1. Catalogue 目录
目录 .......................................................... 2
Management representative Appointment Letter 管理者代表任命书 ........... 4
Employee Representative Appointment Letter 员工代表任命书 .............. 5
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
Company introduction 公司简介 ......................................... 6
Quality /Environment/Safety Policy and Objective 质 量 环 境 职 业 健 康 与 安 全 方 针 与 目
标 ........................................................................ 7
XXX Management 埃孚组织架构 .................................. 8
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
Coverage and exclusion 覆盖范围及删减说明 .......................... 14
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
General requirements 总要求 ......................... 14
Control of documents 文件控制 ....................... 15
Control of records 记录控制 .......................... 16
5. Management responsibility 管理职责 ........................... 16
Management commitment 管理承诺 .................... 16
Customer orientation 以顾客为关注焦点 ....................... 16
Quality environment safety policy 质量、环境、职业健康安全方针 ...... 17
Planning 策划 ...................... 17
Quality environment Occupational health and safety objectives 质量环境职业健康与安全目
标 .............. 17
Management system planning 管理体系策划 ..................... 17
Control planning of identification, evaluation and update of environment aspects. 环境因素识别、
评价、更新控制的策划................................. 18
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
Statuary and regulatory requirements and others 法律法规和其他要求 ......... 18
Environment and safety management program 环境、安全管理方案 .............. 18
Responsibility, authority and communication 职 责 、 权 限 、 协 商 与 沟
通 .................................................... 19
Responsibility, authority 职责与权限 ..................... 19
Management representative 管理者代表 ............................... 19
Communication, participation and consultation 信息沟通、参与和协商 ......... 19
Management review 管理评审 ............................ 20
General 总则 ........................................... 20
Review input 管理评审的输入 ............................ 20
Review output 管理评审的输出 ........................... 21
6. Resource management 资源管理 ................................ 21
Provision of resources 资源提供 ........................ 21
Human resources 人力资源 ................................ 21
总则 ........................................................ 21
, awareness and training 能力、意识和培训 ................. 21
Infrastructure 基础设施 ....................................... 22
Scope 设施范围 ............................................... 22
Infrastructure provision 设施的提供 ..................... 22
Usage, maintenance and repair of equipment 设施的使用、维护和保养 ........ 22
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
Planning of product realization 产品实现的策划 ....... 23
Customer-related processes 与顾客有关的过程 ........................ 23
Determination of requirements related to the product 与产品有关的要求确定 .. 23
Review of requirements related to the product 与产品有关的要求的评审 ...... 23
Customer communication 顾客沟通 ................. 24
Communication in other interested parties 与其他相关方的信息交流 ....... 24
Design and development 设计和开发 .................... 24
Purchasing 采购 ................................................... 24
Purchasing process 采购过程 ............................. 24
Purchasing information 采购信息 ........................ 25
Verification of purchased product 产品的验证 ......................... 25
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
Control of production and service provision 生产和服务提供的控制 ........ 25
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
Emergency preparedness and response 应急准备和响应 ..................... 25
Validation of processes for production and service provision 生 产 和 服 务 提 供 过 程 的 确
认 ...................... 26
Identification and traceability 标识和可追溯性 ........... 26
Customer property—face to face negotiation 顾客财产 ................... 26
Preservation of product 产品防护 .................... 26
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
General 总则 ............................................. 27
Monitoring and measurement 监视和测量 ............. 27
Customer satisfaction 顾客满意 ............................ 27
Internal audit 内部审核 ......................................... 27
Monitoring and measurement of processes 过程的监视和测量 ............ 28
Monitoring and measurement of product 产品的监视和测量 ................. 28
Monitoring and measurement of environment and safety 环 境 / 安 全 项 目 的 监 视 和 测
量 ........................... 28
Evaluation of compliance 合规性评价 ................... 28
Control of nonconforming product and nonconformity 不合格产品及不符合控制 .. 28
Control of nonconforming Products 不合格产品的控制 .................. 28
Occupational health and safety Incident investigation 职 业 健 康 与 安 全 事 件 调
查 .................................... 29
Control of nonconformity 不符合的控制 .............................. 29
Analysis of data 数据分析 ................................... 29
Improvement 改进 ................................................. 29
Continual improvement 持续改进 ....................... 29
Corrective action 纠正措施 ................................... 30
Preventive action 预防措施 .................................. 30
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。
Responsibilities of Management Representative 管理者代表的职责:
1. To ensure the procedure of quality, environment and safety management systems could be identified;
the management system could be established and maintained.
确保质量环境安全管理体系的过程得到识别,管理体系得到建立和保持;
2. Representation on top-managements to take management responsibility of quality, environment and
safety systems. To organize, coordinate and rule the major issues of quality, environment and safety
management systems;
代表最高管理者行使质量环境安全管理职责,组织、协调、裁定质量环境安全管理中的重大事项;
3. Giving reports to top-managements on the performance and improved requirements of quality,
environment and safety systems, timely managing and coordinating problems of quality, environment and
safety management systems running.
向最高管理者报告质量环境安全管理体系的业绩和改进的需求,及时协调处理质量环境安全管理
体系运行的有关问题;
4. To organize, propagandize and implement laws, regulations, and institutions of quality, environment
and safety management systems; to ensure the whole company could improve the awareness of fulfilling
customer requirements and society commitment.
组织宣传贯彻有关质量环境安全方面的法律法规、制度、标准,确保全公司员工提高满足顾客要
求和社会承诺的意识;
5. Be responsible for external liaison for relevant issues concerned with quality, environment and safety
systems.
负责质量环境安全管理体系有关事宜的对外联络。
6. Assuring the product with the marking from the certification institute fulfilling all the certification
requirement
确保加贴该认证标志的产品符合认证标准要求
7. Be responsible to organize to set up written procedure to assure the certification marking is proper
kept and used within the organization.
负责建立文件化的程序,确保认证标志妥善保管和使用;
8. Be responsible to organize to set up written procedure to assure that no attaching certification
marking to the non-conforming product and product which has been changed but without confirmation from
the certification institute.
负责组织建立文件化的程序,确保不合格品和获证产品变更后未经认证机构确认,不加贴标志。
GM 总经理:Alohn
2012 年(y) 3 月(m)23 日(d)
Employee Representative Appointment Letter 员工代表任命书
In order to carry out OHSMS18001 : 2007 Occupational Health and Safety Management
System--Specifications and strengthen the leadership for operating quality, environment and safety
management systems, Mr XXX is hereby specially appointed as quality, environment and safety
management systems Employee Representative of XXX Co., Ltd Company. 为贯彻执行 OHSMS18001:
2007《职业健康安全管理体系 规范》,加强对质量环境安全管理体系运作的领导,特任命 XX 为 XXX
有限公司的质量环境安全管理体系员工代表。 Whose main responsibilities are to:其主要职责为:
1. Be involved in establishing and reviewing the OH&S policy, other policies, objectives and plans;
参与公司职业健康安全方针、各项政策、目标、计划的制定、评审;
2. Be involved in the hazard identification and assessment, the controlling measures formulation,
accidents investigation and handling;
参与公司危险源辨识、评价与控制措施的制定及事故调查处理;
3. Be involved in discussion of improving the employees’ operation status;
参与改善公司员工作业状况的商讨;
4. Be responsible for reporting to the superiors about the employees’ requirements in the aspect of
OH&S;
负责上报员工对职业健康安全方面的要求;
5. Be responsible for participating in saving and recording all the OH&S affairs of the company.
负责保存参与公司职业健康安全事务的各项记录。
GM 总经理:Alohn
2012 年(y)3 月(m) 23 日(d)
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
Company introduction 公司简介
- XXX Solar Production Co., Ltd. manufactures high-quality solar modules using mono- and
polycrystalline solar cells for XXX solar AG, which distributes the modules to the international photovoltaic
market.
XXX 有限公司是一家专门从事晶体硅太阳能电池组件生产的高新技术企业。
- It operates one of the most modern production facilities in Gaomi , province Shandong, China. The
operation started since 2008. In , XXX completed its expansion to 100 MW of an annual production
capacity.
