ISO15195：2018质量手册英文版模板

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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
日期 Date 日期 Date 日期 Date 日期 Date 日期 Date
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.

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。

新版三体系质量手册-英文版模板

Address Line 1Address Line 2Address Line 3Address Line 4PostcodeTelephone No.WebsiteCompany_XBusiness Management ManualThis Manual has been developed in accordance with the following standards:ISO 9001:2015ISO 14001:2015ISO45001:2018Table of ContentsDefinitions (4)1.0 General (5)2.0 Indexing and Revision Status (5)3.0 Company Background (6)4.0 About COMPANY_X (6)4.1 What Influences our Organisation (6)4.2 Expectations of Interested Parties (7)4.3 Scope and Applicability (7)4.4 The Management System (7)4.4.1 System Implementation (8)4.4.2 System Validation (8)5.0 Leadership (8)5.1 Leadership and Commitment (8)5.1.1 Leadership and Company Management (8)5.1.2 Customer Focus (8)5.2 Strategic Policy Management (9)5.2.1 Policies (9)5.2.2 Communicating our Policies (9)5.3 Implementing our Policies (9)6.0 Planning (10)6.1 Identifying Risks and Opportunities (10)6.2 Company Objectives & Targets (10)6.3 Change Management (11)7.0 Support (11)7.1 Resources (11)7.1.1 General (11)7.1.2 People (11)7.1.3 Infrastructure (11)7.1.4 Environment (12)7.1.5 Monitoring and Measuring Resources (12)7.1.6 Organisational Knowledge (12)7.2 Competency (12)7.3 Awareness (13)7.4 Communication (13)7.5 Documented Information (13)7.5.1 General (13)7.5.2 Creating and Updating (14)7.5.3 Control of Documented Information (14)8.0 Operation (15)8.1 Operational Planning and Control (15)8.2 Requirements for Products and Services (16)8.2.1 Customer Communication (16)8.2.2 Determining Client Requirements (16)8.2.3 Review of Client Requirements (16)8.2.4 Changes to Requirements (17)8.2.5 Emergency Planning and Response (17)8.3 Design and Development of Products and Services (17)8.3.1 General (17)8.3.2 Design & Development Planning (17)8.3.3 Design & Development Inputs (17)8.3.4 Design & Development Controls (17)8.3.5 Design & Development Outputs (18)8.3.6 Design & Development Changes (18)8.4 Control of Externally Provided Processes, Products and Services (18)8.4.1 General (18)8.4.2 Type and Extent of Control (18)8.4.3 Information for External Providers (19)8.5 Service Provision (19)8.5.1 Control of Service Provision (19)8.5.2 Identification and Traceability (19)8.5.3 Client Property (19)8.5.4 Preservation (20)8.5.5 Post Delivery Activities (20)8.5.6 Control of Changes (20)8.6 Release of Products and Services (20)8.7 Control of Project Issues and Incidents (20)9.0 Performance Evaluation (21)9.1 Monitoring, Measurement, Analysis and Evaluation (21)9.1.1 General (21)9.1.2 Client Satisfaction (21)9.1.3 Analysis and Evaluation (21)9.2 Internal Audit (22)9.3 Management Review (22)10.0 Improvement (23)10.1 General (23)10.2 Non Conformity and Corrective Actions (23)10.3 Continual Improvement (24)11.0 Standard Cross-Referencing (25)Definitions1.0 GeneralCOMPANY_X have designed and implemented this Business Management Manual as a means of ensuring that a quality service and product is provided in a safe manner whilst addressing all relevant environmental impacts. The manual has been created to identify the key tasks involved for the successful provision of our products or services and to provide us with a tool that can be used to continually improve what we do.Hyperlinks within this document will take you to the live areas of our cloud based management system, isCompliant. This is only accessible if you are a COMPANY_X employee and have the appropriate authorisations.If you have the relevant authorisations you will be able to gain access to isCompliant here. The Manual will provide the general information on the processes used to manage2.0 Indexing and Revision StatusThe numbering of this integrated management manual broadly follows the numbering used in ISO 9001:2015, adapted for the additional requirements of ISO 14001:2015 and ISO45001:2018 where appropriate. This Management Manual is only valid if all pages are at the same issue level as shown on the front page.Editing the relevant sections, adapting the issue level in the Revision Index and headers, and re-issuing the entire document electronically will make updates to this manual. Relevant parties will be automatically notified of any updates to this action via our document alerts.3.0 Company BackgroundEnter basic details about the company in here; when they were established, what they do, any major milestones etc.4.0 About COMPANY_X4.1 What Influences our OrganisationCOMPANY_X’s purpose is to [enter details here, e.g. to providing a superior project and excellent customer service].In doing so, COMPANY_X recognise that this can only be achieved by managing any situation that can influence, either internally or externally the way we deliver our service.The External Influences can be found in the Organisational PESTEC Assessment in the Risk Assessments Module. The Assessment deals with the P olitical / Legislative, E conomic, S ocial / Cultural, T echnological, E nvironmental and C ompetition risks. This assessment is reviewed annually or whenever a major change to an internal or external influence occurs.The Internal Influences can be found in the Process-driven Risk Assessments in the Risk Assessments Module. The following Internal and external influences have been summarised from the risk assessments in isCompliant.4.2 Expectations of Interested PartiesThe following expectations have been identified for both internal and external stakeholders.4.3 Scope and ApplicabilityThis manual has been created to provide guidance on how COMPANY_X manage their activities in a safe and effective manner whilst minimising our effects on the environment.The document is applicable to the following COMPANY_X activities:“[Enter the description of the company’s activities here.]”These controls will be implemented and followed on our operations which occur both in the UK and abroad.A Business Process Map (MR00-01), outlining the main processes within COMPANY_X and how they interact can be found on isCompliant.4.4 The Management SystemCOMPANY_X manages all internal processes using a cloud based solution called isCompliant.The management system segregates all business processes (excluding finance and direct client relationship management) into 15 modules. Each module details what is required to maintain compliance with the COMPANY_X internal processes in order to meet the expectations of both internal and external influences.The processes address all activities including operational, strategy, environmental and occupational health and safety.4.4.1 System ImplementationAll inputs have been identified in either isCompliant or process specific procedures.Required outputs have been detailed in the procedures that govern the modules and the project processes.Any processes that require indicators to validate that a process has been correctly implemented are either automated with the isCompliant Reporting function, or reviewed during periodical process audits.Responsibilities