Contents
Clause No. Description
0Contents
1Foreword
2The management of quality assurance manual
3Terms
4Quality assurance system requirements
4.1Management responsibility
4.2Quality system
4.3Contract review
4.4Design control
4.5Document and data control
4.6Purchasing
4.7Control of Employer-supplied product
4.8Product identification and traceability
4.9Process control
4.10Inspection and testing
4.11Control of inspection, measuring and test equipment
4.12Inspection and test status
4.13Control of nonconforming product
4.14Corrective and preventive action
4.15Handling, storage, packaging, preservation and delivery 4.16Control of quality records
4.17Internal quality audits
4.18Training
4.19Servicing
4.20Statistical techniques
Chart Organization structure of quality assurance system of the Company Attachment No.1: Quality system requirements and quality responsibility Attachment No.2: List of documented procedures
1Foreword
1.1Brief Introduction of the Company
CSCEC Construction Co. LTD is a construction enterprise invested by
his holding company, China State Construction Engineering
Corporation (CSCEC) offering mainly services of general project
management in engineering construction projects contracting business.
The company was established and registered in China in 1993 and it
was ratified as a state-level construction contracting enterprise by the
Ministry of Construction of PRC.
The project of Beijing Lufthansa Center (a national project) contracted
by the predecessor of the company was executed and managed
severely in accordance with FIDIC contract conditions and was
completed on time with good quality. The project was awarded “Lu
Ban Prize ”, the designation of good qualit y project by the Ministry of
Construction of PRC, and the National Prize for Good Quality Project.
The company have enjoyed the high social prestige and obtained the
economic effect. Since the establishment of the Company, the
Company has contracted or completed in succession the major projects,
such as the New German Embassy in Beijing, the NORINCO Building,
Beijing Sunflower Tower, Bayer Pharmaceutical Plant and Head Office
Building of Bank of China, etc.
The Company strictly implements the contract, and puts quality first in
its contracted projects. The Company always satisfies the Employers
by offering the quality services that conform to the international
quality standards.
The Company, soon after its establishment, formulated the quality
assurance system in accordance with the requirement of GB/T 19000
--- ISO 9000 and was given formal recognition and certificate of
quality system certification for ISO 9002.
The Company possesses a group of excellent engineering technical
personnel with the knowledge of the international contract conditions
and the sound contract management, and with rich practical
experiences in this field both in China and abroad. The Company also
posses abundant capital and stable network for purchasing the
materials, machinery and equipment for construction projects both in
China and abroad. The Company may undertake all kinds of Works of
civil Engineering construction, including industrial and civil building
projects.
The Company may offer consultant service for project construction
and project consultant, and project design, and the service for import
and export trade of building materials, etc.
1.2Introduction of the Quality Assurance Manual
This Quality Assurance Manual has described and defined the quality
system, the quantity policy and the quality objectives of the Company.
The manual shall be a guide document concerning the quality system
of the Company.
The manual shall be applied to all kinds of Works of Civil Engineering
Construction contracted by the Company, including industrial and civil
building projects.
The manual shall be a top secrete document controlled by the
Company.
The manual shall be prepared by the Quality Assurance Division and
reviewed by the Management Representative. The manual shall come
into force from the date of approval by the Managing Director of the
Company.
2.The Control and Management of Quality Assurance Manual
2.1Approval
2.1.1Before the manual is officially issued, the Quality Assurance Manual
Shall be reviewed by Managing Director, Management Representative,
Managers of Project Division and Division managers in order to
guarantee its clear and accurate meanings, its suitability and its
reasonable structure.
2.1.2The manual shall come into force beginning from the date of approval
by the Managing Director of the Company and shall be carried into
effect beginning from the approved date of implementation.
2.2Issue
2.2.1The original and the copies of the Manual: The approval page of the
original of the Quality Assurance Manual shall be put by the Managing
Director’s own signature, and the rest page s of the original
Manual shall be signed by those responsible for preparing,
reviewing and approving the document.
The copies of the Manual shall mean the copies of the original of the
Quality Assurance Manual. The original of the Quality Assurance
Manual shall remain in the sole custody of the Quality Assurance
Division and the copies of the Manual shall be issued to all the holders
of the Manual.