公司坐落于山东省高密市。公司拥有功能完善、设施齐全的生产车间。公司于 2008 年正式投产,2011
年 7 月公司完成扩产,产能达 100MW。
- XXX is a Sino-German Joint Venture by XXX solar AG, Germany and the XXXX Group, Gaomi,
China, founded in 2008. One year after production start XXX passed the ISO9001:2008 and VDE
certification in 2009; the UL-Certification in 2010.
公司由 XXX 和 XXX 集团共同投资建立。2009 年公司通过 ISO900:2008 认证和 VDE 认证,2010
年通过 CSA 认证。
- The company has a great geographical advantage, only 30 minutes’ drive to reach Qingdao airport or
Qingdao harbor..The products manufactured are distributed to the international Photovoltaic Market
exclusively by XXX solar, and have the competitive advantage on both price and cost. Based on the raw
materials, the changes in market price, the company is optimizing its production matrix regularly, to save the
cost, thereby offer the maximized profit to the customer.
公司地理位置优越,乘车 30 分钟即可到达青岛机场和青岛港。公司产品由德国 XXX 光伏销往
国际光伏市场。产品在价格和成本方面具有竞争优势。公司根据原材料市场价格变动,定期优化生产
结构,削减生产成本,将最大利润提供给客户。
- With the outstanding management team and well trained employees, the highest possible quality
standard is reached.
公司凭借规范化的操作工艺,严格的质量标准,完善的管理制度,高素质的员工团队,为客户打
造品质卓越的晶体硅太阳能电池。
Quality /Environment/Safety Policy and Objective 质量环境职业健康与安全方针与目标
Quality /Environment/Safety Policy:质量环境安全方针:
Full of accuracy, integrity, dedication and prompt action to pursue excellence going green to protect
the earth People oriented to create harmonious 准诚敬捷 追求卓越 倡导绿色 呵护地球 以人为本
塑造和谐
Quality Objective 质量目标: Bosch Brand modules . A rate ≥99% XXX/XXX Brand
rate ≥99% Cell production breakage rate ≤% 博世品牌组件 A 等级比率 ≥99%; XXX 和 XXX 品牌
组件 A1 率≥99%;电池片生产破损率≤%; Customer satisfaction degree, greater than 85% 顾客满
意度达 85%以上
Environmental Objective 环境目标和指标:
a) Waste emission in accordance with national regulation 废弃物排放符合国家规定
b) Unit consumption of materials under effective control
原材料的单耗控制在指标之内
Material 材料名称 Unit 单位 Planned piece yardage:计划单耗
Tabbing ribbon 焊带 kg 千克 ≤
Flux 助焊剂 L 升 ≤
Barcode 条形码标签 m 米 ≤
c) Unit consumption of electricity descends 1% each year ( produced W)
电的单耗每年下降 1% (千瓦.小时/生产的瓦数) Occupational Health and Safety Objective 职业健
康安全目标:
a) No injury accident 不发生伤害事故
b) Nonoccurrence of fire accident、explosive accident and Electric shock accident
不发生火灾事故、爆炸事故和触电事故
c) Occupational disease incidence is 0 职业病发病率为 0
XXX Management XXX 组织架构
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
- Remarks 备注:▲—Main Responsibilities 主要职责;△—Executive responsibility 相关职责
Standard clause 标准
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4 Quality, Environment and Safety Management System 质量环境安全管理体系 4 4 4
General requirements 总要求 ▲ △ △ △ △ △
Control of documents 文件控制 △ △ △ ▲ △ △
Control of records 记录控制 △ △ △ ▲ △ △
5 Management responsibility 管理职责 5
Management commitment 管理承诺 ▲ △ △ △ △ △
Customer orientation 以顾客为关注焦点 ▲ △ △ △ △ △
Quality environment safety policy 质量、环境、职业健康安全方针 ▲ △ △ △ △ △
Planning 策划
Quality environment safety objectives 质量环境安全目标 ▲ △ △ △ △ △
Management system planning 管理体系策划 △ △ △ ▲ △ △
Control planning of identification, evaluation and update of environment aspects.环境因素识别、
评价、更新控制的策划
NA △ △ △ ▲ △ △
Planning of hazard determination and risk evaluation and control 危险源辨识、风险评价和风险控 NA △ △ △ ▲ △ △
制的策划
Statuary and regulatory requirements and others 法律法规和其他要求 NA △ △ △ ▲ △ △
Environment and safety management program 环境、安全管理方案 NA △ △ △ ▲ △ △
Responsibility, authority and communication 职责、权限、协商与沟通
Responsibility and authority 职责和权限 ▲ △ △ △ △ △
Management representative 管理者代表 ▲ △ △ △ △ △
Management review 管理评审 ▲ △ △ △ △ △
6 Resource management 资源管理 6
Provision of resources 资源提供 ▲ △ △ △ △ △
Human resources 人力资源
General 总则 ▲ △ △ △ △ △
Competence, awareness and training 能力、意识和培训 △ ▲ △ △ △ △
Infrastructure 基础设施 △ ▲ △ △ △ △
Scope 设施范围 △ ▲ △ △ △ △
Infrastructure provision 设施的提供 △ ▲ △ △ △ ▲
Usage, maintenance and repair of equipment 设施的使用、维护和保养 △ ▲ △ △ △ ▲
Work environment 工作环境 NA NA △ ▲ △ △ △ ▲
7 Product realization and operational control of environment and safety 产品实现与环境/安全运行
控制
7
Planning of product realization 产品实现的策划 ▲ △ △ △ △ △
Customer-related processes 与顾客有关的过程
Determination of requirements related to the product 与产品有关的要求的确定 △ △ △ △ ▲ △
Review of requirements related to the product 与产品有关的要求的评审 △ △ △ △ ▲ △
Customer communication 顾客沟通 △ ▲ △ △ △ △
Communication in other interested parties 与其他相关方的信息交流 NA △ ▲ △ △ △ △
Design and development 设计和开发 △ △ △ △ ▲ △
Standard clause 标准
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Purchasing 采购
Purchasing process 采购过程 △ ▲ △ △ △ △
Purchasing information 采购信息 △ ▲ △ △ △ △
Verification of purchased product 采购品的验证 △ ▲ △ △ △ △
Production and service provision 生产和服务的提供 △ △ △ △ △ ▲
Control of production and service provision 生产和服务提供的控制 △ △ △ △ △ ▲
Validation of processes for production and service provision 生产和服务提供过程的确认 NA NA
Identification and traceability 标识和可追溯性 NA NA △ △ ▲ ▲ △ ▲
Customer property 顾客财产 NA NA △ ▲ △ △ △ △
Preservation of product 产品防护 △ △ △ △ △ ▲
Operational control 运行控制 NA △ △ △ △ ▲ △
Control of monitoring and measuring devices 监视和测量设备的控制 △ △ △ △ △ △
Emergency preparedness and response 应急准备和响应 NA △ △ △ △ △ △
8 Measurement, analysis and improvement 测量、分析和改进 8 △ △ △ △ ▲ △
General 总则 △ △ △ △ ▲ △
Monitoring and measurement 监视和测量 NA NA △ △ △ △ ▲ △
Customer satisfaction 顾客满意 NA NA △ △ △ △ ▲ △
Internal audit 内部审核 △ △ △ △ ▲ △
Monitoring and measurement of processes 过程的监视和测量 △ △ △ △ ▲ △
Monitoring and measurement of product 产品的监视和测量 △ △ △ △ ▲ △
Monitoring and measurement of environment and safety 环境/安全项目的监视和测量 NA △ △ △ △ ▲ △
Evaluation of compliance 合规性评价 NA △ △ △ △ ▲ △
Control of nonconformities 不合格品控制 NA NA △ △ △ △ ▲ △
Control of nonconforming Products 不合格品控制 NA NA △ △ △ △ ▲ △
Accident, nonconformity, corrective- and preventive actions 事故、事件、不符合、纠正和预防
措施
NA △ △ △ △ ▲ △
Analysis of data 数据分析
Improvement 改进 NA NA △ △ △ △ ▲ △
Continual improvement 持续改进
Corrective action 纠正措施
Preventive action 预防措施
3. General situation of Manual 手册概述
Coverage and exclusion 覆盖范围及删减说明
. Coverage of the quality management system: processes of production, sales and service related to the
company products. 质量管理体系覆盖:本公司所有产品的生产、销售和服务过程;
. Coverage of the environmental management system: processes of production, sales, service and
relevant management of all products in the company.
