ISO9001-2015物资管理程序(中英文)
ISO9001：2015全套文件英文版(含质量手册及全套程序文件)
Ningbo XXX Material TechnologyCo.,LtdISO9001:2015 Quality ManualRevision [A/0] - [2018/3/1](c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.Revision [A/0] - [2018/3/1]Page 1 of 19TABLE OF CONTENTS0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)Revision [A/0] - [2018/3/1]Page 2 of 198.0 Improvement ............................................................................................................................................... 15 8.1 General .................................................................................................................................................... 15 8.2 Customer Satisfaction ............................................................................................................................. 15 8.3 Internal Audit ........................................................................................................................................... 16 8.4 Corrective and Preventive Action ............................................................................................................ 16 Appendix A: Overall Process Sequence & Interaction ........................................................................................ 17 Appendix B: ISO 9001:2015 Cross Reference . (18)Revision [A/0] - [2018/3/1] 0.0 Revision History and ApprovalRev. Nature of changes Approval DateA/0 Original release. XXX 2018/3/1Page 3 of 19Revision [A/0] - [2018/3/1] 1.0 Welcome to Ningbo XXX Material Technology Co.,LtdNingbo XXX Material Technology Co., Ltd. Was established in 2000, with the UAE businessmen to build the joint venture company; 2004 Ming Shan founded Nissin special adhesive tape and adhesive tape company; 2008 due to the strategic adjustment of 3 company merger and reorganization, the establishment of Ningbo letter mountains adhesive products Manufacturing Co., Ltd..PVC insulation tape is one of China’s national standard drafting unit, the field of adhesive products governing unit of China, Ningbo, adhesives and related products Industry Association, honorary president of the unit.We produce more than 1000 varieties of products of 11 categories. The annual throughput more than 100,000,000 square of the adhesive and 10,000 ton of the adhesive.Our company located in Ningbo which the city of the east China sea, beside 500 kilometers of shanghai, 20 kilometers from Ningbo list airport and 50 kilograms of the Ningbo seaport. The transport is very convenient (Easy to ship to everywhere on the world).2.0 XXX Material: Who We Are2.1 Determining Our Strategic DirectionXXX Material has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:∙Understanding our core products and services, and scope of management system (see 2.2 below).∙Identifying “interested parties” (stakeholders) who receive our [Production of adhesive tape], or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document [Requirements and expectations list of interested parties].∙Understanding internal and external issues that are of concern to XXX Material and its interested parties; also identified in the document [Requirements and expectations list of interested parties]. Many such issues are identified through an analysis of risks facing either XXX Material or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.2.2 Scope of the Management System2.2.1 Scope StatementBased on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX Material has determined the scope of the management system as follows:Production of adhesive tapePage 4 of 19Revision [A/0] - [2018/3/1]Page 5 of 192.2.2 Facilities Within the ScopeThe quality system applies to all processes, activities and employees within the company. The facility is located at: Factory Add ：XXX Tel ：XXX Fax ：XXX XXX XXX2.2.3 Permissible ExclusionsThe following clauses of ISO 9001 were determined to be not applicable to XXX Material.∙ 8.3 Design and development of products and services 2.2.4Scope of the ISO9001：2015 Quality ManualThis manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard.This manual does not follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.This manual presents “Notes” which are used to define how XXX Material has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics .∙ Quality PolicyThe Quality Policy of XXX Material is as follows:Quality first, customer satisfaction;Scientific management, continuous improvement. ∙ Management SystemStructure and Controls 4.1Process Approach4.1.1 Process IdentificationXXX Material has adopted a process approach for its management system. By identifying thetop-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming [Production of adhesive tape] discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight.The controls indicated herein are applicable only to the top-level processes identified.。
ISO9001-2015文件控制程序(中英文)
文件控制程序Document Control Procedure（ISO9001：2015）1.0 Purpose目的Define the requirements and responsibilities for Document control.定义出文件控制的要求和权责。
2.0 S cope范围This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.适用于与质量管理体系有关的所有文件。
包括:手册、程序文件、操作指导书、外来文件及表单。
3.0 Definitions定义3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。
3.2 Procedure: Define the function of QMS requirement allocation by department. Such as document control, management review, internal audit procedure.3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。
如文件控制程序、管理评审控制程序、内部审核控制程序。
3.3 Working Instruction: Operation procedures, inspection standards, design drawing and etc.3.3操作指导书：操作规程、检验标准、加工图纸等。
ISO9001-2015管理评审程序(中英文)
管理评审程序ManagementReviewControlProcedure（ISO9001：2015）1.0目的Purpose:建立一个文件化的系统规范公司管理评审活动的进行，确保管理体系的适宜性、充分性和有效性。
Thepurposeofthisprocedureistohaveasystemtocontrolthemanagementreview activitytoensurethecontinualsuitability,adequacyandeffectivenessofma nagementsystem.2.0范围Scope:适用于质量与环境管理评审活动的控制。
ThisprocedureisapplicabletothecontrolofQMSandEMSmanagementreviewinFl extronicsPlasticsTechnology(Shenzhen)Co.,Ltd.3.0定义Definition:无No.4.0职责和权限Responsibilityandauthority：4.1总经理:负责主持管理评审活动。
GeneralManager:GMshouldbethechairmanofthemanagementreviewmeeting.4.2管理者代表:负责管理评审计划的制定,落实及组织协调工作；负责评审报告的整理发放及改善行动的跟踪验证工作。
Managementrepresentative:MRshouldpreparemanagementreviewplan,carryou tandcoordinatethemanagementreviewmeeting;preparemanagementreviewrepo rtandfollowup/verifycorrectiveandpreventiveactions.4.3各有关部门:负责准备并提供与本部门工作有关的评审所需的资料，并对涉及本部门的不符合采取纠正或预防措施。
ISO90012015记录控制程序英文版
