ISO9001-2015物料免检程序(中英文)

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ISO9001-2015物资管理程序(中英文)

ISO9001-2015物资管理程序(中英文)

物资管理控制程序(ISO9001:2015)1.0 目的 Purpose为有效控制仓库物资进出,确保不断料、不呆料、不囤料,做到帐、物、卡一致,加速资金的周转。

Control the material in and out of the warehouse effectively; make sure warehouse will not run off material, and will not store idle and spare material; make sure that account, material and card are consistent; speed up capital turnover.2.0 范围Scope适用于公司物资的进出、安全、储存、退货、退库、帐务处理等管理。

Apply to management of material incoming and outgoing, safety, storage, returned goods, canceling stock and accounting work and so on.3.0 职责 Responsibilities3.1 仓管负责物资点收,报检,入库、发料、保管。

Warehouse keeper should deal with the check and receive, report, warehouse entry, material issue and storage.3.2 质量部负责来料的检验,逾期材料质量的检验及判定。

Quality department should inspect the incoming quality control and test and judge the quality of outdated material.3.3 采购员负责物资的采购。

Purchaser should deal with the procurement of material.3.4 物资使用部门负责物资的领用。

ISO 9001-2015 中英文对照

ISO 9001-2015 中英文对照

ISO 9001:20151 ScopeThis International Standard specifies requirements for a quality management system when an organization:a)needs to demonstrate its ability toconsistently provide product or servicethat meets customer and applicablestatutory and regulatory requirements,andb)aims to enhance customer satisfactionthrough the effective application of thesystem, including processes forimprovement of the system and theassurance of conformity to customer and applicable statutory and regulatoryrequirements.All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product and service provided.NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 1範圍本國際標準所訂的品質管理系統要求,當一個組織:a)必須展現其提供一致地符合顧客要求和符合適用法令和法規要求之產品或服務的能力。

ISO9001:2015全套文件英文版(含质量手册及全套程序文件)

ISO9001:2015全套文件英文版(含质量手册及全套程序文件)

Ningbo XXX Material TechnologyCo.,LtdISO9001:2015 Quality ManualRevision [A/0] - [2018/3/1](c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.Revision [A/0] - [2018/3/1]Page 1 of 19TABLE OF CONTENTS0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)Revision [A/0] - [2018/3/1]Page 2 of 198.0 Improvement ............................................................................................................................................... 15 8.1 General .................................................................................................................................................... 15 8.2 Customer Satisfaction ............................................................................................................................. 15 8.3 Internal Audit ........................................................................................................................................... 16 8.4 Corrective and Preventive Action ............................................................................................................ 16 Appendix A: Overall Process Sequence & Interaction ........................................................................................ 17 Appendix B: ISO 9001:2015 Cross Reference . (18)Revision [A/0] - [2018/3/1] 0.0 Revision History and ApprovalRev. Nature of changes Approval DateA/0 Original release. XXX 2018/3/1Page 3 of 19Revision [A/0] - [2018/3/1] 1.0 Welcome to Ningbo XXX Material Technology Co.,LtdNingbo XXX Material Technology Co., Ltd. Was established in 2000, with the UAE businessmen to build the joint venture company; 2004 Ming Shan founded Nissin special adhesive tape and adhesive tape company; 2008 due to the strategic adjustment of 3 company merger and reorganization, the establishment of Ningbo letter mountains adhesive products Manufacturing Co., Ltd..PVC insulation tape is one of China’s national standard drafting unit, the field of adhesive products governing unit of China, Ningbo, adhesives and related products Industry Association, honorary president of the unit.We produce more than 1000 varieties of products of 11 categories. The annual throughput more than 100,000,000 square of the adhesive and 10,000 ton of the adhesive.Our company located in Ningbo which the city of the east China sea, beside 500 kilometers of shanghai, 20 kilometers from Ningbo list airport and 50 kilograms of the Ningbo seaport. The transport is very convenient (Easy to ship to everywhere on the world).2.0 XXX Material: Who We Are2.1 Determining Our Strategic DirectionXXX Material has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:∙Understanding our core products and services, and scope of management system (see 2.2 below).∙Identifying “interested parties” (stakeholders) who receive our [Production of adhesive tape], or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document [Requirements and expectations list of interested parties].∙Understanding internal and external issues that are of concern to XXX Material and its interested parties; also identified in the document [Requirements and expectations list of interested parties]. Many such issues are identified through an analysis of risks facing either XXX Material or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.2.2 Scope of the Management System2.2.1 Scope StatementBased on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX Material has determined the scope of the management system as follows:Production of adhesive tapePage 4 of 19Revision [A/0] - [2018/3/1]Page 5 of 192.2.2 Facilities Within the ScopeThe quality system applies to all processes, activities and employees within the company. The facility is located at: Factory Add :XXX Tel :XXX Fax :XXX XXX XXX2.2.3 Permissible ExclusionsThe following clauses of ISO 9001 were determined to be not applicable to XXX Material.∙ 8.3 Design and development of products and services 2.2.4Scope of the ISO9001:2015 Quality ManualThis manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard.This manual does not follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015.This manual presents “Notes” which are used to define how XXX Material has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background.Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics .∙ Quality PolicyThe Quality Policy of XXX Material is as follows:Quality first, customer satisfaction;Scientific management, continuous improvement. ∙ Management SystemStructure and Controls 4.1Process Approach4.1.1 Process IdentificationXXX Material has adopted a process approach for its management system. By identifying thetop-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming [Production of adhesive tape] discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight.The controls indicated herein are applicable only to the top-level processes identified.。

