1、有限公司Co.质量手册Quality Manual文件编号 Document No： QM-01文件版本 Revision: 03实施日期 Implementation Date：2006.04.20制定 Prepared By： 批准 Approved By：质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 2 / 34章 节(Chapter) 内 容 (Contents)0 目录 Table of Contents 0.1 质量手册颁布令 Quality Manual Approval Statem
2、ent 0.2 公司简介 Company Introduction0.3 管理者代表任命书 Management Representative Appointing Letter 0.4 质量政策 Quality Policy 0.5 质量手册说明 Quality Manual Description 0.6 质量管理体系结构图 Quality Management System Structure Chart 1.0 质量管理体系过程间的关系图 Process Relation Map of QMS 2.0 质量管理体系过程职能分配表 QMS Process Function Distrib
3、ution Table 3.0 ISO9001 条文与本公司程序文件对照表Comparison Table of Standard and Quality Procedure 4.1 质量管理体系 总要求 Quality Management System General Requirements 4.2 文件要求 Documentation Requirements 5.1/5.2 管理职责 Management Responsibility 5.3 质量方针 Quality Policy 5.4 体系策划 System Planning 5.5.1/5.5.2 职责、权限 Responsi
4、bility and Authority 5.5.3 内部沟通 Internal Communication 5.6 管理评审 Management Review 6.0 资源管理 Resource Management 7.1 产品实现的策划 Product Realization Planning 7.2 与顾客有关的过程 Customer-related Process 7.3 设计和开发 Research and Development 7.4 采购 Purchasing7.5.1 生产和服务的提供 Production and Service Provision 7.5.3 标识和可
5、追溯性 Identification and Traceability 7.5.5 产品防护 Product Preservation7.6 监控和测量装置的控制 Control of Monitoring and Measurement Device 8.1 策划 Plan 8.2.1 顾客满意 Customer Satisfaction 8.2.2 内部审核 Internal Audit0 质量手册目录 Table of Contents0 质量手册目录质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages
6、: 3 / 348.2.3 过程监视和测量 Monitoring and Measurement of Process 8.2.4 产品监视和测量 Monitoring and Measurement of Product 8.3 不合格品控制 Non-conforming Product Control 8.4 数据分析 Data Analysis8.5 改进 Improvement 9.0 质量手册管理办法 Quality Manual Management Method 10.0 更改记录 Revision History0 质量手册目录 Table of Contents质量手册 (Q
7、uality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 4 / 34本公司根据 GB/T19001-2000 (ISO9001：2000)质量管理体系要求， 结合本公司实际，建立了质量管理体系，编写了本公司的质量手册。The organization establishes the quality management system and compiles the quality manual according to the GB/T19001-2000 (ISO9001：2000) Quality Managemen
8、t System- Requirements and the current situation of the company.本手册中的有关术语按 ISO9000：2000 标准质量管理体系术语中的规定。The manual follows the terms and definitions of ISO9000：2000.本 QM-01质量手册具体阐述了本公司的质量方针、质量目标和质量管理体系，是本公司质量活动和行为准则的纲领性文件，也是证实本公司质量活动能满足顾客期望和相关法律法规要求的依据。公司各部门、全体员工应认真学习、深刻领会、坚决贯彻执行。The manual describes
9、 the quality policy, objectives and quality management system, as the primary document of quality activities and behavior criteria of the organization, as well as the guidelines to demonstrate that the quality activities can meet the customer expectations and related legal requirements. The members
10、of the organization will review fully and implement the manual firmly. 本手册亦可作为对外提供质量保证和第三方审核使用。本手册自 2006 年 4 月 20 日发布，自发布之日起实施。The manual can be used for providing quality assurance or third-party audit. The manual issued and implemented on 20th, April 2006.运营总监 Operation Director：日 期 Date：0.1 质量手册颁
