1、质量环境手册 Edited by 编写： Verified by 确认： Approved by 批准：目录页码1.0INTRODUCTION TO X XL MAMUFACTURING (X) CO., LTD6X精密机械制造（X）有限公司介绍61.1Scope of the Quality & Environmental Management System6质量环境管理体系范围62.0 NORMATIVE REFERENCE6引用标准63.0 TERMS AND DEFINITIONS6术语和定义64.0 QUALITY & ENVIRONMENTAL MANAGEMENT SYSTEM72、质量和环境管理体系74.1Documentation Requirement7文件要求74.1.1Structure of the Quality & Environmental System7质量和环境体系结构74.1.2 Control of Documents7文件管控74.1.3 Control of Records8记录管控85.0 MANAGEMENT RESPONSIBILITY8管理职责85.1 MANAGEMENT COMMITMENT8管理承诺85.2 CUSTOMER FOCUS8以客户为关注焦点85.3 QUALITY & ENVIRONMENTAL POLICY9质量3、和环境方针95.3.1 QUALITY POLICY9质量方针95.3.2 ENVIRONMENTAL POLICY9环境方针95.4 PLANNING9策划95.4.1 QUALITY AND ENVIRONMENTAL OBJECTIVES9质量和环境目标95.4.2 QUALITY AND ENVIRONMENTAL MANAGEMENT SYSTEM PLANNING9质量和环境管理体系策划95.5 RESPONSIBILITY, ROLES, RESOURCES, AUTHORITY AND COMMUNICATION9职责、资源、作用、权限和沟通95.5.1 ORGANIZATIO4、N STRUCTURE.9组织架构95.5.2 INTERNAL COMMUNICATION11内部沟通115.5.3 ENVIRONMENTAL COMMUNICATION11环境沟通115.6 MANAGEMENT REVIEW11管理评审115.7 ENVIRONMENTAL ASPECTS12环境因素125.8 LEGAL AND OTHER REQUIREMENTS12法律法规及其它要求126.0 RESOURCE MANAGEMENT12资源管理126.1 PROVISION OF RESOURCES12资源的提供126.2 HUMAN RESOURCES13人力资源136.2.15、 COMPETENCE, AWARENESS AND TRAINING13能力，意识和培训136.3 INFRASTRUCTURE13基础设施136.3.1 EMERGENCY PREPAREDNESS & RESPONSE13应急准备与响应136.4 WORK ENVIRONMENT13工作环境137.0 PRODUCT REALIZATION13产品的实现137.1 PLANNING OF PRODUCT REALIZATION13产品实现的策划137.2 CUSTOMER-RELATED PROCESSES13与顾客有关的过程137.2.1 DETERMINATION OF REQUIR6、EMENTS RELATED TO THE PRODUCT13与产品有关的要求的确定137.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT14与产品要求有关的评审147.2.3 CUSTOMER COMMUNICATION14与顾客的沟通147.3 DESIGN AND DEVELOPMENT14设计和开发147.4 PURCHASING14采购147.4.1 PURCHASING PROCESS14采购的过程147.4.2 PURCHASING INFORMATION14采购信息147.4.3 VERIFICATION OF PURCHAS7、ED PRODUCT14采购产品的验证147.5 PRODUCTION AND SERVICE PROVISION15生产和服务提供157.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION15生产和服务提供的控制157.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION15生产和服务提供的过程确认157.5.3 PRODUCT IDENTIFICATION AND TRACEABILITY15产品的标识与追溯157.5.4 CUSTOMER PROPERTY15顾客财产18、57.5.5 PRESERVATION OF PRODUCT16产品的防护167.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT16监视和测量设备的控制168.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT16测量、分析和改进168.1 MONITORING AND MEASUREMENT16监视和测量168.2.1 CUSTOMER SATISFACTION17顾客满意178.2.2 INTERNAL AUDIT17内部审核178.2.3 MONITORING AND MEASUREMENT OF PROCESS9、ES17过程的监视和测量178.2.4 MONITORING AND MEASUREMENT OF PRODUCT17产品的监视和测量178.3 CONTROL OF NONCONFORMING PRODUCT17不合格品的控制178.4 Analysis of Data17数据分析178.5 Improvement18改进188.5.1 Continual Improvement18持续改进188.5.2 Corrective Action18纠正措施188.5.3 Preventive Action18预防措施18ATTACHMENTS:附录1.CROSS REFERENCE MATRIX10、交叉参考图2.MANAGEMENT REPRESENTATIVE APPOINTMENT LETTER管理者代表任命书3. PROCESS FLOW CHART1.0INTRODUCTION TO x xL MAMUFACTURING (x) CO., LTDx精密机械制造（x）有限公司介绍x xl Manufacturing (x) Co., Ltd started business formally in Jun.2012 as a wholly owned subsidiary of CMS Group in Italy. CMS Group is major engaged in th11、e business of developing, manufacturing and selling components, modules and complete systems for the food processing and packaging, for the xl field, railways field and industrial plants field, and has many years experience, technology and know-how in such fields.x精密机械制造（x）有限公司，于2012年6月开始正式营业，隶属于意大利12、x集团，集团主要从事食品加工及包装领域、机械领域、铁路及工业领域使用的设备组件、模具和整套系统的研发、生产和销售。x xl (x) Co., LTD is located in the south of x Road and the west ofx Road, x Economic & Technological Development Zone, Jiangsu Province. CMS is built on a factory area of 14000 square meters.x精密机械制造（x）有限公司位于江苏省x经济技术开发区泉德路以南，庞金路以西。工厂占地14000平方米13、。Vision愿景:Addressing the China market as a global partner of leading companies in their sector, for design, development, manufacturing, testing and supply of machines and components involving high levels of complexity and precision致力于成为中国市场行业领先企业的全球合作伙伴，设计、开发、制造、测试和提供高水平、复杂性和高精度的机器和机器零部件。1.1Scope of14、 the Quality & Environmental Management System质量环境管理体系范围The company has identified the scope of the Quality & Environmental Management System to 公司的质量环境管理体系范围是:Manufacturing of machines and equipment for packing, filling, parts handling & transportation, railway equipment, waste disposal, environmen15、t care, industrial/factory automations and the relevant components and parts, sales of self-manufactured products; import, export and wholesale of products of the same category as the self-manufactured products; provision of maintenance services, after-sales services, relevant technical consultation16、 and information consultation.从事包装设备，灌装设备，搬运传送设备，铁路设备，废物处理和环保设备及相关零部件的生产，销售所涉及到的相关活动，从事与本公司生产产品同类商品的批发及进出口业务，并提供维修服务，售后服务和相关技术咨询和信息咨询。ISO 9001:2008 Clause 7.3 Design and Development shall be excluded from CMS Quality Management System, as design and drawings are provided by customers.ISO 9001:2008 条17、款 7.3- 设计和开发不适用于此体系，因为设计和图纸都是由客户提供的。Our company has outsourcing process: surface treatment, outsourced processing, and the outsources activities are controlled and monitored by purchasing procedures.本公司存在外包过程, 表面处理，外发加工，对外包的过程和活动通过采购流程进行管控。2.0 NORMATIVE REFERENCE引用标准The contents and applications of 18、this Quality & Environmental manual refer to the following documents.质量环境手册的内容和应用参考下列文件。