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
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进料检验作业指导书(中英文)
进料检验作业指导书Incoming_Inspection_Work_Instruction（ISO9001：2015）1.0Purpose目的The objective of this procedure is to define a standard inspection method in performing inspection and testing of components or materials.本程序目的在于定义对元件或材料进行检验/测试的标准操作方法。
Scope适用范围This procedure is applicable to all components and materials that require the relevant inspection and testing, as specified in the individual Part or Material Specification.本程序适用于所有按照元件和材料规格进行检验和测试的元件和材料。
2.0Sampling / Equipment Used 取样 / 使用设备2.1Per sampling plan stated in the Incoming Inspection Procedure: AQL：MA=0.4、MI=1.0按照来料检验程序所规定的抽样计划；AQL:MA=0.4、MI=1.0级别进行抽样.2.2Inspection Aids检验工具4.2.1 LCR Meter / LCR 测量仪4.2.2 Fluke Multimeter / Fluke 万用表4.2.3 Caliper / Plug Gauge / Pin Gauge / 游标卡尺/ 塞规/针规4.2.4 Magnifier / Microscope / 放大镜 / 显微镜3.0Reference Documents参考文件3.1 Customer’s AVL / 客户接受的供应商清单3.2 Manufacturer Part Specification / 供应商的元件规格3.3 Yamaoka AVL List / 本公司的AVL3.4 QAP-010 : Incoming Inspection Procedure / 来料检验程序3.5 SOP-QA-003 : Material Aging Control Procedure / 物料保质期控制程序4.0Inspection Criteria / 检验要点4.1MFG AVL Verification / 生产厂商确认Verify that the parts are from the authorized vendor per AVL list.根据AVL清单验证元件是否为承认厂商。
ISO9001：2015仪器设备校准程序英文版
Rev. [Rev Number]Procedure: [Calibration Proc. Title]1.0 SUMMARY1.1.The purpose of this procedure is to define the requirements for calibration or verification of equipme nt used to determ inethe acceptability of product.1.2.Typically, this is limited to inspection or test equipment used to “ buyoff "product prior to movement to a subsequentprocess or prior to final delivery. However, at the discretion of management, calibration or verification may also be appliedto critical process equipment.1.3.The [who?] is resp on sible for impleme ntati on and man ageme nt of this procedure.2.0 REVISION AND APPROVAL3.0 PROCEDURE: CALIBRATION3.1.Devices subject to calibration shall be calibrated by an approved outside service provider, or by trained [Short Clie ntName] employees.3.2.Third party calibration laboratories should be accredited to ISO 17025 whenever possible, as this provides the best controlof calibration activities, and traceability to national standards.3.3.When employees perform in-house calibration, this shall be performed in accordanee with docume nted procedures for each typeof calibrati on performed.3.4.Traceability to the national standards will be maintained for all devices where such traceability is possible by the curre ntstate of the art.3.5.Approved calibration service providers must maintain suitable environmental conditions for calibration, and reporttemperature and relative humidity on any calibration test certificates or other calibration documentation. For in-housecalibration, the [who?] will ensure suitable en vir onmen tal con diti ons for calibrati on.3.6.The Calibrati on Log [ ren ame if n ecessary] will be mai ntai ned by the [who?]. This docume ntwill list all devices, their serial number, date of last calibration, and next scheduled calibration date. The freque ncy ofcalibrati on for each device shall be adjusted based on the history of the device and its impact on product quality. NOTE:third party calibration providers may not establish calibrati on freque ncies; this must be determ ined by [Short Clie ntName].3.7.For tools calibrated by third party laboratories, these shall be returned with a certificate of calibration showing thestatus of the calibration, as well as the condition the equipment wasfound in (e.g., “ defective, " “ out of toleranee " , “ in toleranee " , etc.) Such cRev. [Rev Number]the identification of any standards used by the calibration house, and their serial numbers, allowing for traceability to NIST.For tools calibrated in-house by [Short Clie nt Name] staff, the results and sta ndards used shall be recorded on the Calibration Record and shall in clude any sta ndards an d/or procedures uses. Calibrated devices will be identified with a calibration sticker that includes the current calibration 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 be numbered and the [who?] shall keepa log of those devices and their status. Employees may only use devices for accepta nee testi ng that are curre