ISO9001-2015不合格品处理程序(中英文)

ISO/DIS 9001:2015质量管理体系—要求　Quality management system—Requirements目录　0 引言 (04)0.1 总则 (04)0.2 ISO标准的质量管理 (04)0.3 过程方法 (05)0.4 PDCA 循环 (06)0.5 基于风险的思维 (06)0.6 与其他管理体系标准的相容性 (06)1 范围 (08)2 规范性引用文件 (08)3 术语和定义 (08)4 组织的背景 (20)4.1 理解组织及其背景 (20)4.2 理解利益相关方的需求和期望 (20)4.3 确定质量管理体系的范围 (20)4.4 质量管理体系及其过程 (21)5 领导 (21)5.1 领导和承诺 (21)5.1.1 领导和质量管理体系承诺 (21)5.1.2 以顾客为关注焦点 (21)5.2 质量方针 (22)5.3 组织角色、职责和权限 (22)6 质量管理体系策划 (22)6.1 应对风险和机遇的措施 (22)6.2 质量目标及其实现策划 (23)6.3 变更策划 (23)7 支持 (23)7.1 资源 (23)7.1.1 总则 (23)7.1.2 人 (24)7.1.3 基础设施 (24)7.1.4 过程作业环境 (24)7.1.5 监视和测量资源 (24)7.1.6 组织的知识 (25)7.3 意识 (25)7.4 沟通..................................................... .................. .. (25)7.5 文件信息................................................... .................. (25)7.5.1 总则 (25)7.5.2 创建和更新............................................................... (26)7.5.3 文件信息控制....................................................... (26)8 运作........................................................................ . (26)8.1 运作策划和控制......................... .................. .. (26)8.2 产品和服务要求的确定 (27)8.2.1 顾客沟通............................................................... .. (27)8.2.2 与产品和服务有关的要求的确定................................... (27)8.2.3 与产品和服务有关的要求的评审 (27)8.3 产品和服务的设计与开发............................. .................. .. (27)8.3.1 总则 (27)8.3.2 设计和开发策划....................................... .. (28)8.3.3 设计和开发输入 (28)8.3.4 设计和开发控制 (28)8.3.5 设计和开发输出 (28)8.3.6 设计和开发变更 (29)8.4 外部供应产品和服务的控制 (29)8.4.1 总则 (29)8.4.2 外部供应的控制类型和程度 (29)8.4.3 外部供应商的信息 (29)8.5 产品和服务提供 (30)8.5.1 产品和服务提供的控制 (30)8.5.2 标识和可追溯性 (30)8.5.3 属于顾客或外部供应商的财产 (30)8.5.4 防护 (30)8.5.5 交付后活动 (30)8.5.6 变更控制 (31)8.6 产品和服务的放行 (31)8.7 不合格过程输出、产品和服务的控制 (31)9 绩效评价 (31)9.1 监视、测量、分析和评价 (31)9.1.2 顾客满意 (32)9.1.3 分析和评价 (32)9.2 内部审核 (32)9.3 管理评审 (33)10 改进 (33)10.1 总则 (33)10.2 不合格和纠正措施 (34)10.3 持续改进 (34)附录A（规范性附录）新结构、术语和概念的说明（省略） (35)附录B（规范性附录）质量管理原则（省略） (35)附录C（规范性附录）ISO10000 质量管理标准组合（略） (35)参考文献（省略） (35)0 引言　0.1 总则采用质量管理体系应该是组织的一项战略性决策。

ISO9001:2015质量管理体系要求原文翻译完全版1 范围本标准为有下列需求的组织规定了质量管理体系要求：a）需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力；b）通过体系的的有效应用，包括体系持续改进的过程，以及保证符合顾客和适用的法律法规要求，旨在增强顾客满意。

