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。
Internal auditor: responsible for performance the audit according to audit plan. 3.4 受审部门：组织有关人员配合审核。
Auditee Dept.: ensure full cooperation be given to audit.4.0 参考文件Reference Document4.1 《管理评审程序》（QP-总-002) Management Review Procedure4.2 《纠正及预防措施程序》（QP-品-005）Corrective and Preventive Action Procedure5.0 定义（无）Definition (None)6.0 程序内容Procedure Content6.1 年度内审计划Annual internal audit plan6.1.1 本厂每半年实施内部质量评审一次，但受管理者代表指定时，可追加审核。
Carry out internal quality audit half a year, can add audit times when management representative has special requirements.6.1.2 根据质量体系关于内部审核的时间和内容的要求，在每年12月份由管理者代表编制下一年度的《年度内审计划表》。
Management representative shall make out Annual Internal Plan of next year in December, according to the requirements of internal audit of quality system.6.1.3 各部门及要素的审核频次，应取决于本厂相关阶段的作业现状及相关活动对质量管理体系的影响程度。
但所开展的审核活动在一年内，必须覆盖ISO9001:2000标准所要求的所有要素及相关部门。
The audit times of each Dept. or element shall depend on the current operation status or the affections given to quality management by the relative action. The carried audit action shall refer to all the elements and departments in ISO9001:2000 within the one year.6.2 内审员资格认定Appointment of internal auditor6.2.1 本厂为有效地开展内审工作，应在实施内审前的适当时间，由管理者代表根据内审计划的性质成立内内审小组，并制定组长。
For the better implementation of internal audit, management representative shall set up an internal audit group and assign the leader sometime before the internal audit.6.2.2 内审小组的内审员必须同时具备如下条件：Internal auditor shall meet following requirements:6.2.2.1 熟悉认证的质量管理标准和有关法律、法规。
Be familiar with the law or regulation of quality management standard.6.2.2.2 接受相关机构的培训，并持有内审员资格证书。
Has ever been trained by some training organization and owns the internal audit qualification certificate.6.2.2.3 能确保与被审核部门无直接关系。
Independent of the areas being audited.6.2.2.4 经管理者代表批准。
Approved by the management representative.6.3 内审准备Internal audit perparation6.3.1 具体审核计划的核定Internal audit plan preparation6.3.1.1 具体审核计划由审核组长负责拟定；Audit leader shall make out the detail audit plan.6.3.1.2 内审计划应遵守“确保内审人员与被审核的部门无关”的原则；Audit plan shall stick to the principle of "the auditor is independent of the areas being audited".6.3.1.3 审核计划应包括所有与本次审核目标、范围有关的相关部门和要素。
Audit Plan shall include all the departments and elements relative to the goal and scope of the audit.6.3.1.4 审核小组应与被审核部门负责人商定适当的审核日期，并根据审核的重点与要求拟定好审核路线。
Audit group shall negotiate the appropriate audit date with audit department, and determine the audit route according to the audit focus.6.3.1.5 审核计划经管理者代表核准后，应提前通知被审核单位，以便其作相应的准备工作。
After the approval of the management representative, notify the auditee department in advance for its better preparation work.6.3.2 审核前，审核员必须事先准备与审核程序相关的《内审检查表》，经组长审核后报管理者代表批准。
为顺利开展审核工作，审核员应准备适当的空白《纠正措施单》，以便审核时使用。