nt on calibrati on.Employees shall submit expired tools to [who?] for recalibration, and/or the [who?] shall positively recall such expired tools for recalibrati on.Devices in use for non critical measureme nts are to be marked REFERENCE ONLY. [ this may not be possible for all compa nieswith large amounts of non critical tools. Con sider a differe nt approach in such cases.]Any device faili ng to meet calibrati on sta ndards will immediately be take n out of service. The device may the n bedestroyed or sent out for repair. Repaired devices must be calibrated before being returned to service.When a measuring device is found to be out of toleranee, and/or reported on the calibration” or y “houtlhjfdoleayiceovider,"the [who?] shall be notified immediately. The [who?] or designate shall oversee a study todeterm ine the impact of the out-of-tolera nee device on product shipped; if deemed n ecessary, arecall may be initiated. The customer possessing the material in question is immediately notified of the problem. This studyand the results shall be recorded and placed in the calibration file.Measuring & monitoring devices must be stored and handled in a manner that does not in validate their calibrati on or ability tofun ctio n without error.4.0 VERIFICATION4.1. Where a device cannot be calibrated against traceable standards, it must be verified against some known-good object ormethod. This may be done by compari ng the part aga inst ano ther part or tool which has bee n evaluated and validated and prove n as acceptable.4.2.Known-good objects must be protected so their status is not altered, either by physical damage or deteriorati on. 4.3.Known-good methods must be docume nted in procedures, with a rati on ale for their acceptability being docume nted. 4.4. 3.8. 3.9. 3.10.3.11. 3.12.3.13. 3.14. 3.15. product ion capacity purposes.[Oxebridge recomme nds aga inst this practice, and recomme nds deleti ng this paragraph en tirely.]certificate of hav ing bee n found as defective An “ amn estyw indow ” of 2 weeks [ adjust accord in gly] is allowed bey ond the due date marked on the device,to accommodate arrangement of calibration or verification, or for。
ISO9001最终检验程序(中英文)
ISO9001产品终检程序Final Inspection Procedure文件更改历史记录Amendment HistoryFinal Inspection Procedure产品终检程序1.0目的/Purpose:1.1确保入仓产品之质量以及送给客户前的产品质量符合客户要求。
To ensure productquality meet customer’s requirements prior to enter into warehouse anddeliver to customer.1.2根据最终检验记录分析，提供给生产部和工程部，作为产品质量改进的方向。
Provide final inspection and analysis record to Production Dept andManufacturing Engineering Dept. as an orientation for quality improvement.2.0适用范围Scope:适用于DXC公司终检检验.Apply to final inspection in DXC.3.0定义Definitions:N/A4.0职责Responsibility:4.1QC主管/QE负责对检验结果予以审批。
QC supervisor / QE is responsible forconfirmation of inspection results.4.2FQC组长负责复核检验结果。
FQC leader is responsible for review of inspectionresults.4.3FQC负责对产品进行最终检验，当被检的产品被判为不合格时，FQC有权将不合格产品退回生产部，并要求责任部门的主管﹑组长作出相应的改善，直至结果获得满意为止。
FQC is responsible for the final inspection to the plastic product.If the inspected product is rejected, FQC is authorized to return the rejected parts to the relevant workshop and advise the relevant supervisor and leader make improvement until OK.。
ISO9001不合格品控制程序(中英文)
ISO9001不合格品控制程序Control of Nonconforming Product 1.Revision History 修改记录2. purpose目的为有效地杜绝不合格的物料、半成品及成品的误用、流出; 并对其予以恰当处理.To avoid nonconforming materials, semi-finished products and finished products from misuse and Outflow, and dispose them properly.3. scope范围适用于不同阶段的产品及物料：如进料、制程、成品、库存及客户退货.Applicable for material and products in different level: Incoming, process, finished goods, stock and customer returns.4. Reference Document参考文件4.1《MRB运作程序》 MRB operation procedure4.2《记录管理程序》 Record control procedure4.3《进料品质控制程序》 Incoming quality control procedure4.4《过程质量控制程序》 Process quality control procedure4.5《出货质量控制程序》 Outgoing quality control procedure4.6《纠正与预防措施管理程序》 Corrective and preventive action managementprocedure4.7《产品标识及追溯性管理程序》Product identification and traceabilitymanagement procedure5. Definition定义5.1 合格：满足要求.Conforming: Satisfy the requirement5.2 不合格：未满足要求.Nonconforming: Disatisfy the rewuirement.6. Responsibility职责6.1 品质部：负责对不合格原料及成品的检验判定及标识。
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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:。