2.2.2The holders of the manual shall include the Company’s leaders,
Management Representative, managers of Project Divisions, division
managers, project managers and other approved holders. The details of
the manual holders will be prepared by the Quality Assurance Division
and will be submitted to the Management Representative for approval.
2.2.3The Quality Assurance Division shall in unified way, distribute the
Manual. The seal of controlled documents shall be attached to the
Quality Assurance Manual distributed by the Quality Assurance
Division. The Manual shall be numbered for the control purpose. The
Quality Assurance Division shall fill out a register of controlled
documents.
2.2.4When the above mentioned holders of the Manual leave their relevant
offices, they shall immediately return the Quality Assurance Manual
which they hold, and the Quality Assurance Division shall write off
their registrations.
2.3Amendment
2.3.1 Any amendments to the Manual shall be made by the Quality
Assurance Division and shall be approved by the Managing
Director of the Company. Any amendments without an official
amendment notice shall be deemed to be null and void.
2.3.2The Quality Assurance Division shall be responsible for sending the
amendment notice to the holders of the Manual and shall require all the
holders to be responsible for making amendments. The Quality
Assurance Division shall keep the records of any amendments on the
Amendment Sheets of Quality Assurance Manual. The amendment
sheets shall, together with the contents of amendments, be sent to all
the holders of the Manual.
2.4Use and Custody
2.4.1When the holders of the Manual receive the amendment sheets of the
quality manual, the holders shall sequentially attach the amendment
sheets to the front of the Manual in order to find out the case of
amendments to the Manual.
2.4.2The holders of the Manual shall be responsible for implementation of
the provisions of the Quality Assurance Manual.
2.4.3The holders of the Manual shall be responsible for the custody of the
Manual which they hold, and shall prevent the Manual from any
damage, loss and alterations to the Manual. When the Manual is found
damaged and lost, the holders of the Manual shall immediately report
the matter in question to the Quality Assurance Division.
2.5uncontrolled Copies
2.5.1 For the purposes of Employer and quality audit body off-site usage
and other distribution of the Manual where change control is not
intended, all such distributed manuals shall be clearly identified as
uncontrolled copies.
2.5.2 When any Divisions and Projects need uncontrolled copies of the
Manual, they shall, in written form, apply to the Management
Representative for approval. The applicant shall, in his application,
state the reasons for uncontrolled copies of the Manual and its holder.
2.5.3 The Quality Assurance Division shall be responsible for distribution of
uncontrolled copies of the Manual. The seal of controlled copies shall
not be attached to the cover of the uncontrolled Manual. The Quality
Assurance Division shall fill out a register of distributing uncontrolled
copies.
3Definitions
3.1General Terms
For the purposes of this Quality Assurance Manual, The definitions
given in ISO8402 apply.
3.2Definitions related to this Manual
Terms Definitions
Employer m eans the legal person or natural person who
owns a construction project and decides to
award the project to the Company by the form
of signing and concluding a Contract or an
Agreement.The Employer in the Manual also
refers to his holding company. (It is called
customer in International Standard ISO 9002).
Company means CSCEC Construction Co. LTD.
Company Leaders m eans Managing Director, Deputy General
Manager, Chief Economist, Chief Accountant,
Chief Engineer, and Management
Representative of the Company.
Management Representative means the person from the Company’s
management appointed by the Managing
Director. He shall be responsible for the
quality system of the Company.
Manager of Project Division M eans the person appointed by the Managing
Director to act as Manager of Project Division
who shall be responsible for the management
of all the projects in the project division.
Project m eans the management organization who
Shall execute and manage the construction
project (works) contracted by the Company.
Subcontractor means the legal person or the natural person to
whom some parts of the Works is
subcontracted by singing and concluded the
Subcontract between the Company and the
Subcontractor. Such Subcontractor also means
one of the Subcontractors defined in the
Standards.
Supplier means the legal person or the natural person
who provides products and materials to the
Company by signing and concluding a
Contract for supplying goods. Such Supplier
also means one of the Subcontractors defined
in the Standards.