注 1：在本标准一中，术语“产品”仅适用于：预期提供给顾客或顾客所要求的商品和服务；注 2：法律法规要求可称作为法定要求。

2 规范性引用文件下列文件中的条款通过本标准的引用而构成本标准的条款。

凡是注日期的引用文件，只有引用的版本适用。

凡是不注日期的引用文件，其最新版本（包括任何修订）适用于本标准。

ISO9000：2015 质量管理体系-基础和术语3 术语和定义本标准采用ISO9000：2015 中所确立的术语和定义。

4 组织的背景环境4.1 理解组织及其背景环境组织应确定哪些与其宗旨和战略方向有关且影响质量管理体系实现其预期结果的能力的外部和内部情况。

组织应监视和评审这外部和内部情况的信息。

注 1：事宜可能是正面和负面的因素或要考虑的情况注 2：理解外部的环境，可以通过考虑源于国际、国家、地区的或本地的法律法规、技术、竞争、市场、文化、社会和经济环境的情况，促进对外部情境的了解。

注3：理解组织内部环境，可以通过考虑与价值、文化、知识和组织绩效有关的情况，促进对内部情境的了解。

4.2 理解相关方的需求和期望：出于对组织持续地提供满足顾客和适用法律法规要求的产品和服务的能力的影响或潜在影响，组织应确定：a）与质量管理体系有关的相关方；b）与质量管理体系有关的相关方的要求。

组织应监视和评审有关相关方及其有关要求的信息。

4.3 确定质量管理体系的范围组织应界定质量管理体系的边界和应用，以确定其范围。

在确定此范围时，组织应考虑：a）标准 4.1 条款中提到的内部和外部情况；b）标准 4.2 条款中涉及的有关相关方的要求；c）组织的产品和服务。

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。

进料检验不合格品处理程序（ISO9001：2015）1目的制定组件进料检验发现的不合格品的处理办法，确保材料出现不合格时能有效及时的处理。

2范围本办法适用于公司IQC检验范围内所有不合格物料的处理。

3相关文件3.1不合格品控制程序4定义4.1不合格品：所有来料检验发现的不符合质量标准的原物料。

4.2退/换货：将不合格物料全部退回供应商或部分与供应商更换。

4.3特采：不合格物料因客户、生产需求急迫，客户或销售部代表客户同意授权，或投入后不影响产品功能、构造机能、特殊外观要求及应用功能性，不造成人身安全，可满足最终客户使用品质的不合格品做特殊接收的状态，等同让步接收。

4.4厂内挑选：经过协商，由公司相关部门代为厂商全检不合格品，挑选合格品投入生产，不合格品由采购部负责办理退/换货，并由厂商赔偿工时损失。

4.5供应商挑选：由供应商负责按照我司要求对不合格品进行全检（可派人员来我司进行挑选等）。

5职责5.1质量部（IQC）：物料的检验及物料不合格的及时反馈。

5.2质量部（PQC）：针对特采物料上线使用情况进行跟踪及数据统计。

5.3SQE：不合格物料的评审，联系供应商对已发现的不合格物料进行确认及推动改善。

5.4采购部：不合格物料的评审，联系供应商对不合格物料进行处理。

5.5PMC：物料安全库存的确认；及特采物料上线使用前的信息发布。

5.6工程部：负责对材料的安全性、功能性使用的影响进行评审判定，必要时实施相关实验。

5.7生产部：不合格物料的评审，在线不合格物料的及时提报，配合做好厂内挑选工作，确保合格品投入生产。

5.8仓库：不合格物料的分类存放。

5.9质量部：负责对不合格材料作出最终判定；6环境满足客户要求，符合行业标准7职业健康安全满足客户要求，符合行业标准8管理内容8.1特采原则8.1.1对产品的使用，确定安全性、公害性及功能性的顾虑原则，不致产生客户抱怨事件发生时。

8.1.2对产品功能及产品价值的影响很微小时。

ISO9001-2015客户退货处理程序（中英⽂）客户退货处理程序Customer Returned Product Handling（ISO9001：2015）1.0⽬的Purpose:对客户退货有效控制，并正确处理，为改善措施提供分析资源，⽤以指导⽣产。

