IRIS手册
江苏经纬斯柯达电气有限公司质量手册SKE Quality Manual
质量管理体系指南
A guide to IRIS
Revision Log
1.0 引言Introduction
2.0 适用范围及引用文件Applicable scope, Reference documents
3.0 质量手册介绍Introduction to the quality manual
4.0 质量管理体系要求Quality management system requirements
5.0 管理职责Management responsibility
6.0 资源管理Resources management
7.0 产品实现Product realization
8.0 测量、分析和改进Measurement, analysis and improvement 附录
1.1 公司简介Company introduction
江苏经纬斯柯达电气有限公司（以下称SKE）是由江苏经纬轨道交通设备有限公司与斯柯达电气有限公司共同出资在中华人民共和国江苏省苏州市组建的中外合资企业。合资双方于二零一零年九月签订了合资合同。
Jiangsu Skoda-Kingway electronic Co., Ltd. (SKE) is established in Suzhou, Jiangsu, P. R. China. SKE is a joint venture between Jiangsu Kingway Railway communication equipment Co., Ltd. and Skoda Electronic. The Joint Venture Contract was signed by both parties in September 2010.
SKE的经营范围：轨道运输牵引与控制设备的研发、设计、制造、销售、相关的技术支持、协助及售后服务。
The business scope of SKE is development, design, manufacturing, sales, related technical support, assistant and services of the Rail transportation traction and control equipment.
我们将致力于向国内外客户按时提供高度可靠、质量优良、低运营成本的产品。
Here at SKE we are dedicated to deliver highly reliable, top quality products to the market, domestic and aboard, on time and at the lowest cost of ownership.
公司标识SKE Logo：
公司联系方式：
电话/传真：+86 512 6768 5222 / +86 512 6768 7222
Tel/Fax: +86 512 6768 5222 / +86 512 6768 7222
Website: www. skoda. cz
地址Address：中国江苏省苏州市吴中大道1368号
No. 1368 Wuzhong Road, Suzhou, Jiangsu Province, P. R. China 邮编Zip code：215104
2.1 适用范围Applicable scope
本质量手册适用于SKE。
This Quality Manual is applicable to SKE.
公司的质量管理手册覆盖IRIS标准除信号以外的所有要求，信号的设计由客户自行负责，软
件公司无设计，但对供应商提供产品有验证/确认活动，所以公司的IRIS管理体系删减并排
除了7.3.8设计批准中的信号要求。
SKE quality management system covers all elements except signal related requirements, the design responsibility of signal is customer, the design responsibility of software is supplier, SKE has responsibility to verify/validate supplied software product. So SKE IRIS management excluded signal related clause 7.3.8.
公司IRIS体系认证范围：轨道运输牵引与控制设备的研发、设计、制造、销售、相关的技术
支持、协助及售后服务
The certification scope of this IRIS management system: Development, design, manufacturing, sales, related technical support, assistant and services of the Rail transportation traction and control equipment.
2.2 本手册引用了下列文件中的条款以说明质量管理体系的原则和程序：
The clauses in following standards are quoted to define the policy and procedure of
quality management system.
ISO 9001:2008《质量管理体系――要求》
ISO 9001:2008 Quality Management System-Requirements
ISO9000: 2005 《质量管理体系—基础和术语》
ISO9000: 2005 Quality Management System—Fundamentals and Vocabulary
《国际铁路行业标准》02版
International Railway Industry Standard version 02
ISO 14001:2004《环境管理体系――要求及使用指南》
ISO 14001:2004 Environmental Management Systems - Requirements
ISO 18001:2007《职业健康和安全管理体系–要求》
ISO 18001:2007《Occupational Health & Safety Mgmt. System – Requirements》
EN 50126 《The specification and demonstration of Reliability, Availability, Maintainability and Safety (RAMS)》
3.1 概述General introduction
本手册根据《国际铁路行业标准》02版要求结合本公司实际情况编制，并符合客户和有关法
律、法规和各项政策规定。
This manual is established according to the International Railway Industry Standard
Version 2, and meets our customer requirements and all related legal requirements.