necessary to implement the above processes are detailed in the COMPANY_X procedures, responsibilities matrix and live system actions.Resource gaps will be highlighted and rectified during management team meetings and process reviews.All risks and opportunities are addressed at a strategic level in the company PESTEC and the process driven risk assessments located in the isCompliant Risk Assessments Module.All processes are subsequently reviewed and assessed for effectiveness on a periodical basis as detailed in the Audits Module of isCompliant.4.4.2 System ValidationAll internal processes related to the management system are periodically reviewed for compliance. In addition to this, isCompliant monitors key indicators and alerts the relevant personnel of deviation form expected outputs.This includes alerting the relevant parties of late actions, audits or meetings, assets requiring calibration or servicing, late staff appraisals, or documents requiring review.5.0 Leadership5.1 Leadership and Commitment5.1.1 Leadership and Company ManagementCOMPANY_X place a great deal of emphasis on leadership within the management team by having active roles in both operational and strategic parts of the business.Due to the nature of the management system, all management actions can be traced back to originator and actionee. In addition to this all actions are automatically allocated to the relevant business processes, thus enabling the management team to monitor the areas of the business that are performing well and those that require improvement.5.1.2 Customer FocusThe COMPANY_X management team ensure that delivery of a service in line with customer expectations is delivered by:1.Ensuring that we are offering a service or product that is in line with statutory and regulatoryrequirements.2.Discussing with the client / customer their existing situation and gaining a detailed understanding(where applicable) of their general working environment / requirements.3.Discussing with the client / customer the services and products available and assist in identifying whatbest suits their needs.4.Ensuring that we identify and confirm client requirements prior to agreeing to provide the service orproduct.5.Identifying any possible risks to customer’s expectations, and mitigating where possible.6.Providing the service / product to the customer at the highest possible standard.7.Once each sale is completed, reviewing our delivery for effectiveness and improvement opportunities,whilst offering continued support.8.Gaining feedback from customers on strengths and weaknesses.Ensuring that the customer’s requirements are met is the key objective of COMPANY_X. By following set procedures, COMPANY_X ensures consistency and quality in a safe working environment with limited impact on the environment.In order to achieve the objective of improving customer satisfaction, COMPANY_X seeks feedback from customers on a formal / informal basis and acts on recommendations made.5.2 Strategic Policy ManagementCOMPANY_X ensures that it remains in line with its overall strategic direction by following a series of business policies.5.2.1 PoliciesThe policies are designed to communicate why we operate in the way we do, and how we maintain our strategic direction.[Add example from policy, e.g. commitment to employee wellbeing, protection of the environment etc.] In order to actually achieve those policies we will set company objectives and risk assess our processes in order to ascertain the best possible procedure.All policies are reviewed annually or when an internal or external influence requires.5.2.2 Communicating our PoliciesAll public and private COMPANY_X policies can be found on [enter storage details here, e.g. company server / intranet etc.]. Where necessary there may be Restricted Policies (such as financial) that are only available to upper management.Where necessary, these policies are made available to external interested parties.All staff are made aware of the policies during the induction process and notified should any changes take place.5.3 Implementing our PoliciesAll major responsibilities required to implement the COMPANY_X policies are document and communicated via the responsibilities matrix and isCompliant.System and business performance is communicated both from the management team to the Directors, and likewise from the Directors to the management team where appropriate.All COMPANY_X employees / line managers / senior managers have the ability to report incidents or issues direct to the management team and Directors.Where applicable, automatic RACI reporting is implemented across the organisation.Where an expected output is required to validate conformity, the responsible person or role will be defined and communicated.All processes within the organisation are monitored for performance, both good and bad, via the isCompliant reporting tool. The process performance is monitored at a frequency identified by top management.6.0 Planning6.1 Identifying Risks and OpportunitiesCOMPANY_X have adopted a risk based approach to developing company procedures.COMPANY_X recognise the significant safety mitigations, potential environmentalimpacts and opportunities for improvement can be identified through the riskassessment process.All COMPANY_X Process are risk assessed prior to the establishment of a finalworking procedure. The procedure takes into account any required mitigations oropportunities for improvement highlighted during the risk assessment processHazard identification and risk assessment is performed continually throughout COMPANY_X’s activities. Health, Safety, Business and Environmental risk assessments are carried out in accordance with the Risk Assessment Procedure (P02).The outputs and required mitigation measures are identified on isCompliant under the Risk Assessments Module. Additional actions are then recorded in the Actions Module.Environment aspects and impacts are listed in the Environmental Controls Module. Any actions associated with reducing the impact will be highlighted in the Actions Module. This list is not exhaustive and is reviewed against changing legislation and operations as part of the Management Review.6.2 Company Objectives & TargetsCOMPANY_X periodically define and review the Business, Quality, Environmental andHealth & Safety Objectives of the business. The current objectives can be viewed,alongside their proposed actions, on isCompliant under the Company ObjectivesModule. Alternatively they can be filtered out of the complete company Actions Listin the Actions Module. These objectives have been set to ensure the continualimprovement of the business. It is important that the objectives set are continuallymonitored and reviewed to ensure the improvements are achieved.Once objectives have been defined, they are communicated to all of the relevant individuals. If an objective is specific to a department, programme or an individual, the management will ensure that a full understanding of what is required is achieved.Objectives can be set during the creation of an action from anywhere within isCompliant by simply ticking the ‘Objectives’ box.。

