英文品质手册样板-English_Quality_Manual.doc

MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 1 of 30 Page 文文 件件 编编 号号 QM 0001 Document No 版版 本本 号号 C Rev No 主题主题 Title QUALITY ASSURANCE MANUAL 页页 数数 30 Pages 实实 施施 日日 期期 Effective Date 编编 制制 修修 订订 Originator Revised 审审 核核 Reviewed By 相关部门批准相关部门批准 APPROVALS CONCURRENCE 生生 产产 部部 日日 期期 Production Date 品品 保保 部部 日日 期期 Quality Assurance Date 工工 程程 部部 日日 期期 Engineering Date 物物 料料 部部 日日 期期 Material Date 商商 务务 部部 日日 期期 Program Date 财财 务务 部部 日日 期期 Finance Date 人人 事事 部部 日日 期期 Human Resource Date MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 2 of 30 Page 文文 件件 修修 改改 记记 录录 REVISION HISTORY 版本号版本号 Rev 修修 改改 内内 容容 Description Changes 修修 改改 人人 Originator 日日 期期 Data A B C 第一次发行 First Release 1 Added operation manager responsibility 2 Defined management representative 3 Added content index 4 Updated the abbreviation of terms and definitions Update the organization chart CZ Huang CZ Huang CZ Huang CZ Huang CZ Huang YC Feng 2001 10 05 2002 02 05 2003 06 23 MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 3 of 30 Page TABLE OF CONTENT 1 0SCOPE AND CONTROL 7 2 0NORMATIVER EFERENCES 7 3 0QUALITY POLICYAND QUALITY OBJECTIVES 7 3 1QUALITY POLICY 8 3 2QUALITY OBJECTIVES 8 4 0QUALITY MANAGEMENT SYSTEM 8 4 1 GENERAL REQUIREMENTS 8 4 2 DOCUMENTATION REQUIREMENTS 8 4 2 1GENERAL 8 4 2 2QUALITY MANUAL 8 4 2 3CONTROL OF DOCUMENTS 9 4 2 4CONTROL OF RECORDS 9 5 0MANAGEMENT RESPONSIBILITY 10 5 1MANAGEMENT COMMITMENT 10 5 2CUSTOMER FOCUS 10 5 3QUALITY POLICY 10 5 4PLANNING 11 5 4 1QUALITY OBJECTIVES 11 5 4 2QUALITY MANAGEMENT SYSTEM PLANNING 11 5 5RESPONSIBILITY AUTHORITY AND COMMUNICATION 12 5 5 1RESPONSIBILITY AND AUTHORITY 12 5 5 2MANAGEMENT REPRESENTATIVE 15 5 5 3INTERNAL COMMUNICATION 15 5 6MANAGEMENT REVIEW 16 5 6 1GENERAL 16 5 6 2REVIEW INPUT 16 5 6 3REVIEW OUTPUT 16 6 0RESOURCE MANAGEMENT 16 6 1PROVISION OF RESOURCES 16 6 2HUMAN RESOURCES 17 6 2 1GENERAL 17 6 2 2COMPETENCE AWARENESS AND TRRAINING 17 6 3INFRASTRUCTURE 17 6 4WORK ENVIRONMENT 17 7 0PRODUCT REALIZATION 18 MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 4 of 30 Page 7 1PLANNING OF PRODUCT REALIZATION 18 7 2CUSTOMER RELATED PROCESSES 18 7 2 1DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT 18 7 2 2REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT 18 7 2 3CUSTOMER COMMUNICATION 18 7 3DESIGN AND OR DEVELOPMENT 19 7 4PURCHASING 19 7 4 1PURCHASING PROCESS 19 7 4 2PURCHASING INFORMATION 19 7 4 3VERIFICATION OF PURCHASED PRODUCTS 20 7 5PRODUCTION AND SERVICE PROVISION 20 7 5 1CONTROL OF PRODUCTION AND SERVICE PROVISION 20 7 5 2VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION 20 7 5 3IDENTIFICATION AND TRACEABILITY 21 7 5 4CUSTOMER PROPERTY 21 7 5 5PRESERVATION OF PRODUCT 22 7 6CONTROL OF MEASURING AND MONITORING DEVICES 22 8 0MEASUREMENT ANALYSIS AND IMPROVEMENT 23 8 1GENERAL 23 8 2MONITORING AND MEASUREMENT 23 8 2 1CUSTOMER SATISFACTION 23 8 2 2INTERNAL AUDIT 24 8 2 3 MONITORING AND MEASUREMENTOF PROCESSES 24 8 2 4MONITORING AND MEASUREMENT OF PRODUCT 24 8 3CONTROL OF NONCONFORMING 25 8 4ANALYSIS OF DATA 25 8 5IMPROVEMENT 25 8 5 1 CONTINUAL IMPROVEMENT 25 8 5 2CORRECTIVE ACTION 26 8 5 3PREVENTIVE ACTION 26 9 0 CROSS REFERENCE MATRIX 27 MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 5 of 30 Page ABBREVIATION AND DEFINITION BOM Bill of Materials DCCDocument Control Center ECNEngineering Change Notice MISManagement Information System MRManagement Representation OEMOriginal Equipment Manufacturer QMQuality Manual QMSQuality Management System WIWork Instructions SMT Surface Mount Technology IQCIncoming Quality Control MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 6 of 30 Page MMI ELECTRONICS T J CO LTD INTRODUCTION MMI ELECTRONICS T J CO LTD is based at the Ninth Avenue in the Economy Technology Development District of Tianjin city PRC which is established in August 2001 and is a subsidiary of MMI Holdings Limited MMI TJ is the abbreviation of Micro Machining Industry Co LTD MMI has subsidiaries distributed in Shenzhen of PRC Tampoi Ulu Tiram of Malaysia Penang of Thailand etc Main products of MMI are precise machining and auto equipments MMI ELECTRONICS T J CO LTD will range from processing manufacturing and selling new type of electronic components and assemblies net work communication system devices namely communication equipment terminals and personal