手册中陈述了组织结构、质量方针和质量管理体系的要素，对质量管理体系的过程顺序和相
互作用进行了描述。同时，明确了与质量相关的人员的职责和权限及质量管理体系的执行要
求。
The manual describes SKE organization structure, quality policy, standard elements, the
sequence and interaction of quality related processes, as well as the responsibilities and
authorities of staffs that having impact on product quality.
本手册是SKE质量管理体系的基本准则，公司全体员工须严格执行本管理手册和其它质量管
理体系文件规定，确保质量管理体系、产品和过程的持续改进。定期评审手册并在必要时进
行修订。
This manual is the basic criteria to the operation of QMS in SKE. It is the responsibility for
all employees in SKE to comply with this manual and all management system document
requirements. This system is constantly under review and further developments are
incorporated as required.
3.2 质量手册的控制Control of the Quality Manual
3.2.1 总则General
3.2.1.1 本质量手册依据程序《文件控制》的要求来管理；
This quality manual is controlled according to the Procedure “Control of Document”;
3.2.1.2 手册以电子文件的形式在公司内部办公网络上发布，网络上的文件始终为最新版本。电子文
件的纸介质输出不做受控文件管理。
The manual will be released via SKE OA system; and keep the latest version in the network;
the printout is uncontrolled document.
3.2.1.3 有需求时，经管理者代表批准，手册的非受控拷贝可以发放给任意顾客或其他组织；发放给
供应商的手册应受控。
With the Management Representative (MR) permission, when needed, uncontrolled copy
can be issued to any customer or other organization, controlled copy issued to any supplier.
3.2.1.4 文控中心负责保存手册的批准文本，并保持一份发放记录；
DCC keep the approved paper copy, maintains a record to register and control the
distribution of the manual;
3.2.2 审核和批准Review and Approval
本手册由管理者代表和各部门部长联合评审，由总经理/副总经理批准。
This manual is reviewed by management representative and all departments manager, and
approved by GM / DGM.
3.2.4 更改控制Control of Changes
3.2.
4.1 质量手册的任何更改由管理者代表评审，总经理批准；
Any change to the quality manual is reviewed by management representative and
approved by General Manager;
3.3 术语和定义Terms and definitions
Skoda—斯柯达运输Bombardier Transportation
KWT—江苏经纬轨道交通设备有限公司Jiangsu Kingway railway communication
equipment Co., Ltd.
SKE—江苏经纬斯柯达电气有限公司Jiangsu Skoda-Kingway Electronic Co., Ltd.
GM/DGM—总经理/副总经理General Manager / Deputy General Manager
QMS—质量管理体系Quality Management System
IRIS－国际铁路行业标准International Railway Industry Standard
MR—管理者代表Management Representative
DCC—文件控制中心Document Control Center
EU—欧洲European
SPC—统计过程控制Statistical Process Control
QA—质量部Quality Department
PRO—采购部Procurement Department
OP—生产制造部Operation Department
IT&F&C—信息和财务控制部Information Technology Financial & Control Department
HR—人力资源部Human Resource Department
EN—技术部Engineering Department
PM—项目管理部Project Management
S&M—市场部Sales & Market Department
本手册中的其它术语和定义引用《ISO 9001:2008质量管理体系――要求》、《ISO 9000:2005 质量管理体系基础和术语》和《国际铁路行业标准》02版中的术语。
Others terms and definitions in this manual comply with ISO 9001:2008 “Quality
Management System—Requirement”, ISO9000: 2005 “Quality Management System—
Fundamental and Vocabulary” and International Railway Industry Standard version 02.
4.1 总要求General Requirements
本手册概述了公司为确保产品质量符合顾客的要求，根据《国际铁路行业标准》02版要求，
建立、文件化、实施和持续改进质量管理体系。
This manual describes the established the quality management system in SKE according
to the IRIS requirements and customer requirements, to implement and continuous
improve the management system, the company has:
4.1.1 公司把质量管理体系所需要的过程识别为三大类：顾客导向过程（COP）、支持过程（SP）
和管理过程(MP)，共有22 个过程，包括其在整个组织中的应用。
SKE identify the processes required by the quality management system as three types and
22 processes: Customer Oriented Process (COP), Supporting Process (SP) and
Management Process (MP), which including the application in SKE.