Auditor shall prepare Internal Audit Checklist before audit, after the check by the audit leader, shall send Internal Audit Checklist to the management representative for approval. In order to carry out audit smoothly, auditor shall prepare some blank "Corrective Action Sheet" for the use in the audit.6.4 内审的实施Audit Execution6.4.1 首次会议，审核前由管理者代表召开首次会议，阐明此次审核的有关事项，包括审核目的、范围、时间、路线安排、审核流程以及审核的人员配合要求。
首次会议的参加者应包括内审小组成员、被审部门负责人以及由管理者代表指定的相关人员。
The first meeting：management representative carry out the first meeting before Audit，state the actions including audit scope，purpose，time，route arrangement, audit flow chart and auditor cooperation requirement. The attendance shall include member of internal auditor group, responsible person of auditee dep artment and staff designated by the management representative.6.4.2 审核人员到达现场，在被审核部门指定人员配合下，开展评审工作，审核员应以内审检查表为指引，通过观察、面谈、抽查有关文件记录及相关规定，以获得客观证据，并详细记录在《内审检查表》中。
ISO9001程序文件-中英文
第1页 ,共39页质量环境职业健康与安全手册1. Catalogue目录1.Catalogue目录 (2)1.1 Management representative Appointment Letter管理者代表任命书 (4)1.2 Employee Representative Appointment Letter员工代表任命书 (5)2.General situation of Quality environment Occupational health and safety management system质量环境职业健康与安全管理体系概况 (6)2.1 Company introduction 公司简介 (6)2.2 Quality /Environment/Safety Policy and Objective质量环境职业健康与安全方针与目标 (7)2.3 XXX Management 埃孚组织架构 (8)2.4 Quality 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)3. General situation of Manual手册概述 (14)3.1 Coverage and exclusion覆盖范围及删减说明 (14)3.2 Normative reference引用标准 (14)4. Quality, Environment and Safety Management System质量环境安全管理体系 (14)4.1 General requirements总要求 (14)4.2 Control of documents文件控制 (15)4.3 Control of records记录控制 (16)5. Management responsibility管理职责 (16)5.1 Management commitment管理承诺 (16)5.2 Customer orientation 以顾客为关注焦点 (16)5.3 Quality environment safety policy质量、环境、职业健康安全方针 (17)5.4 Planning策划 (17)5.4.1 Quality environment Occupational health and safety objectives质量环境职业健康与安全目标 (17)第2页 ,共39页质量环境职业健康与安全手册环境因素识别、评价、更新控制的策划 (18)5.4.4 Planning of hazard determination and risk evaluation and control (18)危险源辨识、风险评价和风险控制的策划 (18)5.4.5 Statuary and regulatory requirements and others法律法规和其他要求 (18)5.4.6 Environment and safety management program环境、安全管理方案 (18)5.5 Responsibility, authority and communication职责、权限、协商与沟通 (19)5.5.1 Responsibility, authority职责与权限 (19)5.5.2 Management representative管理者代表 (19)5.5.3 Communication, participation and consultation信息沟通、参与和协商 (19)5.6 Management review管理评审 (20)5.6.1 General总则 (20)5.6.2 Review input管理评审的输入 (20)5.6.3 Review output管理评审的输出 (21)6. Resource management资源管理 (21)6.1 Provision of resources资源提供 (21)6.2 Human resources人力资源 (21)6.2.1General总则 (21)6.2.2Competence, awareness and training能力、意识和培训 (21)6.3 Infrastructure基础设施 (22)6.3.1 Scope 设施范围 (22)6.3.2 Infrastructure provision设施的提供 (22)6.3.3 Usage, maintenance and repair of equipment设施的使用、维护和保养 (22)6.4 