ISO9001出货检验程序(中英文)
ISO9001：2015仪器设备校准程序英文版
Procedure: [Calibration Proc. Title]1.0SUMMARY1.1.The purpose of this procedure is to define the requirements for calibration or verification ofequipment used to determine the acceptability of product.1.2.Typically, this is limited to inspection or test equipment used to “buy off” product prior tomovement to a subsequent process or prior to final delivery. However, at the discretion ofmanagement, calibration or verification may also be applied to critical process equipment.1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVAL3.0PROCEDURE: CALIBRATION3.1.Devices subject to calibration shall be calibrated by an approved outside service provider, or bytrained [Short Client Name] employees.3.2.Third party calibration laboratories should be accredited to ISO 17025 whenever possible, as thisprovides the best control of calibration activities, and traceability to national standards.3.3.When employees perform in-house calibration, this shall be performed in accordance withdocumented procedures for each type of calibration performed.3.4.Traceability to the national standards will be maintained for all devices where such traceability ispossible by the current state of the art.3.5.Approved calibration service providers must maintain suitable environmental conditions forcalibration, and report temperature and relative humidity on any calibration test certificates orother calibration documentation. For in-house calibration, the [who?] will ensure suitableenvironmental conditions for calibration.3.6.The Calibration Log [ rename if necessary] will be maintained by the [who?]. This documentwill list all devices, their serial number, date of last calibration, and next scheduled calibrationdate. The frequency of calibration for each device shall be adjusted based on the history of thedevice and its impact on product quality. NOTE: third party calibration providers may notestablish calibration frequencies; this must be determined by [Short Client Name].3.7.For tools calibrated by third party laboratories, these shall be returned with a certificate ofcalibration showing the status of the calibration, as well as the condition the equipment wasfound in (e.g., “defective,” “out of tolerance”, “in tolerance”, etc.) Such certificates must havethe identification of any standards used by the calibration house, and their serial numbers,allowing for traceability to NIST.3.8.For tools calibrated in-house by [Short Client Name] staff, the results and standards used shallbe recorded on the Calibration Record and shall include any standards and/or procedures uses.3.9.Calibrated devices will be identified with a calibration sticker that includes the currentcalibration status, calibration due date, and device identification number. Where the devicecannot accommodate a calibration sticker due to size or frequency of use, the device shall benumbered and the [who?] shall keep a log of those devices and their status. Employees mayonly use devices for acceptance testing that are current on calibration.3.10.Employees shall submit expired tools to [who?] for recalibration, and/or the [who?] shallpositively recall such expired tools for recalibration.3.11.An “amnesty window” of 2 weeks [←adjust accordingly] is allowed beyond the due datemarked on the device, to accommodate arrangement of calibration or verification, or forproduction capacity purposes. [Oxebridge recommends against this practice, and recommendsdeleting this paragraph entirely.]3.12.Devices in use for noncritical measurements are to be marked REFERENCE ONLY. [← this maynot be possible for all companies with large amounts of noncritical tools. Consider a differentapproach in such cases.]3.13.Any device failing to meet calibration standards will