手袋厂质量手册(中英文)

1、深圳培训网 质量手册QUALITY MANUAL修订日期修订单号修订内容摘要页次版次修订审核批准2011/03/30/系统文件新制定4A/0/更多免费资料下载请进：好好学习社区批准：审核：编制：质量手册QUALITY MANUAL0. 范围Scope0.1 产品范围Product scope 手袋及其它缝纫制品。 Bags and other sewing products.0.2 场所范围Location scope 0.3 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 d

2、evelopment” 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 a

3、fter sample has been approved by xxx1. 引用标准Normative reference1.1 ISO9000: 2005质量管理体系基础和术语 ISO9000: 2005 Quality Management System-Fundamentals and vocabulary 1.2 ISO9001: 2008质量管理体系-要求 ISO9001: 2008 Quality Management System-Requirements 2. 术语和定义Terms2.1 质量Quality一组固有特性满足要求的程度. Degree to which a se

4、t 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 “quality” 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

5、a permanent characteristics 2.2 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 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 abse

6、nce 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 2: even when customers requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction 2.3 顾客Customer接受产品的组织或个人Organization or person that r

7、eceives a product 2.4 供应商/供方Supplier提供产品的组织或个人Organization or person that provides a product 2.5 过程Process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 2.6 产品Product过程的结果Result of a process2.7 合格Conformity满足要求Fulfillment of a requirement 2

8、.8 不合格Nonconformity未满足要求Non-fulfillment of a requirement 2.9 预防措施Preventive action 为消除潜在不合格或其他潜在不期望情况的原因所采取的措施Action to eliminate the cause of a potential nonconformity or other potential undesirable situation2.10 纠正Correction为消除已发现的不合格所采取的措施Action to eliminate detected nonconformity2.11 纠正措施Correct

9、ive 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 other undesirable situation 2.12 文件Document 信息及其承载媒体Information and its supporting medium 2.13 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 perfo

10、rmed 3. 质量管理体系Quality management system3.1 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

11、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 quality 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

12、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 control 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,

13、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 necessary 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 Qu

14、ality 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 process 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

15、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 according to Production Management Procedure. 3.2 文件要求Documentation requirements 3.2.1 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 qua

16、lity 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;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

17、, operation and control of its processes, and QMS Manual and Procedure ListE. ISO9001: 2008质量管理体系-要求所要求的记录(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 3.2.2 质量手册Quality Manual A. 本公

18、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 procedure

19、s 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 description 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 Ge

20、neral 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 Procedure3.2.3 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 d

21、ocument 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: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 upd

22、ate 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 current 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 r

23、emain 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 origin 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 th

24、em if they are retained for any purpose3.2.4 质量记录的控制Control of quality records 建立记录管理程序, 以便:Record Control 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 oper

25、ation 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, readily 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 records4. 管理职责M

26、anagement responsibility 4.1 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:General 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; co

27、mmunicating to the organization the importance of meeting customer as well as statutory and regulatory 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 a

28、vailability of resources4.2 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 shall 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

29、implemented, including the customer Order Review and Customer Satisfaction Survey. 4.3 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 requ

30、irements and continually improve the effectiveness of the quality management systemc. 提供制定和评审质量目标的框架;provides a frame work for establishing and reviewing quality objectivesd. 在组织内得到沟通和理解;is communicated and understood within the organization, and e. 在持续适宜性方面得到评审.Is reviewed for continuing suitabilit

31、y B. 本公司的质量方针, 见“前言”章节.About quality policy of our company, see the Foreword to this Manual 4.4 策划Planning 4.4.1 质量目标Quality objectives A. 总经理应确保在公司的相关职能和层次上建立质量目标, 质量目标包括满足产品要求所需的内容;General Manager shall ensure that quality objectives, including those needed to meet requirements for product, are es

32、tablished at relevant functions and levels within the organizationB. 质量目标应是可测量的, 并与质量方针保持一致;The quality objectives shall be measurable and consistent with the quality policyC. 本公司的质量目标见附件6: 质量目标分解表About the quality objectives of our company, see attachment 6, Quality Objectives4.4.2 质量管理体系策划Quality

33、management system planning 总经理应确保:General Manager shall ensure that A. 对质量管理体系进行策划, 以满足质量目标和本手册第4.1条款的要求;the planning of the quality management system is carried out in order to meet the requirements given in 4.1 of this Manual, as well as the quality objectives, and B. 在对质量管理体系的更改进行策划和实施时, 保持质量管理体系

34、的完整性. the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented4.5 职责、权限和沟通Responsibility, authority and communication 4.5.1 职责和权限Responsibility and authority A. 总经理应确保组织的职责、权限及其相互关系的得到规定和沟通; General Manager shall ensure th

35、e responsibilities and authorities are defined and communicated within our company B. 各部门的职责与权限, 见附件2: 组织架构图; 附件3: 部门职责对照表; 附件5: 部门职责一览表About departmental responsibilities and authorities, see attachment 2: Organizational Structure; and attachment 3: Departmental Responsibility Deployment4.5.2 管理者代表

36、Management Representative 总经理应任命管理者代表 (见附件7: 管理者代表任命书), 以便履行下述职责与权限:General Manager shall appoint a member of management who (see attachment 7: Appointment of QMS Management Representative), irrespective of other responsibilities, shall have responsibility and authority that include A. 确保质量管理体系所需的过程

37、得到建立、实施和保持; ensuring that processes needed for the quality management system are established, implemented and maintained B. 向总经理报告质量管理体系的业绩和任何改进的需求; reporting to General Manager on the performance of the quality management system and any need for improvement, and C. 确保在公司内提高满足顾客和法律法规要求的意识; ensuring

