ISO9001中英文质量手册.doc

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1、 质 量 管 理 体 系 文 件Quality Management System Document 制定Prepared byxxxxxx审核:Checked by:批准:Approved by:日期Date 日期Date日期DateDistribution list 分发签收清单客服部CS Dept日期Date开发部D&D Dept日期Date物料部Material Dept日期Date品质部QA Dept日期Date生产部Prod. Dept日期Date货仓部WH. Dept日期Date运作部OP Dept.日期Date采购开发部Sourcing Dept日期Date工程部Enginee

2、ring Dept日期Date人事 & 行政部HR & Admin. Dept日期Date Revision History 修订记录REVISION版本DESCRIPTION OF CHANGE修订内容ORIGINATOR起草人RELEASE DATE发行日期01Original Release 新版发行xxx20xx-10-0802Change the production department quality objective生产部质量目标变更xxx20xxx-02-18目 录Content0. 前言Prelude0.1 序言6 Foreword0.2 公司简介6 Company pr

3、ofile0.3 质量方针7Quality policy 1. 范围Scope1.1 产品范围.7Product scope1.2 场所范围.7Site scope1.3 删节说明.7Cancellation2. 引用标准.7Normative reference 3. 术语和定义.7-8Terms 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.9-11Documentation requirements 5. 管理职责Management responsibility 5.1 管理承诺

4、.11 Management commitment 5.2 以顾客为中心.11 Customer focus 5.3 质量方针.12 Quality policy 5.4 策划.12 Planning 5.5 职责、权限和沟通.12-13 Responsibility, authority and communication 5.6 管理评审.13-14Management review 6.资源管理Resource management 6.1 资源提供.14-15 Provision of resources 6.2 人力资源.15 Human resources 6.3 基础设施.15-

5、16 Infrastructure 6.4 工作环境.16 Work environment 7.产品实现Product realization 7.1 产品实现的策划.16 Planning of product realization 7.2 与顾客有关的过程.16-18 Customer-related processes7.3 设计和开发.18-20 Design and development 7.4 采购.20-21 Purchasing 7.5 生产.21-23 Production 7.6 监视和测量装置的控制.23-24 Control of monitoring and m

6、easuring devices 8.测量、分析和改进Measurement, analysis and improvement 8.1 总则.24 General 8.2 监视和测量.24-26 Monitoring and measurement 8.3 不合格品的控制.26 Control of nonconforming product 8.4 数据分析.26-27 Analysis of data 8.5 改进.27-28 Improvement 9.附件Attachments9.1 附件1: 质量管理体系流程图.29-30 Attachment 1: QMS Flowchart 9

7、.2 附件2: 组织架构图.31 Attachment 2: Organizational Structure 9.3 附件3: 部门职责对照表.32-34 Attachment 3: Departmental Responsibility Deployment 9.4 附件4: 质量手册和程序清单.35-36 Attachment 4: QMS Manual and Procedure List 9.5 附件5: 部门职责一览表37-41 Attachment 5: Departmental responsibility 9.6 附件6: 质量目标分解表42 Attachment 6: Qu

8、ality Objectives 9.7 附件7: QMS 管理者代表任命书.43Attachment 7: Appointment of QMS Management Representative9.8 附件8:培训表格.44 Attachment 8: Training Form 0. 前言Prelude0.1 序言Foreword企业要发展壮大, 就必须有先进的管理方法. 在结合本厂产品、实际情况、ISO9001: 2008质量管理体系-要求标准的前提下, 制定了本质量手册.Business expansion always depends on advanced managerial

9、methods. Hereby, we have formulated this Quality Manual considering the characteristics of our products, managerial status and ISO9001:2008. 本手册规定了公司质量方针、质量目标及建立、实施和改进质量管理体系的基本要求. This Manual has defined quality policy, quality objectives, and the basic requirements for establishing, implementing an

10、d improving quality management system 全体员工必须依据本手册及其支持性文件程序文件、操作指导书、技术规范、国家法律、法规的规定进行运作，创造一种持续满足顾客要求的机制。Personnel in XXXXX shall go by this manual and its supportive documents, e.g. procedures, work instructions, specifications, and legal requirements to create a mechanism satisfying customer require

11、ments continually0.2 公司简介Company profileA. 公司名字: :xxxxx)/ Company name: XXXXX Ltd ( Include)B. 企业性质: 港资 Capital origin: HK investment C. 成立时间: xxxxx成立于 Founded in: D. 地址Address: 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 Cutt

12、ingLamination/Thermoforming/High frequency/Transfer stickerSewingPackingG. 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

13、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.0.3 质量方针Quality policy:持 续 过 程 优 化 ,追 求 顾 客 满 意 .Continual improvement and customer