ISO 9000:2005 Quality management systems - Fundamentals and vocabularyISO 9000:2005质量管理体系基础和术语ISO 9001:2008 Quality Management SystemsISO 9001:2008 质量管理体系ISO 14001:2004 Environmental Management SystemsISO 14001:219、004 环境管理体系3.0 TERMS AND DEFINITIONS术语和定义QMS：Quality Management System 质量管理体系EMS: Environmental Management System 环境管理体系Environment：The surroundings in which the organization operates, including air, water, land, natural resources, flora, fauna, humans, and their interrelation.组织运行活动的周边环境，包括空气，水，土地，自20、然资源，植物，动物，人，以及他们之间的相互关系。Environmental Aspect: Element of an organizations activities, products and services, which can interact with the environment.环境因素: 一个组织的活动，产品和服务中能与环境发生相互作用的要素Environmental Impact: Any change to the environment, whether adverse or beneficial, wholly or partially resulting from21、 activities, products and services of the organization.环境影响：全部或部分地由公司的环境因素给环境造成的任何有害或有益的变化。Continual improvement: Recurring process of enhancing the system in order to achieve improvements in overall performance, not necessarily in all areas of activity simultaneously, but always in line with an org22、anizations policy.持续改进: 不断对体系进行强化的过程，目的是根据组织的绩效的改进。该过程不必同时发生与活动的所有方面。CMS: x xl Manufacturing (x) Co., Ltdx精密机械制造（x）有限公司4.0 QUALITY & ENVIRONMENTAL MANAGEMENT SYSTEM质量和环境管理体系4.1Documentation Requirement文件要求4.1.1Structure of the Quality & Environmental System质量和环境体系结构The documentation of the Quality &23、 Environmental System is divided to four basic levels namely Manual, Procedures, Work Instructions /Standard Operating Procedures, and checklist.质量环境系统文件可以分为4个基本的级别：手册、程序文件、作业指导书，记录表单。The documents are formulated in accordance to ISO9001 and ISO14001 requirements and consistent with CMS quality and 24、environmental policy.文件的形成是依据ISO9001和ISO14001的要求并与x精密机械制造（x）有限公司的质量和环境方针是相符合的。Level 1 Document states CMSQuality & Environmentalpolicy and gives an outline description of the Quality & Environmental System.一级文件陈述了x精密机械制造（x）有限公司的质量和环境方针并简要的描述了公司的质量环境体系。Level 2 Documents describes the controls of proc25、esses, responsibilities, actions required, method / technique used, frequency and the location.二级文件描述了管控过程，职责，行动方法/技巧，频率和位置。Level 3 Documents are detailed instructions for performing a particular operation or simple instructions displayed at work station for operators reference in the form of visual26、 display.三级文件是详细的作业指导书,或是陈列在工作站点的简单的作业指导，如图片等。Level 4 Documents are checklists for forms.四级文件是记录表单或表格等。Manual手册Procedures程序文件Work Instructions(Standard Operating Procedures)作业指导书Forms and Checklist表格、表单Level 1一级Level 2二级Level 3三级Level 4四级CMS Quality & Environmental Management System frameworkshall c27、omply with the ISO9001 and IS014001 Standard requirements and continually improves the effectiveness of the Quality & Environmental Management System.x精密机械制造（x）有限公司的质量和环境体系架构必须符合ISO9001和ISO14001的标准并能持续改善质量环境管理体系及其有效性。The reference matrix (attachment 1) defined the relation of Quality& Environmental 28、Manual to Procedures and ISO 9001 and ISO 14001 clauses.交叉参考图（附件1）是质量环境手册，程序文件，ISO9001及ISO14001条款的相互关系的比对。4.1.2 Control of Documents文件管控Quality & Environmental manual, procedures, work instructions (SOP) are controlled by Quality Department and distributed to operations, which require them. All docu29、ments are reviewed and approved prior to use. A controlled document list, which identifies the current revisionstatusis maintained by quality department.质量环境手册，程序文件，作业指导书由质量部管控并分发到需要的部门。所有的文件需要在审核和批准之后才可以发行使用。质量部门必须维护受控文件清单。Changes of controlled documents shall be reviewed and approved by the same d30、epartment, which originates the document unless otherwise designated. Amendments shall be clearly identified on the affected documents and stated on the revision history. 受控文件的改版除有另外的指定，必须由起草文件的部门审核和批准。修改的部分必须要能清楚的识别，并在改版履历里面说明。Documents shall be legible and readily identifiable.文件必须是清晰并易于识别的。Extern31、al documents,except from technical files and drawings, should be controlled by Quality Department and distributed to operations which require them. A list of product quality and Environmental and Regulatory requirements shall be listed in the controlled document list.外部的文件除产品的图纸和技术文件以外，其他由质量部管控并发行到相32、关的部门。与产品质量及环境相关的法律法规需要列在文件管控列表中。Obsolete documents should return to quality department and replaced with revised copies.过期的文件必须交还质量部门，并且要更换成新的版本。4.1.3 Control of Records记录管控Control of record shall be established to provide evidence of conformity to requirements of the effective operation of the qual33、ity management system.控制记录应当成立,以提供符合要求的证据的有效运行质量管理系统。Records shall be stored in such a way that will facilitate effective retrieval and will prevent damage ordeterioration. 记录的保存应能够有效的检索并防止破坏和损坏。Upon expiry of retention period, record shall be disposed as normal garbage or shred if contain any confi34、dential information.当超过保存年限时，记录应当丢弃，若含有机密的信息则予以粉碎销毁。5.0 MANAGEMENT RESPONSIBILITY管理职责5.1 Management Commitment管理承诺Top Management shall commit to the development, implementation and well functioning of the QMS(Quality Management System) and EMS (Environment Management System) and continually improve 35、its effectiveness. In order to achieve this, top management shall ensure that quality and environmental policy is established;最高管理者应致力于质量管理体系和环境管理体系的建立、实施和持续提升其有效性。为达成这样的目标，最高管理层应确保建立质量和环境方针。-Quality and environmental objectives is established; 建立质量和环境目标。-The importance of meeting customer requireme36、nts and statutory and regulatory requirements are communicated; 沟通满足顾客要求和法律法规要求的重要性。