环境管理体系覆盖:本公司区域内公司所有产品的生产、销售服务过程及相关管理活动;
. Coverage of the occupational health and safety management system: processes of production, sales,
service and relevant management of all products in the company.
职业健康安全管理体系覆盖:本公司区域内公司所有产品的生产、销售服务过程及相关管理活动;
. The company has no Special Process, therefore, the manual excludes “Validation of processes
for production and service provision” in ISO9001:2008 idt GB/T19001-2008, and the exclusion has no
effect on the ability and responsibility of satisfying customer requirements and applying laws and
regulations.
本公司无特殊过程,所以删减 ISO9001:2008 idt GB/T19001-2008 标准中 “生产和服务提供过
程的确认”条款;该删减不影响本公司提供满足顾客要求和适用法律法规要求的能力和责任。
Normative reference 引用标准
. ISO9001: 2008 idt GB/T19001-2008 Quality Management Systems-Requirements 《质量管理体系
要求》;
. ISO14001: 2004 idt GB/T24001-2004 Environmental Management Systems-Requirements With
Guidance for Use《环境管理体系 要求及使用指南》;
. OHSAS18001: 2007 idt GB/T28001-2011 Occupational Health and Safety Management Systems
-Requirements《职业健康安全管理体系 规范》;
. IEC 61215 Design Qualification and Type Approval of PV Modules 《地面用晶体硅光伏组件—设
计鉴定和定型》;
. IEC 61730 PV Module Safety Qualification《光伏组件安全鉴定》。
- Terms and definitions 术语与定义
. ISO9000: 2005 idt GB/T19000-2008 Quality Management Systems –Fundamentals and Vocabulary
《质量管理体系 基础和术语》
4. Quality, Environment and Safety Management System 质量环境安全管理体系
General requirements 总要求
- In accordance with ISO 9001: 2008 Quality Management System-Requirements, ISO 14001: 2004
Environmental management system-Requirements and OHSAS 18001:2007 Occupational Health and Safety
Management Systems-Requirements, the company shall establish and maintain documented management
systems, develop the quality, environment and safety policies and objectives, define the organization
structure and responsibilities, conduct effective control to environment aspects and hazards of all procedures
affecting the quality of product realization, and continually improve the effectiveness of management
systems on the basis of PDCA and statutory and regulatory requirements.
本公司根据 ISO 9001:2008《质量管理体系 要求》、ISO 14001:2004《环境管理体系 要求及使用
指南》以及 OHSAS 18001:2007《职业健康安全管理体系 规范》三个标准,建立并保持文件化的管理
体系,制定质量环境安全方针和目标,规定组织结构和职责,通过持续的 PDCA 过程循环,并依据
相关法律法规和其他要求,对本公司产品实现过程中影响质量的各个环节的环境因素、危险源进行有
效控制,持续改进管理体系的有效性。
- The company shall establish and maintain quality, environment and safety management systems and
realize the management by the Model of Processes.
本公司建立并保持质量环境安全管理体系,并以过程模式进行管理:
. The quality, environment and safety management systems are defined and divided to four processes:
management activities, resource management, operation control and measurement-analysis-improvement.
Each process can be divided to sub-processes, and processes and sub-processes are all operated based on
PDCA.
将质量环境安全管理体系确定为管理活动、资源管理、运行控制及测量、分析和改进四个过程进
行管理,四个过程均可进一步确定为相对较小的子过程。过程及其子过程均应用 PDCA 过程模式;
. In order to manage the processes, the company shall define the organization structure, responsibilities
of its each part and personnel of each level provide necessary resources and information including human
resources by training, recruiting or position-transferring, capital, infrastructure and communication, to
support operation of the processes.
通过管理活动过程,规定组织结构、各部门和各级人员的职责,实施培训、人员招聘和岗位调换,
适当的资金和设备设施的配置以及沟通过程,确保可以获得必要的资源和信息,以支持这些过程的运
行和对这些过程的监视;
. Monitor measure and analyze the processes by operation control, daily management and internal
audits, management review or other actions.
通过运行控制、日常管理、内审、管理评审等过程监视、测量和分析这些过程;
. Realize the process planning and continually improve the processes by taking corrective and
preventive actions.
通过实施纠正和预防措施,实现对这些过程策划的结果和对这些过程的持续改进。
Control of documents 文件控制
- Document control is under the centralized management of QMS, and each department shall manage
the documents in its responsibility scope according to PI-423-QMS-01 “Control of Documents” and
PI-421-QMS-01 “Requirement for Documents” in order to assure:
品保部对文件控制进行归口管理,各部门依据 PI-423-QMS-01 《文件控制》和 PI-421-QMS-01
《文件要求》对公司文件进行管理,以确保:
. to approve documents for adequacy prior to issue,
文件发布前得到批准,以确保文件是充分与适宜的
. to review and update as necessary and re-approve documents,
必要时对文件进行评审与更新,并再次批准;
. to ensure that changes and the current revision status of documents are identified,
确保文件的更改和现行修订状态得到识别;
. to ensure that relevant versions of applicable documents are available at points of use, 确保在使用处
可获得有关版本的适用文件
. to ensure that documents remain legible and readily identifiable,
确保文件保持清晰、易于识别;
. to ensure that documents of external origin are identified and their distribution controlled, and 确保外
来文件得到识别,并控制其分发;
. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if
they are retained for any purpose.
防止作废文件的非预期使用,若因任何原因而保留作废文件时,对这些文件进行适当的标识。
- The Approving and titles of this manual are different with other Process or work instructions
手册的审批及格式不同于其他文件的控制流程,具体如下
. Approval Procedure: The management representative will organize establishing the manual, and it
will be firstly checked by Document manager, secondly checked by department manager, then it will be
double checked by management representative, the last step is gotten the final approval from DGM and GM.
审批流程:手册的编写由管理者代表组织进行,由文件管理员进行初审,部门经理再次审核,然
后由管理者代表复审,最后一步是获得副总经理和总经理批准。
. Titles : All titles in the manual are written according to the titles in the iso9001:2008,
ISO14001:2004 and OHSAS18001:2007,not according to the titles in FS-421-QMS-01“Form Instruction
Document(Word)”
标题:手册的标题是根据 iso9001:2008, ISO14001:2004 and OHSAS18001:2007 的标题来写的,不
是根据 FS-421-QMS-01 指导类文件格式(Word)。
Control of records 记录控制
- Records derived from the operation of quality, environment and safety management systems shall be
controlled, to provide evidence of the effective operation of the systems and of continuing improvements of
quality, environment and safety.
通过对质量环境安全管理体系运行中形成的记录进行控制,为体系运行状况提供客观证据,为质
量环境安全改进提供依据。
- Each department shall manage the records in its responsibility scope according to PI-423-QMS-01
“Control of Documents”. When storing records, prevent records from losing or damaging.
各部门按照 PI-423-QMS-01《记录控制》对记录进行管理。贮存时,应做到防止记录的丢失和损
坏。
- A documented procedure shall be established to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records.
公司应编制形成文件的程序,以规定记录的标识、贮存、保护、检索、保留和处置所需的控制。
- Records shall remain legible, readily identifiable and retrievable.
记录应保持清阳、易于识别和检索。
5. Management responsibility 管理职责
Management commitment 管理承诺
- GM shall establish and organize to implement the suitable quality, environment and safety policies
and
objectives based on the corporation resources, internal and external environments, management status
and customer requirements or other factors, to realize the management commitment.