ISO9001-2015产品标识和追溯程序(中英文)

ISO9001-2015产品标识和追溯程序(中英文)

产品标识和追溯程序Product Identification and Trace-ability(ISO9001:2015)1.0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 all incoming 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。

DXC is the short form of DXC3.2MFG: Manufacturing的英文缩写;3.3QE:Quality Engineer品质工程师缩写4.0职责Responsibility4.1QE:将客户对产品和包装箱标识要求传达给生产部。

ISO9001出货检验程序(中英文)

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。

ISO9001:2015完全翻译版

ISO9001:2015完全翻译版

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+流程+对照表

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不合格品处理程序(中英文)

ISO9001-2015不合格品处理程序(中英文)

不合格品处理程序Management of Nonconforming Product(ISO9001:2015)1.0目的Purpose:本程序对不合格品的标识、隔离、评估、处置、记录提供指引。

This procedure provides the instructions for the identification, quarantine, evaluation, disposition,documentation of non-conformance associated with incoming materials, in-process incoming materials, semi-product, finished product. .2.0范围Scope:适用于本厂所有不合格来料,半成品及成品。

Apply to all non-conforming incoming materials, semi-products and finished products.3.0定义Definition:3.1DXC: DXC的简称:DXC is short for DXC.3.2UAI:特采,也称让步接受。

UAI is short for use as it is, also calling concession.3.3PM/PA: 项目经理/项目助理 Program manager / Program Assistant.3.4QE: 品质工程师 Quality Engineer3.5ME: 制程工程师 Manufacturing Engineer3.6不合格品:不符合既定的品质标准/要求或客户要求的所有来料、半成品、成品。

Nonconforming Product: All incoming materials, WIP, finished products arenon-compliant with established quality standard/requirements or customers’.3.7可疑物品/物料:检验或试验状态标识不明确或没有标识,或储存超过保存期限或由于包装受损等原因可能引起品质变异或降低的物料/半成品/成品。

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)

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。

ISO9001-2015免检物料控制程序

ISO9001-2015免检物料控制程序

免检物料控制程序
(ISO9001:2015)
1. 制订目的
为更好的加强质量管理,确保检验工作而顺利进行.
2. 适用范围
适用于品管部的检验工作.
3. 部门职责
3.1资材:负责进料数量核对及点收.
3.2品管:负责免检物料的核准及记录标示.
4. 名词定义

