Ingredients, Helsinki, FinlandDestination:Shenzhen, ChinaDate of Export:Apr. 20, 201XSpecificationProductsWeight (kg)DEMINERALIZED WHEY POWDER AS PER CONTRACT NO. CH/99/66.809 AND4760 bags121,380.00 kgs gross119,000.00 kgs netSpecificationAnalysisProtein (N x 6.38)MoistureAsh (550c)Ph (10% sol. 20c)Scorched particles (ADMI)NitrateMin.Max.Max.6.2Disc AMax.12.0%4.0%1.0%--6.930mg/kg13.5%2.1%0.5%6.4Disc Apasses testStandard plate count Enterobacteriaceae YeastsMoundsSulphite reducing clostridia Staphylococcus aureus。
ISO9001：2015质量手册英文版(按标准条款)
ISO 9001:2015Quality ManualA quality manual is a document that states the company’s intentions for operating the processes within the quality management system. It can include policies for all areas of the business that affect your ability to make high-quality products and meet your customers’ and ISO’s requirements. These policies define how your department managers will implement procedures within the boundaries specified in the quality manual. The use of Quality Manual are as follows:1.To communicate management’s expectations to employees2.To demonstrate the company’s plan to conform to therequirements of ISO 9001:20153.To demonstrate the fulfilment of Clause 5.3, thatorganizational roles, responsibilities and authorities are assigned, communicated and understood4.To provide a starting point for auditors:1.Internal2.Customer3.ISO Certification BodyTo develop a quality manual, you might consider these steps: 1.List policies to be written (note any ISO requirements thatdo not apply).2.Draft policies based on applicable ISO requirements.3.List operating procedures or refer to them as appropriate.4.Determine the format and structure of the manual andmake the first draft.5.Circulate the draft manual for input from all departmentsand address inadequacies identified.6.Attain a formal approval and release.The contents of your quality manual are completely up to you. But, remember that everything you say you do, you must show evidence that you really do it! So be careful what you include and make sure the policies reflect actual practices. Here are some common topics included in quality manuals.the scope of QMSQuality policyExplanation of the company’s documentation structureOrganizational chartPolicy statements for each applicable ISO requirementReference to operating procedures1) The scope of the Quality Management System. This is in place to identify the limit of the system and is based on the scope agreed with the registrar to be placed on the ISO9001 certificate. This is the explanation of what your company does, be it “Design and Manufacture of the bevel Gear,” “Machining Services for Customers in the oil and service Industry,” or “Providing Fast Food for People in Kuwait city.” The second part of the scope requirement is to identify any exclusions from the standard. In many cases, the Quality Manual will identify none, but the most common exclusion is the requirement of the ISO 9001 standard for “Design & Development” for companies such as a machining shop, which works exclusively from customer drawings and does not design any products itself.2) The documented procedures established for the Quality Management System (or references): ‘Documentation’ means anything written down or captured in some form such as written procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, IT systems. This is called ‘documentedinformation’ in the current version (2015) of ISO 9001. Confusingly, they have also decided to use the same term for what was formerly called ‘records’ – those things that showed what had been done, such as registers, logs, competed for forms, reports, meeting minutes and so on. ‘Documented information’ in 9001 terms means both the ‘written stuff’ that describe your quality system and say how it should operate (eg, flowcharts, procedures, policies, checklists) and the ‘written stuff’ that shows what was done. A system must be documented to achieve ISO 9001 certification because having certain documented information is required by the Standard. All the documents t needs to control how things are done, whether procedures, flowcharts, checklists, forms, IT systems or any other media or format that work in your business. But note that no mandatory procedures are prescribed. Nor a quality manual. What can confuse people is that actually, you can choose what your documents look like, what format and structure you use, and what to put in them. Provided you meet these requirements. You can use one or many formats, from checklists and flowcharts to intranets, wikis or workflow embedded into IT systems. You can use any media, hardcopy or soft, including intranet, online, internet or wiki. One often used way to do that was with a thingcalled a ‘quality manual’. And you can still do that if you choose. And it can be in hard copy (paper) or softcopy: online documents like web pages, help files or IT systems. And you can write your document in various ways, from easy and user-friendly to bureaucratic, verbose and very hard to follow. And such a manual may be the only document you have for your system, or it may be one of a number of documents. Or something in between.3) A description of the interaction of processes. This is most simply done with a flowchart that identifies all the processes in the organization with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics. Example of Quality Manual1.0 Company ProfileInclude your company profile1.1 The mission of the FirmOur mission is to enhance mobility through innovation, leadership and public service. Innovation by providing unparalleled value combined with flexibility and risk-taking ability, leadership by delivering exceptional performance in every domain and corporate responsibility through service to society.1.2 The vision of the FirmTo strive relentlessly with an aim to achieve excellence in all businesses that we venture into, with the objective of becoming an organization that all its employees and associates are proud of.2.0 Organization ScopeDesign, Development of Land, Construction Sales of Residential and Commercial Complexes2.1 Exclusions:NIL2.1 Quality PolicyXXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectation of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity.2.2 Key ObjectivesTimely completion