To provide a system, handle customer returned products including the authorization, transfer and replacement, and find the root cause, to support thorough improvement action then get smooth process.2.0范围Scope：客户退货Customer returned goods3.0定义Definition3.1RMA: RMA is short for Return Material Authorization. 客户退货批准书3.2批退：指客户IQC检验不合格后，需整批⼀次退货量。

Returned batchsize: Means the quantity of once returned products from a customer IQC inspection non-conformity.3.3PM：Program Manager 项⽬经理3.4PA：Program Assistant 项⽬助理3.5QE：Quality Engineer 品质⼯程师3.6FQC： Final Quality Control终检3.7QD：Quality Department品管部3.8ME：Manufacturing Engineer制程⼯程师3.9ISF: Inventory Scrap Form. The form no is QF-PM-016. 报废单，表格编号为：QF-PM-0163.10RMA Area：Customer Return Area which is designated to place allcustomer returned products.客户退货区，专门⽤于存放客户退货。

ISO9001:2015一整套程序文件-英文版Procedure: [Change Mgmt Doc Title]1.0SUMMARY1.1.The purpose of this procedure is to define the methods for managing changes to processes andother aspects of the management system in a controlled manner.1.2.Where this document discusses changes to processes, this shall be understood to mean the top-level processes identified in the [Quality Manual Doc Title].1.3.The [who?] is responsible for implementation and management of this procedure.2.0REVISION AND APPROVAL3.0CHANGES TO PROCESSES3.1.Management system processes will undergo changes, typically when:3.1.1.Improvement opportunities have been identified, typically to improve processeffectiveness3.1.2.Nonconformities within a process are identified and require corrective action3.1.3.Conditions in the industry or company change, requiring a process to be updated3.1.4.New processes are added which impact on existing processes, requiring changes3.1.5.Customer requirements result in a need to change processes3.1.6.Any other reason determined by management3.2.In such cases, the process must be changed in a controlled manner to ensure properauthorization and implementation of the changes.3.3.At a minimum, process changes shall include the steps herein:3.3.1.The request for a process change shall be documented, typically in a [CAR Form Name]per the procedure [Corrective Preventive Action Proc. Title]. The justification for thechange shall be recorded.3.3.2.The change shall be reviewed by appropriate management, including the senior mostmanager responsible for the process. Changes must be approved prior toimplementation.3.3.3.The appropriate [Process Definition Doc Title] will be updated to reflect the change.This document will undergo review and approval per the procedure [Control ofDocuments Proc. Title]. The revision indicator of the [Process Definition Doc Title]will be incremented, and the nature of the change recorded. [ Delete last sentenceif you are not using Process Definition documents.]3.3.4.The follow-up verification step of the [CAR Form Name] process shall seek to ensurethe change has had the intended effect, and/or has improved the process. If not, thechange may be rolled back or a new change made to correct any new issues that ariseas a result of the change.4.0CHANGES TO DOCUMENTATION4.1.Management system documents undergo changes when there is a need to revise them.4.2.Changes to documentation are done in accordance with the procedure [Control of DocumentsProc. Title].5.0CHANGES TO ORDERS OR CONTRACTS5.1.Changes to active orders or contracts may occur when the customer changes the requirementsafter the work has begun, or may be initiated by [Short Client Name] when unforeseencircumstances are encountered.5.2.Changes to orders or contracts are done in accordance with the procedure [Quoting and OrdersDoc Title].Procedure: [Identification & Traceability Proc. Title]1. SUMMARY1.1. This procedure defines the methods used to identify and (where applicable) provide uniquetraceability for [Short Client Name] products. This procedure includes methods:1.1.1. To define the methods for identifying products (what they are)1.1.2. To define the methods for identifying products as to their current inspection or teststatus1.1.3. To define the methods for segregating and discriminating between product andtooling when their appearance is similar1.1.4. To define the methods for providing traceability, including unique serialization, orproduct as applicable1.2. The [who?] is responsible for implementation and management of this procedure.2. REVISION AND APPROVAL3. APPLICATION3.1. This procedure applies to all departments which use, handle, transport, store, inspect ormanufacture product, raw materials and tooling, at all [Short Client Name] facilities.3.2. This procedure not only applies to typical product, but also deliverables from services, such asreports, schedules, etc.3.3. Non-critical materials or supplies, which are not incorporated into final product or which serveonly to support facilities or operations, are not subject to this procedure.4. DEFINITIONS4.1. Product4.1.1. “Product” includes any of the following:∙Any part, assembly or item ordered by the customer∙Deliverable reports or documents∙Product may refer to finished product, or work in process (WIP)4.2. Raw Materials4.2.1. “Raw materials” include any of the following:∙Any materials or items (metals, plastics, components, pre-built assemblies, small parts) which become part of the finished product’s physical construction; some ofthese items may sometimes be referred to as “consumables”.∙Coatings, paint, plating, adhesives, chemicals or materials which will be incorporated into (or onto) the final product.4.3. Tooling4.3.1. “Tooling” can include any of the following:∙Devices used by manufacturing for setup or production, including fixtures and jigs.∙Devices used by inspection for determining acceptance of product, including test fixtures.∙Shop aids, which are simple devices (blocks, spacers, shapes) used to assist in production or development, but which are not precision tools and which can be usedfor a variety of applications.4.3.2. Tooling does not include:∙Cutting tools, drill bits, etc.