digital aid system devices and providing related technical counseling services To compete effectively in today s demanding business environment zero defect products and satisfactory services must be delivered to our customer in time All MMI TJ employees must share this commitment and MMI TJ policy Refer to section 5 3 MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 7 of 30 Page 1 SCOPE AND CONTROL 1 1 SCOPE This document is a detailed description of the MMI Electronics TJ Co LTD Quality Management System which serves as a reference for the implementation and maintenance of the system to ensure conformance to ISO 9001 2000 Edition and meets customer and applicable regulatory requirements This quality manual also describes the methods and controls for assuring the quality of the products provided by MMI TJ This manual will meet or exceed the requirements ISO 9001 2000 Edition quality systems standards As a quality manual it is intended to be a permanent reference in the implementation and maintenance of the quality system This manual is applicable to all processes within MMI TJ which can influence the quality of products supplied to our customers The certification scope of QM is covering all clauses stated in ISO9001 2000 except from section 7 3 Design And Development As the core business of MMI is to provide manufacturing services to OEM that include all clauses except design and development The operation related to design control is not covered in this quality manual the justification of this exclusion is explained in Design And Development section of this manual 1 2CONTROL DISTRIBUTION AND REVISION The plant Manager or Management Representative MR has the responsibility and authority for distribution and control of this QM The responsibility for detailed activities within this accountability may be delegated The master copy of this manual shall be secured in Document Control Center DCC The manual will be distributed on a controlled basis Uncontrolled copies which have been distributed shall not be recorded updated or maintained after distribution A distribution list of all controlled copies of the manual reflecting to whom they were issued and their revision level shall be maintained at DCC All controlled copies of this manual shall be kept current by DCC Controlled copies distributed to external parties shall be kept current by forwarding changes amendments to the holder at the time of revision of this manual with instructions to dispose of those items being replaced and requesting the return of an acknowledgement of receipt of the changes or replacement of manual 2 NORMATIVE REFERENCES ISO 9000 2000 Quality management systems Fundamentals and vocabulary ISO 9001 2000 Quality management systems Requirements ISO 9004 2000 Quality management systems Guidelines for performance improvements 3 QUALITY POLICY AND QUALITY OBJECTIVES MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 8 of 30 Page 3 1 QUALITY POLICY The quality policy of MMI is as below Striving For Process and Quality Excellence Achieving Total Customer s Satisfaction 3 2 QUALITY OBJECTIVES MMI aims to monitor and work on improving quality performance and meeting quality policy through the following objectives Continually improve MMI TJ s Quality Management System through effective internal and external audits assessments process Meet or exceed Quality Performance Indicators defined by customer Enhance customer satisfaction through understanding customer needs by regular Customer Satisfaction Survey Customer Review Meeting reduction or elimination of customer goods returns and complaints To practice Continuous Process Improvement CPI program for our manufacturing process 4 QUALITY MANAGEMENT SYSTEM 4 1 GENERAL REQUIREMENTS MMI TJ has established documented and maintains a quality system as a means of ensuring that product conforms to specified requirements This quality manual is prepared to document the requirements of ISO9001 2000 Edition Quality system procedures are referred to in this manual in sections and in an index in section 9 0 4 2 DOCUMENTATION REQUIREMENTS 4 2 1 GENERAL MMI TJ will implement maintain the requirements described in this quality manual to document the quality policy quality goal quality procedure standard operation work instruction and quality record MMI TJ will also update the