of projectsIncrease Customer satisfactionReduce Customer Complaint3.0 Glossary & Abbreviations4.0 Context of Organization4.1 Understanding the organization and its context: Shah Promoters and Developers determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system through PEST and SWOT. The external and internal issues identified throughPEST and SWOT are continuously being monitored and reviewed by CEO.PESTSWOT4.2- Understanding the needs and expectations of interested partiesxxx has determined the interested parties who are relevant to the xxx Quality management system and the requirement of the interested parties in order to prevent the potential effect on the organization’s ability to consistently provide products and services which meet the customer and applicable statutory and regulatory requirements.4.3 Determining the scope of the quality management systemThe organization had determined the scope of the Quality management system by considering external and internal issues, the requirement of relevant interested parties and Product & Service of the organization.The scope of Quality Management System isDesign, Development of Land, Construction Sales of Residential and Commercial ComplexesExclusions:NIL4.4 Quality management system and its processes4.4.1: xxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes.xxx has determined the inputs required and the outputs expected from each process in individual process map addressed in the documented information of each process.xxx has determined the sequence and interaction of the processes in Process map & Interactions of processes.xxx has determined and applied the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes in the documented information of each process.xxx has determined the resources needed for these processes and ensure their availability in the documented information of Support process.xxx has assigned the responsibilities and authorities for each processxxx has addressed the risks and opportunitiesxxx has been evaluating these processes and implementing any changes needed to ensure that these processes achieve their intended results and improve the processes and the quality management systemImprove the processes and the quality management system4.4.2- xxx is also maintaining documented information to support the operation of its processes and retaining documented information to have confidence that the processes are being carried out as planned.5.0 Leadership5.1 Leadership and commitmentXxx Management has demonstrated leadership and commitment with respect to the quality management system through1.Taking accountability for the effectiveness of the qualitymanagement system by periodical review of qualitymanagement system through management review meeting, Quality objectives review and providing necessary resources.2.Management has established the quality policy andquality objectives for the quality management system and is compatible with the context and strategic direction of the organization.3.Management has determined the organizationalprocesses and integrated with the quality management system requirement through process map & Interaction this can be demonstrated.4.The established procedure for promoting the use of theprocess approach and risk-based thinking.5.Ensuring that the resources needed for the qualitymanagement system are available, this is being periodically reviewed through management review meeting.municating the importance of effective qualitymanagement and of conforming to the quality management system requirements7.Ensuring that the quality management system achievesits intended results8.Engaging, directing and supporting persons to contributeto the effectiveness of the quality management system by providing training, conducting awareness programs and 9.Promoting improvement by introducing the suggestionscheme, Kaizens and conducting meetings.10.Supporting other relevant management roles todemonstrate their leadership as it applies to their areas of responsibility.5.1.2 Customer focusXxx management has demonstrated leadership and commitment with respect to customer focus by ensuring that: 1.Customer and applicable statutory and regulatoryrequirements are determined, understood and consistently met.2.The risks and opportunities that can affect conformity ofproducts and services and the ability to enhance customer satisfaction are determined and addressedc) The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is addressed5.2 QUALITY POLICYXXX is committed to delivering quality construction work with promised amenities, in time possession, which meets and exceeds the needs & expectation of our customers. We promise our valued customer’s commitment to excellence in each activity by each employee in the organization by adopting innovative and best in class engineering and management practices with continual improvement in business and quality management system as a part of our efforts for enhancement in customer satisfaction while assuring 100% quality and quantity. We are also committed to serving society as a whole by generating through clean development mechanism (CDM) project.5.2.1 Establishing the quality policyXxx management has established, implemented and maintained a quality policy that:1.is appropriate to the purpose and context of theorganization and supports its strategic direction.2.Provides a framework for setting quality objectives3.Includes a commitment to satisfy applicable requirements4.Includes a commitment to continual improvement of thequality management system5.2.2 Communicating the quality policyThe quality policy is1. Available and be maintained as documented informationmunicated, understood and applied within theorganization through display, Training and periodical review.3.Available to relevant interested parties, as appropriate. 