11、布令 Quality Manual Approval Statement质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 5 / 34有限公司始建于 2004 年 4 月，是意大利 Nu Air 公司投资的独资企业，生产和仓储建筑面积占地21672 平方米，现共有职工人数 274，8 条生产线。年产量 20 万台，产值 3600 万美金（截至 2005 年底），主要生产家用及工业用空压机及其配件。公司的产品水平代表着同行业的技术水平和未来发展方向，同时在国内外享有盛誉，产品销往等多个国家，公司致力于加强
12、产品质量控制，从原材料、装配工艺及服务等多个环节严加控制，保证了产品的质量，努力达到客户要求，使产品质量达到国际一流。公司也不断的收集客户的反馈信息，从技术上使产品更加完善，并以向客户提供优质产品与服务，使客户完全满意为宗旨。在市场竞争日趋激烈的环境下，公司决心以健全完善的质量管理体系为基础，以灵活务实的经营策略为手段，以体系认证为契机，按 ISO9001：2000 标准的要求建立质量管理体系，编写质量管理体系文件，并严格按照执行，对产品实施全面、系统的质量控制，从而使产品质量更上一层楼。, is a holly owned enterprise of Italy Nu Air Company
13、, launched in April, 2004. Its production and warehouse occupies an area of 21672 M, with 274 employees and 8 production lines, mainly producing the domestic and industries and its accessories to air compressor, annually produces 200 thousands of air compressor with a turnover of 36 MIL.US$ (by the
14、end of 2005). The products of represents the advanced technology of the direction of product development in future. Nu Air get its name among the fellow traders and distributing its products to many countries. engaging in enhancing the quality control, from the incoming material, assembly workmanshi
15、p to the service etc. so as to ensure the product quality and satisfy the customers requirements, and make the quality being the top rank in the world.is continuously collecting the feedback from customers, and try to do our products better with various of new technologies. Completely satisfy the cu
16、stomers is our mission. Under the cutthroat competition of marketing environment, Nu Air try to perfect its quality management system and use a flexible strategy of business. Taking the opportunity of ISO9001 system audit, we are establishing the documentational quality management system according t
17、o the ISO9001:2000 standard, and implement it strictly, to make an overall and systemic quality control on product, continuously improve our quality and do it better.公司地址： 邮编： 电话：联系人：0.2 公司简介 Company Introduction质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 6 / 34为了贯彻执行 ISO9
18、001:2000质量管理体系要求，加强对质量管理体系运作的领导，特任命质量部总监为我公司的管理者代表。In order to implement the ISO9001:2000 Quality Management System Requirements and enhance the guidance of the QMS operation, the Quality Director is appointed as Management Representative of the organization.管理者代表的职责是：The responsibility of the Manag
19、ement Representative is as follows:1）确保质量管理体系的过程得到建立和保持；To ensure that the process of quality management system can be established and maintained properly;2）向最高管理者报告质量管理体系的业绩，包括改进的需求；Report to top management on the performance of the quality management system and any need for improvement;3）在整个组织内促进顾
20、客要求意识的形成；Promote the awareness of customers requirements throughout the organization;4）就质量管理体系有关事宜对外联络；Contact with external parties on the matters relating to quality management system.望全体员工积极配合和协助他们的工作。Employees will support and assist the related work actively.运营总监 Operation Director： 日 期 Date：0.