顾客导向过程：对顾客直接产生影响，通过输入和输出直接和外部顾客进行联系的过程，会
为公司直接带来经济效益。公司的顾客导向过程识别为6个。
Customer Oriented Process: process directly related to customer through input/output, it is
a value-add process by fulfilling customer requirements, 6 COPs are identified.
支持过程：为支持顾客导向过程的功能过程，公司的支持过程识别为11个。
Supporting Process: functional processes to support customer oriented process. 11 SPs is
identified.
管理过程：指由最高管理者对组织或质量体系进行管理的过程。公司的管理过程识别为5个。
Management Process: processes leaded by management level to manage the company
and its quality management system, 5 MPs are identified.
b. 明确了过程间的次序和相互作用(见附件1：过程关系图)；
Determined the sequence and interaction of the processes; （refer to appendix 1:
processes matrix）
c. 为保证过程的有效运作，对过程制定了过程运行的准则和方法；
determined criteria and methods needed to ensure that both the operation and
control of these processes are effective,
d. 通过资源提供、人力资源管理,设施设备管理和工作环境管理确保必要的资源和信
息,以支持这些过程的操作和监视；
Ensured the availability of resources and information needed to support the operation
and monitoring of these processes through resource provision, human resource,
infrastructure management;
e. 通过内部审核、过程监控、产品监视和测量、数据分析过程对过程实施测量、监控
和分析；
Monitored, measured, and analyzed these processes through internal audit, process
control, product monitoring and measurement, data analysis, etc
f. 实施措施以实现过程策划的结果，并通过质量方针、质量目标、管理评审、纠正与预防
措施等对过程实现结果进行改进；
Implemented actions needed to achieve the planned results and continual improve
these processes through quality policy and objectives, management review and
corrective/preventive action.
g. 公司测量器具检定校准、轮对组装等部分产品制造过程存在外包，按照《计量工具和测
量设备的鉴定/校准》、《外包控制程序》、《采购管理程序》和供应商管理相关程序进行
控制。其内容适当地包括：可行性研究、风险分析、计划、顾客沟通和首件检验。
Measurement instruments verification and some production processes such as wheel
set installation are outsourced, the control of outsourcing process is according to
Production Tools/ Measuring Equipment Certification/Calibration procedure,
outsourcing procedure, supply management procedure, and other supplier
management procedures, including feasibility study, risk analysis, planning,
communication of customer and first article inspection, etc.
4.2 文件要求Document Requirements
4.2.1 总则General
下图为公司的质量管理体系文件文件结构，文件分为如下四级：
The following diagram outlines the structure of SKE QMS. The levels of documentation and
instructions include:
Level 1:质量手册：描述如何按照IRIS 02要求建立、执行并保持公司的质量管理体系；
QMS manual – Description of SKE establishing, implementing and maintaining a Quality
Management System that meets requirements of IRIS 02.
Level 2 –标准操作程序：描述质量管理手册中主要要素具体操作的程序文件；
Standard Operating Procedures (SOP) –Procedures which describe the overall
activities corresponding to the major sections of this QMS Manual.
Level 3 –作业指导书类文件：是详细说明工作的第三级文件，例如生产工作指导书、产品
说明书、图纸、检查指导书、检验计划、项目管理程序、保养说明书等；
Work Instructions: Supporting documents which specify the works to be done, such as
production work instruction, product specification, drawing, inspection
sheet, inspection plan, Project Management Procedure, maintenance
manual , etc.;
Level 4 –记录：用于证实操作效果和符合性的客观证据。
Records Objective evidences to prove the performance and conformance
operations.
以及：
And:
管理体系要求适用的法规要求；
Management system requirements for imposed by the applicable regulatory authorities.
技术安全方针和安全目标的文件化声明(参见附件9 )
Documented statements of a technical safety policy and safety objectives(refer to appendix
9).
公司保证员工能获得企业管理系统文件，并且了解相关的程序。
Company ensures that personnel have access to business management system documentation and are aware of relevant documents.
公司保证顾客和/或法规监管机构的代表能够获得企业管理体系文件。
Company ensures that customer and/or regulatory authorities’ representatives have access to the business management system documentation.