5. 参考标准
ISO9001《质量管理体系要求》
6. 操作内容
6.1凡属下列产品均可视为免检产品.
6.1.1生产用之辅助材料:周转箱,打包带,胶纸等.
6.1.2电工设备:电笔,螺丝刀,板手等.
6.1.3办公用品:办公桌,活页夹,笔等.
6.1.4化工辅材:白电油,海棠粉等.
6.2对单一料号来料由我司IQC在供货商连续二个月质量月评定为A级并放宽
检验状况下连续50批不发生质量问题的产品,由品管经理提出,经公司副总经理核准后此产品可做免验处理.
6.3来料极少,没有规定免检的,又须检验或检验有限的产品,可由品管经理决定是否免检.
6.4对免检之产品如果在本公司发生质量问题,则视问题严重性进行处理,处理方式为抽样批数检查和取消免检资格,抽样批数检验工作由IQC负责实施. 6.5免检产品的标识.
6.5.1对免检产品,IQC在进料验收单上注明”免检”字样.
7.相关文件详见免检物料控制流程
7.1免检物料一览表
免检物料一览表
NO 供应商料号产品名称导入免检时间备注
1 五金店电工设备文件规定
2 办公用品办公用品文件规定
3 化工用品化工辅材文件规定4
5
6
7
8
9
10
11
12
13
14
15。

ISO9001:2015完全翻译版

ISO9001:2015完全翻译版

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。

ISO9001:2015一整套程序文件-英文版

ISO9001:2015一整套程序文件-英文版

Quality System Procedures(ISO 9001:2015)GENERAL INFORMATION Name of the Organisation:Address:E-Mail:Web:QUALITY SYSTEM STATUSQuality System:ISO 9001: 2015 Issue No.:01Issue Date: System Effective Date:December 2017 December 2017Copy No.:01LIST OF CONTENTSection-1 Control of DocumentSection-2Control of RecordsSection-3Management Review MeetingSection-4Resource ManagementSection-5Customer Related ProcessSection-6Purchase ProcessSection-7Supplier Evaluation and Selection Process Section-8Service ProcessSection-9Receipt Storage and Issue of Product Section-10Customer SatisfactionSection-11Internal AuditSection-12Control of Nonconforming Product Section-13Analysis of dataSection-14Continual ImprovementSection-15Corrective Action and Preventive ActionSection-1Control of Documents1.0Purpose1.1To establish a procedure to ensure that the documents required for Quality ManagementSystem are in controlled condition.1.2To ensure that pertinent versions of documents are available at the point of use.2.0Scope2.1Applicable to all documents and data generated for Quality Management System via theProcedures, Work Instructions, Documents, Lists, Formats and Registers etc.2.2This procedure also covers the external origin documents such as Standards and CustomerDocuments.3.0Responsibility3.1 Management Representative is responsible for controlling all the documents of Quality ManagementSystem being originated internally and the documents from External origin.3.2 It is the responsibility of Management Representative to ensure that pertinent documents are available atpoint of use.4.0Procedure4.1The numbering of all Quality Management System documents is done as per the Annexure.4.2Document Generation / Creation4.2.1 Management Representative issues the copies of the Quality System Manual / Procedures /Guidelines / Formats to all concerned personnel and records in Issue Control Register.4.2.3Any Departmental member, who perceives the need for a new quality system documentfor upgrading the system, prepares a draft procedure and forwards it to the ManagementRepresentative.4.2.3Management Representative studies the possibility of modifying any existing procedurein consultation with approving authority or accepts the draft procedures with or withoutmodifications and approves it before issue.4.3Document Change / Modification4.3.1Changes / Modification in document arises in any one of the following area;A.Change in Organization structureB.Any change in the departmental functioningC.Change in / addition / deletion of existing systemD.Change in International / National StandardsE.Findings of Internal Quality Audit4.3.2Departmental members prepares Document Change Request and forwards it toManagement Representative4.3.4 If the changes are acceptable, Management Representative makes necessary changes in thedocumentation and gets it signed by the concerned authority.4.3.5If the document is added or deleted, all linked procedures are updated in theAmendment Record Sheet.4.3.6While issuing the revised copies to all concerned, Management Representative ensures thatthe obsolete documents are retrieved back from all personnel and the same are destroyed.The respective Master copy is stamped as “OBSOLETE” and maintained for a period of oneyear from the date of next revision or till the next revision, which ever is later.4.3.7The Issue No. will be incremented when number of revisions in any section/page ofdocument exceeds 09 revisions. The Issue No. will be TBA…etc. and Revision No. of all thesection / pages shall be reset to 004.4Management Representative shall maintain and update the Master List of Documents.4.5The document status shall be maintained as follows:MASTER“MASTER COPY”(Seal affixed on rear side of each page of document)CONTROLLED“CONTROLLED COPY”(Seal affixed on front right hand side of the document)OBSOLETE“OBSOLETE COPY”(Seal affixed on front side of the document)4.6 The approval authority for various documents is as mentioned below:Document Type Description Approved by Apex ManualProceduresDocument Type Description Approved byGuidelines & Formats As per Master List of Documents4.7External Originated Documents (National / International Standards And Customer Drawings)4.7.1Documents of National / International Standards / any other Guidelines are procured, revisedand implemented by Management Representative.4.7.2 A List of External Origin Documents is maintained by Management Representative and willbe updated whenever necessary.4.7.3All the standards are stamped as “CONTROLLED COPY” on the cover page of the standardand issued to the concerned by making necessary entries in Issue Control Register.4.7.4Documents of customers / suppliers are maintained only after receiving concrete ordersfrom them. If the order does not mature, the documents are either destroyed or returned tothem as the case may warrant.5.0Reference5.1Issue Control Register5.2Document Change Request5.3Amendment Record Sheet5.4Master List of Documents5.5List of External Origin DocumentsAnnexureNumbering System shall be as follows1.Quality System ManualAAG/QSM-XX, whereAAG–refers to the company, AAG Land SurveyQSM–refers to Quality System ManualXX–refers to Section No.2.Quality System ProceduresAAG/QSP/YYAAG–refers to the company, AAG Land SurveyQSP–refers to type of proceduresQSP – Quality Management System ProceduresYY–refers to running Serial Number of procedures3.Documents & RecordsAAG-AXX:YYAAG–refers to the company, AAG Land Survey。