21、3 管理者代表任命书 Management Representative Appointing Letter 质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 7 / 34本公司的质量方针：The Quality Policy of the Organization is:以最高的性价比生产满足顾客期望的可靠产品。Assembly functional and reliable products that satisfy and anticipate the Customer request with
22、the best ratio quality/price本公司的质量目标：Quality Objectives of the Company:1. 确保 ISO 9001：2000 质量管理体系的建立、实施且持续有效；To ensure the establishment, implementation and continuous effectiveness of ISO9001 quality management system; 2. 每年度量化的质量目标由运营总监批准后另行颁布。Annual measurable quality objectives will be issued af
23、ter approval by Operation Director.运营总监 Operation Director： 日 期 Date：0.4 质量政策 Quality Policy质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 8 / 341. 编写本手册的目的是为了建立本公司质量方针、质量目标和质量活动的过程以及要求实施的质量管理体系。The aim of the quality manual is to establish quality policy, objectives, process
24、es of quality activities and quality management system required to be implemented.2. 本手册适应于本公司家用和工业用空压机及其配件的生产和装配过程。The manual is applicable to assembly the domestic and industries and its accessories to air compressor.3. 质量部是本手册的管理部门，负责组织手册的编写、修订、换版和发放。Quality Dept. is responsible for the managemen
25、t of the quality manual and organizing to compile, modify, revision update and issue. 4. 本手册由管理者代表审核、运营总监批准。The Quality Manual is reviewed by Management Representative and approved by Operation Director.5. 本手册配置在持有者所在的工作岗位，归持有者使用和保管。The Quality Manual is hold and retained by the keeper at the work p
26、osition.6. 持有者离开工作岗位时，应将手册返回给质量部并办理有关手续。Person leaves the position will return the Quality Manual to Quality Dept and transact related procedure.0.5 质量手册说明 Quality Manual Description质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 9 / 34运营总监 Operation Director：日 期 Date：运营总监Oper
27、ational Director生产部Production物流部Logistics机头车间 Pumphead整机车间Generalassembly财务部Finance质量部Quality质检 QC 质保 QA原材料库 Rawmaterialwarehouse技术/采购部Technical/Purchasing采购Purchasing技术Technical人事 HR 财务 Finance进出口部 Import/Export成品仓库Finalwarehouse0.5 质量管理体系结构图 QMS Structure Chart管理者代表Management Representative质量手册 (Q
28、uality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 10 / 34顾客要求Customer Requirement质量管理体系改进QMS improvement顾客要求确定评审Confirmation and review采购控制Purchase Control采购验收Purchase Validation生产和服务过程Production and service process产品交付Product Delivery顾客满意Customer Satisfaction管理评审Management Review数据分析、
29、纠正措施、预防措施、持续改进/Dataanalysis,CorrectivePreventiveactions,continuouslyimprovement文件/记录控制Document/Recordcontrol资源提供/Resourcesupply监视和测量装置的控制MonitoringandMeasurementDeviceControl监视和测量/monitoringb) 确定质量管理体系过程的顺序及相互关系，目前没有外部过程；Determine the sequence and interaction of these processes, Have no exterior pro
30、cess currently;c) 确定质量管理体系过程所需的标准和控制要求；Determine criteria and methods needed to ensure that both the operation and control of these processes are effective;d) 为了支持质量管理体系的运行和控制，提供必要的可用资源或资讯；Ensure the availability of resources and information necessary to support the operation and monitoring of these
31、 processes;e) 对质量管理体系的过程进行测量、监督和分析；Monitor, measure and analyze these processes;f) 为确保质量管理体系预期实施，采取必要的持续改善措施。Implement actions necessary to achieve planned results and continual improvement of these processes.本公司按照 ISO9001：2000 质量管理体系要求对质量管理体系进行控制，同时包括对供应商及分承包方提供生产或服务的管理。 The organization controls t
32、he quality management system in accordance with the requirements of ISO9001: 2000, and control outsourced production and service provided by suppliers and subcontractors as where required.注意：供应商与分承包方在本质量体系内被同等对待，相关质量体系文件均适用于双方。Note: Suppliers and subcontractors are treated the same in this quality m
33、anagement system and procedures are common to both.4.2 文件控制 Documentation Control4.2.1 一般要求 General requirement 质量管理体系文件包括以下内容：The QMS documents include:a) 质量政策和质量目标及其质量手册的书面阐述；documented statements of a quality manual, quality policy and quality objectives;b) 按照 ISO9001：2000 质量管理体系要求， 编制了书面化的程序文件；D