4.2.2 质量手册Quality Manual
质量部建立并保持质量手册以描述：
QA establish and maintain a Quality Manual is to describe:
a. 质量管理体系的范围，包括删减的细节和理由(见2.1) ；
The scope of the QMS (including the justification of exclusion, refer to clause 2.1);
b. 质量管理体系的程序及对其引用应得到清楚地说明(见附件--文件清单)；
The QMS procedures and their cross reference (refer to document list)
c. 质量管理体系所有过程之间的相互作用的表述
Quality management system processes and their interaction.
4.2.3 文件控制Document control
质量部建立并保持文件控制程序（），技术部建立技术文件管理程序()以管理文件的建立、修
改、评审、批准、分发、回收、归档及处置等活动，保证：
QA establish and maintain document control procedure () and technical document
management procedure () to manage the establishment, change, review, approval,
distribution, retrieval, archive and destroy of document to ensure:
a. 质量体系文件在签发之前应得到授权人员的审核和批准；
All system documents are reviewed and approved by authorized person before
release;
b. 对文件评审和修改时,文件必须经过重新批准；
Documents are re-approved after review and revision;
c. 文件变更应记录于文件修订记录,并以适当的标识识别现行修订状态；
Changes of document are recorded in revision log, and the current revision status of
documents are identified;
d. 各使用现场能够得到文件有效版本；
Relevant versions of applicable documents are available at points of use;
e. 文件保持清晰并易于识别；
Documents remain legible and readily identifiable;
f. 对外来文件进行评审；，并控制分发；外来文件对公司内部体系的影响须加以评估和落
实
External documents are reviewed, identified and their distribution controlled; the
influence of external origin document shall be evaluated and actions shall be taken
where necessary
g. 失效文件应由文件发放人负责收回；
Obsolete document retrieved by the distribution function.
SKE对所有适用产品有关的文件进行有效控制，明确授权并执行审查文件的人员的姓名。
SKE control all applicable product related document, identify staff that have the
authorization to review the documents.
项目部建立并保持顾客文件管理程序()，对外来文件进行评审、分发等受控管理，以确保顾
客规范/要求在整个供应链内的可追溯性。外来文件包括：行业规范、标准、顾客的特殊文件、法律法规要求等。
PM establish and maintain customer document management procedure(SKE SOP 40 10
05 114) to ensure the traceability of customer documents throughout the entire supply
chain, SKE review and control the external document according to document control
procedure. External documents can be: industry rules, standards, customer document,
statutory and regulatory requirements
4.2.4 记录控制Control of records
质量部建立并保持记录控制程序，用来规定质量管理体系中记录的标识、储存、保护索引、
保存和处置的要求。
A Documented procedure on record control () is established to define the requirements to
identification, storage, protection, retrieval, retention and disposition of records.
程序文件和作业指导书等要求建立的表单记录（格式），与相应质量管理体系文件一起由相关
部门负责人批准。
Records attached to procedures and work instructions shall be approved with the related
documents.
所有与活动、产品或服务相关的记录应是清晰、易于识别和利用。各部门确定专/兼职人员负
责按照记录控制程序要求，标识、编码、收集、归档、检索、借阅、复制、贮存、保护、保
存和处置质量记录，以确保：
All records are legible and identifiable to the activities, products or services involved. Each
department shall nominate personnel to control the records (including identification, coding,
collection, archive, sorting, borrowing, copy, storage, protection and disposition) to ensure:
a. 质量记录都得到正确处理，包括来自供应商的质量记录；
Correct disposition of all quality records, including records from supplier;
b. 能方便地找到有关质量体系运行有效性的证据；
Easy to get the evidences to demonstrate the efficiency of quality management
system;
c. 当需要将记录作为资源加以利用时，不致失实；
The records is right when it is use as resources;
d. 符合法律法规的要求；
Appliance to legislation requirements;
e. 记录正式发布之前，对记录的结果予以批准；见记录授权清单
Approve record results before official release. Refer to record authorization list
f. 各项记录的保存期限得到规定。
Retain time is regulated for all records;
g. 记录必须是可用的，能够提供给顾客和法规监管机构用于评审或授权放行。
Records shall be available for review and/or release by customers and regulatory
authorities
4.3 知识管理Knowledge Management
项目部建立并保持知识管理过程和知识管理程序()，以识别、获取、维护、应用和评价信息、知识和技术，并且定期更新，以改进公司过程效率和改善产品质量、成本和交货绩效。知识
管理内容包括（但不限于）：
PM establish and maintain a knowledge management procedure () to identify, obtain,
protect, use and evaluate information, knowledge and technology, and regularly update the
improved the company process efficiency and product in quality, costs and delivery
performance. Knowledge management includes but not limited to:
a. 设计标准、设计规则,design rules, engineering standards,
b. 项目完成后的经验,lessons learn after a project;
c. 制造实践manufacturing practices
d. 程序；procedures
e. 客户反馈、内部异常处理状况等。Customer feedback, internal
知识信息可作为新项目/产品、人员培训提供输入。
The knowledge can serve as inputs for new project/product, and internal training.