Employer’s Contract means the Contract for the construction
project (works) signed and concluded by and
between the Employer and the Company, or
means all the requirements (hereinafter also
called the Contract) agreed and communicated
by any means between the Employer and the
company.
Subcontract means the Subcontract for part of the
contraction works signed and concluded by
and between the Company and the
Subcontractor.
Products means all raw materials, semi-finished
products, structural components and
machinery and equipment for incorporation in
the permanent works.
Division / Project means the short form for all the Division
and/or the Project.
4Quality Assurance System Requirements
4.1Management Responsibility
4.1.1Quality Policy
4.1.1.1The quality policy of the Company shall be as follows:
We believe in the principle of winning our Employers’ trust with
excellence in the quality of our products and services.
4.1.1.2The policy reflects what we require of our entire staff: devotion and
trustworthiness. Translated into action, this means continuous drive to
raise the efficiency of management and update our expertise with
concerted effort. Such improvement is seen in the quality of our
products and services and in our unfailing effort to meet all the
requirements of our Employers.
4.1.1.3The quality objectives of the Company shall be as follows:
Strict procedures for the best possible management, high level
expertise, first class quality guaranteed for all the contracted Works,
projects meeting all requirements for their immediately acceptance by
Employers upon completion (immediately acceptance ratio up to
100%), good quality ratio up to 80 percent per unit of works, works
eligible for “Excellence in Quality” and “Luban Prize” awards of the
Municipality and the Ministry, guaranteed satisfaction and
zero-complaints from Employers.
4.1.1.4The Personnel Division shall be responsible for training courses of the
quality policy and the quality objectives. The Personnel Division shall
ensure that all the Company staff shall be familiar with and master the
quality policy and the quality objectives.
4.1.1.5In order to implement the quality policy and the quality objectives in
all the projects, each construction project shall work out the quality
planning prior to the commencement of the works, and shall define the
quality objectives and the management measures of the project.
4.1.2Organization
4.1.2.1Responsibility and Authority
A.Establishment of Organization Structure
The Company Leaders are responsible for establishing and adjusting
the Company Organization structures, defining the responsibility,
authority and the Company Leaders shall define interrelation of the
personnel who engage in the work affecting the quality. The
organizational structures related to the Company’s quality assurance
system and functions related to the quality assurance system are
annexed to this Manual (See Attachment No.1)
B.Description of Quality Responsibility
a.The Managing Director of the Company shall
--- control and manage the overall work concerning the quality system of the Company;
--- be responsible for working out the quality policy and the quality objectives of the Company, and approve the Quality Assurance
Manual.
--- establish and adjust the organization of the Company and define the responsibility and authority of the divisions of the Company.
--- be responsible for the management review of the quality system and appoint the Management Representative.
b.Deputy General Manager of the Company shall
--- assist the Managing Director in the management of the quality system;
--- participate in working out an d implementing the Company’s quality policy and the quality objectives, and assist the Managing
Director in the management work;
--- be authorized by the Managing Director to be responsible for the function divisions of the Company;
--- Control and manage the plan and objectives of the work that he shall be i n charge of , and supervise the implementation of the plan
and the objectives of the work;
--- be responsible for the quality assurance and the quality improvement that he shall be in charge of.
c. Management Representative shall
--- ensure that the Co mpany’s quality system shall be established, implemented and maintained;
--- participate in working out and implementing the quality policy and the quality objectives of the Company;
--- be responsible for approving the documented procedures and the Project Quality Plan;
--- be responsible for supervising the internal quality system audits of the Company;
--- assist the Managing Director in management reviews;
--- report the results of the operations of the quality system of the Company to the Managing Director;
--- arranging the quality system audits of Subcontractor;
--- on behalf of the Company, deal with and coordinate all the work concerning quality management and the quality assurance between
the Contractor and the Employer, and be responsible for the work
relating to the quality system certification.
d. Three Chiefs shall
--- participate in working out and implementing the quality policy and the quality objectives of the Company, and assist the Managing
Director in t he Company’s work;
--- be authorized by the Managing Director to be responsible for the divisions of the Company;
--- control and manage the plan and objectives of the work that he shall be in charge of, and implement the plan and the objectives of
the work in question;
--- be responsible for the quality assurance and quality improvement of the work he shall be in charge of.
e.Manager of Project Division shall
--- Participate in working out and implementing the quality policy and the quality objectives of the Company;
--- be authorized by the Managing Director to be responsible for the projects in the project division, and shall, on behalf of the
Company, accept the Works and guide the execution of the Works;
--- carry out the following work: Contract review, tendering, signing the Contract, the Project Quality Planning, the completion of the
Works and remedying defects in the Works;
--- be responsible for the quality assurance and the quality improvement of the projects in the project division that he shall be
in charge of.