∙Hand tools∙Machining equipment5. PRODUCT5.1. There are many ways to identify product; this procedure presents the most typical, acceptablemethods. Additional product identification methods may be called out in the design orproduction documentation.5.2. Identification typically includes the part number, revision, Work Order # and unique serialnumber (if applicable).5.3. Identification is done through any of the following methods:5.3.1. Part marking, by way of ink marking, etching or some other method.5.3.2. Bag-and-tag methods, especially for small parts.5.3.3. Placement of parts on shelves or in containers that are properly marked, withsignage or other methods.5.3.4. Placement of parts near associated paperwork, for the purpose of identification andtraceability, may be used if the paperwork can clearly be identified as relating to theparts in question, typically by way of the inclusion of a drawing which can becompared to the product.5.3.5. Segregating entire areas of the production floor with belt stanchions and attachedsignage, indicating what type of items are allowed, or disallowed, within theenclosed area.5.4. Where unique serialization is required for traceability, the parts shall be identified with a serialnumber in accordance with customer requirements, or in a manner developed to ensure that no two parts are given the same number. Serial number logs may be used to control this; workorders shall reference the serial numbers under which the unique parts were built.5.5. All product may be assumed to be inspected and/or tested and found to be acceptable for useif identified in accordance with the rules above, unless it is marked as nonconforming product.For the methods of identifying nonconforming product, see procedure [Control of NCP Proc.Title].6. RAW MATERIALS6.1. Raw materials requiring traceability back to heat lot numbers, manufacturer lot or batchnumbers, certificates of conformity or analysis, etc., must be marked in a way that provides this traceability. This is typically done by marking the raw materials with the [Short Client Name]purchase order number under which the items were purchased, and the supplier’s lot number.6.2. When raw materials are used, any remaining material that will be returned to stock and used inthe future must be re-identified before re-entry into inventory.6.3. Raw materials which are determined to require identification and traceability, but which lacksuch identification, may not be used for flight hardware. These may be used for tooling stock or other non-product purposes.6.4. All raw materials may be assumed to be inspected and/or tested and found to be acceptable foruse if identified in accordance with the rules above, unless it is marked as nonconforming. For the methods of identifying nonconforming raw materials, see procedure [Control of NCP Proc.Title].7. PRODUCTION TOOLING7.1. Tooling used for production (fixtures, molds, jigs, setup devices, product supports or stands,etc.) shall be designed and built according to engineering data, and then validated to ensurethe tool performs the intended function without risk or harm to product. Validation of tooling istypically done by using the tooling and inspecting the resulting parts to ensure the toolingresults in parts that meet dimensional or other requirements.7.2. Once validated and approved for use, the tool will be marked with a tooling ID number, which istypically the part number for which the tool is to be used.7.3. Tools that produce production hardware or are used to accept hardware must undergoinspection before release. [QC or QA Preferred Term] must stamp or mark the tool as accepted before it can be used.7.4. Shop aids for setup of production operations, supporting a part temporarily, or other simple ortemporary use, may not require identification with a unique identifier. Instead, these must beidentified as tooling by either marking the item itself as “TOOLING” (or similar language) orplacement in an area, shelf, cabinet or other container that is properly marked as “TOOLING”or “SHOP AIDS”(or similar language). T he marking must allow tooling to clearly bedistinguished from raw material or product (whether flight or development).7.5. Tooling used for lifting shall be proof load tested and include an upper load lift limit, as requiredby regulations.7.6. Tooling found to be nonconforming shall be tagged to prevent use until fixed, repaired ordeemed acceptable. Segregation of nonfonconforming tooling from the production area shouldbe performed when possible.7.7. When approved tooling undergoes modification, the identification must be updated to reflect thechange; this is typically done by editing or re-marking the item with the latest revision of theengineering part number.8. SERVICE DELIVERABLES (← delete if not applicable)8.1. Service deliverables, such as reports and schedules, shall be identified with a title and, ifapplicable, reference to the project or contract under which they are developed.8.2. Customer contracts may indicate additional methods for identification of service deliverables.8.3. In all cases, the deliverable will be identified in a way that makes it clearly understood forwhich contract or project the deliverable is subject to.8.4. As required, service deliverables may be subject to date and revision control, to distinguishearlier versions or submittals.9. STAMP CONTROL (← delete this section if QC stamps are not used)9.1. Quality stamps or employee initials are used to indicate product acceptance or for other quality-related notations. Individual authorities for signing off for inspection, testing and operations aredefined on the Stamp & Signature Control Log; this log is maintained to identify the owner of each stamp.9.2. The [who?] shall maintain the Stamp and Signature Control Log.9.3. Stamps are numbered, and taken out of service for six months after an employee leaves thecompany; after the six-month period, the stamp may be reissued to a different employee.9.4. No employee may use any stamp except that which was issued to them.。