4.4 多现场项目管理
项目部建立并保持项目管理程序()，以管理当项目涉及多现场时，确保项目满足要求并且至
少包括：
PM establishes and maintains a project management procedure () to ensure the project requirements are met in case where a project involves multiple sites, covers:
a. 工作分工和工作接口（包括内外部）；
work split and operational interfaces, (including internal and external)
b. 职责、权限和公司内部沟通渠道和与顾客的沟通渠道（包括每个现场职责范围内的结果
反馈）；
Roles, responsibilities and communication channels internal and with the customer
including feedback on the results for each sites scope of responsibility.
c. 每个现场适用的过程、程序、文件和记录；
applicable processes, procedures, documents and records on each site;
d. 确保符合IRIS要求。
Assurance of IRIS compliance.
公司在项目合适的层面上和阶段定期评估多现场过程的效率（如：审核、管理评审、过程评
审、顾客抱怨处理等），并且必要时加以改进。
Efficiency of multi-site project activities shall regularly be assessed to the appropriate level (throughout audit, management reviews, process reviews, analyzing customer complaints) and improved where necessary.
5 管理职责Management Responsibility
5.1 管理承诺Management Commitment
公司的最高管理层负责研究并执行本手册概述的质量管理体系，并通过如下的活动持续改
进其有效性：
The top Management commits to develop and implement the quality management system described in this manual and continuously improve its effectiveness by:
a 通过教育培训及公告、员工手册、内部网络的方式，向全体职员传达符合顾客、相关
法律法规要求的重要性；确保顾客和法律法规要求得到满足；
Communicate to all staff through training, employee manual, intranet about the
importance of meeting customer and related legal requirements, ensure the
customer and regulatory requirements are met;
b 制订质量方针和质量目标；
Establish Quality Policy and Objectives;
c 主持管理评审；
Host Management Reviews;
d 订定年度经营计划，确保维护和持续改进质量管理体系所需的资源。
Establish yearly business plan, ensure the availability of resources for maintain and
continuous improve the quality management system;
这些活动的记录应作为承诺的证据得到保存。
Records of these actions are kept as the evidence of commitment.
5.2 以顾客为焦点Customer focus
通过顾客的信息或调查，公司的最高管理层识别顾客的要求/期望，并将其转化为顾客满意
度目标，确保顾客的需求和期望得到满足；定期调查顾客的满意度，并将评估报告输入
管理评审。组织方针必须反映满足顾客要求的意愿。
SKE top management identifies customer requirements / expectations customer communication or survey, and transfer to customer satisfaction objectives. Regularly do customer satisfaction survey, the evaluation report will be the input of management review meeting. Company’s policy shall reflect the vision to satisfy customer requirements.
5.3 质量方针Quality Policy
公司确定和实施了经营管理过程，用以战略和方针的制定，该过程包括对法律法规要求的
分析，同时也包括对顾客需求和期望的分析。质量方针是公司总的质量目标和质量原则。
公司的最高管理层负责：
Define and implement a business management process to establish strategy and policy, this process includes analysis to statutory and regulatory requirements and customer requirements and expectations. The quality policy is the overall quality intention and direction of the company. Top management is responsible for:
a. 根据公司的经营理念和经营方针建立、执行并维护质量方针（见附件2），以满足顾客
要求和持续改进质量管理体系有效性的承诺。；
Establish, implement and maintain the quality policy according to company’s
business principle and business policy (refer to appendix 2) to meet the customer
requirements and commitment to continuous improve the efficiency of the
management system.;
b. 通过培训、公告、内部网络方式，向所有雇员介绍质量方针。确保组织各个层次上的
人员理解质量方针；
Introduce the quality policy to all employees by training, publisher, intranet, etc..