immediately be taken out of service. Thedevice may then be destroyed or sent out for repair. Repaired devices must be calibrated beforebeing returned to service.3.14.When a measuring device is found to be out of tolerance, and/or reported on the calibrationcertificate of having been found as “defective” or “out of tolerance” b y the third-party provider,the [who?] shall be notified immediately. The [who?] or designate shall oversee a study todetermine the impact of the out-of-tolerance device on product shipped; if deemed necessary, arecall may be initiated. The customer possessing the material in question is immediately notifiedof the problem. This study and the results shall be recorded and placed in the calibration file.3.15.Measuring & monitoring devices must be stored and handled in a manner that does notinvalidate their calibration or ability to function without error.4.0VERIFICATION4.1.Where a device cannot be calibrated against traceable standards, it must be verified againstsome known-good object or method. This may be done by comparing the part against anotherpart or tool which has been evaluated and validated and proven as acceptable.4.2.Known-good objects must be protected so their status is not altered, either by physical damageor deterioration.4.3.Known-good methods must be documented in procedures, with a rationale for theiracceptability being documented.4.4.。
ISO9001出货检验程序(中英文)
ISO9001出货检验程序Out-going Inspection Product 文件更改历史记录Amendment HistoryISO9001出货检验程序Out-going Inspection Product一、目的Purpose:規定出貨檢查工作在有效受控下進行。
To ensure that out-going inspection is performed under effective control.二、適用範圍說明Scope:一般情況下，本公司产品终检后不再做出貨檢查：但在以下四种情況任一種出現時，必須進行出貨檢查。
對于特別的部品(如尼龙用料部品)在某种情況必需做出貨檢查的，由项目部、QC部门等相關人員共同确定。
Generally, no need out-going inspection after final inspection. But in any one of the following situations, out-going inspection is necessary.Related personnel in Program Dept and QC section are responsible for determining whichparts need to do out-going inspection.1.產品庫存期超過6個月(若FQC当月已对待出货产品进行了仓贮品质评估，可根据其《仓库物资评估报告》QF-PW-009的结果进行，反之，则必须做出货检查)。
Stored more than 6 months (If the waiting-for-delivery product has been assessed byFQC in the same month, then FQC conduct in accordance with the result of thecorresponding <<Material/product assessment report>> QF-PW-009, otherwise it is amust for FQC to perform out-going inspection.)2.因受外界環境的影響發生异常，影響到產品質量Product quality is effected by thechanging of environment;3.包材被損坏.Damage of package;4.出貨海外（包括香港）或客户指定产品。
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。
ISO9001-2015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。
ISO9001标志和可追溯性程序（中英文）
ISO9001标志和可追溯性程序（中英文）ISO9001产品标识和追溯程序Product Identification and Trace-ability文件更改历史记录Amendment HistoryISO9001产品标识和追溯程序Product Identification and Trace-ability1.0目的 Purpose:生产物料、产品施以明确的标记，以识别质量状态，产品种类，并反映某一箱或某一批产品的历史，以对质量问题及原因、责任等进行追溯，需要时追回不合格的产品。
Make clear identification to allincoming materials and product manufactured by DXC to identify their status of quality and specifications, to reflect the history of a certain carton or a certain batch of production so that trace the problem and its cause, responsibility and collect the rejected product if required.2.0范围Scope:所有生产的塑料产品于来料、生产过程、储存、检查和交付的各阶段，如果客户有特别的要求，则按客户的要求进行标识。
Apply to all injection molding plastics product, incoming material, product in process, storage, inspected and delivery stages. Make identification in accordance with customer if customer have special requirement.3.0定义Definitions:3.1DXC: 的简称。
ISO9001-2015物料免检程序(中英文)
物料免检程序Material STS Procedure（ISO9001：2015）1.Purpose 目的Establish this procedure to define the qualification criteria of STS material, to define the operation procedure for STS materials, to enhance IQC work efficiency of inspection.Note: This procedure can’t as the supplier’s excuse who wants to relax or exempt the quality liability for their products.建立免检物料的评价标准，规范免检物料的操作流程，提高IQC的检验效率。