1 目的对不合格品进行识别与控制，防止不合格品非预期使用或交付，确保产品质量符合客户要求。

引用标准/文件：ISO 9001:2015版 8。

3 不合格品的控制2 适用范围适用于公司采购进料、生产制程、成品各阶段发生的不合格品的控制和管理.3 职责划分3。

1质量控制部：负责生产进料、生产制程半成品及成品的不合格判定、标识、隔离；发起《纠正预防措施》反馈给供应商限期改善，并于下批次产品追踪验证改善效果；发起组织对不合格品评审工作；3.2生产管理部：负责对生产过程中不合格品的标识、隔离，负责不合格半成品、成品的返工，并参与不合格品评审工作;3.3技术工艺部：负责对技术方面出现的异常进行分析，提出解决办法与纠正/预防措施，参与不合格品的评审;3。

4采购部：根据需要，从产品交货期、缺陷重要程度、等各方面综合评估，并为评估、考核供应商提供参考依据；发起组织相关部门进行特采评审；联系供应商处理不合格品退货事宜；3.5总经理：对不合格品各部门评审不一致时或特殊情况给予最终裁决和处理导向.4 工作程序4.1不合格品判定分类与处理类型4。

1.1不合格品分类1)严重不合格：经检验和试验判定的批量不合格，或造成较大经济损失，直接影响产品质量、主要功能、性能技术指标及涉及产品安全、环境和健康等特性的不合格。