--- be responsible for approving the Project Quality Plan prepared by the Project.
f.Quality Assurance Division shall
--- assist the Management Representative in promoting and implementing the ISO9000 family;
--- assist the Manager Director in preparing the quality policy and the quality objectives of the Company.
--- be responsible for the work relating to preparation, issue, amendment and version change of the Quality Assurance Manual
and documented procedures;
--- assist the Management Representative in carrying out the internal quality system audits of the Company, and promoting and
implementing the Internal Quality Audits Procedures;
--- be responsible for reviewing the “Project Quality Plan”. and responsible for reviewing the Project Quality planning;
--- implement the laws and regulations of the safety and prepare the detailed rules and regulations for implementation, and be
responsible for reporting, analyzing and dealing with the incidents
and educating the relevant personnel;
--- promote and implement the Process Control Procedures, the
Control of Nonconforming Product Procedures and the
Corrective and Preventive Action Procedures;
--- be responsible for preparing the training plan for all personnel performing activities affecting the quality system and the personnel
performing specific assigned tasks, and implement the training plan
together with the Personnel Division;
--- pay a return visit to the completed works and deal with the claims from the Employer, and shall supervise and implement the
Servicing Procedures;
--- be responsible for supervising the application of the statistical techniques, and for implementing the Statistical Techniques
Procedures.
g.Planning Division shall
--- assist the Managing Director in adjusting the Company organization structure, and defining the responsibility and authority
of all personnel of the Company.
h.Administration Division shall
--- be responsible for the management and control of the Company’s documents, and shall supervise and implement the Document and
Data Control Procedures ;
--- be responsible for the management and control of the Company’s files, and shall supervise and implement the Control of Quality
Records Procedures.
i.Personnel Division shall
--- prepare the training plan for all personnel of the Company, and shall supervise and implement the Training Procedures;
--- provide all personnel relating to the quality management and other personnel of the management, and shall assess their assigned tasks;
--- be responsible for training all personnel performing specific assigned tasks and shall ensure that all staff members are the
holders of the professional qualification certificate.
j.Estimation Division shall
--- prepare the tender documents, guide and participate in the Contract evaluation, and shall promote and implement the Contract Review
Procedures;
--- be responsible for evaluating the Subcontractor, assist the Project Divisions in selecting the Subcontractor, and shall supervise and
implement the Subcontractor Select Procedures;
--- prepare the training plan for the personnel relating to the tendering and other business management and shall implement the training
plan together with the Personnel Division.
k.Financial Division shall
--- review the relevant Sub-clauses concerning financial matters in the Contract (by and between the Employer and the Company), the
Sub-Contract (by and between the Company and Subcontractor)
and the purchase Contract (by and between the Company and the
Supplier);
--- participate in reviewing the qualification and selection of Sub-contractor and the Suppliers, and shall be responsible for
analysis and evaluation of the financial position and the
payment ability of the Subcontractor and the Suppliers.
l.Legal Division shall
--- be responsible for reviewing the legal documents of the Contract;
--- ensure that the original copy of the Contract shall be in his custody. m.Purchase and Supply Division shall
--- be responsible for the evaluation of the Suppliers, the purchase of the materials and the verification the purchased product, and shall
supervise and implement the Product Purchasing Procedures ;
--- supervise and implement the Product Identification and Traceability Procedures, and the Handling, Storage, Packaging,
Preservation and Delivery procedures;
--- be responsible for purchasing machinery and equipment for the contracted construction works including the corresponding
servicing;
--- prepare the training plan for the personnel relating to purchase and supply of the materials, and shall implement the training plan
together with the Personnel Division.