14、 satisfaction.1. 范围Scope1.1 产品范围Product scope 手袋及其它缝纫制品。 Bags and other sewing products.1.2 场所范围Location scope 1.3 删节说明CancellationA. 本手册 “第7.3条-设计和开发”只适用于xxxxx,不适用于xx .The elements “7.3 design and development” is only applicable for xxxL but not applicable for xx.B. 因为xx依据xxxxx的样板、技术图纸进行制作样板, 在样板得到

15、xxxxx的承认之后进行产品生产, 故本要素不适用于xxxxx.The cause of not applicable: because xx carries out sample making based on benchmarking samples or specification provided by xx, and xx commence mass production only after sample has been approved by xxx2. 引用标准Normative reference2.1 ISO9000: 2005质量管理体系基础和术语 ISO9000: 2

16、005 Quality Management System-Fundamentals and vocabulary 2.2 ISO9001: 2008质量管理体系-要求 ISO9001: 2008 Quality Management System-Requirements 3. 术语和定义Terms3.1 质量Quality一组固有特性满足要求的程度. Degree to which a set of inherent characteristics fulfills requirements 注1: 术语“质量”可使用形容词如差、好或优秀来修饰Note 1: the term “quali

17、ty” can be used with adjectives such as poor, good or excellent注2: “固有的”(其反义是“赋予的”)就是指在某事或某物中本来就有的, 尤其是那种永久的特性Note 2: “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristics 3.2 顾客满意Customer satisfaction顾客对其要求已被满足的程度的感受Customers perception of the

18、degree to which the customers requirements have been fulfilled 注1: 顾客投诉是一种满意程度低的最常见的表达方式, 但没有投诉并不一定表明顾客很满意Note 1: customer complaint are a common indicator of low customer satisfaction but their absence dose not necessarily imply high customer satisfaction 注2: 即使规定的顾客要求符合顾客的愿望并得到满足, 也不一定确保顾客很满意Note

19、2: even when customers requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction 3.3 顾客Customer接受产品的组织或个人Organization or person that receives a product 3.4 供应商/供方Supplier提供产品的组织或个人Organization or person that provides a product 3.5 过程Pr

20、ocess一组将输入转化为输出的相互关联或相互作用的活动Set of interrelating or interacting activities which transforms inputs into outputs 3.6 产品Product过程的结果Result of a process3.7 合格Conformity满足要求Fulfillment of a requirement 3.8 不合格Nonconformity未满足要求Non-fulfillment of a requirement 3.9 预防措施Preventive action 为消除潜在不合格或其他潜在不期望情况

21、的原因所采取的措施Action to eliminate the cause of a potential nonconformity or other potential undesirable situation3.10 纠正Correction为消除已发现的不合格所采取的措施Action to eliminate detected nonconformity3.11 纠正措施Corrective action 为消除已发现的不合格或其他不期望情况的原因所采取的措施Action to eliminate the cause of a detected nonconformity or ot

22、her undesirable situation 3.12 文件Document 信息及其承载媒体Information and its supporting medium 3.13 记录Record 阐明所取得的结果或提供所完成活动的证据的文件Document stating results achieved or providing evidence of activities performed 4. 质量管理体系Quality management system4.1 总要求General requirements 本公司将按照本质量手册的要求建立质量管理体系, 形成文件, 加以实施

23、和保持, 并持续改进其有效性.Our company shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this Quality Manual A. 本公司将:Our company shall a. 识别质量管理体系所需的过程及其在公司内的应用;Identify the processes needed for the qual

24、ity management system and their application throughout our companyb. 确定这些过程的顺序和相互作用(见附件1: 质量管理体系流程图);Determine the sequence and interaction of these processes (see attachment 1: QMS Flowchart)c. 确保为这些过程的有效运作和控制所需的准则和方法;Determine criteria and methods needed to ensure that both the operation and contr

25、ol of these processes are effectived. 确保可以获得必要的资源和信息, 以支持这些过程的运作和监视;Ensure the availability of resources and information necessary to support the operation of these processese. 监视、测量和分析这些过程;Monitor, measure and analyze these processes, and f. 实施必要的措施, 以实现对这些过程所策划的结果和对这些过程的持续改进Implement actions neces

26、sary to achieve planned results and continual improvement of these processes B. 本公司必须按照ISO9001: 2008质量管理体系-要求管理上述的过程;These processes shall be managed by our company in accordance with ISO9001:2008 Quality Management System C. 针对本公司所外包的任何影响产品符合性的过程, 本公司将确保对其予以识别和控制.Where we choose to outsource any pr

27、ocess that affects product conformity with requirements, we shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. 本公司的外包活动: 部分工序, 按照本公司生产管理程序进行控制. Some processes will be outsourced sometimes, and shall be in control a