注：本程序的建立和执行旨在提高IQC的检验效率，鼓励供应商持续高品质的为我司供货，但并不作为供应商对其产品质量责任豁免的依据。
2.Scope 适用范围This procedure applied for all production materials which in mass purchasing stage, but not include critical part, subcontract part, customer’s part or customer have special request.适用于本公司量产采购阶段所有的生产性物料，但关键元器件、外协加工件、客供料或客户有特别要求的物料除外。
3.Definition 定义3.1 STS Ship To Store / 直接入仓，即物料免检3.2 RDS Request of Disqualify STS / 物料免检资格取消申请4.Responsibility 职责SQE 供应商品质工程师Drive supplier to improve the quality performance to get STS certification for their product;推动供应商进行品质改善，以促其产品达到STS状态；Review the <STS Material Application List>;《STS物料评审表》的复审；IQE 来料品质工程师Prepare and update the <STS Material Application List>, and submit to SQE to review and submit to quality manager for approval;制备和更新《STS物料评审表》，提交SQE复审以及品质经理批准；Release RDS, to disqualify the STS material;发出RDS，以取消物料的STS资格；Update ERP system data about the material inspection type;更新ERP系统物料检验模式信息；IQC 进料检验组Inspect and mark the STS materials base on ERP system information; 根据ERP系统信息检验和标识STS物料5.Procedure 工作程序5.1 The qualification criteria of STS material / STS物料评定标准The materials may apply to STS if all conditions in below are achieved: 符合下述全部条件的物料，可以申请成为STS物料：a.Continual pass 10 lots by IQC, without any abnormal case or reject; 连续10批IQC检验无异常、无退货；b.The material DPPM in process under the control limit last for 3 month: 在我司生产制程中，该物料连续三个月DPPM达成下述指标：Electrical part and active optical part / 电子物料及有源光器件：100DPPM Mechanical part / 结构件：500DPPMPassive optical part / 无源光器件：500DPPMPCB / 印刷电路板：500DPPMPacking materials / 包材：1000DPPMComments / 注：The total incoming qty and consumed qty should more than 30kpcs.来料总数量和我司使用的总数量须在30K以上。
ISO9001程序文件中英文(DOC 39页)
5.5.1Responsibility, authority职责与权限 ..................... 19
2.3XXXManagement 埃孚组织架构.................................. 8
2.4Quality Environment Occupational Health and Safety Responsibility Distribution Matrix质量环境职业健康与安全管理职能分配表........................... 9
5.5.2Management representative管理者代表............................... 19
5.5.3Communication, participation and consultation信息沟通、参与和协商......... 19
5.6Management review管理评审 ............................ 20
4.Quality, Environment and Safety Management System质量环境安全管理体系 .............................................. 14
4.1General requirementБайду номын сангаас总要求 ......................... 14
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ISO9001出货检验程序
Out-going Inspection Product 文件更改历史记录
Amendment History
ISO9001出货检验程序
Out-going Inspection Product
一、目的Purpose:
規定出貨檢查工作在有效受控下進行。
To ensure that out-going inspection is performed under effective control.
二、適用範圍說明Scope:
一般情況下，本公司产品终检后不再做出貨檢查：但在以下四种情況任一種出現時，必須進行出貨檢查。
對于特別的部品(如尼龙用料部品)在某种情況必需做出貨檢查的，由项目部、QC部门等相關人員共同确定。
Generally, no need out-going inspection after final inspection. But in any one of the following situations, out-going inspection is necessary.
Related personnel in Program Dept and QC section are responsible for determining which
parts need to do out-going inspection.
1.產品庫存期超過6個月(若FQC当月已对待出货产品进行了仓贮品质评估，可根
据其《仓库物资评估报告》QF-PW-009的结果进行，反之，则必须做出货检查)。
Stored more than 6 months (If the waiting-for-delivery product has been assessed by
FQC in the same month, then FQC conduct in accordance with the result of the
corresponding <<Material/product assessment report>> QF-PW-009, otherwise it is a
must for FQC to perform out-going inspection.)
2.因受外界環境的影響發生异常，影響到產品質量Product quality is effected by the
changing of environment;
3.包材被損坏.Damage of package;
4.出貨海外（包括香港）或客户指定产品。
Oversea delivery(including H.K.) or customer
appointed products.
三、執行單位Performer:
FQC科、貨倉部、船务部、PMC 。
FQC section, Storage dept, Shipping dept, PMC。
四、程序Procedure:。