34、ocumented procedures required by ISO9001：2000 International Standard;c) 通过编制作业指导书，确保生产和服务过程的有效运行；Documented work instruction needed by the organization to ensure the effective operation of production and service;4.0 质量管理体系 Quality Management System质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revi
35、sion: 03页 数 Pages: 14 / 34d) 规定生产和服务过程所需的质量记录。Quality records required by production and service process.4.2.2 质量手册 Quality Manual本公司建立和维持质量管理体系所需的质量手册包括以下内容：The organization establishes and maintains the quality manual which includes:a) 本公司质量管理体系的范围: 家用和工业用空压机及其配件的生产和装配过程。Quality Management System
36、scope of the organization is applicable to assembly the domestic and industries and its accessories to Air Compressor as service.b) 质量管理体系所需的程序文件及其相关作业指导书；The documented procedures and related work instruction established for the quality management system, andc) 本公司质量管理体系过程之间的相互关系（参见本手册第 1.0 章节）。The
37、 description of the interaction between the processes of the quality management system (refer to Chapter 1.0).4.2.3 文件控制 Document Control本公司对书面化的质量管理体系进行控制，同时建立 PO-4.2.3文件控制程序进行管理：The organization establishes documented procedure PO-4.2.3 to manage:a) 质量管理体系文件在编制完成后都必须按照 PO-4.2.3文件控制程序的规定, 经过制订、审核及批
38、准，以确定其适用性和可操作性；the QMS documents is compiled, reviewed and approved for adequacy and applicability prior to issue in accordance with PO-4.2.3;b) 文件修改后必须按程序要求由原制订、审核部门再次进行审核，并经相关领导批准发布；The documents should be reviewed, approved and issued as per the procedure after modification;c) 保证在与质量管理体系有效运行有关的所有
39、场所、岗位都能得到相应文件；Related documents are available at the point or position of use; d) 经批准必须保留的文件，需确保对文件修改过程的控制以及修订后的版本标识，防止误用失效或废止的版本文件；Changes and the current revision status of documents are identified to prevent unintended use or invalid of documents;e) 各类文件要按统一的标识规则进行标识，以便识别和检索；All documents are ide
40、ntified by uniform mark to remain legible and retrieval; f) 外来文件由质量部负责备案登记后转发相关部门流转或执行；External documents are registered and transferred to related departments by quality Dept;g) 对于失效或废止文件应及时回收。Invalid or obsolete documents should be reclaimed in time. 4.2.4 质量记录控制 Quality Record Control通过制定的 PO-4.2
41、.4记录控制程序，对质量记录标识、收集、编目、查阅、贮存、保存期限和处理予以具体规定，实施质量记录的全面控制，确保本公司质量管理体系所需的质4.0 质量管理体系 QMS质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 15 / 34量记录被有效控制。The organization establishes PO-4.2.4 to specify identification, storage, protection, retrieval, retention time and disposition o
42、f records, so as to ensure effective control of the quality records required by QMS.4.3 相关程序文件 Referred Procedure:PO-4.2.3文件控制程序PO-4.2.4记录控制程序4.0 质量管理体系 QMS质量手册 (Quality Manual)文件编号 Document No: QM-01版 本 Revision: 03页 数 Pages: 16 / 345.1 管理承诺 Management Commitment本公司承诺：在公司内部按照 ISO9001：2000 标准建立质量管理体
43、系、有效实施、保持并持续改进；公司的一切质量管理活动坚持以顾客为关注焦点，顾客的要求和期望必须得到满足并符合法律法规，通过以下活动予以实现并加以证实。The organization commits to establish, effectively implement quality management system according to ISO9001：2000 and continuously maintain and improve the system. All quality management activities should insist in focusing on
44、 customer, customer requirements and expectations should be met and conform to the law and regulation. It will be achieved and validated by the following activities:a)向员工传达满足顾客要求和遵循法律法规的重要性；Conveying to the employees the importance of meeting customer as well as statutory and regulatory requirements
45、;b)制定质量方针（见 5.3 节）; Establishing the quality policy (refer to chapter 5.3);c)确保质量目标的制定(见 5.4.1 节); Ensuring that quality objectives are established;d)进行管理评审( 见 5.6 节); Conducting management reviews, ande)提供质量管理体系所需的资源(见 6.0 节) 。Ensuring the availability of resources for QMS.5.2 以顾客为中心 Customer Focus本公司以实现顾客满意为目标，了解顾客的需求和期望，并将其转化为要求，在法律和法规允许的条件下予以满足。The organization should comprehend customer requirement and expectation with the aim of achieving customer satisfaction, and translate it into the requirements to be met on the condition of law and