-Resources for the implementation and maintenance of the quality and environment management system and its process are provided in a timely manner; 建立和维护质量和环境管理体系的过程中所需要的资源能够及时获得。-Management Reviews areconducted.进行管理37、评审5.2 Customer Focus以客户为关注焦点General Managers, Managers, in their various capacities, are fully focused to meet customer requirements in terms of product quality, delivery and cost. Top Management ensures that internal and external communication is well developed.总经理，经理等通过充分发挥各自的工作职能，达到客户对质量、交货期以及价格的38、要求。最高管理者确保良好的内外部沟通来确保客户的要求可以得到满足。5.3 QUALITY & ENVIRONMENTAL POLICY质量和环境方针The management of CMS has developed a corporate quality and environmental policy which meets the needs of CMS and its customers.x的管理层已经建立了公司的质量和环境方针,满足自身和客户需求。5.3.1 Quality Policy质量方针CMS is fully committed to customer satisfac39、tion, providing products and services of high standards and pursuing continuous improvement in quality, delivery, reliability and performance, with the aim to achieve the highest level of excellence.x致力于提供高质量的产品和服务，确保客户满意。在质量、交货、可靠性方面进行持续改进并追求卓越。5.3.2 Environmental Policy环境方针CMS is fully committed t40、o continuously improving the environmental-related performance, complying with applicable laws and regulations, minimizing the ecological impacts and making resources efficiency and waste control core requirements of all our operations.x将遵守适用的法律法规，持续提高环境相关绩效，对生态影响最小化，并将能源的高效使用和污染控制作为生产的核心要求。 - MR. E41、milio x xr总经理Achievement of companys policy is measured in terms of attainment of objectives set by individual department on a yearly basis and monitored on a monthly basis. 公司的方针是通过每年度各个部门的目标达成情况来衡量，每月监控目标达成情况。5.4Planning策划5.4.1 Quality and Environmental Objectives质量和环境目标Top management shall ensure42、 that quality and environmental objectives, including those needed to meet requirements for product, commitment to prevent pollution, compliance to all legal requirements are established at relevant functions and levels within the company. The quality and environmental objectives shall be measurable43、 and consistent with the quality and environmental policy.管理者应确保在公司的相关职能层次上建立质量和环境目标。质量和环境目标包括满足产品要求、防止污染以及满足法律法规等内容，质量和环境目标应是可测量的并与质量和环境方针保持一致。Base on the internal and external measurable results, these quality and environmental objectives are reviewed during the management reviews regarding their 44、continuing suitability.根据内外部衡量的结果，质量和环境目标需在管理评审时审核其持续的适宜性。5.4.2 Quality and Environmental Management System Planning质量和环境管理体系策划Management shall ensure that the planning of the QMS and EMS is carried out in order to meet the requirements of the ISO9001，ISO14001 standard and the quality and environmen45、tal objectives of the company. The management, through MR (Management Review), shall also ensure that the integrity of the QMS and EMS is maintained when changes to the QMS and EMS are planned and implemented. The management must review all changes to the QMS and EMS. The documented QMS and EMS shal46、l be reviewed once a year to ensure its suitability and effectiveness.管理者应确保对质量和环境管理体系的策划是满足ISO9001，ISO14001的标准以及质量和环境目标的要求。管理者通过管理评审对质量和环境管理体系的更改进行策划和实施时，应保证质量环境管理体系的完整性并审核质量和环境管理体系的变更。为确保文件的适宜性和有效性，质量和环境管理体系的文件必须每年审核一次。5.5 Responsibility, Roles, Resources, Authority and Communication职责、资源、作用、权限和沟通47、5.5.1 Organization Structure.组织架构For procedures and instructions that refer to G&A and sales & Marketing, GM means Executive Director.对程序和作业指导书涉及一般行政管理，业务部时，总经理指执行总监。For procedures and instructions that refer to Technical, Quality, Supply chain, Production and Assembly, GM means Plant Manager.对程序和作业48、指导书涉及技术、质量、供应链、生产和装配时总经理则指代工厂长。The management of CMS consists of General Manager and Management Team. Management Team ensures the availability of resources essential to establish, implement, maintain, and improve the quality and environment system, including human and specialized skills, organizatio49、nal structure, technology and financial resources.公司的管理层包含总经理和管理组人员。管理组确保质量和环境管理体系的建立、实施、维护和改进的必要的资源能够获得。包括人员，特殊技能，组织架构，技术以及财政资源等。Roles, responsibilities and authorities are defined, documented and communicated to facilitate an effective quality and environmental system.为促进质量和环境管理体系的有效性，角色、职责、权限需得到文50、件化规定和沟通。Department managers and supervisors shall be held responsible and accountable for the activities in his department.He shall ensure adequate staffing and designation of competent staff to perform department functions, including internal quality and environmental audits.部门经理和主管对部门内部的活动负责，他必须确保51、有足够的充分人员担任部门的职能，包括内部质量和环境审核。Specific job description and duties of individual are maintained by HR & Admin Section.详细的工作岗位说明由人事行政部门保存和维护。Key Persons主要人员General Manager总经理 :Overall responsible for the performance of x xl Manufacturing (x) Co., LTD. Establish and improve the companys management system52、 and organizational structure, and presided over the companys day-to-day operations and management; company management and development objectives.负责x精密机械制造（x）有限公司的整体业绩，指定和实施公司的整体战略和年度运营计划；建立和健全公司的管理体系和组织结构；支持公司的日常运营和管理工作，实现公司经营管理和发展目标。Management Representative (MR):管理代表（MR）Quality manager is appoint53、ed by the Management as the management representative (MR) who, irrespective of other duties and responsibilities, has a defined authority and responsibility for:质量经理除本身职责之外还被任命为管理代表。管理代表的职责包括:-Ensuring that a quality and environmental management system is established and implemented and maintained 54、in accordance with the requirements of the international standard of ISO9001:2008 and ISO14001:2004.