Work environment工作环境 (22)7. Product realization and operational control of environment and safety (23)产品实现与环境、职业健康与安全运行控制 (23)7.1 Planning of product realization产品实现的策划 (23)第3页 ,共39页质量环境职业健康与安全手册7.2.2 Review of requirements related to the product与产品有关的要求的评审 (23)7.2.3 Customer communication顾客沟通 (24)7.2.4 Communication in other interested parties与其他相关方的信息交流 (24)7.3 Design and development设计和开发 (24)7.4 Purchasing采购 (24)7.4.1 Purchasing process采购过程 (24)7.4.2 Purchasing information采购信息 (25)7.4.3 Verification of purchased product产品的验证 (25)7.5 Production and service provision, operational control of environment and occupational health and safety生产和服务的提供、环境、职业健康与安全运行控制 (25)7.5.1 Control of production and service provision生产和服务提供的控制 (25)7.5.2 Operational control of environment and occupational health and safety (25)环境、职业健康与安全的运行控制 (25)7.5.3 Emergency preparedness and response应急准备和响应 (25)7.5.2 Validation of processes for production and service provision生产和服务提供过程的确认 (26)7.5.3 Identification and traceability标识和可追溯性 (26)7.5.4 Customer property—face to face negotiation顾客财产 (26)7.5.5 Preservation of product产品防护 (26)7.6 Control of monitoring and measuring devices监视和测量设备的控制 (27)8. Measurement, analysis and improvement测量、分析和改进 (27)8.1 General总则 (27)8.2 Monitoring and measurement监视和测量 (27)8.2.1 Customer satisfaction顾客满意 (27)8.2.2 Internal audit内部审核 (27)8.2.3 Monitoring and measurement of processes过程的监视和测量 (28)第4页 ,共39页质量环境职业健康与安全手册量 (28)8.2.6 Evaluation of compliance合规性评价 (28)8.3 Control of nonconforming product and nonconformity不合格产品及不符合控制 .. 288.3.1 Control of nonconforming Products不合格产品的控制 (28)8.3.2 Occupational health and safety Incident investigation职业健康与安全事件调查 (29)8.3.3 Control of nonconformity不符合的控制 (29)8.4 Analysis of data数据分析 (29)8.5 Improvement改进 (29)8.5.1 Continual improvement持续改进 (29)8.5.2 Corrective action纠正措施 (30)8.5.3 Preventive action预防措施 (30)第5页 ,共39页质量环境职业健康与安全手册1.1 Management representative Appointment Letter管理者代表任命书In order to carry out ISO9001：2008 Quality Management System--Requirements, ISO14001：2004 Environment Management System--Requirements and Implementation Guidelines and OHSMS18001：2007 Occupational Health and Safety management System--Specifications and strengthen the leadership for operating quality, environment and safety integration management systems, Mr. Gao Peng is hereby specially appointed as Management Representative. 为贯彻执行ISO9001:2008《质量管理体系要求》、ISO14001:2004《环境管理体系要求及使用指南》和OHSAS18001:2007《职业健康安全管理体系规范》标准，加强对质量环境安全一体化管理体系运作的领导，特任命高鹏为管理者代表。
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)
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文件控制程序(含流程图)
文件控制程序（ISO9001-2015）1.0目的确保管理体系在组织内能够有效落实，对管理体系所要求的文件予以控制；通过相关文件的编号、版本、类别、分发、回收、修订和批准等活动进行规划，防止作废的文件非预期使用，保持现场操作中的文件版本是最新、最有效。
2.0范围本程序适用于本公司的文件（包括外来文件）的控制。
3.0定义与术语3.1文件：信息及其承载媒体；3.2顾客图面资料：指顾客提供的产品组装图、部品表、包装资料、说明书、及各种标签。