[Full Client Name Reg Caps]Procedure: [Control of Records Proc. Title]Rev. [Rev Number]Procedure: [Control of Records Proc. Title]1.0 SUMMARY1.1.This procedure defi nes the requireme nts for the ide ntificati on, storage, protect ion, retrieval, rete nti on timeand dispositi on of con trolled quality records.1.2.“ Quality records ” are those records which provide evidenee of [Short Client Name] having met or not met-requirements. This may include requirements related to inspection requirements, purchas ing requireme nts, contractual requireme nts, etc. The full list ing of records affected bythis procedure is give n in the table at the end of this procedure.1.3.Records outside of this scope do not require con trol, but may be con trolled at the discreti on of man ageme nt.1.4.The [who?] is resp on sible for impleme ntati on and man ageme nt of this procedure.2.0 REVISION AND APPROVAL3.0 IDENTIFICATION3.1.[Short Client Name] maintains records that are needed to provide evidenee of conformity to requirements and of theeffective operation of the quality management system. The records are identified in the table below, along with thecontrols for each record type.4.0 STORAGE4.1.Storage methods are in dicated in the table below, for each record type.4.2.Softcopy records and data are stored on the company server or computers; in all cases, computers are subject to backup.4.3.Hardcopy records are stored in suitable cab in ets that preve nt damage or deteriorati on.5.0 RETENTION, RETRIEVAL & DISPOSITION5.1.Records shall be main tai ned a minimum of XX years [ defi ne actual rete nti on time; should not be less tha n 3years due to ISO audit cycle requireme nts] uni ess otherwise in dicated below or as defi ned by customer, statutoryor regulatory requireme nts.5.2.Training records and other records pertai ning to employees must be reta ined at least one year beyond that employee' s end of employment.5.3.Records that are discarded after rete nti on shall be perma nen tly destroyed.[Full Client Name Reg Caps] Procedure: [Controlof Records Proc. Title] Rev. [Rev Number]5.4.When archived records are stored offsite or in another location, these shall be stored in a con trolled en vir onmentthat also protects them from damage or deteriorati on.5.5.As required by customer con tract or regulatory requireme nts, quality records shall be made readily available forreview by the requesting authority. Such review is limited to those records applicable to the customer or regulatory authority, and shall not allow for the accidental or inten ti onal release of con fide ntial in formati on to an un authorized party.56 PROTECTION & PRESERVATION5.7.The listed “ con troller sho” n in the table below must en sure their assig ned records rema in legible, readilyidentifiable and retrievable.5.8.In order to en sure protect ion of records, electr onic records are subject to periodic backups, with the backup storedon a separate server. [Add details of backup procedures and methods here; if complex, a separate procedure may be required.]5.9.The [who?] is resp on sible for backup of data.5.10.Quality records data stored on individuals computers must either be backed up through the server (as above), or backedup manu ally onto the server. The in dividual users of such data are responsible when data is not backed up by the server. [Delete if not applicable.]5.11.En tries made by hand on hardcopy forms shall be made in ink.5.12.White-out or correct ion tape is not to be used on any quality records. The correct procedure for maki ng corrections is to cross the error out, make the correct ion and in itial it. Opti on ally, datesen sitive correcti ons should be dated as well.。
ISO9001-2015供应商质量管理程序（中英文）
ISO9001-2015供应商质量管理程序（中英文）供应商质量管理程序Supplier Quality Management Procedure（ISO9001：2015）1.PURPOSE 目的:To establish a guideline to control and monitor supplier quality performance, manage supplier to improve quality system and product quality to meet DXC expectations. 建立监控供货商质量绩效的方针,管理供货商改进质量系统及产品质量以达到的期望目标.2.SCOPE 范围:2.1This procedure applies to all suppliers that provides production material products to DXC .此程序适合于提供生产性物料的所有供货商.2.2This procedure is applicable for QA to manage supplier quality and related issue only.此文件仅适用于QA管理供货商质量及相关问题.3.DEFINITIONS 定义:3.1Key Supplier :The supplier provides the material that is either valuable and / or critical impact to product’s characteristics关键供货商: 提供对产品价值或性能有关键影响物料的供货商.3.2SRS: Supplier Rating System.SRS: 供货商评估系统.3.3FAI: First Article Inspection.FAI: 首件检验.3.4LAR: Lot Accept Rate from incoming inspection.LAR: 来料检查批接收率.4.REFERENCE DOCUMENT 参考文件:4.1 BZQP-7-06 Supplier Rating System Procedure 供货商评估系统程序.4.2 BZQP-8-07 Corrective and preventive actions procedure 纠正及预防措施程序.5.RESPONSIBILITY 职责:5.1Purchasing staff 采购5.1.1 Arrange consolidation of the overall material supplier performance and distribute to related parties.整理供货商质量绩效并发布给相关部门5.1.2Review the supplier performance and enhance supplier improvement management.评估供货商绩效加强供货商改善管理.5.1.3 Coordinate and plan supplier’s support both for ongoing & future if necessary. 协调和规划供货商现在及将来的支持5.2QA质量工程师.5.2.1Follow supplier corrective action in line complaint. 跟进产线投诉问题和供货商的改善行动.5.2.2 Define key supplier for evaluation or assessment with purchasing staff.与采购定义关键供货商以便评估.5.2.3 Review the assessment result for further improvement or supplier quality related matters..审核供货商质量相关的事项的评估结果,达到持续改善.5.3 ME制造工程If necessary, ME will support QA to perform supplier process audit and technology evaluation.必要时,ME将协助QA执行供货商制程审核及技朮评估.6.PROCEDURE 程序:6.1 Supplier Rating System 供货商级别评估体系.Purchasing and QA shall select the key supplier and perform SRS. Refer to Supplier Rating System Procedure(BZQP-7-6).采购和QA 选择关键供货商进行评估, 参照供货商评估系统程序(BZQP-7-6)6.2 Material qualification 物料资格认证.6.2.1 Under selection of a potential supplier, Sourcing or purchasing sends the specification or drawing component requirements to supplier and Engineer instruct supplier to submit sample and related document (Attachment 1.)选定部分供货商后，资材部或采购将部件规格要求或图纸转交给供货商﹐工程部工程师指导供货商按照提交样品和相关档(附檔1)6.2.2Engineer will cooperate to complete FAI, detail operation process refer to “Incoming First Article Inspection Instruction (BZQAWI-003)”.工程师将完成物料的FAI检查,具体作业方法请参考“来料首件检查指示(BZWIQA-003)”6.2.3After the internal inspection completed, QA submit the passed part and FAI documents to customer for make final approve if need. After customer approve the sample, QA distribute the approved sample and relative files to IQC and buyer as the proof of approved by DXC .内部检查完成后, 如客户要求, QA将零件批准的数据 (零件样板) 和FAI报告送与客户批准. 客户检查并批准后, QA将客户最终承认的样板及相关文件分发至IQC和采购, 作为样板被承认的依据.6.2.4If material is rejected by customer, the original copy of material approval should return back to QA. Return process from 6.2.1 to 6. 2.4 如零件承认被客户否决, 则承认零件退回给QA. 重复步骤6.2.1至6.2.4.6.2.4.1For the critical to quality indirect material and not customer specified ,new developed supplier material needs to pass Engineer’s approval, and send to customer for approval as required.对于客户未指定的间接物料,在其对产品质量有重要影响的状况下,新物料需要经过工程师批准,如果客户要求将送给客户进行批准.6.2.5Material disqualification procedure.物料资格取消程序。
ISO 9001 2015 中英文
strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a) understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.Figure 1 — Schematic representation of the elements of a single process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International 维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。
ISO-9001-2015-中英文
strategicdirection of the organization. Management of theprocesses and the system as a whole can be achieved using thePDCA cycle (see 0.3.2) with an overall focus on risk-basedthinking (see 0.3.3) aimed at taking advantage of opportunitiesand preventing undesirable results.The application of the process approach in a quality managementsystem enables:a) understanding and consistency in meeting requirements;b) the consideration of processes in terms of added value;c) the achievement of effective process performance;d) improvement of processes based on evaluation of data andinformation.Figure 1 gives a schematic representation of any process andshows the interaction of its elements. The monitoring andmeasuring check points, which are necessary for control, arespecific to each process and will vary depending on the relatedrisks.Figure 1 — Schematic representation of the elements of asingle process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the qualitymanagement system as a whole. Figure 2 illustrates how Clauses4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。