确保x的质量和环境管理体系能够按照ISO9001:2008和ISO14001:2004的要求得到建立、实施和维护。-Reporting on the performance of the quality and environmental management system to the top management, and needs for improvement向最高管理者汇报质量和环境管55、理体系的业绩和任何改进的需求。-The proper coordination of quality and environmental related issues and activities within the company, with external customers and suppliers and other external partners and authorities.对公司内部活动，外部客户，供应商合以及政府部门就质量和环境相关的问题进行协调。-Promoting the awareness of environmental protection, custom56、er requirements and expectations throughout the company.提高满足客户要求和环境保护的意识。Refer to attachment 2, MR appointment letter.参考附件2，管理者代表任命书。5.5.2 Internal Communication内部沟通Top Management shall ensure that appropriate communication processes are established. Communicate regarding the effectiveness of the Qu57、ality Management System within the company via e-mails, memos, meeting minutes or kanban.管理者应确保在公司内部建立有效的沟通过程，如邮件，备忘录，会议记录以及看板等。Any communication problems regarding quality and environmental management system are reported to the Management Representatives for corrective actions.质量和环境的任何沟通问题都应报告给管理者代58、表并采取改善措施。5.5.3 Environmental Communication环境沟通CMS establishes a system to collect both internal and external information related to environmental management system. And these information received shall be considered during the setting of environmental objectives and targets.公司就环境管理体系建立一个收集内部和外部信息的系统59、。这些信息将在设定环境目标时进行考量。When significant environment occurs, e.g. fire, explosion, environmental contamination or major occupational injury, upon approval of the general manager, CMS will communicate information to the related department.当发生重大环境影响时，如：火灾、爆炸、环境污染及重大工伤，经公司总经理批准，将主动和相关方进行沟通。5.6Management Rev60、iew管理评审Management Review is held at least once a year and may be more frequent depending on the necessity. Participants of the management review consists of General Manager, manager, supervisor and Management Team. The review shall include assessing opportunities for improvement and the need for cha61、nges to the quality and environmental management system, including the quality and environmental policy and quality and environmental objectives.管理评审至少每年进行一次，可根据内部需要增加评审的次数。参加管理评审的人员应包括总经理，经理，部门主管等管理层。评审应包括质量和环境体系改进的机会和变更的需要、质量和环境方针，质量和环境目标。1) Results of audits, including internal and external syste62、m audit, customer audit, process audit and nonconformity corrective action validation审核结果:包含内外部体系审核，客户审核，制程审核以及一些不符合项的验证2) Interested party feedback，including customer satisfaction, interested party complaint, customer requirement and suggestions相关方反馈:包含客户满意度，相关方抱怨要求及建议等。3) Process performance and p63、roduct conformity, including performance trends过程的业绩和产品的符合性,包含业绩趋势图4) Status of preventive and corrective actions for process and product过程，产品的预防和纠正措施的状况5) Follow-up actions from previous management reviews以往管理评审的跟踪措施6) Changes that could affect the quality and environmental management system includ64、ing the changes of organizational structure, laws and regulations internal and external changes in the environment可能影响质量和环境管理体系的变更,包含组织架构的变动，法律法规的变化，内外部环境的变更等7)Assessment of improvement opportunities and recommendations for improvement评估改进的机会和建议8) Achievement of departmental quality objectives and t65、o what extent the environmental objectives are achieved部门质量目标的达成情况以及环境目标指标的达成程度9) Human resources, training and staffing requirements人力资源、培训和人员需求10) Evaluation of compliance to legal requirements合规性评价的结果11) Communication from external interested parties, including complaints和外部相关方的交流包括抱怨12)The envir66、onmental performance of the organization环境方面的绩效The output of the management review include any decisions and actions related to管理评审的输出应包括以下方面的任何决定和措施1) The suitability and effectiveness of the quality and environmental management system质量和环境体系的适宜性与有效性2) Improvement of effectiveness of the quality an67、d environmental management system and its process质量和环境管理体系过程有效性的改进3) Improvement of product related to customer requirements 与顾客要求有关的产品的改进4) Suitability of corporate quality and environmental policy公司质量和环境方针的适宜性5) Resource needs资源需求6) Other elements of the environmental management system环境管理体系的任何其它要68、素Records of such reviews shall be maintained and the Quality Department shall follow-up on all the suggestions or recommendations that mentioned during the meeting.对管理评审的记录应予以保存和维护。质量部门应对会议中提出的建议事项进行进一步追踪。5.7Environmental Aspects环境因素CMS will establish and maintain a procedure to identify the environ69、mental aspects of our activities, products and services of which we can control within the defined scope of EMS and expects to have an influence. The identification will cover the direct and indirect aspects covering normal, abnormal and emergency situations, planned or new developments, or modified70、 the activities, products and services. The identified aspects will be evaluated in order to determine those that have or can have significant impacts on the environment. CMS will ensure that the aspects related to these significant impacts are considered in setting its environmental objectives and 71、targets.The organization shall ensure that the significant environmental aspects are considered in developing, implementing and maintaining its EMS. The document and information shall be kept up to date.公司应建立并维护确定环境管理体系范围内的活动、产品及服务中能够控制和施加影响的环境因素。