4.0职责4.1总经理负责质量手册批准，副总经理负责质量手册审核及程序文件的批准；4.2管理者代表负责制订质量手册及三级文件的批准；4.3文控中心负责公司体系文件、外来文件的登录、发放、回收、作废；4.4各部门负责程序文件、工作文件、表单的编制、使用及保存、外来文件的收集；4.5文控中心责接收顾客图面资料及登记并转交给开发部进行转化；4.6工程部负责技术文件的审批、控制、发放、回收、作废；5.0作业流程5.1文件的分类a.受控文件:凡质量管理体系运行的部门（含提供认证机构）、场所、班次，使用的文件均为受控文件，包括：质量体系文件：如质量手册、程序文件和其它质量文件（表格、报告等）。
管理文件：如制度等。
技术、支持性文件：如工程图样、工程标准、数据资料、检验指导书、试验程序等。
外来文件：国家标准、行业标准、法律法规、顾客工程规范、供方记录等。
b.非受控文件凡于质量管理体系运行无关联的文件属于非受控文件，如行政任命、事务性通知等。
因评审、考察等用的，向上级机关或顾客提供的质量体系文件，均为非受控文件。
“非受控”文件，更改不通知，作废不回收。
c.文件层次分灰a.一阶文件：质量手册；b.二阶文件：程序文件；c.三阶文件：检验标准、技术标准、作业指导书、设备操保保养规程、日常管理制度、管理办法等；d.四阶文件：记录表单；5.2文件编号a.由文件起草人到文控中心申请文件编号；b.文件编号要求：b1.一阶文件编号要求(1)□□□□—01—□□；①文件的制订部门代码②文件的阶层类别③一阶文件的流水号（01、02、03……）示例1：如质量手册b2.二阶文件编号要求(1)□□□□—02—□□；①文件的制订部门代码②文件的阶层类别③一阶文件的流水号（01、02、03……）示例1：如文件控制流程b3.三阶文件编号要求(1)□□□□—03—□□；①文件的制订部门代码②文件的阶层类别③一阶文件的流水号（01、02、03……）示例1：如文件控制流程b4.四阶文件（表单记录）编号要求二阶文件表单记录编号要求(1)□□□□—□□；①二阶文件编号②表单的流水号（01、02、03……）示例1：如文件控制流程表单三阶文件表单记录编号要求(1)□□□□—□□；①三阶文件编号②表单的流水号（01、02、03……）示例1：如文件控制流程表单4.2.5文件版本要求当文件更改时文件版本按照001、002、003……规律更新c.部门代码部门代码部门代码总经办01 资材部06管理部02 资材部/采购课0601 管理部/稽核课0201 资材部/物料课0602管理部/品管课0202 生产部07管理部/业务0203 生产部/生管0701 工程部03 生产部/一课0702 工程部/LED课0301 生产部/二课0703 总务部05 生产部/三课0705财务部08 生产部/五课0706内贸部09d.外来文件编号直接引用外来文件的编号。
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文件控制程序(含流程图)
文件控制程序（ISO9001-2015）1.0目的确保管理体系在组织内能够有效落实，对管理体系所要求的文件予以控制；通过相关文件的编号、版本、类别、分发、回收、修订和批准等活动进行规划，防止作废的文件非预期使用，保持现场操作中的文件版本是最新、最有效。
2.0范围本程序适用于本公司的文件（包括外来文件）的控制。
3.0定义与术语3.1文件：信息及其承载媒体；3.2顾客图面资料：指顾客提供的产品组装图、部品表、包装资料、说明书、及各种标签。
4.0职责4.1总经理负责质量手册批准，副总经理负责质量手册审核及程序文件的批准；4.2管理者代表负责制订质量手册及三级文件的批准；4.3文控中心负责公司体系文件、外来文件的登录、发放、回收、作废；4.4各部门负责程序文件、工作文件、表单的编制、使用及保存、外来文件的收集；4.5文控中心责接收顾客图面资料及登记并转交给开发部进行转化；4.6工程部负责技术文件的审批、控制、发放、回收、作废；5.0作业流程5.1文件的分类a.受控文件:凡质量管理体系运行的部门（含提供认证机构）、场所、班次，使用的文件均为受控文件，包括：质量体系文件：如质量手册、程序文件和其它质量文件（表格、报告等）。
管理文件：如制度等。
技术、支持性文件：如工程图样、工程标准、数据资料、检验指导书、试验程序等。
外来文件：国家标准、行业标准、法律法规、顾客工程规范、供方记录等。
b.非受控文件凡于质量管理体系运行无关联的文件属于非受控文件，如行政任命、事务性通知等。
因评审、考察等用的，向上级机关或顾客提供的质量体系文件，均为非受控文件。
“非受控”文件，更改不通知，作废不回收。
c.文件层次分灰a.一阶文件：质量手册；b.二阶文件：程序文件；c.三阶文件：检验标准、技术标准、作业指导书、设备操保保养规程、日常管理制度、管理办法等；d.四阶文件：记录表单；5.2文件编号a.由文件起草人到文控中心申请文件编号；b.文件编号要求：b1.一阶文件编号要求(1)□□□□—01—□□；①文件的制订部门代码②文件的阶层类别③一阶文件的流水号（01、02、03……）示例1：如质量手册b2.二阶文件编号要求(1)□□□□—02—□□；①文件的制订部门代码②文件的阶层类别③一阶文件的流水号（01、02、03……）示例1：如文件控制流程b3.三阶文件编号要求(1)□□□□—03—□□；①文件的制订部门代码②文件的阶层类别③一阶文件的流水号（01、02、03……）示例1：如文件控制流程b4.四阶文件（表单记录）编号要求二阶文件表单记录编号要求(1)□□□□—□□；①二阶文件编号②表单的流水号（01、02、03……）示例1：如文件控制流程表单三阶文件表单记录编号要求(1)□□□□—□□；①三阶文件编号②表单的流水号（01、02、03……）示例1：如文件控制流程表单4.2.5文件版本要求当文件更改时文件版本按照001、002、003……规律更新c.部门代码部门代码部门代码总经办01 资材部06管理部02 资材部/采购课0601 管理部/稽核课0201 资材部/物料课0602管理部/品管课0202 生产部07管理部/业务0203 生产部/生管0701 工程部03 生产部/一课0702 工程部/LED课0301 生产部/二课0703 总务部05 生产部/三课0705财务部08 生产部/五课0706内贸部09d.外来文件编号直接引用外来文件的编号。
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。
(整理)ISO9001中英文对照.