ISO9001：2015全套程序文件英文版(本人辛苦原创)
ISO9001：2015全套程序文件英文版(本人辛苦原创)Code QM-COP-01Date2018.10.24Date2018.10.241.0 PurposeAll the documents required by the Company’s quality management system should be controlled to ensure the version applied by all the relevant departments is valid.2.0 ScopeIt is applicable to all the documents pertaining to the quality management system including external documents.3.0 Definition3.1 Controlled document: The document applied in and out of the Company is controlled in modifications, identities, versions, version numbers, formats, fonts, etc.3.2 DCC: Document Controlling Center3.3 External document: It refers to the document that has been handled by outside individuals like national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates, amendment advice, etc.3.3.1 Administrative documents on quality management system or product, released from local government authorities and regulatory agencies such as the notices from Guangdong Food and Drug Administration.3.3.2 National laws and regulations such as Product Quality Law of the People’s Republic of China, Regulation on the Supervision and Administration of Medical Devices, 93/42/EEC, etc.3.3.3 International standards such as Medical devices—Quality management systems—Requirements for regulatory purposes.3.3.4 National standards such as Medical electrical equipment – Part 1: General requirements for safety.3.3.5 Regulations and standards provided by customers such as agreements and commitments signed with customers.3.3.6 Drawings provided by customers such as drawings, mold drawings provided by a certain customer.3.3.7 Other important external documents relating to the product, including official materials like customer’s notice.4.0 Duties4.1 General Manager: Responsible for approval of the Company’s quality manual.4.2 Management Representative: Responsible for the Company’s procedure files, quality plans and cross-department three-order files and approval of external documents.4.3 Principals of each department: Responsible for approval of three-order files and all kinds of tables as well as department-related external documents.4.4 Department: Responsible for compilation, number and review of the documents dominated by the department.Code QM-COP-01Date2018.10.24Date2018.10.244.5 Quality Management Department: Responsible for all the controlled documents of the Company to ensure the electronic document is the latest version, and responsible for the updating of the controlled document list of all the departments.5.0 Procedures5.1 Document classification: The management system documents includes four layers and external documents5.1.1The Quality Manual (including policies and goals) is a principle-based and master document guiding the implementation of the quality management system. As the first level document, it does not just explain the scope of application but also describe the interaction among all the procedures in the quality management system.5.1.2 The procedure document is the expansion and specification of the Quality Manual, providing the process, methods and controlling means for carrying out quality management. It belongs to the second level document.5.1.3 Supporting documents (operation/technical specifications, process/inspection standards, technical guidance and position description) specify the quality management goals, duties of the posts of all levels and specific operation methods. It belongs to the third level document.5.1.4 The table is applied to record the state and result of activities, belonging to the fourth level document.5.1.5 External document: It refers to the document directly obtained from outside and cited by the Company, including national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates and amendment advice.5.1.6 The document is drawn up mainly in written or electronic form, and both shall be under control.5.2 Document compilation and approval5.2.1 The formats of the second and third level documents are the same as that of the document.5.2.2 The date of the document must be written in the form of “year month day”.5.2.3 Limits for examination and approving authority for documentsS/N Order Type ofdocumentPrepared byReviewedbyJointreviewed byApprovedbyRemark1 First ManagementManualQualityManagementDepartmentManagementRepresentativeSupervisorof eachdepartmentTopmanagement2 SecondProceduredocumentAlldepartmentDepartmentRelevantdepartmentManagementCodeQM-COP-01Date2018.10.24 Date2018.10.245.3 Document’s number and version/version number5.3.1 Number: The document compiler numbers the newly compiled documents according to the Basic Rules for Numbering the Controlled Documents and the document list of the department, and confirms the uniqueness of the numbers with the controlling center.5.3.2 Version/Version number: The version or version number of the controlled document is compiled insmanagermanagerRepresen tative3ThirdManagement documentAll department sDepartme nt managerRelevant department manager and Managemen tRepresentat iveManage ment Represen tativeJob Description of the personnel below the manager level is reviewed by the department manager and approved by the manager of HR Department.4ThirdProcess, inspection standarddocument and specification (including external document)All department sQuality Manageme nt Departme ntDepartm ent manager5Fourt hTablesAlldepartment sQualityManageme nt Departme ntDepartm entmanagerAdditional remarks: 1) The document can be compiled by the compilers or above the compiler level but must be approved by the personnel upper than the compiler.2) The relevant department refers to the departments having ties with others involved in this system. 3) When the approver of the above documents is absent, his agent or Management Representative can sign it up instead to make the document effective.Code QM-COP-01Date2018.10.24Date2018.10.24the form of 26 alphabets from A to Z. The initial version number is “A/0”, the next revised version is “A/1” and so on. Changing Arabic numbers is enough for minor revisions while changing alphabets, for instance, from “A” to “B”, is necessary in case of major revisions.5.4 Document distribution and storage5.4.1 The document compiler sends the copy of the approved document and its electronic version to the Quality Management Department where the document will be checked whether it has been approved by designated personnel. After that, the document will be registered, controlled with the controlled document list updated.5.4.2 The document controller determines the scope of distribution, makes copies of the electronic file ina required number according to the List of distributed controlled documents, add the watermarks of correspondent departments on these copies, save them to the folder for controlled documents of each department and notify the departments for making and using the documents by email.5.4.3 All the department are responsible for checking if the controlled document is correct or not.5.4.4 The authority for the controlled document folder of each department shall be set as follows:①Document controller is permitted to modify, delete the content or add new content to the document.