This is done to ensure all levels of the company know and understand the policy;
c. 在管理评审会议上对质量方针的持续适宜性进行评审。确保方针为制定和评审质量目
标提供框架。
Review the continuously suitability of quality policy in the Management Review
Meeting, provides a framework for establishing and reviewing quality objectives. 5.3.1 经营计划Business plan
公司建立公司经营活动范围内的经营计划（短期/长期计划），并定期评审，至少包括以下主
题：
Establish and regularly review the business plan (short/long term plan) for the scope of the rail sector activities, covering as a minimum the following topics:
a) 公司使命和远景；
company mission and vision;
b) 已识别的降低风险计划；
plan to reduce identified risks;
c) 技术和法规要求变化的影响；
impact of changes in technologies and in statutory and regulatory requirement;
d) 营销和产品战略，包括新产品/过程开发计划和退出策略；
market and product strategy, including development plans of new products/process
and phase out strategies;
e) 自制品或采购件的策略；
make or by strategy;
f) 公司产能（当前和未来）；
company capacity (current and future)
g) 经营目标；
business objectives
确保经营计划在公司内得到有效和适当的沟通，并获得中长期行动计划和远景的支持。
The business plan effectively and appropriately communicated throughout the company and supported by mid and long term action pans in accordance with the business plan.
财务控制部建立成本管理过程和成本管理程序(SKE SOP 20 15 30 135)，管理公司财务，
包括会计和控制准则；预测、监视和控制财务资源。
F&C establish cost management procedure (SKE SOP 20 15 30 135) to manage the finances of the company , including rules for accounting and controlling; predict, monitor and control financial resources.
5.4 策划Planning
5.4.1 质量目标Quality Objectives
公司的最高管理层负责制订年度质量目标，公司的管理团队负责将质量目标分解到适当的
过程或部门层次，并利用各种方式通过各种渠道向全体员工传达。
Top management is responsible to establish the annual Quality Objectives; the
management team is responsible to break down the objectives to appropriate process or
department and communicate to the company through different channel.
这些质量目标应与质量方针一致性和可测量，并定期对其进行评审。
These quality objectives are measurable and consistent with the quality policy, and
reviews on a regular basis.
a) 经营目标应当在公司内逐层展开和分解，并定期评审。
Business objectives should be cascaded and broken down consistently in the
company, and reviews on a regular basis.
b) 经营目标应当阐述顾客期望并在规定的时间内是可以实现的。
Business objectives should address customer expectations and be achievable
within defined timescales.
公司确定和实施经营管理过程，该过程必须考虑外部变化趋势和内部相关方要求。每年制
定并更新经营目标（包括质量目标）。
Define and implement business management process, this process considers the
changing external trends and interested parties need, update the business objectives
(including quality objectives) every year.
5.4.2 质量管理体系策划Quality Management System Planning
SKE根据IRIS的标准要求策划了SKE综合质量体系过程框架（见附件1过程关系图），以
满足公司年度质量目标以及本手册4.1的要求。
SKE develops the Integrated Quality System Process Structure （refer to appendix 1:
processes matrix）in accordance with the IRIS requirement to meet the company annual
quality objectives and requirements of clause 4.1 this manual.
在本手册、相关的标准操作程序和其它相关的文件中，对质量体系策划的输出形成了文件。
这些文件识别并定义了质量体系的所有过程。
The output of quality system planning is documented in the manual related standard
operating procedures, and some other documents. These documents identify and define
all processes of the quality system.
