Quality Manual_质量手册.doc

质量手册 (Quality Manual)文件编号 Document No: QM-01版 本Revision: 03页 数Pages: 34 / 34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： 0 质量手册目录 Table of Contents章 节(Chapter) 内 容 (Contents)0 目录 Table of Contents 0.1 质量手册颁布令 Quality Manual Approval Statement 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 Distribution 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 Responsibility 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 Purchasing0 质量手册目录7.5.1 生产和服务的提供 Production and Service Provision 7.5.3 标识和可追溯性 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 Contents8.2.3 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 History0.1 质量手册颁布令 Quality Manual Approval Statement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 Management 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 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 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：0.2 公司简介Company Introduction 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, 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 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 workmanship 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 customers 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 to 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：0.3 管理者代表任命书 Management Representative Appointing Letter 为了贯彻执行ISO9001:2000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 Management 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：0.4 质量政策 Quality Policy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 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 after approval by Operation Director. 运营总监Operation Director： 日 期 Date： 0.5 质量手册说明 Quality Manual Description1. 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, processes 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 management 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 position.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.财务部Finance技术/采购部Technical/Purchasing运营总监Operational Director 0.5 质量管理体系结构图 QMS Structure Chart管理者代表Management Representative物流部Logistics质量部Quality生产部Production财务Finance人事HR技术Technical采购Purchasing原材料库Raw material warehouse进出口部Import/Export质保QA质检QC机头车间Pump head 整机车间General assembly成品仓库Final warehouse运营总监Operation Director：日 期Date：顾客要求Customer Requirement质量管理体系改进QMS improvement1.0 质量管理体系过程间的关系图 QMS Process Relation Map内部沟通Internal Communication顾客沟通Communication数据分析、纠正措施、预防措施、持续改进/Data analysis, Corrective Preventive actions, continuously improvement 顾客要求确定评审Confirmation and review管理活动/Management activities监视和测量装置的控制Monitoring and Measurement Device Control供方选择和评价控制Supplier Control顾客财产控制Customer Property采购控制Purchase Control文件/记录控制Document/Record control采购验收Purchase Validation监视和测量/monitoring & Measurement不合格品控制Non-conforming Product Control生产和服务过程Production and service process资源提供/Resource supply产品交付Product Delivery检测InspectionInspec内部审核Internal Audit管理评审Management Review顾客满意Customer Satisfaction序号No.3.0 ISO9001条文与本公司程序文件对照表 Comparison of ISO9001 and Quality Procedures Department 职能部门体系要求Quality system requirement运营总监Operation Director管代Management Representative质量部Quality物流部Logistics采购/技术部Purchasing/Technical生产部Production财务部Finance4.1总要求General requirement4.2文件要求Documentation requirements5.1管理承诺 Management Commit 5.2以顾客为关注焦点 Customer Focus5.3质量方针Quality Policy5.4策划Planning5.5职责、权限和沟通 Responsibility, authority and communication5.6管理评审Management Review6资源的提供Resource Provision6.2人力资源Human Resource6.3基础设施 Infrastructure6.4工作环境Work Environment7.1产品实现过程策划 Product Realization Plan7.2与顾客有关的过程Customer-related Process7.4采购 Purchasing7.5生产和服务的提供 Provision of product and service7.6测量和监控装置的控制Monitoring and Measurement Device Control8.1策划 Plan8.2测量和监控 Monitoring & Measurement8.2.1顾客满意 Customer Satisfaction8.2.2内部审核 Internal Audit8.2.3过程的监视和测量Process M&M8.2.4产品的监视和测量Product M&M8.3不合格品控制 Non-confirming Product8.4数据分析Data Analysis8.5改进Improvement注：“ ”表示责任部门， “”表示配合部门。 “ ” Main responsibility “” Supporting responsibility 3.0 ISO9001条文与本公司程序文件对照表 Comparison of ISO9001 and Quality Procedures序号No.程序文件名称Quality Procedure Name文件编号Document NoISO9001条文ISO9001 Clause1文件控制程序Document Control ProcedurePO-4.2.34.2.32记录控制程序Quality Record Control ProcedurePO-4.2.44.2.43管理评审控制程序Management Review Control ProcedurePO-5.65.64人力资源控制程序Human Resource Control ProcedurePO-6.26.25基础设施、工作环境控制程序Infrastructure and environment control processPO-6.3/6.46.3/6.46采购过程控制程序Purchasing Process Control ProcedurePO-7.47.47首件样品审批程序First sample approval processPO-7.4.17.4.18检验和测量仪器控制程序Monitoring & Measurement Device Control ProcedurePO-7.67.69顾客满意度控制程序Customer Satisfaction Control ProcedurePO-8.2.18.2.110内部审核控制程序Internal Audit Control ProcedurePO-8.2.28.2.211不合格品控制程序Non-conforming Products Control ProcedurePO-8.38.312持续改进控制程序Continual Improvement Control ProcedurePO-8.58.54.1 一般要求General Requirement 4.0 质量管理体系 Quality Management System本公司根据ISO9001：2000质量管理体系要求建立了文件化的质量管理体系并通过其有效运行，以保持质量管理体系的持续改进，作为服务质量满足规定要求的一种手段。The organization establishes documented quality management system according to ISO9001：2000 requirement and maintain continuous improvement through effective operation as one of the means to make service quality meet specific requirements. 本公司的质量管理体系包括：The quality management system of the company includes:a) 确定本公司质量管理体系所需的过程且加以控制；Identify the processes needed for the quality management system and their application throughout the organization;b) 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 process 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 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 the 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 management 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；Documented 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 QMSd) 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 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 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 identified 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-4.2.4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 of records, so as to ensure effective control of the quality records required by QMS.4.0 质量管理体系 QMS4.3 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5.1 管理承诺Management Commitment5.0 管理职责 Management Responsibility 本公司承诺：在公司内部按照ISO9001：