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 Aaudit3.9.1审计audit client 3.9.7客户审计audit conclusion3.9.6审计结论audit criteria3.9.3审计标准audit evidence3.9.4审计证据audit findings3.9.5audit programme3.9.2审计大纲audit team3.9.10审计团队auditee3.9.8auditor3.9.9Ccapability3.1.5characteristic3.5.1concession3.6.11conformity3.6.1continual improvement3.2.13 correction3.6.6corrective action3.6.5customer 3.3.5customer satisfaction3.1.4 competence3.9.12Ddefect3.6.3dependability 3.5.3design and development3.4.4deviation permit3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency3.2.15Ggrade3.1.3Iinformation3.7.1infrastructure3.3.3inspection3.8.2interested party3.3.7Mmanagement3.2.6management system3.2.2 measurement control system3.10.1 measurement process 3.10.2 measuring equipment 3.10.4 metrological characteristic3.10.5 metrological confirmation3.10.3 metrological function3.10.6Nnonconformity 3.6.2Oobjective evidence3.8.1客观证据organization3.3.1organizational structure3.3.2Ppreventive action3.6.4 procedure3.4.5process3.4.1product3.4.2project3.4.3Qqualification process3.8.6 quality3.1.1quality assurance3.2.11quality characteristic3.5.2 quality control3.2.10quality improvement 3.2.12 quality management3.2.8quality management system3.2.3 quality manual3.7.4quality objective3.2.5quality plan 3.7.5quality planning3.2.9质量计划quality policy3.2.4Rrecord3.7.6记录regrade3.6.8release3.6.13放行repair3.6.9requirement3.1.2review3.8.7rework3.6.7返工Sscrap3.6.10specification 3.7.3supplier 3.3.6供应商system3.2.1系统Ttechnical expert<audit>3.9.11技术出口test3.8.3测试top management3.2.7高层管理traceability3.5.4可塑性Vvalidation3.8.5verification3.8.4验证Wwork environment3.3.4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/T19001、GB /T19002和GB/T19003实施通用指南Quality mana gement and quality assurance standards－－Part 2:Generic guidelines for the application of GB /T19001、GB/T19002and GB/T19003质量管理和质量保证标准第3部分:GB/T19001在计算机软件开发、供应、安装和维护中的使用指南Qu ality management and quality assurance standard s－－Part3:Guidelines for the application of GB/T19001to the development,supply,installa tion 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－－Part4: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 rt2: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－－Part1: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－－Part2: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－－Part3: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 Part1: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 t2: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