根据企业资源、内外部环境、安全管理现状、顾客需求等要素,总经理制定并组织贯彻实施适宜
的质量环境安全方针和质量、环境、安全目标,使管理承诺得到落实。
- Ensure the availability of resources. 保证资源的可获得性。
- Communicate to the company the requirements of customers and laws and regulations as well as their
importance.传达顾客要求和法律法规要求,以及其重要性。
Customer orientation 以顾客为关注焦点
- The company shall work in a customer-oriented way. The company objectives are based on customer
satisfaction, and the customer satisfaction degree could be confirmed by questionnaire.公司应以顾客为关
注焦点,公司目标是以顾客满意度为基准,并且顾客满意度可利用调查问卷来确认。
- The company shall determine the other interested parties’ requirements on environment and
occupational health and safety including government, employees and their families, contract parties,
non-employees, surrounding organizations or any others. Establish the quality, environment and safety
management systems and maintain their continuing effectiveness to lower the effects on environment and
occupational health and safety to reach the satisfaction of interested parties mentioned above.本公司识别其
他相关方的要求,包括政府、员工、员工家属、合同方、外来人员、周围企事业单位等在内的相关方
在环境、职业健康安全方面的要求,建立质量环境安全管理体系并保持有效性,以降低环境危害和职
业健康安全风险,达到相关方的满意。
. Communicate with interested parties especially the employees to understand their requirements on
occupational health and safety.
与相关方特别是本公司的员工良好沟通,了解其职业健康安全需求;
. Let the non-employees who enter XXX know the risks of environment and occupational health and
safety and controlling measures in the company.
对进入本厂的外来人员施加影响,使其了解本厂存在的环境和职业健康安全风险及其控制措施;
. Let any interested party realize the potential risks on environment and safety from its actions, and
regulate their own activities.
使相关方了解其活动带来的环境影响和安全风险,并规范自己的行为;
. When signing a contract, the company shall stipulate the terms on environment and safety to define
the environmental and safety responsibilities and commitments of two parties.
与合同方在环境/安全方面签订相关协议,明确双方的环境/安全责任和义务。
Quality environment safety policy 质量、环境、职业健康安全方针
- The quality environment and safety policy shall be established and implemented with the company
and meet the requirements of quality, environment and occupational health and safety requirements. 质量环
境职业健康安全方针要在公司内开展并实施。方针满足质量、环境、职业健康安全体系的要求。
- GM is responsible for organizing to establish, approving and issuing the policy.
总经理组织制定并批准、发布质量环境职业健康安全方针。
- The suitability of the policy shall be excluded in the management review, and update it as necessary
to ensure the policy meet the requirements of internal and external changes and customers and consist to the
company aim.
利用管理评审等机会对质量环境安全方针的适宜性进行评审,并在必要时进行修订,确保质量环
境安全方针能够适应公司内、外部条件的不断变化,达到与公司的宗旨、顾客的要求相适应。
- See details in 具体见
Planning 策划
environment Occupational health and safety objectives 质量环境职业健康与安全目标
- GM shall ensure the company establish and maintain the quality, environment and safety objectives in
the relevant levels, and the objectives shall include aspects related to product requirements. The objectives
include conformity to product requirements. The objectives include the content of the conformity to product
requirements.总经理确保在本公司的相关职能层次上建立并保持质量环境职业健康与安全目标,该目
标包括满足产品要求的内容。
. Objectives shall be measurable, and consist to the quality, environment and safety policies, and
distributed into relevant functions and levels.质量、环境、安全目标是可测量的并与质量、环境、职业健
康安全方针保持一致,并分解到相关的职能和层次;
. Every year, the management representative shall organize to establish the general objective, and the
annual objectives shall be submitted to GM for approval and distributed into relevant functions and levels.每
年由管理者代表组织制定总的目标,年度目标报总经理批准,并在相关职能层次上分解。
- Quality objectives, environmental objectives and targets, occupational safety objectives shall be
reviewed in the management review and updated as necessary.质量目标、环境目标和指标、职业健康安全
目标通过管理评审进行评审并在必要时予以更新。
- See details in 具体见
system planning 管理体系策划
- GM shall plan the quality environment and safety management systems to ensure:
总经理对质量环境安全管理体系进行策划,以确保:
. Quality environment and safety management systems conform to quality and safety objectives, and
environmental objectives and targets, and all processes be identified and managed in the process model of
PDCA.质量环境安全管理体系满足质量、安全目标、环境目标和指标的要求,对所有的过程进行识别
并按照过程模式进行 PDCA 管理。
. The integrity of the management systems shall be maintained when changes to the management
systems are planned and implemented.在对管理体系的变更进行策划和实施时,保持管理体系的完整性。
planning of identification, evaluation and update of environment aspects.
环境因素识别、评价、更新控制的策划
- Environment protection is also one of the company focuses, and the company determines the potential
environment aspects and control the potential effects resulted from the aspects.本公司以环境保护为关注焦
点,对公司可能产生的环境因素进行识别,并对环境因素进行对可能对环境造成影响的因素加以控制。
- Determination and evaluation shall be conducted once a year, and updated as necessary.
对环境因素的识别与评价每年进行一次,必要时可随时更新。
- See the requirement details in PI-431-QMS-01 “environmental factors identification and assessment
control procedures”
具体要求见 PI-431-QMS-01《环境因素识别与评价控制程序》
of hazard determination and risk evaluation and control
危险源辨识、风险评价和风险控制的策划
- Occupational health and safety is one of the company focuses, and the company determines hazards
and conducts risk evaluation, and takes measures to control the determined middle and heavy hazards. 本公
司以职业健康安全为关注焦点,对可能产生的危险源进行识别,并对危险源进行风险评价,对评价出
的中等和重大危险源采取措施进行控制,预防发生事故。
- See the requirement details in PI-446-QMS-01 “Safety Management System”.
具体要求见 PI-446-QMS-01 安全管理制度
and regulatory requirements and others 法律法规和其他要求
- QMS is responsible for organizing to produce the list of applicable requirements from laws,
regulations and other aspects, and keep the requirement documented and update them timely. Review on
conformity to laws, regulations and standards shall be conducted once a year, and communicate to
employees and other interested parties the information arising from the review. 品保部负责组织建立适用
于公司的法律法规及其他要求清单,保管法律法规及其他要求文本,并及时更新有关法律法规和其他
要求。对法律法规及标准的遵循情况每年评审一次,并将这些信息传达给员工和其他相关方。
- See the requirement details in PI-432-QMS-01“Legal and other requirements control procedures”. 具
体要求见 PI-432-QMS-01《法律法规和其他要求控制程序》
and safety management program 环境、安全管理方案
- The company shall establish and maintain the environment and safety management program to realize
the environment and occupational health and safety objectives, including:
本公司建立并保持环境、安全管理方案,以实现环境、职业健康安全目标,其中应包括:
. Environmental objectives and targets, and occupational health and safety objectives;
环境目标和指标、职业健康安全目标;
. Responsibility and authority for realizing the environment and occupational health and safety
objectives;为实现环境、职业健康安全目标所赋予的有关职能的职责和权限;
. Method, budget and schedule for realizing the objectives.
实现目标的方法、预算费用和时间表。
- QMS conducts review on the environment and occupational health and safety management programs,
at planned intervals, and revises the program according to the new project or changes of activities, products,
services and running conditions to ensure their suitability.本公司定期在计划时间间隔内由品保部对环境、
职业健康安全管理方案进行评审,必要时针对企业新项目及活动、产品、服务或运行条件的变化对环
境、职业健康安全管理方案进行修订,以确保其适应性。
- QMS is responsible for organizing to establish the programs which shall be examined and verified by
the management representative and approved by GM.
管理方案由品保部负责组织编制,管理者代表审核,总经理批准。
Responsibility, authority and communication 职责、权限、协商与沟通
, authority 职责与权限
- General management shall ensure that the responsibilities and authorities are defined and
communicated within the company. The responsibility and authority organization refers to the organization
structure”.
总经理管理层应确保组织内的职责、权限得到规定和沟通。各部门职责具体见组织结构图。
representative 管理者代表
- See details in .具体见 .