引言0.1 General总则The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by a) its organizational environment, changes in that environment, and the risks associated with that environment,b) its varying needs,c) its particular objectives,d) the products it provides,e) the processes it employs,f) its size and organizational structure.采用质量管理体系应当是组织的一项战略性决策。
一个组织质量管理体系的设计和实施受下列因素的影响：a) 组织的业务环境、该环境的变化或与该环境有关的风险，b) 组织的不同需求，c) 组织的特定目标，d) 所提供的产品，e) 所采用的过程，f) 组织的规模和组织结构。
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.统一质量管理体系的结构或文件不是本标准的目的。
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.本标准所规定的质量管理体系要求是对产品要求的补充。
ISO9001生产过程控制程序(含表格)
ISO9001生产过程控制※※※※※※※※※此文件未经批准﹐不准复印※※※※※※※※※※1.0 目的对手套生产过程实施有效的控制，确保直接影响产品质量的各生产过程在受控情况下进行，使生产出来的产品符合规定的质量要求。
2.0 适用范围用于本公司手套产品形成各过程的控制。
3.0 职责3.1 手套部工艺技术组负责有关产品技术性文件及关工艺文件的提供。
3.2 品质部负责产品质量计划的制订及对生产过程中产品质量的监视和测量。
3.3 辅助部门及各生产车间、班组负责生产过程中各工序的控制。
4.0 定义4.1 关键过程：1）对成品的质量性能、功能、寿命、可靠性及成本等有直接影响的工序；2）产品重要质量特性形成的工序；3）工艺复杂、质量容易波动，对工人技艺要求高或问题发生较多的工序。
4.2 特殊过程：1）产品质量不能通过后续的测量和监控加以验证的工序；2）产品质量需进行破坏性试验或采用昂贵的方法才能测量或只能进行间接监控的工序；3）该工序产品仅在产品使用或服务交付后不合格的质量特性才能暴露出来。
5.0 程序5.1 生产准备5.1.1相关部门接到《生产任务单》后，依计划表时程，进行人员、生产设备、工装夹具、检测设备及所有有关此产品的工艺技术、检验文件的准备。
5.1.2生产车间工段长根据《生产任务单》和《领料单》到安排第一工序操作员工仓库领料。
5.1.3在做生产准备同时，生产组长须事先对生产操作员工解说相关产品特性及质量要求水准，以利过程质量的控制。
5.2 首件生产5.2.1生产车间在每份生产工单生产开始及换装工装、换刀、改程序、换人后对质量有影响和生产设备经过较大维修后等情况，均须进行首件生产，生产数量以1～3个为宜。
5.2.2生产首件后，生产车间填写《首件确认书》连同首件一并交品质部门确认。
5.2.3如首检不合格，生产车间须通知相关` 技术人员、品管人员解决异常原因后，须重新生产首件交品质部门确认。
5.2.4如因首检不合格而解决异常原因影响生产计划时，生产车间须通知生产计划部，由生产计划部作出生产调整。