5.3 Organizational roles, responsibilities and authoritiesXxx management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and understood within the organization. While assigning roles, responsibility and authority, top management has considered and ensured that1.The quality management system conforms to therequirements of this International Standard2.The processes are delivering their intended outputs3.Reporting on the performance of the quality managementsystem and on opportunities for improvement, in particular, to top management4.The promotion of customer focus throughout theorganization5.The integrity of the quality management system ismaintained when changes to the quality management system are planned and implemented.Roles, responsibility and authorities assigned are available in process & as per Organization chart wiseDirectorsResponsibilityOverall Responsibility for formulating and communicating Quality Policy & Quality objectives.Formulation of Strategy for continuous up gradation of Business and Quality System.Ensure periodic assessment of the performance of Quality System.Approval of Quality System Manual.Budget Approval for the organization.Overall Responsibility for Business Development & all financial issues.Provision of resources as required.Strategic decisions on developments and technical setups. To provide the leadership for efficient implementations of the system.Authorities:Approval of customers orders, P.O. and Cheque.Sanctioning leaves of all Staff.Approval of funds for Training needs.All the authorities of downline personnel.Chairing Management review meetings.Project PlanningResponsibilities:Overall coordination between client, project managers and office department.Follow up for Schedules.The entire responsibility of Quality.Monitoring Client Satisfaction.Coordination with the consultants.Disciplinary actions against the staff.Prime responsibility for the safety at the siteProvision of a suitable working environmentEnsure the quality system is established, implemented and maintained.Authorities:Appointment of the staff, engineers and tech staff.Sanctioning the Leaves to Staff.All the authorities of downline personnel.Project ManagersResponsibilities:Responsibilities for the entire Project work, i.e. Quality, Quantity and Time.Coordination with consultants and contractors.Coordination with Consultants for drawings.Coordination with the Site engineers.Coordination with the client for the ongoing changes in drawings and projects.Monitoring site engineers work on a daily basis.Reporting to the GM Projects on the above issuesResponsibilities for safety at the site. (Good working environment).Authorities:Make or force a required decision at all levels to achieve project objectives.Initiate actions on the Contractors and consultants for Quality, Quantity and Timeframe issues related to project work.To stop and initiate corrective actions on non–confirming products/services.Site SupervisorResponsibilities:Coordinating with all staff for the Quality related issues of Construction.Daily Labour Handling for Civil Work.Monitoring of Work progress and daily reporting.Preparation of work progress report / Quality Documentation.Control of non – conformities on siteSafety at site / Construction work.Coordination with the Site Contractor for the daily work requirements.Coordination with external agencies for calibration of instruments and material testing.Authorities:Initiate actions on the staff for non-fulfillments of the documentation related qualityTo stop and initiate corrective actions on non–conforming products.Site engineerResponsibilities:Monitoring of site and labour contractors.Monitoring of work progress and daily reportingPreparation of work progress report.Control of non – conformities on site.Ensuring instruments are properly used and are with the status of calibration.Track Project progress & produce regular weekly status reports.Coordinate with all labour contractors to achieve continuous progress at the site as per schedule.Follow up with the Project manager for pending decisions/drawings/building specifications.Communicate management decisions and information to Site subordinate staff.Ensuring the worker’s safety at site and usage of safety equipment.Implementation and follow up and regular monitoring of implemented ISO 9001 system at the site.Coordination with the Quality Person for Quality related issues.Coordinating Material Accountability at siteAuthorities:Initiating the corrective and preventive actions as needed on contractors and consultants.Decision making on during any emergencies at the site.In-charge Marketing:Managing & motivating the sales force towards the achievement of target.Preparation of Sales plan.Annual sales forecast.Monthly sales forecast.Implementation of sales plan.Authorities:Approval of documents as per the Master list of Quality System Document.Authorized to decide corrective & preventive action.Authorized to obtain concessional acceptance for non – conforming product from the customer.InCharge – ADMIN + ACCOUNTResponsibilities:Responsible for tendering activity.Customer order review.Handling and coordinating customersIdentification of resources, as applicable.Document & Data control system pertaining to his department.Maintain all documents related to the quality system.Coordinator for Management reviews.Promoting awareness of customer requirements throughout the Organization.Compliance & effectiveness of the training system.Suitable working environment (cleanliness, ventilation, lighting, safety etc.).Record maintaining for Sales Register, Rent Register, Sale Files, Stationery and Office equipment.Archiving and record keeping of old files.Payroll Monthly: Salary –To release monthly salary of the employees as per policy finalized.Leave – To keep the record of leave as per policy finalized.Annual Allowance – To release annual allowances as per policy finalized.Employee Record – To update employee details as per organization Policy and QMS.To prepare an appointment letter, confirmation letter, experience letter & all employee-related matter as per policy finalized with the help of the Managing Director.Authorities:Approval of customer orders.Approval of documents as per the master list of Quality System Document.Authorized to decide corrective & preventive action.In charge Purchase:Responsibilities:Overall in charge of purchase activities.Identification of resources, as applicable.Purchasing system – Evaluation, selection, purchasing, monitoring.Document & Data control system pertaining to his department.Corrective / Preventive action system (subcontractor non-conformances, in particular.)Control of recordsAuthorities:Authorized to review & approve purchasing documents.Authorized to select & discontinue sub-contractor6.0 