②Each department can only read but cannot delete, modify or add the content of controlled documents.5.4.5 The document controller must copy the electronic document as a backup.5.4.6 Visual management of documentsAs for the documents which are frequently applied at production site, all the departments should take correspondent measures such as hanging them on the wall, beside the equipment or enveloping them with plastic so to make it easy for operators to use.5.5 Document reading5.5.1 In case of reading the documents, the relevant personnel can open the PDF file which are saved in the Company’s share disk.5.6 Document review, modification, recovery, invalidation and destruction5.6.1 Review①The documents of the quality management system should be reviewed once a year by the Quality Management Department and internal review team organized by the Management Representative along with the Company’s internal review and reviewed with the result put down in the internal review record.②In case of special circumstances, some documents should be reviewed by the relevant department.③The review must take into account the influence of both the internal factors like the Company’s organization and position changes and the external factors like laws, regulations, relevant standards and market demands upon the sufficiency and applicability of the documents with the Review Record filled in.5.6.2 Revision/alteration①The director and executor of each unit should check the effect after implementing the documents. If the documents are not applicable or in doubt in addition to the opinions on the content of the documents from other units, the documents can be revised or modified by the department which revised or compiledCode QM-COP-01Date2018.10.24Date2018.10.24them last time after the discussion among the relevant departments. Relevant approval process is the same as that in 5.2.2.②All the modifications or alterations must be underlined (“___”). In case of version change, the previous underline should be substituted by the latest one.③The revision record should be written on the first page of the documents, containing the content of the revision, identification of the affected documents, signature of the approver, date of approval and effective time.④The relevant departments shall be notified of review and confirmation of the alteration, and personnel training will be provided if necessary.⑤In the following circumstances that there is any alteration to the documents of the quality management system or the documents relating to the Company’s medical device products, the top management or Management Representative of the Company should be notified of deciding whether to inform the competent authority or notified bodies about it. If it is necessary, the notification should be implemented in accordance with the local laws and administrative regulations.a. Major alterations to the Quality Manual.b. Major alterations to the product’s functions, performance, safety, reliability and electromagnetic compatibility, caused by altering product standards.c. Major alterations to the product’s functions, performance, safety, reliability and electromagnetic compatibility, caused by changing key components of products.d. Stipulated by laws and regulations.5.6.3 Once the new version of controlled document is distributed, the old one becomes invalid automatically. The document controller should delete the copies of invalid controlled documents in the controlled document folder, upload the latest version and keep the original documents printed with an “invalid” stamp at the document controlling center till the expiry date (at least five years) before destruction.5.6.4 As for the invalid original documents, the document controlling center should destruct them uniformly after Document/Record Destruction Registration Form filled in by the center is approved by the Management Representative.5.7 The non-controlled document is identified as the “Reference”. If a Company’s customer or other personnel need it for their jobs, they must have the copies of the Company’s controlled documents and get its copies approved by the Management Representative and stamped with the ‘Reference’ seal by the Quality Management Department. The ‘Reference’ documents will not be withdrawn or changed to the latest version.5.8 Temporary documentIt is not yet official for some reasons but needed by each department. Such document should have a ‘Temporarily Controlled’ stamp as well as the time limit and distribution department on them. The temporary document cannot be valid for more than 3 months.Code QM-COP-01Date2018.10.24Date2018.10.245.9 Management of external documents5.9.1 Each department of the Company can collect external documents through the following channels.a. National, provincial, municipal governments and their relevant functional departments.b. All kinds of meetings, professional newspapers, magazines, publishers and suppliers.c. Internet, telephone and fax.5.9.2 The external document collected by each department should be selected timely and delivered to the relevant department to recognize its contents and decide whether make it a controlled document.a. The collected technical standards on our products should be delivered to the Technical Department to recognize its year, version and applicable articles.b. The laws, regulations and rules that are issued by the state on the quality and safety of the product should be delivered to the Quality Management Department to identify the required department and scope.c. Policy documents issued by the superior should be delivered to the administration department for recognition.d. The technical documents provided by suppliers or customers should be delivered to the Technical Department and Quality Management Department for recognition.f. The design input documents provided by customers should be delivered by the Market Department to the R&D Department for recognition. Saved in DHF format, they don’t have to be controlled by document controller.5.9.3 Numbering of external documentsAs for the external documents on technology and standards as well as other external documents, the Quality Management Department should number them in accordance with the Basic rules on numbering controlled documents.5.9.4 Distribution of external documentsa. After being recognized, the external documents should be kept on a file and put down on a list.b. The external documents should be distributed after the distribution scope is confirmed according to 5.4 of this procedure.5.9.5 Updating of external documentsAs for the external documents which need updating, the new version should be distributed with the invalid ones withdrawn immediately.5.9.6 Preservation and destruction of external documentsThe preservation and destruction should be implemented according to 5.6.3 of this procedure.5.10 The Quality Management Department should supervise and inspect irregularly the controlling process implemented by each department.6.0 Records and Tables6.1 Controlled Document DirectoryCode