ISO9001-2015采购程序(中英文)

ISO9001-2015采购程序(中英文)

采购管理程序Management of PURCHASING PROCEDURE(ISO9001:2015)1. Purpose目的Provide a consistent method for assuring purchased material meet DXC and customer requirements and optimize purchasing cost and efficiency.为了确保所采购的物料满足DXC公司及客户的需要,优化采购成本及效率。

2. Scope范围Apply to all direct and indirect material used for finish goods andnon-production material.所有用于成品或生产当中的直接或间接物料。

3.流程图 Flow Chart:Appendix I 附录IPurchasing control flow chart (Direct material) 采购控制流程图(直接物料) Appendix II 附录IIPurchasing control flow chart (Indirect material) 采购控制流程图(间接物料) Appendix III 附录IIIRTV control flow chart退货流程图4. Reference Document参考文件4.1 Purchasing control flow chart (Direct Material) OP-PU-FC-01采购控制流程图(直接物料)4.2 Purchasing control flow chart (Indirect Material) OP-PU-FC-02采购控制流程图(间接物料)4.3 RTV control flow chart OP-PU-FC-03退货流程图4.4 Approval Vendor List (Direct Material) OP-PU-FO-01合格供应商清单4.5 Lead Time Summary (Direct Material) OP-PU-FO-02交货周期汇总4.6 Sorting Cost monthly report OP-PU-FO-05挑选费用月报表4.7 Purchase Request OP-MC-FO-03采购申请表5. Definition定义5.1 MPS - Master Production Schedule主生产计划5.2 MRB – Material Review Board物料评审会5.3 MRP – Material Request Plan物料需求计划5.4 PO - Purchase Order采购单5.5 PR - Purchase Request采购申请表6. General procedure一般程序6.1 Responsibilities 责任人6.1.1 Buyer is responsible for creating PO, issuing PO to supplier and followingup delivery.采购员负责下订单,分发订单及跟踪交期。

ISO9001-2015进料检验作业指导书(中英文)

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物料评审MRB程序(中英文)