documents in time as required 4 2 2 QUALITY MANUAL MMI TJ quality management system includes all the elements required in ISO9001 2000 except 7 3 design and or development control Our documented quality systems are structured into 4 levels LEVEL Documented quality manual outlining MMI TJ quality system Refer to QM 0001 LEVEL Documented procedure to detail how an operation is performed LEVEL Standard Operation Procedure Work Instruction Quality Inspection Instruction Specification of Component and assembly LEVEL All records relating to quality and its form MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 9 of 30 Page 4 2 3 CONTROL OF DOCUMENTS Document and date that have an effect on the QMS will be controlled Document and date control will be applied to both internal documents and external documents such as customer drawing in which applicable controls will be applied Document may be in the form of hard copy or electronic media A master list identifying the correct revision of documents will be maintained for the different levels of documents by the DCC The master list shall be available to the personnel to ensure use of the correct document 4 2 3 1 Document Approval and Issuance Procedure for document control Doc QAE QP 0001 Requests all documentation procedures specification bills of materials standard operation processes workmanship standards in MMI TJ are controlled reviewed and approved by authorized personnel This control ensures that A Relevant information and appropriate revision documents are available at all locations where required B Obsolete documents are promptly removed as necessary C External origins are reviewed and confirmed prior to releasing for implementation through Document control Responsibility and approval authority for these functions will be as follows unless noted otherwise in that specific documentation In the absence of responsible managers his or her designate signatory authority person may sign and approve the documents Document TypeResponsibility LEVEL QM Managing Director LEVEL QP Department Managers LEVEL SOP WI QII Production Supervisors Section Managers Engineer LEVEL Records and Form As applicable in conjunction with the above authority levels 4 2 3 2 Document Change and Modification Doc QAE QP 0001 also controls Changes modifications to documents These procedures ensure that changed documents are reviewed and approved by designated authorities prior to re issue Records of all changes are retained 4 2 4 CONTROL OF RECORDS Quality records are maintained to demonstrate achievement of quality and effective operation of the quality system All the records relating to product quality shall be retained for as long as they may be useful but may be discarded and destroyed when their likely useful period has expired The procedure for control of quality records has defined the individual record retention time Every department is MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 10 of 30 Page responsible for its records retention Quality records include but are not limited to the following A Inspection and testing records B Nonconformance records C Corrective actions reports D Calibration records E Contract review records F Management review reports G Internal audit reports H Purchasing control records I Training records J Process control records When required due to contract requirements quality records will be made available to the customer or an authorized representative of the customer for review or contract requirement 5 MANAGEMENT RESPONSIBILITY 5 1 MANAGEMENT COMMITMENT Top management has established a quality policy and quality objective that is appropriate to the purpose of MMI TJ It is published in front of QM and signed by Managing Director Top management provides framework for establishing and reviewing quality polity and quality objectives and communicating this within the company to customers and suppliers It is reviewed minimum of once per year at management review meetings Quality objectives are set above customer s requirement The main task of top management is to communicate to the company the importance of meeting quality objectives as well as statutory and regulatory requirements and to ensuring the availability of resources 5 2 CUSTOMER FOCUS MMI TJ shall continually focus on customer satisfaction as our primary goal We will ensure