此时还应考虑到正常，异常和紧急状态下的直接和间接环境因素，已纳入计划的或新的开发、变更的活动、产品和服务；72、判定那些对环境具有重大影响，或可能具有重大影响的因素(即重要环境因素)。公司在建立目标指标，建立、实施和保持环境管理体系时，对重要环境因素加以考虑，并将这方面的信息形成文件并及时更新。Significant environmental aspects are considered during the setting of environmental objectives and targets.在设定环境目标时需考虑重大环境因素。5.8 Legal and other Requirements法律法规及其它要求CMS shall establisha procedure to identif73、y and have access to the applicable legal requirements to determine how these requirements apply to its environmental aspect. And CMS ensure that applicable legal requirements and other requirements to which the organization subscribe are taken into account in establishing, implementing and maintain74、ing its environmental management system.公司将建立程序识别和获得适用的法律要求来确定这些要求如何应用其环境方面。公司确保适用的法律要求和其他要求在公司建立、实施和保持环境管理体系时予以考虑。6.0 RESOURCE MANAGEMENT资源管理6.1Provision of Resources资源的提供Top Management shall determine and provide resources needed to implement and maintain the Quality and Environmental Management S75、ystem and continually improve its effectiveness and enhance customer satisfaction.最高管理者应确定并提供实施和保持质量和环境管理体系和持续改进其有效性、增强客户满意度所需的资源。6.2 Human Resources人力资源6.2.1 Competence, Awareness and Training能力，意识和培训It is the responsibility of department heads to identify qualification requirements of personnel as76、signed to defined activities, which affect product quality or environmental performance. Qualification requirements include education, training, skills and experience as appropriate.The requirements need to be documented and training is provided to employees or other actions are taken in order to me77、et defined qualifications.部门主管确定参与相关活动影响产品或环境人员的资格要求。资格要求包括教育、培训、技能和适当的经验。相关的要求需要形成文件化的岗位说明书。为满足各岗位能力的需求，对员工应经行相应的培训等。CMS shall be aware of the importance of the role and responsibility in achieving conformity with requirements of the quality and environment system.公司应意识到质量和环境意识对达成符合性要求及相关岗位的重要性。6.378、Infrastructure基础设施Facility Maintenance Section maintains the buildings, workspace and associated utilities. IT shall provide supporting services (e.g. hardware, software, and communication or information systems) which needed to achieve conformity to product requirements.为达到产品的符合性，满足相关的要求，设施维护部门应维护房79、屋，工作场等相关设施。信息技术应提供相关的支持性服务(如硬件,软件，通讯或信息系统)。6.3.1 Emergency Preparedness & Response应急准备与响应CMS establishes an emergency plan identifying potential accidents & emergency situations, preventing & mitigating potential environmental impacts that may be associated with them, and periodically testing such p80、rocedures where practical. This plan shall be reviewed periodically to check the necessity to be revised. 公司建立应急计划并识别潜在事故和紧急情况,预防和缓解与其相关的潜在的环境影响。定期对计划进行测试，确认是否有必要修改。6.4 Work Environment工作环境The company has determined and managed the work environment needed to achieve conformity to product requirement81、s through 5S campaign and general cleaning. Where necessary, the relevant infrastructure as in 6.3 will be provided and maintained to achieve the required work environment.公司通过5S活动和一般清洁等管控工作场所的环境来满足实现产品的符合性的工作环境需求。提供与维护与6.3的相关的基础设施来确保所需要的工作环境。7.0 PRODUCT REALIZATION产品的实现7.1 Planning of Product Reali82、zation产品实现的策划Planning of product realization shall be consistent with the requirements of the other processes of the Quality Management System and the requirements of the Environmental Management system. Processes needed for the product realization has been planned and developed.产品实现过程的策划应与质量和环境管理体系83、其他过程的要求相一致。产品实现的过程必须得到策划与建立。Quality Planning is also in the form of procedureswhich defines the working flow, working instructions which defines the operation, tools used, methods and some other related documents.质量策划通过程序文件定义作业的流程，作业指导书以及其他相关的文件定义作业的方法，使用的工具等。7.2 Customer-Related Processes与顾客有关的过程7.84、2.1 Determination of Requirements Related to the Product与产品有关的要求的确定CMS defines product requirements include those specified by the customer, those not stated by the customer but necessary for the intended use, statutory and regulatory requirements related to the product, delivery and post-delivery a85、ctivities, and any additional requirements defined by CMS.x定义产品需求包括客户明确的要求,以及非客户规定但必要的预期用途的要求、相关的法律和法规要求、产品交付及交付后活动,以及其他任何附加的要求。7.2.2Review of Requirements Related to the Product与产品要求有关的评审CMS reviews product related requirements per the customer drawings and specifications. These reviews are conduct86、ed prior to any commitment to supply to customer to ensure that product requirements are defined. Records of the results of the review and actions arising from the review are maintained. Where product requirement are changed, need to ensure that relevant documents are amended and that relevant emplo87、yees are made aware of the changed requirements.x根据客户的图纸和规格来确定客户的相关的要求。在承诺供应产品给客户之前，需要对客户的要求评审和定义。评审结果以及矫正措施进行维护。产品需求有变化时,需要确保相关文件修改,相关员工了解变化的需求。7.2.3 Customer Communication与顾客的沟通Customer communication is vital to customer satisfaction.The communication with customers should be before, after and the88、 whole process of product realization. The communication shall include product information, inquires, contracts or order handling, including amendments, customer feedback and customer complaints.与客户沟通对于客户满意度是至关重要的。与顾客的沟通应在产品实现之前，之中，之后的整个过程中实现。沟通的内容包括产品信息，合同，订单的处理修改，顾客的反馈,包括顾客抱怨等。7.3 Design and Devel89、opment设计和开发This clause is not applicable to CMS (x) Co., Ltd, as design and drawings are provided by the customers, CMS is not authorized to revise the drawings.