ISO文件控制程序(中英文)
ISO9001供应商控制程序(中英文)
ISO9001供应商控制程序SUPPLIER Control PROCEDURE 1.Revision History 修订记录2.Purpose目的:2.1.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。
3.Scope范围:3.1.This procedure applies to all DXC suppliers.该程序适用于DXC公司所有供应商。
4.Reference Document参考文件4.1.Quality Manual 品质手册4.2.Purchasing Procedure 采购程序4.3.Incoming Quality Control Procedure进料品质控制程序4.4.IQC monthly report IQC月报4.5.Sourcing Procedure. 供应商开发程序5.Definition定义5.1.AVL– Approved supplier list 合格供应商清单5.2.CPAR –Corrective and preventive action request.纠正与预防措施申请5.3.P.O.–Purchase order.采购订单6.Responsibility职责：6.1.QA Department 品质部:6.1.1.R esponsible for the verification of the supplier’s qualitymanagement system, imposed requirement for the corrective and preventiveaction.负责确认供应商质量管理体系，纠正与预防措施的要求。
ISO9001程序文件-中英文+流程+对照表
ISO9001程序文件-中英文1.0目的：为确保质量管理体系持续有效运行，使其充分符合ISO9001：2000标准的要求，特制定本程序，以规定开展相应的审核活动，来评价本厂质量管理体系是否有效，是否需要采取纠正及预防措施。
Purpose: In order to ensure the effective and continuous implementation of the quality management, fully meet the requirements of ISO9001:2000 standard, specially make the procedure so as to implement audit action and verify the effectiveness of the quality management system and to take corrective or preventive action if needed.2.0 范围：本厂所开展的内部质量审核的全部活动均适用本程序。
Scope: applies to all the actions relating to internal quality audit.3.0 职责 Responsibility3.1 管理者代表：负责年度内审计划的拟定并计划组织实施。
Management Representative: responsible for the annual internal audit plan and its implementation.3.2 内审组长：负责制定审核日程并具体组织、指导内审作业。
Internal audit leader: responsible for making audi agenda and instructing audit.3.3 内审员：负责按审核计划要求对相关单位实施审核。
ISO13485设备控制程序(中英文)
xxxxxxxxxxxx有限公司质量管理体系管理性文件QUALITY SYSTEM PROCEDURE编制：日期：审核：日期：批准：日期：发放范围Distribution scope：局域网生效日期Effective on：2022年05月21日文件更改履历Document History Summary目录CONTENT序号名称页码Number Title Page 文件更改履历DOCUMENT HISTORY SUMMARY (1)1.目的PURPOSE (3)2.适用范围SCOPE (3)3.职责RESPONSIBILITIES (3)4．设备的控制THE EQUIPMENT CONTROL (4)5．相关文件RELEV ANT DOCUMENTS (12)6．记录RECORDS (12)1.目的Purpose加强设备管理，使其在合适的状态下工作，确保不影响产品质量。
The purpose this procedure is to strengthen the equipment management, making the equipment operate in an appropriate state and ensuring that the equipment will not have bad effect on the products.2.适用范围Scope本公司各种产品生产所涉及的全部设备及实验设备。
The procedure is applicable to all the company’s manufacturing equipment and R &D facilities.3.职责Responsibilities3.1设备管理组职责The responsibilities of the equipment management teams should include the following aspects:3.1.1负责制订全年的设备管理计划和目标，并组织实施管理Establish annual equipment management plans and objectives as well as organize and implement the management.3.1.2负责设备的状态进行分析，掌握设备技术状态Analyze and master the equipment technical state.3.1.3负责设备档案的汇集和设备台帐的建立.Take charge of collecting equipment files and establishing equipment list.3.1.4负责组织设备引进方案的调研、论证，统筹设备的选型、安装调试、维修保养、改进更新等Take charge of organizing the investigation and demonstration of the equipment introducing plan and coordinating the equipment type-selection, installation, maintenance, improvement, etc.3.1.5负责设备的改进, 验收.Improve and accept the equipment.3.1.6负责设备验证的IQ、OQ工作Take charge of IQ and OQ.3.1.7负责参与新设备的采购Engage in the purchasing of new equipment.3.2生产技术部职责The responsibilities of Manufacturing Techniques contain the following items.3.2.1负责新产品、新工艺相关的设备引进工作的规划方案的工艺评审工作和参数确认工作Process