质量体系的变更应策划纳入到管理评审中。这些变更可为情况改变，如产品、过程、能力、或其它操作上和组织的改变做出的一种反应；或为改善质量体系的有效性和效率做出的一
种反应，保持质量管理体系的完整性。
Changes to the quality system are planned in the management reviews. The changes can
be a response to changing circumstances (such as product, process, capacity, operation
or organization change); or to improve the effectiveness and efficiency of the QMS,
ensure the integrity of the quality management system.
5.5 职责、权限和沟通Responsibilities, Authority and Communication
5.5.1 职责和权限Responsibility and authority
公司内建立组织机构图，描述各职能的工作划分(见附件3：各职能职责权限)，各部门和他
们之间的关系，在组织机构图（见附件4）中做了规定。
Departments and their interrelations are defined in the organizational chart of quality
management system of SKE. The functional responsibility and authority refer to appendix
3, and the organizational chart refer to the appendix 4
对从事与质量有关的所有管理、执行和验证工作的人员，规定其职责、权限和相互关系，
并在《人力资源管理程序》中规定岗位任职条件。识别了与顾客的接口，并描述和交流其
沟通渠道（电话，传真，邮件等）。
Responsibilities and authorities are defined for employee that working on quality related
management, operation or verification tasks, the qualifications are regulated in HR
management procedures, interface with customer and communication channel (such as
phone, fax, email, etc) is defined.
明确所有过程的责任人、职责和权限，过程的主要负责人应当对过程进行监控，当过程不
符合或过程KPI出现偏移趋势时，有权提出纠正措施要求，并提出改进资源要求。
Responsible personnel, his/her responsibilities and authorities is defined for all processes, the responsible personnel shall monitor the process, where there process nonconformity
detected or KPI deviate from the trends, he/she has the right to raise corrective action
request and resource requirements.
公司中的每位员工有责任向他/她的管理人员提出偏离要求的任何问题/偏差，以便采取适当
的措施。
Anyone in the company has responsibility to report to the direct manager any
problem/deviation to take appropriate actions.
5.5.2 管理者代表Management Representative
最高管理者应指定一名管理者作为管理者代表（见附件5：管理者代表任命书），无论该成
员在其他方面的职责如何，应具有以下方面的职责和职权：
General Manager nominates the Management Representative (refer to appendix 5:
Management representative nomination letter), irrespective of other responsibilities, shall
have responsibility and authority that includes:
a. 确保公司所需的过程按照IRIS要求得到建立、实施并保持；
Ensure that the needed processes is established, implemented and maintained in
accordance with requirements of IRIS standards.
b. 向最高管理者报告质量管理体系的业绩和任何改进的建议；
Report to top management the performance of the Quality Management System
and any need for improvement.
c. 采取措施，提高全体员工满足顾客要求的意识；
To take effective action to ensuring the promotion of awareness of customer
requirements throughout the organization.
d. 代表公司就质量管理体系的相关事宜进行内部协调和外部联络。
Represent the company in internal coordination and external liaison on matters
relating to the Quality Management System.
e. 有解决质量问题的自主权，在没能满足关键要求的情况下，有权要求停止开发、生产、
交付和现场支持等活动。
The organizational freedom to resolve matters pertaining to quality or stop
development/production/delivery/field support activities, if critical requirements are
not met.
5.5.3 内部沟通Internal Communication
公司确定并实施信息沟通管理过程，在管理层和员工之间建立一个双向的沟通系统，用以
管理内外部沟通。沟通的内容至少包括以下方面：
Define and implement communication process to establish a communication system
between management and employee, at least communicate the following information:
?使命和愿景Mission and vision;
?方针Policy;
?公司绩效company performance
?与顾客相关的事宜issues related to customer
5.5.3.1 对质量体系的内部沟通采用两种方法：
Internal communication regarding the quality system flows two ways:
最高管理层向公司内部传达质量方针和质量目标、顾客和法规的要求、产品和过程的规范、验证和确认要求、以及如何实施和利用质量体系的说明。
Top management communicates quality policy and objectives, customer and legal
requirements, product/process specifications, verification/validation requirements, and
instructions on how to implement and use quality system within the company.
公司内部向最高管理层汇报有关顾客需求和期望的信息和数据、顾客满意度、质量业绩、
质量体系的有效性以及改进的机会。
The lower level reports information of customer needs and expectations, customer
satisfaction, quality performance, QMS effectiveness and improvement opportunities to
Top management.