此条款对于x机械制造（x）有限公司不适用，因设计和图纸都是由客户提供的，本公司无修改的权力。7.4 Purchasing采购7.4.1 Purchasing Process采购的过程Purchasing procedures are in place to ensure tha90、t purchased products meet the requirements. The type and extent of control applied to the supplier and purchased products shall be dependent upon the effect of the purchased products. CMS shall evaluate and select suppliers based on their ability to supply product in accordance with internal require91、ments. Criteria for selection, evaluation and re-evaluation shall be established. Records of these evaluation and following actions shall be recorded.制定采购程序以确保采购的产品符合要求。控制的方式和程度根据采购产品对之后的实现过程及其输出的影响确定。公司根据供方按本公司的要求提供产品的能力评价和选择供方，并制定选择、评价和重新评价的原则予以规定，评价的结果和跟踪措施应予以记录。Suppliers who directly deal with s92、ignificant aspects shall be made aware of CMSs environmental policy.提供与环境有关的产品和服务的供应商应了解公司的环境方针。7.4.2 Purchasing Information采购信息Internal requisition and purchase orders used for the placement of orders shall contain all the pertinent information. Prior to release to suppliers, purchase order shall b93、e reviewed and finally approved by General Manager.用于下单的请购单和采购单必须含有所有相关的信息。在发给供应商之前，采购定单需要审核并最终由总经理批准。7.4.3 Verification of Purchased Product采购产品的验证7.4.3.1 Incoming Inspection进料检验Incomingproductqualityisassuredbyutilizingoneormoreofthefollowingmethods:进料的质量通过以下的方法来保证Evaluationofsupplierstatisticalda94、ta评估供应商的统计数据Receivinginspectionsamplingplans 进货检验抽样计划Secondorthirdpartyassessmentscoupledwithrecordsofacceptabledeliveredproductquality 第二或第三方测试结果和可接受的产品的质量报告。Internal inspection is carried out by trained inspectors in accordance to Quality Inspection Instruction (QII), and been recorded in inspecti95、on sheet.内部进料检验是由受过训练的检验员按照质量检验指导书进行，并记录在检验记录表中。7.4.3.2 Verification at suppliers premises. 供应商现场的确认Verification arrangement and the method of product release shall be specified in purchasing documents should CMS or customer choose to verify purchased product at suppliers premises.当本公司或客户需要在供应商现场对材料96、进行验证时，则验证的安排以及产品放行的方法必须在采购的文件中进行定义。7.5 Production and Service Provision生产和服务提供7.5.1 Control of Production and Service Provision生产和服务提供的控制Production& Assembly Department shall manufacture and exercise control on all production processes, in accordance to procedures and work instructions. 制造和装配部必须根据程序97、和作业指导书对生产和装配的过程进行管控。Production and Assembly Manager shall ensure that suitable equipment is adequate at the workshop and personnel involved in production are well trained and understand the requirements of the job. Production supervisor shall ensure that operators comply with stated procedures and w98、orking instructions. Effective feedback system shall be enforced to enable notification of any abnormality. Nonconformities at above allowable limits shall be treated as per Section 8.2 (Control of Nonconforming Product).制造和装配部经理需确保工作现场有足够的适宜的工具和设备，并且生产相关的人员得到充分的培训，了解工作的要求。生产主管必须确保员工能够按照作业指导书进行作业。需要99、有效的信息反馈系统能在异常发生时得到有效的反馈。对于不合格的产品应根据8.2节（不合格品管理程序）进行处理。When environmental aspects are considered to be significant, CMS shall establish related control methods to reduce or eliminates the impact to the environment and to seek for conformity to the policy.当评价与所确定的重要环境因素运行时，为确保其在运行过程中能够控制或减少对环境的影响，应建立相100、应的控制措施，以满足环境方针。7.5.2 Validation of Processes for Production and Service Provision生产和服务提供的过程确认CMS validates processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. Validation demonstrates the ability of the processes to ach101、ieve planned results. CMS establishes defined criteria for review and approval of the process, approval of equipment and qualification of employees, use of specific methods and procedures, requirements for records and re-validation. CMS need to validate the welding process and establish related docu102、ment to control the process.当输出不能由后续的监视或测量验证时，公司对这样的过程进行验证。验证证明了过程的能力和策划的结果。公司定义标准来审查设备的认可和人员资质的鉴定,使用特定的方法和程序进行记录和再验证，公司需要进行过程确认的工序为焊接工序，以建立相关的文件对其进行管控。7.5.3 Product Identification and Traceability产品的标识与追溯The identification and traceability shall be implemented throughout the product realization to 103、keep the traceability and prevent the unintended use.为保持产品的追溯性预防非预期的使用，在产品实现的全过程中应用适宜的方法进行标识。CMS shall identify the product status with respect to the monitoring and measurement status.Product quality status: OK, NG and to be processed公司将在产品实现的全过程中，对其监视和测量状态进行标识，产品的质量状态有：合格，不合格，待处理。Product processin104、g status: raw materials, finished products, semi-finished products, can be identified through the seal, place area, labels, signs, tags, inspection records, etc. 产品的加工状态有：原料，成品，半成品，可通过印章、放置区域、标签、标牌、标记、检验记录等对产品的状态进行区分。7.5.4 Customer Property顾客财产CMS needs to identify, verify, protect and safeguard cus105、tomer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records shall be maintained.公司应识别、验证、保护供使用和构成产品一部分的顾客财产。当顾客财产发生丢失，损坏或发现不适合的情况时，应通知客户，并保持记录。7.5.5 Preser106、vation of Product产品的防护Thispreservationincludesidentification,handling,packaging,storageandprotection.Preservationalsoappliestotheconstituentpartsofaproduct.Appropriate methods for preservation and segregation shall be observed in storage areas. Handling and storage of raw materials and components ar107、e defined in Store procedures while finished goods packing are carried out in accordance to work instructions Allproductsshallbepackagedforshipmentinamannertopreventdamage to the products during delivery.产品的防护包括标识，搬运，包装，存储和防护。产品的防护同样适用于产品的组成部分。仓库区域应采用恰当的防护区隔。原材料和零部件储存与管控方法由仓库的程序文件定义。