review and parameter confirmation of the introduction plan on the equipment related to new products and processes.3.2.2负责设备的PQ验证Equipment’s PQ.3.3采购部职责The responsibilities of Purchasing Department should cover the following aspects.3.3.1负责新设备的采购管理工作Take charge of the purchasing management of new equipment.3.3.2采购负责联系新购设备供应商进行调试并协助设备管理组进行保修服务Communicating with the supplier of the new-purchased equipment, optimize the equipment debugging and coordinate with the Equipment Management Teams to carry out the equipment warranty service.3.4QA部职责The responsibilities of QA include the following item.3.4.1负责设备验证的管理工作Manage the equipment validation.3.5设备使用部门职责The responsibilities of the departments that use the equipment are as follows.3.5.1负责本部门设备日常维护保养实施及配合进行定期保养工作Implement the daily maintenance of the equipment and cooperate with other departments to carry out the periodical maintenance3.5.2负责组织培训工作Organize relevant trainings4设备的控制The Equipment Control4.1设备管理计划和目标的制定和实施Establishing and implementing the equipment management plans and objectives每年初，设备管理组按前一年度的运营情况以及本年度规划，制订出“设备年度保养计划”，分解成每月的定期维护保养内容。
ISO14001文件管理与控制程序(中英文版)
文件管理与控制程序Docume nts man ageme nt and con trol procedure1. 目的Purpose确保环境管理体系文件、适用的外来文件(有关的法律、法规、标准、相关方提供的文件或规范)使用的有效性。
To assure the2. 适用范围scope适用于对环境管理体系相关文件及适用的外来文件的控制。
It is apply to theen vir onment man ageme nt system relati on docume nts and usable exter nal docume nts 'con trol.3. 职责Responsibility3.1环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。
The environment team: to man age and be in charge of en vir onment man ageme nt docume nts and exter nal docume nts.3.2各部门in dividual departme nt :确保各相关场所均使用现行文件的有效版本。
To en sure Therelative workplace is using the curre nt effective docume nts.4. 工作程序Work procedure4.1 文件控制范围包括：documents control ' s scopea) 环境管理手册；en vir onment man ageme nt manu al;b) 环境管理体系程序文件；en vir onment man ageme nt system procedure docume nts;c) 环境管理体系作业指导文件；the work in structio n docume nts for en vir onmentman ageme nt system;d) 环境记录表格；en vir onment record form;e) 夕卜来文件。
文件控制程序中英文对照
Revision HistoryApproved DCN on File in Document Control1.0 PURPOSE 目的1.1 To define a procedure for the generation, revision, handling, approval, retention, storage ofinternal documents as well as control of external documents.为内部文献的生成，修改，解决，同意，保存，保存以及对外部文献的控制订义程序。
2.0 SCOPE 范畴2.1 This procedure is applicable to quality management system (QMS) documentation such assystem manual, procedures & work instructions.本程序合用于质量管理体系（QMS）的系统文献，如体系手册，程序文献及作业指导书。
2.2 This procedure also covers the DCN & ECN generation and approval signatory for QMSdocumentation and product documentations.本程序还涉及质量管理体系文献和产品文献的文献变更告知（DCN）&工程变更告知（ECN）的生成和审批订立。
2.3 This procedure also covers control and handling of customer documents and otherregulatory requirements.本程序还涉及客户文献和其它法规规定的控制和解决。
2.4 This procedure also covers control and handling of supplier documents.本程序还涉及对供应商文献的控制和解决。
ISO17025：2017文件控制程序-英文版
General quality documents are documents defined for the general administrative and management system including Quality Manual (QM), Quality Procedure (QP), Work Instruction (WI) and Forms.
5 PROCEDURE
5.1 The Quality system staff prepares a draft of new or re-issued general quality document (hereafter referred to as “document”) as requested by the Quality Manager.