QM-COP-01Date2018.10.24Date2018.10.246.2 Document/Record Destruction Registration Form6.3 Review Record7.0 Flow ChartCode QM-COP-01Date2018.10.24Date2018.10.24Code QM-COP-02Date2018.10.24Date2018.10.241.0 PurposeAll the records required by the Company’s quality management system should be controlled to ensure evidence that products accord with regulations and quality system operates effectively and their history are provided .2.0 ScopeIt is applicable to all the records pertaining to the quality management system, including those designated by suppliers and customers.3.0 DefinitionsRecord: A document illustrating the results achieved or proving the activities finished.DHF: It refers to the records describing the design process of a finished medical device.DMR: It refers to the full record including the procedures and regulations of manufacturing a standard finished medical device.4.0 Duties4.1 Quality Management Department: responsible for all the controlled record forms of the Company to ensure the record is comprehensively examined and numbered uniformly.4.2 Each department shall be responsible for collection, archiving, marking, storage and disposal of the documents dominated by the department.5.0 Procedure contents5.1 Records and the establishment, record-keeping and identification of Record List5.1.1 Establishment of Record ListQuality Management Department compiles the Record List according to the requirement of quality management process. The name, number, storage department and expiry of the records should be explicit and shared in the servers so that each department can verify the consistency of the versions.5.1.2 Record compilation①Each department should design its own form according to requirements, including the name, number and version.②The record compiler numbers the newly compiled records according to the Basic Rules for Numbering the Controlled Documents.③Quality Management Department examines the formats and contents of record documents drawn up by each department. Department manager approves it to ensure its qualification of quality management system regulation.5.1.3 The keeping, identification and distribution of record documents shall be done according to the Document Control Procedures.CodeQM-COP-02Date2018.10.24Date2018.10.245.1.4 When relevant departments receive electronic file forms, the new version should be applied immediately with the old one being invalid.5.1.5 The invalidation of form must be reviewed by managers of the relevant department and the Management Representative. 5.2 Use of records5.2.1 There will be recorder and verifier in all records. Time will be recorded in at least one place in the full records.5.2.2 The records should be clear and the facts and data should be authentic, accurate and complete. Do not alter the records at will. Cross out the old contents by using “\” if necessary. After that, write down the new contents, the signature of the person who alters the data and date, and make it clear as before. Give an account of the alteration if necessary.5.2.3 The record form should be filled in a stipulated way. Use “/” in the places that do not have to be filled in. No blank should be left.5.3 Collection and management of records5.3.1 Each department is responsible for collecting, sorting out and archiving all its records, with establishing index and directory for ready reference.5.3.2 The records filled out should be kept properly in case of damage and loss. 5.4 Storage expiry of records5.4.1 In accordance with laws and rules, the regulations for the record are as follows: Heads of each department compiling the form should be responsible for confirming the storage life of new table after referring to the following attached form. Upon issuance of the new form, the Quality Management Department should take storage life into Record List for reference and performance of each department. 5.4.2 The storage life of account records and vouchers related to finance shall be 5 years, including the inventory of stock, purchase note, quotation, etc.5.5 Invalidation of records: With the approval of the principles of relevant department and management representative, Quality Management Department destructs the records exceeding storage life. Mark and make independent cover for the records needed to be kept for special requirement.5.6 Quality Management Department shall supervise and examine the control process of records of eachType of formStorage life Remark Account record or voucher related to financeAt least 5 years Determine the storage life according to client’s special requirements if necessaryRecord on products technology, quality and salesAt least 3 years Equipment maintenance and check At least 1 years Weekly and monthly report At least 1 years MiscellaneousAt least 1 monthsCode QM-COP-02Date2018.10.24Date2018.10.24department irregularly (at least 2 times a year/ can be conducted during internal review) .6.0 Records and Tables6.1 Record List6.2 Document/Record Destruction Registration Form7.0 Flow ChartCode QM-COP-02Date2018.10.24Date2018.10.24Code QM-COP-03Date2018.10.24Date2018.10.241.0 PurposeThe purpose of this procedure is to define DaMei’s requirements for conducting Management Reviews.2.0 ScopeThis procedure is the primary document meeting the applicable regulatory requirements for conducting Management Reviews as defined in DaMei’s Quality System Manual (QM-A-01).References and RelationshipsISO 13485:201621 CFR 820.203.0 Responsibilities and AuthoritiesRole Responsibilities and AuthoritiesQuality Management / Management Representative Primary responsibility for maintaining this process and ensuring that Management Review meetings are scheduled, conducted and the minutes are recorded.Top Management The Management responsible for attending Management ReviewMeetings as identified in DaMei’s organization chart. These managers areresponsible for participating in Management Reviews—including thepreparation of inputs to the Management Review and completion ofaction items resulting from Management Reviews. The organization chartshould also identify the following personnel:Management RepresentativeDeputy Management RepresentativeMost Senior Executive ManagerSecond Most Senior Executive ManagerIt is not recommended to have the same person hold two of the abovefour positions.4.0 Procedure1 Management Review meetings shall be scheduled at least once a year.2 The following inputs are required to the Management Review meeting for discussion:Quality policyQuality objectivesResults of audits – including internal, supplier, certification audits and FDA inspectionsCustomer feedback – including complaints and post-market surveillanceProcess performanceCode QM-COP-03Date2018.10.24Date2018.10.24Product conformitySupplier quality performanceStatus of corrective and preventive actionsFollow-up of action items from the previous Management Review(s)Changes that could affect the quality systemRecommendations for improvementNew and revised regulatory requirementsRisk management process (ISO 14971)Overall quality system effectiveness3 Management Review inputs shall be documented in a presentation slide deck using a controlledtemplate. The Management Representative shall assign responsibility for completing each slide of the presentation as an action item in the previous Management