n.Technical Supply Division shall
--- be responsible for the technical specifications of the Works and the standards management, and shall define the standards of
workmanship and the construction methods, and shall supervise
and implement the Inspection and Testing Procedures and the
Inspection and Test Status Procedures;
--- participate in the tendering of the project, and shall prepare the construction plan;
--- assist the Project in preparing the Construction organization, design and the major construction plan;
--- be responsible for the development and the promotion of new technology, new workmanship and new construction materials;
--- be responsible for the control of inspection, measuring and test equipment and the quantity measurement, and shall supervise and
implement the Control of Inspection, Measuring and Test
Equipment Procedures;
--- be responsible for preparing the corrective and preventive action on the nonconforming products of the project;
--- prepare the training plan for the personnel in the technical system, and shall implement the training plan together with the Personnel
Division.
o.Mechanism and Electricity Division shall
--- be responsible for the evaluation of the Supplier of mechanical and electrical equipment, and the procurement of the mechanical and
electrical equipment;
--- be responsible for the second design of the mechanical and electrical installation project, and shall prepare the construction
plan for the mechanical and electrical installation project;
--- assist the Project in the implementation of the mechanical and electrical installation project.
p.Finishing and Decoration Division shall
--- be responsible for the second design for the finishing and decoration project, and shall prepare the construction plan for the
finishing and decoration project;
--- assist the Project in the supervision and the implementation of the finishing and decoration project.
q.Project shall
--- prepare the Project Quality Plan, and shall supervise and implement the Project Quality Plan;
--- prepare the construction yearly, quarterly and monthly plan of the project ;
--- prepare the guidelines for the operation, the operation procedures, and shall tell the details of the technical specifications and
standards to the Subcontractor;
--- prepare the plan of the project construction products;
--- fill in the form for the evaluation to the Subcontractor and the Supplier;
--- collect and take care of the quality records for the construction works.
4.1.2.2Resources
The Company shall provide the necessary resources to satisfy the
implementation of the quality policy and the quality objectives. The
suitability of the resources shall be evaluated by the management
review. When the case of the non-suitability, the Managing Director
shall deal with the matter in question. The resources for incorporation
in the works shall, in accordance with the provisions of the Contract,
the character of the Works and the quality objectives, be defined when
the project quality is planned, and shall be guaranteed and coordinated
by the Company
The Company shall take appropriate measures to assign the trained
personnel to verify and audit the quality system. The verification shall
cover the whole process of the Work such as, the inspection, testing
and supervising of the design, execution, installation and technical
services, etc, and the inspection, testing and supervising of the
completed works. All quality audits activity shall be carried out by the
personnel independent of those having direct responsibility for the
activity being audited.
4.1.2.3Management Representative
The Managing Director shall appoint a member of the Company’s
management as the Management Representative. The Management
Representative shall arrange and supervise the implementation of the
quality system. The Quality Assurance Division shall assist the
Management Representative in the implementation of the quality
system. For the detailed responsibility of the Management
Representative, please see Sub-Clause 4.1.2.1 c of this Manual.
4.1.3Management Review
a.The Managing Director shall be responsible for supervising and implementing
the management review. The management review shall, in general, be
implemented once every interval of 12 months, usually at the end of
the year, that is the Month of December each year. The Managing
Director shall decide to increase the intervals of the management
reviewing when the organizing structure, the quality system, the
market situation or rules and regulations have been Changed greatly.
b.The Management Representative shall convene the meetings of the
management review. The Company leaders, the manger of Project
Divisions and the managers of Division shall attend the meetings.
c.Contents of Management Review
--- to analyze the conformity of the quality system;
--- to analyze the effectiveness of the quality system;
--- to analyze the suitability of the quality system;
--- other important matters relating to the management review .
d. The management review shall be carried out in accordance with the
Management Review Procedures. The records of management review
shall be maintained and stored in accordance with the provisions
defined in Sub-Clause 4.16 of this Manual.
e. The Management Representative shall be responsible for supervising
and implementing the spirit and the requirements decided in the
meeting of management review, and all the tasks put forward by
the meetings.
f. The Quality Assurance Division shall assist the Managing Director and
the Management Representative in dealing with the day to day work of
the management review.