Planning6.1 Actions to address risks and opportunities6.1.1Xxx is addressed the issues, requirements the risks and opportunities1.give assurance that the quality management system canachieve its intended result(s)2.Enhance desirable effects3.Prevent, or reduce undesired effects4.achieve improvement6.1.21.actions to address these risks and opportunities2.How to1.integrate and implement the actions into its qualitymanagement system processes2.Evaluate the effectiveness of these actions6.2.2 Quality objectives and planning to achieve them 6.2.1Xxx establish quality objectives at relevant functions, levels and processes needed for the quality management system.The quality objectives shall1.Be consistent with the quality policy2.Be measurable3.Take into account applicable requirements4.Be relevant to the conformity of products and services andto the enhancement of customer satisfaction5.Be monitored6.Be Communicated7.Be updated as appropriate6.2.2 Xxx achieve its quality objectives,1.What will be done?2.What resources will be required?3.Who will be responsible?4.When it will be completed5.How the results will be evaluatedOur Quality Objectives are as below:Timely completion of projectsEnergy Generation Per YearIncrease Customer satisfactionReduce Customer Complaint6.3 Planning of changesXxx determines the need for changes to the quality management system, the changes are carried out in a planned manner1.the purpose of the changes and their potentialconsequences2.the integrity of the quality management system3.the availability of resources4.the allocation or reallocation of responsibilities andauthoritiesXxx has determined the processes needed for the quality management system and their application throughout the organization in Process map & Interactions of processes7 Support7.1 Resources7.1.1 GeneralXxx is determined and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. Xxx is consider1.the capabilities of, and constraints on, existing internalresources2.what needs to be obtained from external providersHR determine and provide the resources needed to implement and maintain the quality management system and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirement. The resources will be in the form ofHuman resources including qualified personnel for verification activities.Manufacturing machines, Test Equipment’s &infrastructure.Provide raw material & other inputs for the realization of the product.Providing funds.The Required resources are identified in the event of new Process Development / Business plan review, Mfg Process Flow, also based on the Organization performance review in MRM and monthly business reviews.7.1.2 PeopleXxx determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. HR along with respective process IN CHARGE ensures that personnel performing work affecting product quality is competent and training to give on the basic operation and control of its processes.7.1.3 InfrastructureXxx is determined, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure can include1.buildings and associated utilities2.equipment, including hardware and software3.transportation resourcesrmation and communication technologyAt Xxx management determine, provide and maintain the infrastructure needed to achieve conformity to product requirements & in identifying the required resources the PARTNER play a key role based on their day to day interactions with respective IN CHARGE’s and employees 7.1.4 Environment for the operation of processesXxx is determined, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. A suitable environment can be a combination of human and physical factors1.Social (e.g. non-discriminatory, calm,non-confrontational)2.Psychological (e.g. stress-reducing, burnout prevention,emotionally protective)3.Physical (e.g. temperature, heat, humidity, light, airflow,hygiene, noise).Project in coordination with respective IN CHARGE determines and manages the work environment needed to achieve conformity to product requirement and reviewed ongoing basis.7.1.5 Monitoring and measuring resources7.1.5.1 GeneralXxx is determined and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided1.are suitable for the specific type of monitoring andmeasurement activities being undertaken2.are maintained to ensure their continuing fitness for theirpurposeXxx is retained appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources7.1.5.2 Measurement traceabilityXxx is measurement traceability is maintained requirement if applicable for the instruments or is considered by them to be an essential part of providing confidence in the validity of measurement results,1.calibrated or verified, or both, at specified intervals, orprior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information2.identified in order to determine their status3.safeguarded from adjustments, damage or deteriorationthat would invalidate the calibration status and subsequent measurement resultsXxx is determined the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.Control of Monitoring & Measuring Equipments. Measurement & Monitoring system is well equipped and the system has complete control over the monitoring andMeasuring Equipment. The measurement methods used are evaluated to ensure that they are appropriate and reliable. To ensure that the measuring equipment operates effectively and give reliable results, we have taken the following steps:Equipments are maintained properly and are calibrated & adjusted as and when needed. Necessary safeguards are in place to take care of adjustments that could lead to invalid results.Calibrations are carried out as per national standards (by NABL accredited laboratories only). Where no such standard exists, the basis used for calibration or verification is recorded. The calibration records include the last date of calibration, calibrating agency (for the external agency), calibration result, and frequency of calibration as per the process and/or instrument requirement and the next calibration date. The required accuracy is identified and compared to the measurement that meets expectations. Identification of appropriate equipment is accomplished by tagging, labelling, numbering or by including it in a calibration/maintenance database.。
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.