Review. These assignments shall be documented in the meeting minutes. Each input slide shall be provided to theManagement Representative at least 10 calendar days prior to the planned review date, and the Management Representative shall combine the slides into a draft presentation andelectronically deliver the draft presentation to Top Management at least 7 calendar days prior to the planned review date. Any necessary corrections to slides should be communicated to the Management Representative as soon as possible so that corrections can be communicated to Top Management prior to the planned review date.4 During the Management Review, Top Management shall review the Quality Policy to ensure it:is appropriate to DaMei’s purpose,includes a commitment to comply with requirements and to maintainthe effectiveness of the quality management system,provides a framework for establishing and reviewing qualityobjectives,is communicated and understood within the organization, andis reviewed for continuing suitability during at least one Management Review meeting eachyear.5 During the Management Review meeting, the Management Representative is assigned the roleof scribe to record notes about the discussions.6 Top management shall ensure that quality objectives, including thoseneeded to meetrequirements for product, are established for all functions (i.e., departments) and all levelswithin the organization. The qualityobjectives shall be measurable and consistent with thequality policy. The status of quality objectives shall be reviewed during management reviews and when one objective is met, Top Management shall determine if the objective shall bemaintained or if a new objective shall be set.7 The risk management process should be reviewed by Top Management for effectiveness duringCode QM-COP-03Date2018.10.24Date2018.10.24reviews, but it is allowed to schedule the review of the risk management process at anothertime. The risk management review should include a review of risk management plans duringdesign projects and as part of past-market data collection. Compliance with the riskmanagement plans should be reviewed, and any corrective actions taken to improve riskcontrols and/or update a risk analysis should be reviewed as a possible opportunity to improve the risk management process or the risk management training of personnel.8 The following items shall be documented as outputs from Management Review meetings in themeeting minutes:the date of the next scheduled Management Review Meeting and the rationale for the interval between reviews,actual attendance of Top Management,any changes to the quality policy required,any new quality objectives,any corrective actions recommended for initiation,improvements needed to maintain the effectiveness of the qualitymanagement system and its processes,improvement of product related to customer requirements,changes needed to respond to applicable new or revised regulatory requirements,resource needs,assignments to Top Management for preparing the Management Review meeting inputs for the next meeting, andany additional action items identified during the review.Improvement required to maintain the effectiveness of the quality system may include changes to the following:the monitoring and measurement of processes, andthe auditing schedule.9 The draft meeting minutes shall be distributed to Top Management within 7 calendar days ofthe review, and Top Management shall provide corrections and additional comments within 14 calendar days of the review. The Management Representative shall distribute the final version of the meeting minutes to Top Management with 21 calendar days and the minutes shall bemaintained as a quality system record.5.0 Records5.1 Management Review Plan5.2 Management Review ReportCode QM-COP-03Date2018.10.24Date2018.10.245.3 Management Review meeting recordCode Date 2018.10.24Date2018.10.241.0 Introduction & PurposeThe purpose of this procedure is to define internal audits in order to assess the effectiveness of the application of ISO13485:2016 & 21 CFR 820.20 and also to define the responsibilities for planning and conducting audits, reporting results and retaining associated records.2.0 Terms & Definitions2.1 Non-conformity: Non-fulfilment of a requirement.2.2 Preventive Action: Action taken to eliminate a potential non-conformity.2.3 Corrective Action: Action taken to eliminate the cause of a non-conformity.2.4 Audit: A systematic, independent documented process for obtaining and evaluating audit evidence objectively to determine the extent to which audit criteria are fulfilled.3.0 Application & ScopeThe scope of this procedure is focused on assessing the effectiveness of DaMei’ QMS. Where such processes are found to be deficient, the audit will lead to improvement in those processes.4.0 RequirementsAn audit of the QMS is conducted at planned intervals to:●Determine whether the QMS conforms to planned arrangements●Determine whether the QMS is properly implemented and maintained●Provide information on the results of audits during Management Review5.0 ProcessInternal auditing is undertaken at least once annually. Audits may be completed with a greater frequency if determined by the QA Officer or as determined by:●Customer complaint●QMS requirements●Quality objectives/policy●Corrective actions●Statutory/legal requirements●Management decisions●Concerns raised by 3rd parties●Results of 3rd party audits●Employee concerns●Management Review concerns6.0 Management Review concerns6.1 Auditors will be trained in the auditing process, including the intent of the procedure. The completed。
ISO9001：2015一整套程序文件-英文版
Quality System Procedures(ISO 9001:2015)GENERAL INFORMATION Name of the Organisation:Address:E-Mail:Web:QUALITY SYSTEM STATUSQuality System:ISO 9001: 2015 Issue No.:01Issue Date: System Effective Date:December 2017 December 2017Copy No.:01LIST OF CONTENTSection-1 Control of DocumentSection-2Control of RecordsSection-3Management Review MeetingSection-4Resource ManagementSection-5Customer Related ProcessSection-6Purchase ProcessSection-7Supplier Evaluation and Selection Process Section-8Service ProcessSection-9Receipt Storage and Issue of Product Section-10Customer SatisfactionSection-11Internal AuditSection-12Control of Nonconforming Product Section-13Analysis of dataSection-14Continual ImprovementSection-15Corrective Action and Preventive ActionSection-1Control of Documents1.0Purpose1.1To establish a procedure to ensure that the documents required for Quality ManagementSystem are in controlled condition.1.2To ensure that pertinent versions of documents are available at the point of use.2.0Scope2.1Applicable to all documents and data generated for Quality Management System via theProcedures, Work Instructions, Documents, Lists, Formats and Registers etc.2.2This procedure also covers the external origin documents such as Standards and CustomerDocuments.3.0Responsibility3.1 Management Representative is responsible for controlling all the documents of Quality ManagementSystem being originated internally and the documents from External origin.3.2 It is the responsibility of Management Representative to ensure that pertinent documents are available atpoint of use.4.0Procedure4.1The numbering of all Quality Management System documents is done as per the