4.2Quality System
4.2.1General
The Company shall, in accordance with the standards and requirements
of ISO9002 1994, establish and document the quality assurance
system.
The documents of the quality system of the Company shall include the
four level documents as follows:
--- quality assurance manual
--- documented procedures
--- supported documents
--- quality records
4.2.2Quality System Procedures
The Company shall prepare documented procedures and shall
effectively implement the quality assurance system in the whole
construction processes. For the details of documented procedures,
please see Attachment No.2.
The documented procedures shall be established as a management
system in connection with the requirements by all elements of the
quality system, and shall also be deemed to be the way defined for the
implementation of a quality activity.
4.2.3Quality Planning
4.2.3.1The quality system of the Company and its relevant documents shall
apply to all the projects contracted by the Company. To guarantee
effectively the performance of the quality assurance system in each
construction project, the Project Division shall, in accordance with the
provisions specified in the contract, prepare the Project Quality Plan
before the commencement date of the Works.
4.2.3.2The managers of Project Division shall, in accordance with the Project
Quality Planning Procedures, do the quality planning carried out by the
relevant divisions and the Project, and shall prepare the Project Quality
Plan.
4.2.3.3Contents of the Project Quality Planning
--- to determine the quality objectives of the project and the objectives for management on the Site;
--- to recommend the administrative personnel to the Project;
--- to prepare the plan of Subcontracted Works;
--- to prepare the plan of the purchase of products;
--- to prepare the plan of providing necessary equipment for the execution of the Works;
--- to determine the construction plan.
4.2.3.4The Project Quality Plan shall be prepared by the Project and reviewed
by the Quality Assurance Division and shall be approved by the
Manager of Project Division.
4.2.3.5The Quality Assurance Division shall be deemed to be a management
division in charge of the Project Quality Plan.
ABC Farms ISO 14001 - Environmental Management System Manual Prepared By: Approved By: Signature: ____________________________ Date: _________ / Revision #: 0 / Revision Date: / Effective Date:
SECTION 0 - TABLE OF CONTENTS MANUAL ISO SECTION SECTION TITLE PAGE SECTION 0TABLE OF CONTENTS x SECTION I INTRODUCTION x SECTION II DISTRIBUTION, REVISION & CONTROL x 4.2 4.2ENVIRONMENTAL POLICY x 4.3 4.3PLANNING x 4.3.1 4.3.1 Environmental Aspects x 4.3.2 4.3.2 Legal and Other Requirements x 4.3.3 4.3.3 Objectives and Targets x 4.3.4 4.3.4 Environmental Management Programs x 4.4 4.4IMPLEMENTATION & OPERATION x 4.4.1 4.4.1 Structure and Responsibility x 4.4.2 4.4.2 Training, Awareness