− Master Document Register
− Electronic document − Original document file − Document Review
Record
2 PURPOSE
The purpose of this procedure is to establish and maintain a system to control all general quality documents that relate to the management system of NIMT.
In case of a re-issued document, the designated personnel will receive an electronic file of original document from quality system staff. He/she shall have access to pertinent background information prior to instigating a change. For the QM, changes are made as the whole document while changes are made separately for each individual QP and the number of revision is changed accordingly. The altered or new text is marked in such a way to make the change observable.
文件和记录控制程序(中英文)
文件和记录控制程序1.0 目的 Purpose对与管理体系有关的文件、资料和记录(含电子版)进行控制，确保所有使用部门使用的文件和记录(含电子版)都有效。
Control over documents and materials related to management system so as to ensure that all the documents and materials and records (electronic)used by each department are current and valid. 2.0 范围Scope合用于所有与管理体系等有关的文件、资料和记录(含电子版)的控制。
Applicable to the control over documents and materials and records (electronic) related to management systems.3.0 职责 Responsibility3.1 管理者代表负责手册(质量手册、 EHS 手册)及程叙文件的批准。
Management Representative is responsible for the approval of manuals (quality manual,EHS manual) and procedure files.3.2 质量部经理负责质量手册、 EHS 手册的审核，程叙文件的复核。
QM is responsible for verification of quality manual, EHS manual , recheck procedure files.3.3 体系工程师负责质量手册、 EHS 手册的编制、更改和控制；程叙文件的编写和三级文件的审核。
ISO specialist is responsible for compilation, alternation and control of quality manual and EHS manual and procedure documents and review thesupportive documents.3.4 文控室负责检查文件编号、控制，外来文件的控制、管理。
ISO程序文件中英文版04设计和开发控制程序
1. 目的：对产品设计开发全过程进行控制，确保设计和开发的新产品满足规定的要求。
Purpose：Control the whole process of product design and development to ensure that the design and development of new product meet the stated requirements.2. 适用范围：适用于产品设计和开发的全过程。
Applicable Scope：Apply to the whole process of product design and development.3. 职责Responsibility：3.1董事总经理负责设计开发项目的立项、设计输入及试产交接会的组织和批准工作。
The Director General shall be responsible for approving the establishment of design and development project, design input and organizing the meeting for hand-over of pre-production .3.2技术总监领导负责产品的设计开发全过程的组织协调及审批工作。
The C.T.O will organize and coordinate the overall process of design and development of product, take charge of audit and approval as well.3.3项目工程师负责统筹产品的设计开发、型式试验及组织设计开发过程中产品的装配测试工作。
The project engineer shall be in charge of coordinating the design and development and type-test of product, organize the work related to assembly and test during the process of design and development.3.4 生产技术部负责配合执行产品测试及试验工作，组织产品试产，组织生产装配工艺文件和检验文件的编制及审核工作。
ISO文件控制程序（中英文）
ISO文件控制程序（中英文）ISO文件控制程序Document Control Procedure1.0目的Purpose:此文件的目的是按照ISO或其他适用的文件的要求建立一个控制所有文件的程序, 并且保证所有适用的文件的现行版本在使用中。
The purpose of this document is to have an established procedure to control all documents that are required as per ISO and other applicable systems. This procedure will also ensure that current versions of the applicable documents are available at the point of use.2.0范围Scope:适用于所有质量、环境健康与安全管理体系文件和技术文件以及有关的外来文件的控制。
This procedure is applicable to the control of documents and data related to QMS/EHS and external documents relating to products and environment.3.0定义Definition:3.1内部文件和资料：本公司ISO系统文件、资料、表格，它可以是以硬拷贝（指以纸张形式存在）和软拷贝(指以电子文档或各种光盘、软盘、录像带）形式存在。
Internal document and data: documents , data and forms of ISO managingsystem of our company. This could be in the form of hard copy (viz. paper)or in soft copy form (viz. electronic doc. floppy disk or video tape).3.2外来文件和资料：非本公司编制的文件，包括：国家标准、企业行业标准、与公司环境因素有关的法律法规及其他要求、与公司产品有关的法律法规及客户提供检验标准、产品图纸等。
ISO设计控制流程图英文版