Annexure.4.2Document Generation / Creation4.2.1 Management Representative issues the copies of the Quality System Manual / Procedures /Guidelines / Formats to all concerned personnel and records in Issue Control Register.4.2.3Any Departmental member, who perceives the need for a new quality system documentfor upgrading the system, prepares a draft procedure and forwards it to the ManagementRepresentative.4.2.3Management Representative studies the possibility of modifying any existing procedurein consultation with approving authority or accepts the draft procedures with or withoutmodifications and approves it before issue.4.3Document Change / Modification4.3.1Changes / Modification in document arises in any one of the following area;A.Change in Organization structureB.Any change in the departmental functioningC.Change in / addition / deletion of existing systemD.Change in International / National StandardsE.Findings of Internal Quality Audit4.3.2Departmental members prepares Document Change Request and forwards it toManagement Representative4.3.4 If the changes are acceptable, Management Representative makes necessary changes in thedocumentation and gets it signed by the concerned authority.4.3.5If the document is added or deleted, all linked procedures are updated in theAmendment Record Sheet.4.3.6While issuing the revised copies to all concerned, Management Representative ensures thatthe obsolete documents are retrieved back from all personnel and the same are destroyed.The respective Master copy is stamped as “OBSOLETE” and maintained for a period of oneyear from the date of next revision or till the next revision, which ever is later.4.3.7The Issue No. will be incremented when number of revisions in any section/page ofdocument exceeds 09 revisions. The Issue No. will be TBA…etc. and Revision No. of all thesection / pages shall be reset to 004.4Management Representative shall maintain and update the Master List of Documents.4.5The document status shall be maintained as follows:MASTER“MASTER COPY”(Seal affixed on rear side of each page of document)CONTROLLED“CONTROLLED COPY”(Seal affixed on front right hand side of the document)OBSOLETE“OBSOLETE COPY”(Seal affixed on front side of the document)4.6 The approval authority for various documents is as mentioned below:Document Type Description Approved by Apex ManualProceduresDocument Type Description Approved byGuidelines & Formats As per Master List of Documents4.7External Originated Documents (National / International Standards And Customer Drawings)4.7.1Documents of National / International Standards / any other Guidelines are procured, revisedand implemented by Management Representative.4.7.2 A List of External Origin Documents is maintained by Management Representative and willbe updated whenever necessary.4.7.3All the standards are stamped as “CONTROLLED COPY” on the cover page of the standardand issued to the concerned by making necessary entries in Issue Control Register.4.7.4Documents of customers / suppliers are maintained only after receiving concrete ordersfrom them. If the order does not mature, the documents are either destroyed or returned tothem as the case may warrant.5.0Reference5.1Issue Control Register5.2Document Change Request5.3Amendment Record Sheet5.4Master List of Documents5.5List of External Origin DocumentsAnnexureNumbering System shall be as follows1.Quality System ManualAAG/QSM-XX, whereAAG–refers to the company, AAG Land SurveyQSM–refers to Quality System ManualXX–refers to Section No.2.Quality System ProceduresAAG/QSP/YYAAG–refers to the company, AAG Land SurveyQSP–refers to type of proceduresQSP – Quality Management System ProceduresYY–refers to running Serial Number of procedures3.Documents & RecordsAAG-AXX:YYAAG–refers to the company, AAG Land Survey。
ISO9001：2015管理评审程序英文版(含流程图)
MRF Name / LogoQP03 – Management reviewApproved:Management RepresentativeNote:Within this manual template, red italic text should be replaced by MRF specific information and any guidance in ‘text boxes’ should be implemented.1 PurposeThis procedure defines the Management Review process, its objectives, inputs and outputs. The Management Review process requires that the Quality Management System (QMS) is reviewed by Senior Management at planned intervals to ensure continued system effectiveness and alignment with quality policy and objectives.2 ScopeThis procedure contains the following sections:4.1 Format and objectives4.2 Review input4.3 Review output5 Related documents3 GlossaryCSAT - Customer SatisfactionMD - Managing DirectorQF - Quality FormMR - Management RepresentativeMRM - Management Review MeetingQMS - Quality Management System4.0 ProcedureThe Management Representative (MR) is to ensure the implementation of this procedure and is responsible for the compilation and analysis of appropriate review data and scheduling the periodic Management Review Meeting (MRM). The Managing Director (MD) is responsible for chairing the MRM and ensuring appropriate attendance.This procedure covers the MRM process as described in ISO9001:2008. Results from associated business objectives and activities will be fed into this review as appropriate.4.1 Format and objectivesA formal MRM is held at least annually and is attended by the MD and MR as a minimum. Other members of staff will be invited to participate in this review as appropriate.The objective of the review will be to ensure continued QMS suitability, adequacy and effectiveness. The review will include the assessment of opportunities for improvement and any potential QMS changes. The review is planned and captured using Management Review Agenda and Minutes QFnn.4.2 Review inputThe input to the MRM will include information on:•Follow-up actions from previous review.•Results of internal audits.•Customer feedback including:a)Customer Satisfactionb)Customer complaintsc)Results of Customer visits/audits•Process performance and product/service conformity.•Status of preventive and corrective actions.•Changes affecting the QMS.•Recommendations for improvement.4.3 Review outputThe output from the MRM will include any decisions or actions in relation to:•Improvements needed to maintain the effectiveness of the MS and associated processes•Improvement of Customer satisfaction and service delivery•Resource needs•Required auditsRecords of Management Reviews are minuted and are maintained in accordance with Control of Records procedure QP02.5 Related documents•Control of records procedure QP02.•Data analysis reports.•Management review agenda and minutes QFnn.。
ISO9001-2015采购程序(中英文)
采购管理程序Management of PURCHASING PROCEDURE（ISO9001：2015）1. Purpose目的Provide a consistent method for assuring purchased material meet DXC and customer requirements and optimize purchasing cost and efficiency.为了确保所采购的物料满足DXC公司及客户的需要，优化采购成本及效率。
2. Scope范围Apply to all direct and indirect material used for finish goods andnon-production material.所有用于成品或生产当中的直接或间接物料。