28、ccording to Production Management Procedure. 4.2 文件要求Documentation requirements 4.2.1 总则General 质量体系文件包括:Documentation of the quality management system consists of A. 质量方针和质量目标;Quality policy and quality objectivesB. 质量手册;Quality Manual C. ISO9001: 2008质量管理体系-要求所要求的程序文件和本公司确定的其它程序文件, 见附件4:质量手册和程序清单;

29、Documented procedures required by ISO9001:2008 Quality Management System and our company, see attachment 4: D. 本公司为确保过程有效策划、运作和控制所需的文件;Documents needed by our company to ensure the effective planning, operation and control of its processes, and QMS Manual and Procedure ListE. ISO9001: 2008质量管理体系-要求所

30、要求的记录(见本手册第4.2.4条)Records required by ISO9001:2008 Quality Management System (see 4.2.4 in this Manual F. 文件的形式: 纸质或电子文件.Media of documents: paper or electronic carrier 4.2.2 质量手册Quality Manual A. 本公司编制和保持本质量手册, 且包括:We shall establish and maintain this Quality Manual that includes a) 质量管理体系的范围,包括任何删

31、节的细节和合理性,见本手册第1章节: “范围”; The scope of the quality management system, including details of and justification for any exclusion (see chapter 1: Scope) b) 为质量管理体系编制的形成文件的程序或对其引用;The documented procedures established for the quality management system, or reference to them, and c) 质量管理体系过程的相互作用的表述.A desc

32、ription of the interaction between the processes of the quality management system B. 本质量手册由管理者代表编制、总经理审核;This Quality Manual shall be drafted by Management Representative, and shall be approved by General Manager C. 本质量手册按照文控程序进行控制.This Quality Manual shall be controlled based on Document Control Pr

33、ocedure4.2.3 文件控制Control of document A. 质量管理体系所要求的文件必须予以控制. 质量记录是一种特殊类型的文件, 应按照第4.2.4条款的要求进行控制;Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4 B. 建立文控程序, 以规定以下方面所需的控制:

34、Document Control Procedure shall be established to define the controls needed a. 文件发布前得到批准, 以确保文件是充分与适宜的; to approve documents for adequacy prior to issue b. 必要时, 对文件进行评审与更新, 并再次批准; to review and update as necessary and re-approve documents c. 确保文件的更改和现行修订状态得到识别; to ensure that changes and the curre

35、nt version status of documents are identifiedd. 确保在使用处可获得有关版本的适用文件; to ensure that relevant versions of applicable documents are available at points of usee. 确保文件保持清晰、易于识别; to ensure that documents remain legible and readily identifiablef. 确保外来文件得到识别, 并控制其分发; to ensure that documents of external ori

36、gin are identified and their distribution controlled, andg. 防止作废文件的非预期使用, 若因任何原因而保留作废文件时, 对这些文件进行适当的标识. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose4.2.4 质量记录的控制Control of quality records 建立记录管理程序, 以便:Record Co

37、ntrol Procedure shall be established to A. 建立并保持质量记录, 以提供符合要求和质量管理体系有效运行的证据;establish and maintain quality records in order to provide evidence of conformity to requirements and of the effective operation of the quality management systemB. 确保质量记录保持清晰、易于识别和检索;ensure records can remain legible, readil

38、y identifiable and retrievable C. 规定质量记录的标识、贮存、检索、保存期限和处置所需的控制. to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records5. 管理职责Management responsibility 5.1 管理承诺Management commitment 总经理将通过以下活动, 对建立、实施质量管理体系并持续改进有效性的承诺提供证据:Genera

39、l Manager shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness byA. 向公司全体成员传达满足顾客和法律法规要求的重要性; communicating to the organization the importance of meeting customer as well as statutory and regulator

40、y requirements,B. 制定质量方针; establishing the quality policyC. 制定质量目标, 并定期进行统计和检讨; ensuring that quality objectives are establishedD. 进行管理评审; conducting management reviews, andE. 提供适当的资源; ensuring the availability of resources5.2 以顾客为中心Customer focus A. 总经理以增强顾客满意为目的, 确保顾客的要求得到确定并予以满足;General Manager s

41、hall ensure that customer requirements are determined and met with the aim of enhancing customer satisfactionB. 建立和实施客户服务程序,包括对顾客订单进行有效评审及顾客满意度的调查.Customer Service Procedure shall be established and implemented, including the customer Order Review and Customer Satisfaction Survey. 5.3 质量方针Quality policy A. 总经理应确保质量方针:General Manager shall ensure that the quality policy a. 与公司的宗旨想适应;is appropriate to the purpose of our company b. 包括对满足要求和持续改进质量管理体系有效性的承诺;includes a commitment to comply with requirements and continually improve the effectiveness of the quality management systemc. 提供制定和评审质量目标