, participation and consultation 信息沟通、参与和协商
- External Communication 外部协商与沟通:
. LOG is responsible for information exchanges with customers to meet their demands. For the
disposition of the information (including complaints, suggestions, etc.) from customers, relevant
departments find out reasons and formulate measures, and QMS solves them or gives feedback.物流部负责
与顾客的信息联络,以满足顾客要求。对来自顾客的信息(包括投诉、建议等)的处理,由相关部门
找出原因,制定措施,由品保部解决或答复。
. PUR is responsible for negotiating and communicating with suppliers, and timely pass on the
information to relevant departments.采购部负责供应商的协调和沟通。并及时将信息传递给相关部门。
. QMS is responsible for negotiation and communication on environment and safety. QMS is
responsible for collecting information of motoring, inspection and feedback from external agencies in the
aspects of local environment and safety and passing on the information to relevant departments. In case that
the monitoring or inspection results are non-conformity, QMS shall issue written report, report to superiors
and top managements, and dispose it as required.品保部负责地方环境、安全方面外部机构的监测、检查
结果及反馈信息的收集,由品保部及时传递到公司相关部门,当监测或检查的结果出现不符合情况时,
由品保部写出书面报告,报上级部门及公司领导,并按要求进行处理。
. For others aspects except the two mentioned above, each department is responsible for negotiation and
communication of information in its responsibility scope.
其他方面各部门负责本部门工作范围内信息的协商和沟通。
- Information can be passed by means of written data, records, discussions, electronic media,
audio-visual apparatus and communication, etc.
信息可采用书面资料、记录、讨论交流、电子媒体、声像设备、通讯等方式予以传递
- Internal Communication 内部沟通
. With regard to employee safety, employee representative is responsible for consulting and
communicating with QMS. 员工安全方面由员工代表和品保部负责进行协商和沟通。
. With regard to environment, OFE is responsible for consulting and communicating with each
department.环境方面由综合部负责与各部门进行协商和沟通
- Company encourages its employees to feedback their opinion or suggestion to management
公司鼓励员工将他们的想法和建议反馈至有关管理层。
- Computer network has been setup and MIS has also been setup, employees who has the computer
could use their account to access the latest and issued documents in MIS.
计算机网络已经搭建,MIS 系统也被建立起来,员工可以通过他们的账号 MIS 获得最新的释放
的文件。
Management review 管理评审
总则
- The company shall review the company’s quality environment and safety management systems, at
planned intervals, to ensure their continuing suitability, adequacy and effectiveness. QMS is responsible for
organizing the management review.公司每年按策划的时间间隔组织管理评审确保质量环境安全管理体
系的持续适宜性、充分性和有效性。由品保部负责组织管理评审。
input 管理评审的输入
- QMS review content 质量管理体系评审内容
. Audit results:external and internal audit 审核结果:外审及内审结果;
. Customer feedback:Customer satisfaction and customer complaint; 顾客反馈:顾客满意度以及顾
客投诉;
. Process performance and product conformity: the extent to which objectives and targets have been
met,Whether a product comply with customer requirements, laws and regulations, etc.;过程的绩效和产品
的符合性:目标指标的完成情况,产品是否符合顾客的要求、法律法规的要求等;
. Status of preventive and corrective actions;预防措施和纠正措施的状况;
. Follow-up actions from previous management reviews;以往管理评审的跟踪措施;
. Changes that could affect the quality management system 可能影响质量管理体系的变更;
. Recommendations for improvement.改进的建议。
- EMS review content 环境管理体系评审内容
. Results of internal audits and evaluations of compliance;内部审核和合规性评价的结果;
. Communication from external interested parties, including complaints;来自外部相关方的交流信息,
包括抱怨;
. The environmental performance of the organization;组织的环境绩效;
. The extent to which objectives and targets have been met;目标和指标的实现程度;
. Status of corrective and preventive actions;纠正和预防措施的状况;
. Follow-up actions from previous management reviews;以前管理评审的后续措施;
. Changing circumstances, including developments in legal and other requirements related to its
environmental aspects;
客观环境的变化,包括与组织环境因素有关的法律法规和其他要求的发展变化;
. Recommendations for improvement.改进的建议。
- OHSAS review content 职业健康安全管理体系评审内容
. Results of internal audits and evaluations of compliance with applicable legal requirements and with
other requirements to which the organization subscribes;
内审的结果,以及组织应遵守的适用的法律法规和其他要求符合性评价的结果;
. The results of participation and consultation;参与和协商的结果;
. Relevant communication(s) from external interested parties, including complaints;
与外部相关方的相关沟通信息,包括投诉;
. The OHSAS performance of the organization;组织的 OHSAS 绩效;
. The extent to which objectives have been met;目标指标达成的程度;
. Status of incident investigations, corrective actions and preventive actions;
事件调查、纠正措施与预防措施的状态;
. Follow-up actions from previous management reviews;先前管理评审的跟踪措施;
output 管理评审的输出
- After the review, QMS shall immediately draw the management review report, and for the problems
detected in the review, the responsible department shall plan corrective actions which shall be submitted to
QMS for collection and verified by QMS.
管理评审后,品保部及时组织编制管理评审报告,评审中提出的问题,相关部门制定整改计划,
有品保部进行汇总,并且品保部负责对整改措施及实施效果进行验证。
6. Resource management 资源管理
Provision of resources 资源提供
- The company shall determine and provide resources necessary for ensuring conformity to customer
satisfactory and environmental requirements, reducing occupational injuries, implementing and maintaining
quality, environment and safety management systems and continuingly managing and improving their
effectives. To realize the provision, each department shall establish the resource demand plan based on the
real need, plan budget, including human resources, infrastructure and environment, etc, and submit the both
to the supervisor for check and GM for approval and then implement the plan. In the case of unsuitability of
any resource or that any resource cannot be applied, GM shall decide the solution. 公司应确定并提供确保
顾客满意、符合环境要求、减少职业病危害和实施、保持质量环境安全管理体系并持续改进其有效性
所需的资源,并对资源进行有效的管理。为此,各部门根据实际需要制定资源需求计划,编制预算,
包括人力资源、基础设施与设备、工作环境等方面,报分管领导审查,总经理批准后实施。当资源出
现不适用时,由总经理解决。
Human resources 人力资源
总则
- GM is responsible for planning and deploying the human resources, and HRM allocates and
distributes the employees.总经理负责对人力资源实施决策与配置,人力资源部门依据决策意见实施定
岗定员与人员调配。
- HRM is the responsible department for human resources management, and organizes and allocates the
human resources.
人力资源部门是人力资源的归口管理部门,负责人力资源调配工作的组织管理。
, awareness and training 能力、意识和培训
- HRM organizes all departments to determine the necessary competence for personnel performing
work affecting conformity to product quality, environment and safety, and establish the “Job Description”
for the main basis of selecting, employing and arranging personnel.人力资源部门组织各部门确定从事影
响产品质量环境安全工作人员所必需的能力,制定《职责描述》,作为选择、招聘、安排人员的主要
依据。
- Measures such as the job training, as the main method, competition, technique race, establishment of
shift and others are taken to ensure the employees qualified for their jobs with the essential knowledge,
skills, experience and competence, and maintain improvement of all the aspects.公司以采取为员工提供岗
位培训作为主要手段,并通过其它诸如岗位竞争、技术比武、班组建设等措施,确保员工具备相应的
岗位知识、技能、经验和能力素质,并得以持续提高。
- All trainings shall be conducted according to PI-622-HRM-01 “Training Management Regulation”. 公
司培训等按照 PI-622-HRM-01《培训管理规定》执行。
Infrastructure 基础设施
设施范围
- The infrastructure necessary for product realization includes workspace (factory, office and
warehouse), buildings, equipment and tools, software, supporting services (such as transport,
communication information systems).公司为实现产品所需的基础设施,包括工作场所(车间、办公场
所、生产厂房、产品库房等)、设备和工具、软件、支持性服务(运输、通讯和计算机网络)等。
provision 设施的提供
- Each department shall draw the equipment application plan, and implement the plan with the approval
of GM and DGM.各部门根据需要编制设施申请计划,经副总经理和总经理审批后,由相关部门按照
有关规定执行。
, maintenance and repair of equipment 设施的使用、维护和保养
- TEF is responsible for controlling the usage, maintenance and repairing of factory, equipment and
tools to ensure meeting requirements.
设备部对厂房、生产设备、工具的使用、维护和保养进行控制,确保满足需要。
- Software and electronic supplies are maintained and repaired by OFE.
办公软件、生产使用的软件、电子产品由综合部负责维护和保养。
- Fire extinguishers and hydrants are maintained and repaired by TEF.
灭火器、消防栓由设备部负责维护和保养。
Work environment 工作环境
- The temperature and humidity shall be controlled according to the requirements of products and
material. See details in FS-640-QMS-01 “Environment Requirements for Storage Shelf-life of Materials”.