3.流程图 Flow Chart:Appendix I 附录IPurchasing control flow chart (Direct material) 采购控制流程图(直接物料) Appendix II 附录IIPurchasing control flow chart (Indirect material) 采购控制流程图(间接物料) Appendix III 附录IIIRTV control flow chart退货流程图4. Reference Document参考文件4.1 Purchasing control flow chart (Direct Material) OP-PU-FC-01采购控制流程图(直接物料)4.2 Purchasing control flow chart (Indirect Material) OP-PU-FC-02采购控制流程图(间接物料)4.3 RTV control flow chart OP-PU-FC-03退货流程图4.4 Approval Vendor List (Direct Material) OP-PU-FO-01合格供应商清单4.5 Lead Time Summary (Direct Material) OP-PU-FO-02交货周期汇总4.6 Sorting Cost monthly report OP-PU-FO-05挑选费用月报表4.7 Purchase Request OP-MC-FO-03采购申请表5. Definition定义5.1 MPS - Master Production Schedule主生产计划5.2 MRB – Material Review Board物料评审会5.3 MRP – Material Request Plan物料需求计划5.4 PO - Purchase Order采购单5.5 PR - Purchase Request采购申请表6. General procedure一般程序6.1 Responsibilities 责任人6.1.1 Buyer is responsible for creating PO, issuing PO to supplier and followingup delivery.采购员负责下订单，分发订单及跟踪交期。
ISO9001-2015设备请购和验收管理程序(中英文)
生产、检验设备请购和验收管理控制程序（ISO9001：2015）1.0 目的Purpose规范设备的申购，安装调试，和验收，去保障采购的设备性能最优、质量可靠、价格合理，以提高设备运行效率。
Specify equipment purchase, installation, test & acceptance, to ensure property of equipment procured is excellent with reliable quality, reasonable price. The operation efficiency of equipment will be enhanced accordingly.2.0 适用范围 Scope价值在2000元以上、使用寿命在一年以上的生产、检验及其他辅助设备。
Equipments value more than 2000RMB with 1 year product life cycle and use in manufacturing, inspection or auxiliary purposes.3.0职责 Responsibilities3.1 技术部 TD3.1.1 负责新增设备的需求评估。
In charge of equipment demand evaluation of new project。
3.1.2 技术方面需求与供应商进行交流。
In charge of communicating to supplier for technical information. 3.1.3 协助设备的安装、调试和验收。
Assist for equipment installation and acceptance etc。
3.2 设备部ED3.2.1负责公司所有的生产、检验及其他辅助设备固定资产申购、协助制造商安装调试、验收等。
ISO9001_2015_中英对照介绍
Secretariat of ISO/TC 176/SC 2Date: 3 June 2013To the Members ofISO/TC 176/SC 2 -Quality Management andQuality Assurance/Quality SystemsISO/CD 9001目录1 Scope范围2 Normative references规范性引用文件3 Terms and definitions术语和定义4 Context of the organization组织的背景4.1 Understanding the organization and its context理解组织及其背景4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望4.3 Determining the scope of the quality management system质量管理体系范围的确定4.4 Quality management system质量管理体系5 Leadership领导作用5.1 Leadership and commitment领导作用和承诺5.2 Quality policy质量方针5.3 Organizational roles, responsibilities and authorities组织的作用、职责和权限6 Planning策划6.1 Actions to address risks and opportunities风险和机遇的应对措施6.2 Quality objectives and planning to achieve them质量目标及其实施的策划6.3 Planning of changes变更的策划7 Support支持7.1 Resources资源7.2 Competence能力7.3 Awareness意识7.4 Communication沟通7.5 Documented information形成文件的信息8 Operation运行8.1 Operational planning and control运行的策划和控制8.2 Determination of market needs and interactions with customers市场需求的确定和顾客沟通8.3 Operational planning process运行策划过程8.4 Control of external provision of goods and services外部供应产品和服务的控制8.5 Development of goods and services产品和服务开发8.6 Production of goods and provision of services产品生产和服务提供8.7 Release of goods and services产品和服务放行8.8 Nonconforming goods and services不合格产品和服务9 Performance evaluation绩效评价9.1 Monitoring, measurement, analysis and evaluation监视、测量、分析和评价9.2 Internal Audit内部审核9.3 Management review管理评审10 Continual improvement持续改进10.1 Nonconformity and corrective action不符合和纠正措施10.2 Improvement改进附录A Annex A Quality management principles (Informative)质量管理原则文献1．Scope范围This International Standard specifies requirements for a quality management system where an organization本标准为有下列需求的组织规定了质量管理体系要求：a）needs to demonstrate its ability to consistently provide goods and services that meet customer and applicable statutory and regulatory requirements, and需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力；b）aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements通过体系的的有效应用，包括体系持续改进的过程，以及保证符合顾客和适用的法律法规要求，旨在增强顾客满意。
ISO9001-2015供应商控制程序(中英文)
供应商控制程序SUPPLIER Control PROCEDURE（ISO9001：2015）1.Purpose目的:1.1.To define supplier management procedure, and ensure that the suppliermaterial will follow DXC quality requirements.确立供应商管理程序，确保供应商之产品能满足DXC公司品质要求。
2.Scope范围:2.1.This procedure applies to all DXC suppliers.该程序适用于DXC公司所有供应商。
3.Reference Document参考文件3.1.Quality Manual 品质手册3.2.Purchasing Procedure 采购程序3.3.Incoming Quality Control Procedure进料品质控制程序3.4.IQC monthly report IQC月报3.5.Sourcing Procedure. 供应商开发程序4.Definition定义4.1.AVL– Approved supplier list 合格供应商清单4.2.CPAR –Corrective and preventive action request.纠正与预防措施申请4.3.P.O.–Purchase order.采购订单5.Responsibility职责：5.1.QA Department 品质部:5.1.1.R esponsible for the verification of the supplier’s qualitymanagement system, imposed requirement for the corrective and preventive action.负责确认供应商质量管理体系，纠正与预防措施的要求。
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物资管理控制程序
（ISO9001：2015）
1.0 目的 Purpose
为有效控制仓库物资进出,确保不断料、不呆料、不囤料，做到帐、物、卡一致，加速资金的周转。
Control the material in and out of the warehouse effectively; make sure warehouse will not run off material, and will not store idle and spare material; make sure that account, material and card are consistent; speed up capital turnover.
2.0 范围Scope
适用于公司物资的进出、安全、储存、退货、退库、帐务处理等管理。
Apply to management of material incoming and outgoing, safety, storage, returned goods, canceling stock and accounting work and so on.
3.0 职责 Responsibilities
3.1 仓管负责物资点收，报检，入库、发料、保管。
Warehouse keeper should deal with the check and receive, report, warehouse entry, material issue and storage.
3.2 质量部负责来料的检验，逾期材料质量的检验及判定。
Quality department should inspect the incoming quality control and test and judge the quality of outdated material.
3.3 采购员负责物资的采购。
Purchaser should deal with the procurement of material.
3.4 物资使用部门负责物资的领用。
Material using department should deal with the distribution of material.
4.0 程序Procedure
4.1 仓库物料储存区域划分定位 Division of warehouse storage place
各仓库根据物料的品种、类型、属性等合理规划所需仓储位及其面积，在不影响搬运及安全的原则上，尽量考虑使用空间立体存放，如储物架，并予编号管理。
以使库位空间有效利用。
Each warehouse should plan appropriate position and size according to the verities, types, and attributes of material. Under safety conditions, try to place things in Three-dimensional storage space such as storage shelf and compile number to manage so that the warehouse can be fully used.
4.2 仓储位规划应依下列规定：
Planning of warehouse position should conform to the following specifications:
4.2.1 配合各仓库内设备(例如叉车、消防通道、电源、通风设备等)及所使用的储运工具规划出入运输通道。
A transportation channel for all kinds of warehouse equipments such as forklift, fire passage, electric power, ventilation installation and so on and the transportation vehicles
4.2.2 按物资类型、品种、规格、特性、储存周期等分区定位存放，并做明确标识，以利管理。
收发频繁的物资应存放于进出便捷的库位。
Material should be placed separately according to type, variety, specifications, features, storage cycle and mark them clearly to make management convenient. The material that receive and send frequently should be place in an easily accessory position.
4.2.3 将库位的具体划分绘制《仓储区规划图》标示在仓库显眼处。
在使用空间立体存放时，应依物料或成品的包装、质量要求及特性等设定其堆放方式和层数，以避免物料或成品因堆放不合理，受挤压而影响质量。
Draw the detail divisions into planning map of warehouse and stick it to an obvious place in warehouse. When placing things in Three-dimensional storage space, the way of stacking and the number of layers should be decided according to the packing, quality requirements and attributes so that quality of material will not be affected because of unreasonable stacking or crowing.
4.3 根据材料的贮存条件要求，确定适当的贮存区域。
仓库划分为“合格区”、“不合格区”、“退货区”。
物料状态用颜色标志标识物料状态：
Divide appropriate storing place according to the storage requirements of material. The warehouse is divided into qualified goods area, unqualified goods area, returned purchase area. The status of material should be identified by color.
a. 合格——绿色
Qualified--green
b. 不合格——红色。