and Competence x 4.4.3 4.4.3 Communication x 4.4.4 4.4.4 Environmental Management System Documentation x 4.4.5 4.4.5 Document Control x 4.4.6 4.4.6 Operational Control x 4.4.7 4.4.7 Emergency Preparedness and Response x 4.5 4.5CHECKING AND CORRECTIVE ACTION x 4.5.1 4.5.1 Monitoring and Measurement x 4.5.2 4.5.2 Non-conformance and Corrective Action x 4.5.3 4.5.3 Records Management x 4.5.4 4.5.4 Environmental Management System Audits x 4.6 4.6MANAGEMENT REVIEW x
ID 号：33526871 受控文件 编制: 汪斌,叶雁飞;文控审核: 赵建岭;会签: 何伟,丁云长,崔载福,陈卫德,胡雄旺,徐华2,徐海波;意见汇总: 汪斌,赵建岭;审核: 徐华2;批准: 刘向阳;发布目标: 赵建岭 归档日期：2012-04-20 17:16:38 编码： GL 质量管理体系文件 文件名称 吉利供应商质量手册 版 本 1 页码 / 文件编号 GLW000864 生效日期 2012年4月23日
供应商质量手册 （第一版） 浙江吉利控股集团有限公司
前 言 《供应商质量手册》是参考吉利公司的质量管理手册、程序文件，并结合当前吉利供应商管理的现状而编制的，以指导供应商在准入、零部件开发、量产初期及批量生产管理等过程中的需要开展哪些工作及提交哪些文件。 当前，吉利在不断提升自身竞争能力的同时，努力打造具有“三高一低”（高质量、高技术、高忠诚度和低成本）的、一流竞争力的供应商体系。相信通过相互合作、沟通理解和及时采取措施将有利于吉利和供应商双方事业的发展，最终实现“让世界充满吉利”的美好愿景！ 本手册版权属于浙江吉利控股集团有限公司及其各子公司。 未经吉利的书面许可，本手册的任何内容都不能以任何形式和手段进行复制、储存和传送。供应商不得以任何方式将本手册中提到的吉利品质体系内容提供给第三者。 本手册将在运用过程中不断更新完善，各供应商朋友如在应用过程中发现不足，请及时反馈指正。 如有任何问题，请与相关SQE联系。 吉利集团质量管理部 供应商管理室 2012年4月
目录 第一章 供应商选点 (4) 第二章 先期产品质量策划 (6) 第一节 第一阶段供应商品熟评价 (6) 第二节 第二阶段供应商品熟评价 (25) 第三节 第三阶段供应商品熟评价 (34) 第四节 第四阶段供应商品熟评价 (53) 第五节 第五阶段供应商品熟评价 (59) 第六节 生产件批准程序（PPAP） (61) 第三章 量产管理 (66) 第一节 驻厂检验 (66) 第二节 受控发运 (69) 第三节 统计技术 (71) 第四节 质量改进 (73) 第五节 供应商审核管理 (80) 第六节 免检管理 (81) 第七节 供应商优化管理 (82) 第八节 供应商违约管理 (83) 第四章 供应商品质五星级评价 (84)
Ningbo XXX Material Technology Co.,Ltd ISO9001:2015 Quality Manual Revision [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 19 TABLE OF CONTENTS 0.0 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 .. 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质量手册翻译中英文术语表 3.1.1 质量 quality 3.1.2 要求 requirement 3.1.3 等级 grade 3.1.4 顾客满意 customer satisfaction 3.1.5 能力 capability 3.2.1 体系(系统) system 3.2.2 管理体系 management system 3.2.3 质量管理体系 quality management syste m 3.2.4 质量方针 quality policy 3.2.5 质量目标 quality objective 3.2.6 管理 management 3.2.7 最高管理者 top management 3.2.8 质量管理 quality management 3.2.9 质量策划 quality planning 3.2.10 质量控制 quality control 3.2.11 质量保证 quality assurance 3.2.12 质量改进 quality improvement 3.2.13 持续改进 continual improvement 3.2.14 有效性 effectiveness 3.2.15 效率 efficiency 3.3.1 组织 organization 3.3.2 组织结构 organizational structure 3.3.3 基础设施 infrastructure 3.3.4 工作环境 '77ork environment 3.3.5 顾客 customer 3.3.6 供方 supplier 3.3.7 相关方 interested party 3.4.1 过程 process 3.4.2 产品 product 3.4.3 项目 project 3.4.4 设计和开发 design and development 3.4.5 程序 procedure
核准人：审核人：制修订人：
文件编号：XXX-QM -2017 编 制： 年 月 日 审 核： 年 月 日 批 准： 年 月 日 受控状态： 发 放 号： 2017年01月04日 发布 2017年01月04日 实施 密 级： 版本号：B/0
目录 0.2、前言及简述 (5) 0.3、管理者代表任命书 (6) 0.4、质量手册发布令 (7) 质量手册发布令 ............................................................................................................................................... 错误！未定义书签。 1. 范围 (8) 1.1 总则 (8) 1.2 应用 (8) 2. 引用标准 (8) 3. 术语 (8) 4 .质量管理体系 (8) 4.1 总要求 (8) 5.管理职责 (11) 5.1 管理者承诺 (11) 5.2 以顾客为关注焦点 (11) 5.3 质量方针 (11) 5.4 策划 (12) 5.5 职责、权限和沟通 (12) 5.6 管理评审 (15) 6 .资源管理 (16) 6.1 资源提供 (16) 6.2 人力资源 (16) 6.3 基础设施 (16) 6.4 工作环境和污染控制 (16) 7 .产品实现 (17) 7.1 产品实现的策划 (17) 7.2.2 与产品有关的要求的评审 (18) 7.3 设计和开发 (18)