38、the promotion of awareness of customer requirements throughout our company, and D. 与质量管理体系有关事宜的外部联络, 如: 认证机构、咨询机构, 等. liaising with external parties on matters relating to the quality management system 4.5.3 内部沟通Internal communication A. 总经理应该确保在组织内建立适当的沟通过程, 并确保对质量管理体系的有效性进行沟通;General Manager shall

39、 ensure that appropriate communication processes are established within our company and that communication takes places regarding the effectiveness of the quality management system B. 本公司的沟通途径: 电子邮件、信件、会议, 等Communication channels in our company include email, letter, meeting, etc 4.6 管理评审Management

40、review4.6.1 总则General 总经理应确保建立、实施和改进管理评审程序, 以便 General Manager shall establish, implement and improve Management Review Procedure to A. 最少一年一次评审公司的质量管理体系, 以确保其持续的适宜性、充分性和有效性;review the quality management system of our company at least yearly to ensure its continuing suitability, adequacy and effecti

41、veness, and B. 评审应包括评价质量管理体系改进的机会和变更的需要, 包括质量方针和质量目标;assess opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives 保留管理评审记录Records from management review shall be maintained4.6.2 评审输入Review input 管理评审的输入必须包括以下方面的信息

42、:The input to management review shall include information onA. 质量方针的适宜性;suitability of the quality policy B. 质量目标的适宜性;suitability of quality objectivesC. 外/内部审核的结果;results of both internal and external auditsD. 顾客反馈;customer feedbackE. 过程的业绩和产品的符合性;process performance and product conformity F. 预防和纠正

43、措施的状况;status of preventive and corrective actionsG. 以往管理评审的跟踪措施;follow-up actions from previous management reviews H. 经策划的可能影响质量管理体系的变更;changes that could affect the quality management system, and I. 改进的建议recommendations for improvement 4.6.3 评审输出Review output 管理评审的输出应该包括与以下方面有关的任何决定和措施:The output f

44、rom the management review shall include any decisions and actions related to A. 质量管理体系及其过程有效性的改进;Improvement of the effectiveness of the quality management system and its processesB. 与顾客有关的产品的改进;improvement of product related to customer requirements, and C. 资源的需求.resource needs 5. 资源管理Resource mana

45、gement 5.1 资源提供Provision of resources 总经理应确定并提供所需要的资源, 以:General Manager shall determine and provide the resources needed A. 实施、保持质量管理体系并持续改进其有效性;to implement and maintain the quality management system and continually improve its effectiveness, and B. 通过满足顾客要求, 增强顾客满意.to enhance customer satisfactio

46、n by meeting customer requirements 5.2 人力资源Human resources 5.2.1 总则General 基于适当的教育、培训、技能和经验, 从事影响产品质量工作的人员应是能够胜任的. Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience5.2.2 能力、意识和培训Competence, awareness and trai

47、ning 建立、实施和改进培训程序, 以:Training Procedure shall be established, implemented and improved to A. 确定从事影响产品质量工作的人员所必要的能力; determine the necessary competence for personnel performing work affecting product quality B. 提供培训或采取其它措施以满足这些需求; provide training or take other actions to satisfy these needs C. 评价所采取

48、措施的有效性; evaluate the effectiveness of the actions taken D. 确保员工意识到所从事活动的相关性和重要性, 和如何为实现质量目标作出贡献;ensure that the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and E. 保持教育、培训、技能和经验的适当记录. maintain appropriat

49、e records of education, training, skills and experience 5.3 基础设施Infrastructure A. 公司应确定、提供并维护为达到产品要求的符合性所需的基础设施, 如:Our company shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicablea. 建筑物、工作场所和相关设施;buildin

50、gs, workspace and associated utilities b. 过程设备, 包括硬件和软件;Process equipment (both hardware and software), and c. 支持性服务, 如运输或通讯supporting services (such as transport or communication)B. 建立、实施和改进生产设备管理程序, 以对生产设备进行正确的操作、保养和维修;Production Equipment Management Procedure shall be established, implemented and

51、 improved to properly operate, maintain and repair production equipment C. 建立、实施和改进监控与测量设备控制程序, 以对测量和监视装置进行正确的操作、保养和校正;Monitoring and Measuring Device Management Procedure shall be established, implemented and improved to properly operate, maintain and calibrate measuring and monitoring devices D. 建

52、立、实施和改进模具管理程序, 以对模具装进行验证和保养. Mold Management Procedure shall be established, implemented and improved to verify and maintain molds. 5.4 工作环境Work environment 公司应确定和管理为实现产品要求符合性所需的工作环境。Our company shall determine and manage the work environment needed to achieve conformity to product requirements，6. 产

53、品实现Product realization 6.1 产品实现的策划Planning of product realization A. 本公司将策划和开发产品实现所需的过程. 产品实现的策划应与质量管理体系其他过程的要求相一致. Our company shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the

54、 quality management system B. 在对产品实现进行策划时, 应确定以下方面的适当内容:In planning product realization, we shall determine the following, as appropriate a. 产品的质量目标和要求;quality objectives and requirements for the productb. 针对产品确定过程、文件和资源的需求;the need to establish processes, documents, and provide resources specific t

55、o the product c. 产品所需求的验证、确认、监视、检验和试验活动, 和产品接收准则;required verification, validation, monitoring, inspection and test activities specified to the product and the criteria for product acceptance d. 为实现过程及其产品满足要求提供证据所需的记录.records needed to provide evidence that the realization processes and resulting pr

56、oduct meet requirements C. 策划的输出形式应适于本公司的运作方式.The output of this planning shall be in a form suitable for our companys method of operations 注1: 对应用于特定产品、项目或合同的质量管理体系的过程(包括产品实现过程)和资源作出规定的文件可称之为质量计划;Note 1: A document specifying the processes of the quality management system (including the product realizatio