Audit FindingsResponsibilities : Technical Director Associated Records : Job files, Specifications, Drawings, Quotes, Client approval evidence, Test/Inspections sheets, Delivery/Collection sheetsEnquiries & TendersArrange & meet with clientComplete Control PanelEnquiry SheetClient produces functionaldesign specificationClient confirms loads, motortypes & ratings Yes Does specification requireJHE assistance?NoJHE assists in completion of comprehensive specificationConfirmation:E-mail Signed approvalFaxScanJHE produces consultationdrawings, if requiredClient checks drawings &confirms loadsJHE select materialsComponentsContactorsOverloadsTerminalsCable sizes Approved Suppliers/SubcontractosObtain quote for materialsGo to next pageMay 2015Issue No: 1NoYesNo Audit FindingsResponsibilities : Technical DirectorSubmit quote (including JHEservices/materials) to clientAwait client purchase orderProduce drawings for approvalAwait client approval to build Confirmation: E-mailSigned approval FaxScanOrder materialsPurchasingBuild panel as per specifications & drawingsIs interim inspectionrequired?Inspection Ok? Make adjustments/reworkInstall back plate into enclosureGo to next pageYesMay 2015Issue No: 1NoYes YesYes NoNo NoYes Audit FindingsResponsibilities : Controls Engineers/Panel Shop Conduct final test andinspectionInspection Ok?Make adjustments/reworkIs software test of PLC &HMI applicable?Is client witness (F.A.T)requested?Arrange for client to attend witness testTest Ok?Discuss & agreeresolution with clientComplete test sheets.Client sign off (F.A.T)No Yes Does equipment requireCollection?Make arrangements for CollectionEnsure Delivery/Collection Slip iscompleted & signedEnsure Delivery/CollectionSlip is completed & signedwhen item is received bythe customerConduct software testNoYes Test Ok?Make adjustments/reworkMay 2015Issue No: 1。
ISO9001程序文件-中英文+流程+对照表
ISO9001程序文件-中英文1.0目的：为确保质量管理体系持续有效运行，使其充分符合ISO9001：2000标准的要求，特制定本程序，以规定开展相应的审核活动，来评价本厂质量管理体系是否有效，是否需要采取纠正及预防措施。
Purpose: In order to ensure the effective and continuous implementation of the quality management, fully meet the requirements of ISO9001:2000 standard, specially make the procedure so as to implement audit action and verify the effectiveness of the quality management system and to take corrective or preventive action if needed.2.0 范围：本厂所开展的内部质量审核的全部活动均适用本程序。
Scope: applies to all the actions relating to internal quality audit.3.0 职责Responsibility3.1 管理者代表：负责年度内审计划的拟定并计划组织实施。
Management Representative: responsible for the annual internal audit plan and its implementation.3.2 内审组长：负责制定审核日程并具体组织、指导内审作业。
Internal audit leader: responsible for making audi agenda and instructing audit. 3.3 内审员：负责按审核计划要求对相关单位实施审核。
ISO9001文件控制程序(中英文)
ISO9001文件管理程序Document Control Procedure文件更改历史记录Amendment History版次Revision更改日期Change Date更改概要Description of Changes更改人Prepared by批准人Approved byPrepared by编制Reviewed by审核Approved by批准ISO9001文件管理程序Document Control Procedure1.0 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 Scope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 bydepartment. Such as document control, management review, internalaudit 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。
ISO14001运行控制程序(中英文)
ISO14001运行控制程序Operational control procedure1.0Purpose目的:To use effective and efficient operational controls to manage the company’s significant environmental aspects ensure consistency with its environmental policy, achieve its objectives and targets and continual improvements of environmental performance.对与公司的重要环境因素有关的运行与活动进行有效控制，确保其符合环境方针、目标与指标的要求，以实现环境效绩的改进。
2.0Scope适用范围:It is applicable to operational controls to manage environmental aspects.适用于公司环境因素的运行控制。
3.0Responsibility 职责:3.1 FM is responsible to supervise the environmental impactoccurred by the new or improvement projects.设施管理部负责新上或改进工程项目的环境影响控制。
3.2 FM is responsible to maintain the environmental equipments.设施管理部负责环境设备的维护保养。