5.5.3.2 通过手册、程序、作业指导书、图纸、技术规范、质量记录、报告等进行信息传递；同时，
也通过培训和会议来传递信息。在相关标准操作程序中对其进行了规定。
Information is communicated through manuals, procedures, instructions, drawings,
specifications, quality records, reports, etc, as well as training and meeting; these
activities are regulated in related SOPs.
5.5.3.3 管理评审会是确保最高管理层和公司内部之间的有效沟通的重要方式。会议为公司内部汇
报质量相关问题和活动的状况，及为最高管理层制定方针政策以改进质量体系提供了一个
框架。
Management review meeting take a special role in efficient communication between the
top management and the lower level. The meeting provides a framework for reporting
quality issues/activities, and to improve the quality system by establish policies.
5.5.4 顾客关系管理Customer relationship management
最高管理者指定一名管理者作为顾客代表（见附件6：顾客代表任命书），无论该成员在其
他方面的职责如何，应具有以下方面的职责和职权：
General Manager nominates the Customer relationship Representative （refer to
appendix 6: customer representative nomination letter）, irrespective of other
responsibilities, shall have responsibility and authority that includes:
a. 确保公司按照IRIS要求建立、实施并保持满足顾客要求所需的过程；
Ensure that processes needed to satisfy customer requirements are established,
implemented and maintained in accordance with requirements of IRIS standards.
b. 向最高管理者报告这些过程的业绩和任何改进的建议；
Reporting to top management the performance of these processes and any need
for improvement.
c. 通过有关培训，确保在公司中提升顾客满意的意识。
Ensuring the promotion of awareness of customer satisfaction throughout the
company and related training.
5.6 管理评审Management Review
5.6.1 概述General
质量部建立并保持管理评审程序()，管理评审由总经理主持，管理者代表协助，最高管理层
和各部门部长参加。以评审质量体系的适宜性、充分性和有效性。评审应包括评价质量管
理体系改进的机会和变更的需要，包括质量方针和质量目标。质量部负责管理评审的记录
及其保存。
Establish and maintain management review procedure (), General Manager chairs the reviews meeting with the support from management representative, and attendance of top management and all managers, to review the continuing suitability, adequacy and effectiveness of the management system, assessing opportunities for improvement and the need for changes to the quality management system, including quality policy and quality objectives, Quality department retain the review meeting records.
管理评审时间间隔不能超过12个月。当组织或产品发生变更，或其它情况需要引起最高管
理层注意时，可以不定期进行更多次的管理评审。
Management review intervals shall not exceed 12 months. More frequent reviews are scheduled when organizational or product changes occurred, or other circumstances that need the top management attention.
5.6.2 评审输入Review input
评审输入包括了有关公司质量业绩的信息和数据。至少，应包括：
Management review Input consists of quality performance information. At a minimum, this includes:
a. 审核结果（体系内部审核/总部进行的内部审核/第三方认证机构审核）
Results of audits (internal audit/BT audit/third party audit)
b. 顾客反馈（抱怨）和投诉Customer feedback and complaints
c. 过程的业绩和产品符合性数据Process performance and product conformance data
d. 纠正和预防措施的状态Status of corrective and preventive actions
e. 可能影响质量体系的变更Changes that could affect the quality system
f. 以往管理评审提出措施的追踪Follow-up actions from earlier management reviews
g. 改进的建议Recommendations for improvement
h. 以前项目评审的关键问题；Key issues form previous project reviews
i. 以前过程评审的结果Results of previous process review
j. 实际和潜在的现场失效分析，以及它们对安全和环境的影响
Analysis of actual and potential field-failures and their impact of safety and
environment.
必须评审以下关键绩效指标：
The following KPIs shall be reviewed:
a. 所有强制性和推荐性KPIs(见附件7）All mandatory and voluntary KPIs(refer to
appendix 7 )
b. 向顾客的按时交付业绩customer on time delivery performance;
c. 和在整个项目生命周期中，顾客提出的不合格项
nonconformities raised by the customer throughout the entire project life cycle.
d. 在整个项目生命周期中，公司内部和供应商的不符合项；