公司的温湿度根据产品和原材料的要求进行控制。由设备部负责控制公司的温湿度。具体见
FS-640-QMS-01 《原材料的保存环境和保质期要求》
- The company shall provide good work conditions for production and management. All departments
shall identify and manage the factors related to personnel and articles affecting conformity to product
requirements, and determine and provide essential infrastructure to meet production requirements and create
the good occupational health and safety environment, including:公司要给员工提供良好的工作条件。各有
关部门识别并管理为实现产品符合性所需的工作环境中人和物的因素,根据生产作业需要,负责确定
并提供作业场所必须的基础设施,创造良好的职业健康安全工作环境,包括:
. Provision of applicable workspace and equipment, and maintenance and repair according to
production requirements.
配置适用的生产、办公场所和设施并根据生产需要适当维护、维修;
. Provision of essential ventilation and air-condition equipment, and maintaining of appropriate
temperature and humidity to ensure the occupational health and safety of employees. 配置必要的通风、空
调设备,保持适宜的温度、湿度,保证职工身体健康和人身安全;
. All equipment in the workshop shall be managed at the fixed places, and kept clean and in order. 车间
设施实行室内定置管理,保持清洁卫生、排列整齐有序;
- OFE is responsible for organizing cultural and recreational activities to enrich employees life,
promote the spiritual civilization construction, to create a humanity environment of demonstrating personnel
values of employees and developing the teamwork spirit.综合部组织文化娱乐活动,丰富职工业余文化生
活,搞好精神文明建设,提供充分体现个人价值的人文环境,使员工树立良好的团队精神。
7. Product realization and operational control of environment and safety
产品实现与环境、职业健康与安全运行控制
Planning of product realization 产品实现的策划
- The company shall ensure that its products meet customer requirements.
公司应保证其所提供的产品在各方面均满足顾客要求。
- The company shall plan the product realization process, including purchase, production, packing,
transport, delivery and service after delivery, etc.
公司应针对产品的实现过程进行策划,包括采购、生产、包装、运输、产品交付、售后服务等。
Customer-related processes 与顾客有关的过程
of requirements related to the product 与产品有关的要求的确定
- LOG and Warehouse shall identify the customer requirements on products by collecting customer
feedback information and analyzing the customer order requirement such as contract draft or oral order, etc,
and records arising from the process shall be maintained. Product requirements includes: 物流&仓储部通过
收集顾客信息反馈、分析顾客订货要求,如合同草案及口头订单等渠道识别顾客对公司产品的有关要
求,并保存相关记录。产品要求主要有:
. Product requirements stated by customers, including quality, environment and safety requirements and
usability, delivery, supporting service (such as transport, training etc) and price,顾客明示的产品要求,包括
产品质量环境安全要求及涉及可用性、交付、支持服务(如运输、培训等)、价格等方面的要求;
. Requirements not stated by customers, but necessary for specified or intended use, where known, 顾客
没有明确的要求,但预期或规定的用途所必需的产品要求;
. Compulsive national standards related to product, environment and safety, and statutory and
regulatory requirements 与产品、环境、安全有关的国家强制性标准及法律法规的要求;
. Any additional requirements considered necessary by the company.
公司确定的其它附加要求。
- Relevant department shall determine the compulsive national standards, laws and regulations in
relation to their responsibility scope, and submit the updated version or new standards and laws and
regulations to QMS.
相关部门收集职能管理范围内相关的国家、国际标准及法律法规,并及时将最新的传递给品保部。
of requirements related to the product 与产品有关的要求的评审
- Before acceptance of contract and order, LOG shall organize related departs to review contracted
product requirements according to identified customer requirements and additional requirements considered
necessary by the company, to ensure that
在接受合同或订单之前,物流部根据已识别的顾客要求及公司确定的附加要求组织相关部门对合
同的产品要求实施评审,确保:
. Requirements of product, including those from customers and additional requirements considered
necessary by the company, and environment and occupational health and safety have been defined and
enter into contract or other written official file,
产品要求(包括顾客的和公司自行确定的要求)、环境及职业健康安全要求得到明确规定,并形
成合同等书面文件;
. Any requirement not in written form such as oral order, shall be verified before acceptance of contract
or order,
顾客没有以文件形式提出的要求(如口头订单)要在接受合同或订单前得到确定;
. Contract or order requirements differing from those previously expressed are resolved
与以前表述不一致的合同或订单的要求已予以解决;
. The company has the ability of meeting customer requirements through effective planning. 证实公司
有能力通过有效的策划满足顾客对产品的各种要求。
- During reviewing, to any question raised or recommendation of modification by reviewer in relation
to product requirements, LOG shall communicate with customers to obtain their opinion in written.在评审
过程中,评审人员对产品要求中有关内容提出问题或修改建议时,由物流部负责与顾客联系,征求其
书面意见。
- During performance of contract, any change on contract item, delivery quantity or delivery term, shall
be communicated to customers by LOG to define the supplementary agreement, and review twice as
necessary, and ensure that the files applied for reviewing are updated with changes.合同执行中,合同条款
或交货数量、交货方式发生变化时,物流部负责与顾客协商,制定补充协议。必要时重新评审,并使
相应的评审文件得到修改。
- LOG is responsible for organizing the review of product information such as catalog, product
advertisement content released to outside.
物流部负责组织对向社会公开发布的公司产品信息(如产品目录、产品广告内容等)进行评审。
communication 顾客沟通
- LOG is responsible for communication with customers, including product information, modification
of contract or order, feedback etc.
物流部负责与顾客的沟通。包括产品信息、合同或订单的修改、顾客反馈等。
in other interested parties 与其他相关方的信息交流
- The company shall determine and execute communication to other external interested parties the
following information: 本公司在以下方面确定并实施与其他外部相关方的信息交流:
. Quality, environment and safety policies, objectives and status,
质量环境安全方针、目标及其现状;
. Environment and occupational health and safety risks from external interested parties and appropriate
controlling actions,
外部相关方面的环境、职业健康安全风险及相应的控制措施;
. Conformity to laws and regulations on environment and occupational health and safety
相关环境、职业健康安全法律法规的遵循情况;
. Information communication in the case of emergency or accident.
紧急情况或事故状态下有关的信息交流。
Design and development 设计和开发
- New products design and development follows the specific requirements in PI-730-ENG-02_01
Design and Development Control Program.
公司对新产品进行设计和开发,具体要求见 PI-730-ENG-02_01 Design and Development Control
Program 设计和开发控制程序
Purchasing 采购
process 采购过程
- The company establishes and implements PI-741-PUR-01 “Management Regulations of Purchasing
Control” to control the purchasing process and ensure the conformity of the purchased product to
requirements.公司制定并实施 PI-741-PUR-01《采购控制管理规定》,对采购过程实施控制,确保所采
购的产品符合规定要求,满足公司生产经营需要。
- All suppliers shall be evaluated according to PI-741-PUR-02“Supplier Evaluation Criteria”, and only
the qualified supplier will be registered in the “Supplier List” and those unqualified will have no opportunity
to supply materials.对供方的评价按照 PI-741-PUR-02《供方评价准则》进行,合格列入《供方名单》,
不合格不列入供方名单,不进行采购。
information 采购信息
- Each department shall draw its purchase plan, including article, specification, quality standard,
quantity and planned date of starting using the articles. PUR shall implement the purchasing plan with the
approval of management layer according to the purchasing plan requirements.采购计划由各使用部门提出,
采购计划应包括采购物资的名称、规格型号、质量标准、采购数量及用货时间等。采购部根据采购计
划的要求经管理层审核后,进行采购。
- Establish and maintain process (es) for important environment aspects and occupational health and
safety risks from articles, equipment and services identified in the duration of their purchasing and using,
and communicate to suppliers and contract parties the process (es) and relevant requirements. PUR
maintains and manages the records arising from supplier evaluation and purchasing processes.