成品的包装方法根据作业指导书进行108、。对成品必须进行充分的防护以防止在交货过程中造成损坏。Hazardous materials, industrial wastes and hazardous wastes are stored in designated storage areas or in controlled accumulation points.危险材料、工业废物和危险废物储存在指定的存储区域或固定的收集点。7.6 Control of Monitoring and Measuring Equipment监视和测量设备的控制Inspection, measuring and test equipment/jigs 109、used are subjected to routine maintenance and calibration. Quality Department to ensure that such equipment are capable to perform as intended. Appropriate inspection, measuring and test equipment shall be selected for the required accuracy and precision. A measuring equipment management list is mai110、ntained by Quality Department which list the equipment information and the due date for calibration. 检验，量测设备/治具必须进行日常的保养。由质量部进行校验，确保仪器可以按照预期的状况使用。根据需要的精密度选择适当的检验，量测和测试设备。质量部建立一个包含仪器信息和下次校验日期的测具管理清单。External calibration is conducted by qualified laboratories or equipment manufacturers and substantiat111、ed by calibration records. The reference standard used for calibration shall be traceable to internationally or nationally recognized standards. In the absence of such standard, the calibration method shall be documented. When calibration or test result is unsatisfactory, the equipment shall be prom112、inently identified with sticker and removed from point of use where possible.外部的校验必须由具有资质的实验室或仪器制造商进行，校验后提供校验报告。仪器校正的参考标准必须追溯到国际或国家标准。如果没有此种标准，则需要记录仪器校验的方法。当仪器校正的结果不合格时，则必须在仪器的显著位置帖上标签，并从使用地点移除。Care shall be taken when handling equipment and shall be stored as recommended by the manufacturer to ensu113、re accuracy and fitness for use. Suitable method to prevent tempering with calibration setting shall be used such as location of calibration sticker and password.对设备必须小心操作，并按照厂商建议的条件储存以确保其精度与准确性。对于仪校之后的设置应避免进行破坏，可采取适当的方法，如加上仪器校正的标签或用密码进行控制。When the equipment is found not to conform to requirements. 114、CMS shall take appropriate action on the equipment and any product affected.当发现设备不符合要求时，公司应对以往测量结果的有效性进行评价和记录，并对该设备和任何受影响的产品采取适当的措施。8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT测量、分析和改进8.1 Monitoring and Measurement监视和测量8.1.1 CMS shall plan and implement the monitoring and measurement analysis and impro115、vement process needed to ensure conformity to product requirements and continually improve the effectiveness of the system.公司应策划并实施监视、测量、分析和改进过程以确保质量管理体系的符合性，持续改进质量管理体系的有效性。8.2 CMS will establish and maintain documented procedures to monitor and measure on a regular basis the key characteristics of 116、our operations and activities that can have a significant impact on the environment. This shall include the recording of information to track performance, relevant operational controls and conformance with our objectives and targets.CMS will establish and maintain a documented procedure for periodic117、ally evaluating compliance with relevant environmental legislation and Regulations.公司应建立和保持形成文件的程序，对可能具有重大环境影响的运行的关键特性进行例行监视和测量。这些程序应包括对绩效、有关的运行控制、组织环境目标和指标符合情况的信息文件。公司应建立和保持形成文件的程序以定期评估适用法律法规和其他要求的符合性。8.2.1 Customer Satisfaction顾客满意A system of monitoring information relating to customer perception 118、is in place as to whether CMS has met customer requirements in terms of product quality, delivery on time and service and technical support provided to customers.具备一个量测客户满意度的体系，衡量公司是否在就产品的质量、交期、服务和技术支持上满足客户的要求。The areas of focus shall encompass but not limited to quality issues, delivery, service/te119、chnical support and cost. 关注点应包括但不局限于质量问题、交期、服务/技术支持和价格。8.2.2 Internal Audit内部审核Systematic and periodic Internal Quality and Environmental Audits are carried out to ensure effective implementation and compliance to the requirements system documents, laws and regulations and the requirement from inte120、rested parties. Quality Department shall plan, coordinate, arrange and conduct Internal Quality and Environmental Audit. Audits shall be conducted by qualified personnel and audit will be carried out in form of cross audit.系统的内部审核必须定期举行以确保能够有效地执行并符合公司系统文件、法律法规及相关方要求。质量部门必须计划，协调安排，组织审核开展。审核必须由有资质的人员进121、行且不能审核与直接责任相关的工作。Each department shall be audited at least once a year. Results of the audits shall be disclosed to Quality Manager and the Management Team. The results shall be reviewed during the management review meeting. Corrective actions taken shall be verified.公司的各个部门至少每年被稽核一次。审核的结果应反馈给质量经理和管122、理层并在管理审查时进行讨论。对纠正措施应进行确认。8.2.3 Monitoring and Measurement of Processes过程的监视和测量To determine appropriate monitoring and measuring rules to monitor the process. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and123、 corrective action shall be taken.通过适宜的方法对过程进行监视和测量，这些方法能够证实过程实现所策划的结果的能力。当未达到结果的能力时应采取适当的纠正和预防措施。A written procedure shall be established to describe how the periodic monitoring and measurement of the key characteristics, which could impact its Significant Aspects or Environmental Objectives are co124、nducted.A process for periodically evaluation compliance with relevant environmental legislation and regulations. Any environmental deficiencies are immediately brought to the attention of the management representative as soon as it is discovered. Management representative is responsible for immedia125、te corrective actions and notification to an external agency if required by law.制定书面程序定义可能会影响环境方面的因素和影响环境目标的活动是如何进行定期的测量的。对环境方面法律法规的符合性要进行定期的合规性评价。一旦发现有任何的环境方面的不符合，应立即通知管理者代表。管理者代表需要立即采取改善措施，如有法规要求，还需要通知到相关单位。