ISO9001-2015物料评审MRB程序(中英文)

物料评审程序Material Review Board (MRB)(ISO9001:2015)1.PURPOSE 目的:To establish a procedure for reviewing and disposingnon-conforming materials, semi-product, finished products and RMA control in DXC.本程序规定对来料检验及生产过程中发现的不合格物料,半成品,成品及客户退回品的评审及处置方法.2.SCOPE 范围:This procedure is only applicable to DXC.本程序适用于DXC公司.3.DEFINITIONS 定义:3.1 PRD: Product Department 生產部3.2 ME: Manufacture Engineering 制造工程3.3 RTV: Return To Vendor/Supplier 退回供應商3.4 UAI: Use As It Is 讓步接受3.5 SORT: Segregation Of Bad And Good Unit 選用3.6 SCAR Supplier/Sub-contractor Corrective Action Request (8D) 供應商改進行動要求 (8D)3.7 GRN: Goods Receipt Note 收货单3.8 MRR: Material Review Record 物料评审记录4.REFERENCE DOCUMENT 参考文件:4.1 DXC-7-05 Raw Material Quality Control Procedure原材料质量控制程序4.2 DXC-8-05 Nonconforming Control Procedure 不合格品控制程序4.3 DXC-8-06 Stop Shipment and Purge Order Procedure 停止出貨和清除指令程序.4.4 DXC-8-07 Corrective and Preventive Actions Procedure 纠正及预防措施程序.5.RESPONSIBILITY 职责:5.1 QA is responsible to chair MRB meeting when defective materialare defected in line, QA review the non-conforming productsand issue SCAR (8D) if necessary.当不合格物料在产线发现时,QA负责主持MRB会议, 确认不合格产品, 并在必要的情况下发出SCAR(8D).5.2 PRD is responsible to fill MRB label and inform QA membersto review the non-conforming products, and return them to warehouse.生产部负责填写MRB标签并通知品质部成员评审不合格品, 并将不合格品退回货仓.5.3 PUR/ IQC are responsible to inform supplier of thenon-conforming data, PUR responsible to arrange thenon-conforming materials RTV.采购/IQC负责将不合格批物料状况通告客户或供货商, 采购还负责安排将不合格品退回供货商.5.4 PUR is responsible to charge the supplier ofsorting/reworking cost and other loss due to materialquality issue, and call MRB meeting to review the reject lots of IQC raised.采购负责向供货商索取选用或重工费用及由于物料问题而导致的损失, 并召集MRB会议处理IQC拒收的紧急物料.5.5 ME is responsible to analyze non-conforming products.ME负责分析不合格品.5.6 All MRB members are to propose and decide on defective。

ISO9001不合格品控制程序(中英文)

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。

ISO9001-2015供应商控制程序(中英文)

ISO9001-2015供应商控制程序(中英文)

供应商控制程序SUPPLIER Control PROCEDURE(ISO9001:2015)1.Purpose目的:1.1.To define supplier management procedure, and ensure that the suppliermaterial will follow DXC quality requirements.确立供应商管理程序,确保供应商之产品能满足DXC公司品质要求。

2.Scope范围:2.1.This procedure applies to all DXC suppliers.该程序适用于DXC公司所有供应商。

3.Reference Document参考文件3.1.Quality Manual 品质手册3.2.Purchasing Procedure 采购程序3.3.Incoming Quality Control Procedure进料品质控制程序3.4.IQC monthly report IQC月报3.5.Sourcing Procedure. 供应商开发程序4.Definition定义4.1.AVL– Approved supplier list 合格供应商清单4.2.CPAR –Corrective and preventive action request.纠正与预防措施申请4.3.P.O.–Purchase order.采购订单5.Responsibility职责:5.1.QA Department 品质部:5.1.1.R esponsible for the verification of the supplier’s qualitymanagement system, imposed requirement for the corrective and preventive action.负责确认供应商质量管理体系,纠正与预防措施的要求。

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物料免检程序
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:500DPPM
Passive optical part / 无源光器件:500DPPM
PCB / 印刷电路板:500DPPM
Packing materials / 包材:1000DPPM
Comments / 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。

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