对于购买和使用的货物、设备和服务中已识别的重要环境因素和职业健康安全风险, 建立并保持
程序,并将有关的程序和要求通报供方和合同方。采购部对供方评价和采购过程中所形成的记录进行
管理、保存。
of purchased product 产品的验证
- When the purchased product arrives in XXX, the employees in charge of inspection or verification
shall conduct inspection or verification to the materials or accessories. Any product detected as
nonconformity shall be handled according to PI-830-QMS-01 “Control of Nonconforming Products”. 采购
的物资购进公司后,由检验或验证人员依据检验规范进行检验或验证,如不合格,按 PI-830-QMS-01
《不合格品控制程序》执行。
- The acceptance of purchased product under concession shall be agreed and approved by Quality
Manager, DGM and GM.
如果采购的产品让步接收,需由质量经理或副总经理、总经理签字同意。
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
of production and service provision 生产和服务提供的控制
- MFG is in charge of overall management of production process, TEF production equipment, ENG
production technology and LOG service process.生产部负责生产过程的归口管理;设备部负责生产设备
的归口管理;技术部负责工艺技术的归口管理;物流部负责服务过程的归口管理。
control of environment and occupational health and safety
环境、职业健康与安全的运行控制
- The environmental and OHSAS operation shall be monitored by QMS department ,each department
manager has the responsibility to ensure all the activities within its department is under control.品保部负责
环境和职业健康安全运行情况进行监督, 每个部门经理负责在部门内部的所有活动处于控制中。
- Occupational Safety Team shall conduct evaluation to hazards in the company, take protective actions
to the significant hazards , and establish the occupational health and safety management program to
control the identified significant hazards.
安全小组针对公司存在的危险源进行评价,对评价出的重要危险源采取措施进行防护。对于评价
出的重大危险源制定职业健康安全管理方案进行控制。
- QMS shall conduct evaluation to environmental aspects in the company, take actions to reduce
injuries from the evaluated Middle-level aspects, and establish the environment management program to
control the evaluated Heavy-level aspects.
品保部对公司的环境因素进行评价,对于评价出的中等环境因素采取措施减少危害,对于评价出
的重大环境因素制定环境管理方案对其进行控制。
preparedness and response 应急准备和响应
- The company shall develop appropriate emergency-response plan based on its real situation, and
establish the Occupational Safety Team to handle the emergencies and accidents to reduce loss arising from
the emergencies and accidents.公司根据本公司的实际情况制定相应的应急预案,成立安全小组。对于
突发的事故进行处理,以便于减少公司 的损失。
- The company shall coordinate the emergency materials and the Occupational Safety Team shall
examine the materials regularly.
公司根据需要配置相应的应急物资,安全小组负责对应急物资进行检查。
of processes for production and service provision 生产和服务提供过程的确认
- There is no Special Process in the company.本公司的产品为固定生产流程,无特殊规程。
and traceability 标识和可追溯性
- The company shall classify and indentify finished and semi-finished products by using appropriate
marks.本公司对产品、半成品进行明确分类和标识。
. Product identification: During production, each semi-finished or finished product shall be clearly
identified by MBZ. The materials shall be identified by stored in the designated areas.产品标识:生产过程
中,每个半成品、成品用《生产工艺流转单》进行标识。原材料采用划分区域进行标识。
. Identification status of inspection: the three status “conformity” “Uninspected” and “unconformity”,
and marking methods including labels, area designation, recording etc, can be used to prevent unintended or
mixed use of different types of products or semi-finished products.检验状态标识:检验状态标识主要包括
“合格”、“待检”、“不合格”三种,标识方法采用标牌、区域划分、记录等形式防止不同状态的产品混用
或误用。
. Traceability: it can be realized through label, marks and MBZ.
可追溯性:根据公司标识、产品流转单来实现产品的追溯。
property—face to face negotiation 顾客财产
- Customer property includes production materials and equipment attachments and technical materials
etc.
顾客财产是指由顾客提供的各种原材料、设备配件、技术资料等。
- The production materials provided by customers shall be inspected by QMS, stored by Warehouse,
and protected by other involved departments in the duration of using.
顾客提供的原材料有品保部进行检验,仓库进行存储,其它各部门负责其顾客财产的防护和使用。
- Technical materials shall be listed in the external document list and be recorded and controlled for
secret information by document manager. These information and materials can’t be released to, leaked to or
copied by the outside without the agreement and authority by customer.对于顾客的技术资料由文件管理
员登记在《外来文件清单》中,并进行保密控制,未经顾客书面允许,不得向外界泄露、复制。
- Strictly control customer property which cannot be handled unless with the agreement and authority
of customer. If any customer property is list, damage or otherwise found to be unsuitable for use, the
company shall report this to the customer and maintain records.
对于顾客财产要严加控制,未经顾客同意不得作任何处理,若有异常现象,如顾客财产发生丢失、
损坏或发现不适用情况时,应及时反馈给相关领导,以便与顾客协商处理。
of product 产品防护
- The company shall preserve the product during internal processing and delivery to the intended
destination before acceptance of customer in order to maintain conformity to requirements. The preservation
taken by the company includes identification, handling, packing, storage and protection.
从内部处理和送至顾客交付地点由顾客接收之前,公司应对产品进行防护,确保产品符合要求,
这些防护措施包括标识、搬运、贮存、包装和防护。
. Handling: In the different stages of internal processing and delivery, appropriate handling equipment
and methods are using with according to characters and statuses of each stage to prevent hitting or damaging
and to ensure the safety of product, employees and equipment.搬运:在生产和交付产品的不同阶段,应根
据产品的特点,选用适当的搬运设备及搬运方法,搬运过程中防碰撞,确保产品、人员、设备的安全。
. Storage: Raw materials shall be stored according to the storage requirements, such as controlling the
warehouse temperature and humidity.
贮存:原材料根据原材料的储存要求进行储存,控制仓库的温度和湿度。
. Packing: The carton is chosen to pack the product according to customer requirement and product
character. 包装:根据顾客要求和产品特点,本公司的产品采用纸箱包装。
. Protection: Products shall be protected from collision, fire and damage during internal processing and
delivery to the intended destination before acceptance of customer.保护:从原材料、半成品、成品直至交
付,由顾客接收前,公司应采取措施防碰撞、防火、防损坏等。
Control of monitoring and measuring devices 监视和测量设备的控制
- TEF is responsible for developing the calibration plan of monitoring and measurement equipment
based on the requirements of customer, laws and regulations, and commissioning an external organization to
execute the calibration according to the plan.
设备部对公司监视和测量设备根据顾客要求、法律要求等制定检定计划,按照计划的要求委托外
部机构对监视和测量设备进行校准。
- The calibration will be executed by an external qualified organization.
校准均由有资质的机构进行。
- TEF shall conduct regular examination to the monitoring and measuring equipment to prevent the
using of nonconforming equipment.
设备部定期对监视和测量设备进行检查,防止不合格的监视和测量设备的使用。
8. Measurement, analysis and improvement 测量、分析和改进
General 总则
- The company shall plan and implement the monitoring, measurement, analysis and improvement
processes needed 本公司策划并实施以下方面所需的监视、测量、分析和改进过程:
. To demonstrate conformity to product requirements,证实产品的符合性;
. To ensure conformity of the quality, environment and safety management systems, and
确保质量环境安全管理体系的符合性;
. To continually improve the effectiveness of the quality, environment and safety management systems,
including determination of applicable methods (including statistical techniques), and the extent of their use,
and 持续改进质量环境安全管理体系的有效性,包括对统计技术在内的适用方法及其应用程度的确
定;
. To ensure the monitoring and measurement to environment and safety performance.
环境及安全绩效测量和监视。
Monitoring and measurement 监视和测量
satisfaction 顾客满意
- LOG is responsible for collecting, arranging, analyzing, handling and communicating the information
on customer satisfaction and maintaining relevant records.
物流部负责收集、整理、分析、处理并传递顾客满意程度的信息,并保存相关记录。
- LOG shall take corrective and preventive actions in regard to customer satisfaction, and review its
effectiveness.