8.2.4 Monitoring and Measurement of Product产品的监视和测量To verify the that the product requireme126、nts have been met, inspection of raw materials, semi-finished products and finished goods shall be carried out. Evidence of conformity with acceptance criteria shall be maintained. To release the product into the next process or delivery to customer without undergoing inspection or approved by autho127、rized personnel is not allowed.Nonconforming parts and products shall be treated as referring to Nonconformity Management Procedure.为确保产品符合要求，应对产品的特性进行测量，包括原材料，半成品和成品。保存符合接收标准的证据。未经检验合格并由授权人员批准放行的产品不得流入下一道工序或出厂。出现的不合格品部件和产品应按不合格品控制程序的规定和要求处理。8.3Control of Nonconforming Product不合格品的控制Nonconforming pr128、oducts are properly identified with red card and quarantined in a specific area. A nonconforming sheet shall be raised by quality department and to be issued to the related department or supplier for corrective action.Records of the nonconformity products ,including the type of the nonconformity, ac129、tions taken and concessions obtained are maintained.不合格的产品应用标签来标示隔离并存放在特定的区域。质量部应发出不符合报告给相关的单位或供应商进行改善。不合格品所形成的记录,包含不合格的类型,采取的行动以及取得让步接收等。Some deficiencies which could result in an adverse environmental impact shall be identified and labeled with suitable warning tag other indicator to improve.一些会导致130、环境不利影响的不合格，应被识别并贴上合适的警告标记或其它标识,并加以改善。8.4 Analysis of Data数据分析Appropriate data relating to customer satisfaction, product conformity, process characteristic and supplier shall be collected and analyzed to demonstrate the suitability and effectiveness of the Quality Management System and to evaluate a131、ny continual improvement can be made, as well as to initiate any possible preventive action.与客户满意度、过程绩效、产品的符合性以及供应商有关的数据必须要收集，分析。在适当的时候采取必要的持续改善措施以及开展相关的预防措施。8.5Improvement改进8.5.1 Continual Improvement持续改进Continual improvement on the effectiveness of the Management System through quality and environ132、mental policy, objectives, audit results, analysis of data, corrective and preventive actions, management review.对管理体系的有效性通过方针，目标，审核结果，数据分析，纠正预防措施，管理评审进行持续的改善。8.5.2 Corrective Action纠正措施Following the established procedures for corrective action, nonconformities are identified, root cause are determi133、ned, corrective action is evaluated and defined, recurrence of the nonconformity is prevented, corrective actions and their results are recorded, and the effectiveness of corrective action taken is reviewed. Actions are initiated to eliminate the cause of quality or environmental nonconformities in 134、order to prevent reoccurrence.根据建立的程序分析不良的原因，评估须采取的行动并采取必要的措施，记录所采取措施的结果, 评审所采取的纠正措施的有效性，确保质量和环境的不良不再发生。Corrective action taken by supplier as stated in the nonconforming material report shall be verified by follow-up audit or result of incoming inspection on subsequent deliveries.不合格材料报告所记录的供应商改善措施135、内容，必须在下次稽核时或根据之后的交货进料检验结果进行核实。8.5.3 Preventive Action预防措施Preventive actions shall eliminate the cause of potential nonconformities in order to prevent their occurrence. And preventive actions shall be appropriate to the effects of the potential problems. The process of the preventive action includes136、 the following steps: identify potential nonconformities, deficiencies or problems; determine the root causes; determine the necessary preventive action; Implement the action; follow-up on status and results; Review the effectiveness of preventive action.预防措施应能消除不合格的原因，防止不合格的发生。预防措施的过程包括以下步骤:识别潜在的不合137、格、缺陷或问题,确定根本原因,确定必要的预防措施,落实行动;后续状态和结果;预防措施有效性的审核。1. CROSS REFERENCE MATRIX交叉参考图Work Order, Self-Control工单，自检GongdangC-PL01 Material Resources Planning Procedure物料需求计划程序C-PQ07 New Supplier Approval Procedure新供应商选择程序C-WQ006 Approved Supplier Management Instruction合格供应商管理规范C-PQ11 Inspection Procedure 检138、验程序xinProcedure2. MANAGEMENT REPRESENTATIVE APPOINTMENT LETTER管理者代表任命书ASSIGNMENT授权书This is to assignto be the ISO9001:2008, ISO14001:2004 Quality and Environmental Management System Management Representative for x xl Manufacturing (x) Co., Ltd.兹任命先生为x精密机械制造（x）有限公司ISO9001:2008,ISO14001:2004质量环境管理体系管理139、者代表。The management representatives responsibility and authority as follow:管理者需履行以下职责和权限：-Ensuring that a quality and environmental management system is established and implemented and maintained in accordance with the requirements of the international standard of ISO9001:2008 and ISO14001:2004.确保x的质140、量和环境管理体系能够按照ISO9001:2008和ISO14001:2004的要求得到建立、实施和维护。-Reporting on the performance of the quality and environmental management system to the top management, and needs for improvement向最高管理者汇报质量和环境管理体系的业绩和任何改进的需求。-The proper coordination of quality and environmental related issues and activities within141、 the company, with external customers and suppliers and other external partners and authorities.对公司内部活动，外部客户，供应商合以及政府部门就质量和环境相关的问题进行协调。-Promoting the awareness of environmentalprotection, customer requirements and expectations throughout the company.提高满足客户要求和环境保护的意识。Signature of the GM：_Date: _ 签名(总142、经理)日期3.PROCESS FLOW CHART生产流程图Machine to warehouse整机入库Parts to warehouse零部件入库Assembly组装Testing测试Washing水洗Electro polishing电抛光Degreasing bath脱脂Washing水洗Acid pickling酸洗Washing两级水洗Inspection检查Wielding焊接Machining机加工Cutting切割Attachment 4:附件4： Management System Functional Unit Table 管理体系职能单位分配表5. COMPANY LAYOUT公司平面图x xl Manufacturing (x) Co., Ltdx精密机械制造（x）有限公司Address：No. 1929,x Road, x Economic & Technological Development Zone, Jiangsu Province, P.R.C地址：x经济技术开发区庞金路1929号