that customer needs and expectations are determined and converted into requirements with the aim of achieving customer confidence We will then ensure that identified customer requirements and relevant legal requirements are fully understood and met 5 3 QUALITY POLICY It is the policy of MMI TJ to adhere to a management philosophy and operational methods which recognize customer satisfaction as a primary goal We will ensure that it Is appropriate for our needs and those of our customers Includes our commitment to meeting QMS requirements and continual improvement Is communicated and understood within MMI TJ Provides a framework for establishment and reviewing quality objectives Is reviewed for continuing suitability MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 11 of 30 Page 5 4 PLANNING 5 4 1 QUALITY OBJECTIVES MMI has established clear quality objectives that are consistent with our quality policy at each department level within the company These objectives cover quality system processes and necessary to produce the products and services that we offer to our customers We will identify the quality characteristics at appropriate stages of process production and verification and identify criteria for acceptability The QM QP and WI constitute the primary quality plan for the facility Customer defined product specific quality requirement are reflected in WI customer contracts and in quality procedures In order to meet customer quality requirements consideration is given to the following activities as appropriate Determine the sequence and interaction of these processes Identification of the process needed for the QMS and their application throughout MMI Determine criteria and methods needed to ensure that both the operation and control of these processes are effective Ensure the availability of resources and information necessary to support the operation and monitoring of these processes Monitor measure and analyze these processes Implement actions necessary to achieve planned results and improvement of these processes Any outsourced processes that affect product conformity with requirements shall be identified within the QMS The integrity of the QMS is maintained when changes to the QMS are planned and implemented 5 4 2 QUALITY MANAGEMENT SYSTEM PLANNING Documented quality plans shall be utilized to define how the requirements for quality shall be met Any activities related to quality shall be defined to meet specified requirements for products projects or contracts Quality plan shall specify the controls throughout the manufacturing processes All quality plan shall be reviewed when required as requested by the customer to ensure it reflect the current practices Quality plan shall identify and tell the acquisition of any control processes equipment including inspection and test equipment fixtures resources and skills as well as training may be needed to achieve the required quality Quality plan shall ensure the compatibility of the production process inspection test installation servicing procedures and the applicable documentation Quality plan shall be updated as necessary the quality control inspection and test methods Quality plan shall identify the appropriate verification methods at the key stage in the realization of the product Quality plan shall define the criteria of all features and requirements including those subjective elements Quality plan shall identify and prepare the quality records of the product MMI Electronics TJ Co LTD 微密电子 天津 有限公司微密电子 天津 有限公司 文文 件件 编编 号 号 QM 0001 Procedure No 版版 本本 号号 C Rev No 页页 数数 12 of 30 Page Quality plan shall identify the guidance to implement actions necessary to achieve planned results and continual improvement of these processes 5 5 RESPONSIBILITY AUTHORITY AND COMMUNICATION 5 5 1 RESPONSIBILITY AND AUTHORITY The management and every employee shall dedicate our efforts towards maintaining the quality system cost reduction elimination and prevention of quality deficiencies so that the customer requirements can be met Top management shall promote employee involvement and ensure that responsibility and authority are defined and communicated within MMI TJ MMI TJ s organization structure and the organization inter relationship is defined in this QM ORGANIZATION CHART Test SMT Process Facility General Manager QA Asst ManagerOperatio