物流部针对顾客满意程度情况,采取纠正或预防措施,并评审其有效性。
audit 内部审核
- The company shall establish and implement PI-822-QMS-01 “Internal Audit Control Procedure”,
define procedure and method of the internal audit, and conduct it according to the planned arrangement to
realize the monitoring and measurement to processes of the quality, environment and safety management
systems, and to ensure the effectiveness of the systems and their continuing improvement.公司制定并执行
《内部审核控制程序》,确定审核的过程和方法,并按照策划的方案进行内部审核,以对各项质量环
境安全管理过程进行监视和测量,确保质量环境安全管理体系的有效性,并不断地实现持续改进。
and measurement of processes 过程的监视和测量
- The company shall use appropriate methods to monitor and measure, as necessary, all processes of the
quality, environment and safety management systems. Monitoring will demonstrate the ability of the
processes to achieve planned results. For those that fail to achieve the planned result, corrective and
preventive actions shall be taken to ensure its conformity to requirements.本公司采用适宜的方法对质量环
境安全管理体系过程进行监视,并在适用时进行测量。通过监视方法的实施,以证实过程实现所策划
的结果的能力。当未达到所策划的结果时,采取适当的纠正和纠正措施,以确保符合性。
and measurement of product 产品的监视和测量
- All products shall be inspected by MFG, and sampling-inspected by QMS.
公司的产品由生产部进行全部检查,品保部进行抽检。
- QMS is responsible for establishing standards or criteria for all inspections, and MFG shall conduct
inspection to products according to those standards or criteria.
品保部负责编制各类产品的检验标准,生产部依据检验标准对产品进行检验。
- Authorized inspection employees shall conduct inspection to semi-finished or finished products by the
standards and criteria and determine statuses of conformity or nonconformity.
经授权的检验人员按产品标准及检验规范对负责的半成品、成品进行检验,并判定合格与否。
- The company shall not conduct emergency release to products. Any product without inspection
cannot be warehoused.
公司不对产品实行紧急放行。未经检验的一律不得入库、使用或交付。
and measurement of environment and safety 环境/安全项目的监视和测量
- QMS is responsible for drawing the monitoring regulation of environment and safety, defining the
monitoring positions, program and methods, implementing internal measuring to environment and safety,
and checking and verifying regularly the conformity of results to the requirements of environmental targets.
品保部组织编制本公司环境、安全监测规程,明确监测点、监测项目、监测方法等,实施内部测量,
并负责定期监测、验证是否达到了环境指标的要求。
- For the monitoring and measurement of environment and safety that need to entrust an external
institute, QMS shall assign and connect with an institute to conduct the external monitoring and
measurement according to the applicable frequency.
需外委监测的环境、安全项目,由品保部根据监测频次定期委托外检。
of compliance 合规性评价
- The company shall identify, collect, review, communicate the applying laws, regulations and
requirements, and determine the compliance. QMS is responsible for organizing relevant departments to
review the compliance annually. The review shall be conducted before the management review to determine
the realization of the compliance commitment.本公司对公司适用的法律法规及其他要求的识别、收集、
评审、传达、遵循情况由品保部组织各部门进行评价,一般每年评价一次,在管理评审前进行,以证
实公司对合规性的承诺。
Control of nonconforming product and nonconformity 不合格产品及不符合的控制
of nonconforming Products 不合格产品的控制
- The company shall ensure that product which does not conform to product requirements is identified
and controlled to prevent unintended use or delivery. QMS is responsible for managing the nonconforming
products. The responsibilities and authorities to control review and handle the nonconforming product are
defined PI-830-QMS-01 “Control of Nonconforming Products”. 本公司确保不符合产品要求的产品得到
识别和控制,以防止其非预期的使用或交付。品保部为不合格品的管理部门,不合格品控制以及不合
格品评审处置的有关职责和权限在 PI-830-QMS-01《不合格品控制程序》中予以规定。
Occupational health and safety Incident investigation 职业健康与安全事件调查
- The investigation and disposition of occupational health and safety incidents are in accordance with
PI-453-QMS-01 “Accident, Incident, Nonconformity Control Procedures Implementation”.
职业健康与安全事件的调查和处理按照 PI-453-QMS-01 《事故、事件调查、不符合控制程序执
行.》
of nonconformity 不符合的控制
- The company takes the following actions to handle accident and nonconformity:
本公司对于发生的事故,要采取如下措施:
. Handling and investigation to accidents and nonconformity,
处理和调查事故、事件、不符合;
. Taking action to eliminate the effect of accident and nonconformity
采取措施减小因事故、事件、不符合产生的影响;
. Taking corrective and preventive actions, and reach the planned target,
采取纠正与预防措施,并予以完成;
. Verification of the effectiveness of corrective and preventive actions, and
确认所采取的纠正和预防措施的有效性;
. Before implementation, the corrective and preventive actions shall be evaluated in the respect of
environmental impact and reviewed in the respect of risk control.
对于所拟订的纠正和预防措施,在其实施前应先通过环境影响评价和风险控制过程进行评审。
- Actions for correcting or preventing nonconformity and eliminating its cause shall be appropriate to
the seriousness of the nonconformity, arisen environmental impact and occupational health and safety risk.
任何旨在消除实际或潜在不符合的原因而采取的任何纠正和预防措施,都应与问题的严重性和伴随的
环境影响以及职业健康安全风险相适应。
- As to any change of documents arising from corrective and preventive actions, all departments shall
implement the updated documented processes and maintain relevant records.
对于纠正与预防措施所引起的对程序文件的任何修改,相关部门均应遵照实施并予以记录。
Analysis of data 数据分析
- The company shall determine, collect and analyze appropriate date to demonstrate the suitability and
effectiveness of the quality, environment and safety management systems, and to evaluate where continual
improvement of the effectiveness of the systems can be made.
收集和分析适当的数据,以确定质量环境安全管理体系的适宜性和有效性,并识别可以实施的改
进。
- QMS is responsible for collecting and analyzing the data from product quality, environment, safety,
material inspection and internal audit,
品保部负责收集产品质量方面、环境方面、安全方面、原材料检验方面、内审方面的信息并进行
分析;
- PUR the date from suppliers, 采购部负责收集供方方面的信息并进行分析;
- LOG the data from customers, 物流部负责收集顾客方面的信息并进行分析;
- MFG the date from production process control and capacity,
生产部负责收集车间过程控制、产量方面的信息并进行分析;
- TEF the data from equipment and measurement.
设备部负责收集设备方面、计量方面的信息并进行分析。
Improvement 改进
improvement 持续改进
- The company realizes the continual improvement through the establishment of quality, environment
and safety policies objectives and targets, data analysis, daily monitoring and inspection, internal audit,
management review and preventive-& corrective actions.
公司通过建立质量环境安全方针,制定质量、安全目标、环境目标和指标管理方案,通过数据分
析、日常的监督检查、内审、管理评审以及实施纠正和预防措施等活动,进行持续改进。
action 纠正措施
- The company shall take action to eliminate the causes of nonconformities to the quality, environment
and safety management systems and requirements on product, environment and safety, and prevent the
recurrence of the nonconformities to realize the continual improvement of quality, environment and safety.
为消除已存在的影响质量环境职业健康与安全管理体系和产品、环境、安全不符合的原因,并防止类
似不符合的再发生,实现持续的质量环境安全改进。
- After implementation of corrective action, the effect shall be determined. If the previous action has no
or less effect, new action shall be taken until the effect reaches the planned arranged and the
nonconformities don’t reoccur. 纠正措施实施完毕,应对效果进行检查,效果不明显或无效的,重新
采取纠正措施,直至有效,确保不合格不再发生。
action 预防措施
- The information supporting the preventive action can be sourced from:
预防措施的信息来源
. The external and internal audit reports on quality, environment and safety management systems,内、外
部质量环境安全管理体系审核报告;
. Management review report,管理评审报告;
. Market information, including service, report and customer intention,
市场信息,包括服务、报告、顾客意向等;
. Experiences and lessons,同行业的经验教训;
. Production techniques, equipment operation and quality record such as quality inspection.生产工艺、
设备操作、检验等质量记录;
. Customer satisfaction survey and feedback from customers,
顾客满意度调查及反馈方面的信息;
. Information from other sources.其它。
- As appropriate, prevention action shall be taken to eliminate causes of nonconformities to ensure the
effectiveness continual improvement of quality, environment and safety management systems. 针对潜在的
不符合原因,采取适当的预防措施,避免不符合的发生,确保质量环境安全管理体系的有效性,实施
持续的质量环境安全改进。