3.3 Warehouse is responsible to manage the chemicals storage inwarehouse and transportation inside factory, M is responsibleto control use of chemical on production line.仓库部门负责管理化学物品贮存和厂内运输，生产部门负责控制生产线化学品的使用。
ISO 中文和英文版
ISO9001：2000中英文对照Quality management systems — Requirements质量管理体系——要求1 Scope1 范围1.1 General1.1 总则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 product that meets customer and applicable regulatory requirements, and需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；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 regulatory requirements.通过体系的有效应用，包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求，旨在增进顾客满意。
NOTE In this International Standard, the term “product”applies only to the product intended for, or required by, a customer.注：在本标准中，术语“产品”仅适用于预期提供给顾客或顾客所要求的产品。
ISO9001程序文件-中英文
2.2Quality /Environment/Safety Policy and Objective质量环境职业健康与安全方针与目标 ........................................................................ 7
6.4 Work environment工作环境 ................................ 22
7.Product realization and operational control of environment and safety ... 23
产品实现与环境、职业健康与安全运行控制 .............. 23
7.6 Control of monitoring and measuring devices监视和测量设备的控制 ...... 27
8.Measurement, analysis and improvement测量、分析和改进 ............ 27
8.1 General总则 ............................................. 27
4.2Control of documents文件控制 ....................... 15
4.3Control of records记录控制 .......................... 16
5.Management responsibility管理职责 ........................... 16
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ISO文件控制程序
Document Control Procedure
1.0目的Purpose:
此文件的目的是按照ISO或其他适用的文件的要求建立一个控制所有文件的程序, 并且保证所有适用的文件的现行版本在使用中。
The purpose of this document is to have an established procedure to control all documents that are required as per ISO and other applicable systems. This procedure will also ensure that current versions of the applicable documents are available at the point of use.
2.0范围Scope:
适用于所有质量、环境健康与安全管理体系文件和技术文件以及有关的外来文件的控制。
This procedure is applicable to the control of documents and data related to QMS/EHS and external documents relating to products and environment.
3.0定义Definition:
3.1内部文件和资料：本公司ISO系统文件、资料、表格，它可以是以硬拷贝（指以纸
张形式存在）和软拷贝(指以电子文档或各种光盘、软盘、录像带）形式存在。
Internal document and data: documents , data and forms of ISO managing
system of our company. This could be in the form of hard copy (viz. paper)
or in soft copy form (viz. electronic doc. floppy disk or video tape).
3.2外来文件和资料：非本公司编制的文件，包括：国家标准、企业行业标准、与公司
环境因素有关的法律法规及其他要求、与公司产品有关的法律法规及客户提供检验
标准、产品图纸等。
它可以是硬拷贝和软拷贝形式存在。
External documents and data : not compiled by our company including national standard, enterprise standard , law and regulation and other
requirements related to our environmental aspects, law and regulation related to our products, test standard and product drawing provided by customers etc . They can be in hard copy or soft copy form.
3.3参考文件是指由DCC发出的仅供参考的文件。
Reference document refers to document is used for reference only and issued by DCC.
4.0职责和权限Responsibility and authority：
4.1品质部文控负责受控文件的编号、登记、分发, 过期、无效文件的回收, 正本的保
管及维护。
Quality Dept DCC is responsible for the document no. giving, registeration and release of controlled
documents, retrieveal of expired and non-effective documents and maintaining of original documents.
4.2文件使用部门负责本部门文件的保管与维护，包括记录。
Each dept. is responsible for keeping and maintaining of documents related to their own dept.
including records.
4.3项目部负责核查所使用的工程方面的行业标准等外来文件的有效性。
Project dept. is responsible for checking the validity of industry standards in engineering aspect.
4.4品质部负责核查所使用的品质/环境等方面的国际、国家标准等外来文件的有效性。
Quality dept is reponsible for checking effectiveness of the external documents from international and national standard on quality and environment etc.
5.0 程序Procedure:。