2)一般不合格：经检验和试验判定不符合要求，但不影响产品的主要性能与使用，可以通过采取措施得到解决的不合格。

3)轻微不合格：经检验和试验判定为不合格，但不影响产品质量与使用，经过相关部门评审后，可以特采放行的不合格。

4.1。

2不合格品处理类型1)严重不合格品一律拒收或退货处理;2)一般不合格品可选择返工/返修；3)轻微不合格作返工/返修、特采处理或挑选使用。

4。

2 进料不合格品的管理4.2.1进料检验不合格品的标识、隔离、记录进料报检后，质控部IQC检验员根据对应来料检验标准（规范）、包装文件及图纸等文件进行抽检(样）/检验，对出现的不合格品用红色不良标签进行标识并隔离，并在检验报告注明：异常现象、抽检比例、不良数、检验人员名称及检验日期等要点;标识完成后，及时将不合格品隔离，（或通知相关部门/人员搬运到不合格品放置区域);做好不合格品记录备注，出具IQC检验报告交由部门负责人审核确认，在检验报告中需要体现：不良现象描述（简洁明了，必要时可以照片记录）、抽检比例等关键要素。

不合格品处理流程英文Nonconforming Product Handling Procedure.Purpose.The purpose of this procedure is to establish a consistent and effective process for handling nonconforming products to prevent their unintentional use or release.Scope.This procedure applies to all nonconforming products, including raw materials, components, subassemblies,finished goods, and services.Definitions.Nonconforming product: A product that does not meet specified requirements.Hold: To prevent the use or release of a product until its disposition is determined.Disposition: The final determination of what to do with a nonconforming product.Procedure.1. Identification and Hold.Nonconforming products shall be identified and immediately placed on hold to prevent their unintentional use or release.The hold shall be clearly marked and labeled with the reason for the nonconformance.2. Investigation.An investigation shall be conducted to determine the cause of the nonconformance.The investigation shall be documented, including the date, time, product description, nonconformance details, and corrective actions taken.3. Disposition.The disposition of the nonconforming product shall be determined based on the severity of the nonconformance and the potential risk to the end user.Possible dispositions include:Rework: The product can be repaired or reworked to meet specifications.Scrap: The product cannot be repaired or reworked and must be discarded.Return to supplier: The product is returned to the supplier for credit or replacement.Use-as-is: The product can be used as-is, with thecustomer's knowledge and approval, if the nonconformance does not affect the intended use of the product.4. Documentation.All actions taken regarding the nonconforming product shall be documented, including:Identification of the product.Date and time of hold.Investigation findings.Disposition of the product.Corrective actions taken.5. Corrective Action.Corrective actions shall be taken to address the root cause of the nonconformance and prevent its recurrence.Corrective actions may include:Revising specifications or design.Improving manufacturing processes.Training employees.Implementing new inspection or testing methods.6. Release.Nonconforming products that have been repaired or reworked and meet specifications shall be released for use.The release shall be documented and approved by authorized personnel.Responsibilities.Production staff: Identify and hold nonconformingproducts.Quality control staff: Investigate nonconformances and determine dispositions.Management: Ensure the implementation and effectiveness of the procedure.All employees: Comply with the procedure and report any nonconformances.Forms and Records.Nonconformance Report.Investigation Report.Disposition Report.Revision History.Version 1.0: Initial release.Version 1.1: Updated to include use-as-is disposition.Version 1.2: Added requirement for management approval of release.。

strategicdirection of the organization. Management of theprocesses and the system as a whole can be achieved using thePDCA cycle (see 0.3.2) with an overall focus on risk-basedthinking (see 0.3.3) aimed at taking advantage of opportunitiesand preventing undesirable results.The application of the process approach in a quality managementsystem enables:a) understanding and consistency in meeting requirements;b) the consideration of processes in terms of added value;c) the achievement of effective process performance;d) improvement of processes based on evaluation of data andinformation.Figure 1 gives a schematic representation of any process andshows the interaction of its elements. The monitoring andmeasuring check points, which are necessary for control, arespecific to each process and will vary depending on the relatedrisks.Figure 1 — Schematic representation of the elements of asingle process0.3.2 Plan-Do-Check-Act cycleThe PDCA cycle can be applied to all processes and to the qualitymanagement system as a whole. Figure 2 illustrates how Clauses4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International维（见0.3.3）对过程和整个体系进行管理，旨在有效利用机遇并防止发生不良结果。