2 OF 57
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
4 OF 57
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

产品质量法 2018版英文版

产品质量法 2018版英文版The Product Quality Law of 2018 (also known as the Product Quality Law of the People's Republic of China) is a set of regulations that govern the quality standards and requirements for products manufactured, sold, or imported in China. It aims to ensure the safety and reliability of products, protect consumer rights, and promote fair competition in the market.Here is an accurate translation of the Product Quality Law of 2018 in English:Article 1: This Law is enacted to strengthen the supervision and management of product quality, ensure the safety of people’s lives and property, safeguard the order of production and operation, protect the rights and interests of consumers and maintain social and economic order.Article 2: This Law is applicable to the quality, safety, and other aspects of products produced, sold, imported or used within the territory of the People’s Republic of China.Article 3: The state establishes and improves the system of standards for products, formulates technical regulations for product quality, and establishes a product quality certification system.Article 4: People’s governments at the county level or above shall strengthen the leadership and organization of product quality work within their respective administrative areas.Article 5: The relevant industry administrative departments of the State Council and people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall supervise and manage the product quality work according to their respective responsibilities.Article 6: Product producers and sellers shall establish and improve the quality assurance systems, and ensure that their products are in conformity with the standards or technical requirements and that they are safe and reliable.Article 7: The state adopts a compulsory product certification system for products that affect personal or property safety in accordance with relevant laws and administrative regulations.Article 8: The state establishes and improves the product recall system, urges producers and sellers to improve product quality and adopt effective measures for recall and disposal in accordance with laws and regulations, in case of discovering that their products have been identified as substandard, defective or unsafe.Article 9: The state establishes and improves the system of product quality supervision and random inspection.Article 10: Consumers have the right to demand compensation in accordance with the law from producers or sellers for losses caused by products that are not in compliance with product standards or contract requirements, or that cause personal or property harm.This is a summary of the Product Quality Law of 2018 in English. Please note that this is a general translation and may not capture all the nuances and details of the original text. For a comprehensive understanding of the law, it is advisable to consult the official version or seek legal advice.。

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管理评审┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄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设计和开发输出┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄┄ 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》。

ISO15195：2018质量手册英文版模板

ISO9001质量手册-中英文版

质量手册2018版

ISO 9001质量手册英文版(ISO 9001 Quality Manual)

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