(21) 7.5 生产和服务提供 (22) 7.6 监视和测量设备的控制 (24) 8 .测量、分析和改进 (25) 8.1 总则 (25) 8.2 监视和测量 (25) 8.3 不合格品控制 (27) 8.4 数据分析 (28) 8.5 改进 (28) 9 .MDD要求 (29) 9.1 总则 (29) 9.2 适用范围 (29) 9.3 职责 (29) 9.4 程序要求 (29) 附录A 公司质量目标 (31) 附录B 各部门目标分解 (32) 附录C 职责分配表： (33) 附录D 程序文件清单 (34) 附录E 组织架构图 (35) 附录F YY/T 0287-2017 和GB/T19001-2016 对应关系表 (36)
质量手册 （YY/T 0287-2017/ISO 13485-2016） 目录
1.0范围 1.1总则 本质量手册是依据YY/T 0287-2017/ISO 13485：2016《医疗器械质量管理体系用于法规的要求》和GB/T 19001-2016/ISO9001:2015《质量管理体系要求》标准制定。公司生产医疗器械产品的设计和开发、生产、贮存和流通、安装或服务，以及相关活动（如技术支持）的设计和开发或提供应当遵守本手册的要求。 本质量手册适用于本公司生产产品生命周期内全过程的控制与管理，适用于向本公司提供产品（包括与质量管理体系相关的服务）的供方或外部方，也适用于证实本公司有能力提供持续满足顾客要求和适用的法规要求的医疗器械和相
关服务。对于本手册要求的适用于公司但不是由公司组织实施的过程，公司应在质量管理体系中通过监视、维护和控制这些过程并对其负有责任。 本质量手册是公司执行质量管理体系的纲领性文件，其它质量文件若与手册不符之处，以本手册为准。 质量手册由质管部负责编写，管理者代表审核，总经理批准，发放到公司各部门，文件领用人在“文件发放登记表”上签名后领取封面有“受控”印章、发放日期、分发号的有效文件。未经管理者代表同意，任何人员不得将本手册提供给本公司以外的人员。具体规定按《文件控制程序》执行。 1.2删减和不适用说明 1.2.1 YY/T0287-2017/ISO13485：2016不适用条款说明 1.2.2医疗器械生产质量管理规范不适用条款说明 公司生产的医疗器械产品体积较大、价值较高，不适宜留样，因此《医疗器械生产质量管理规范》中第六十一条“企业应当根据产品和工艺特点制定留样管理规定，按规定进行留样，并保持留样观察记录。”不适用本公司质量体系。 2.0规范性引用文件
Table of Contents 1. Purpose & Scope (2) 2. Applicable Standards (2) 3. Business Profile (2) 4. Authority & Responsibility (2) 5. Terms & Definitions (2) 6. Policy & Objectives (3) 7. Application (4) 8. Quality Management System (4) 9. Management Responsibility (6) 10. Resource Management (8) 11. Product Realization (8) 12. Purchasing (11) 13. Production Control / Product Identification & Traceability (12) 14. Control of Inspection, Measuring, and Test Equipment (13) 15. Measurement, Analysis, Improvement (14)
1. Purpose & Scope This manual describes the Quality Management System (QMS) established by and for Dongguan XXX Appliances Limited. The principles and policies on which this manual is based; along with operating procedures, work instruc-tions, and other supporting documents; govern all processes that affect quality throughout the organiza-tion. 2. Applicable Standards 2.1 The QMS is structured and intended to be in compliance with the following standards. ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 21 CFR Part 820 Quality System Regulation (Exclusions and Exceptions noted below.) 2.2 Normative References ISO 9000:2015 Quality Management Systems · Fundamentals and Vocabulary ISO 13485:2016 Medical devices · Quality Management Systems · Guidance on the Application of ISO 13485:2016 3. Business Profile 3.1 Mission Statement To deliver zero defects to our internal and external suppliers and customers. 3.2 XXX, with one facility located at xxx, Dongguan City, Guangdong Province, China. 3.3 The organizational structure is described by Dongguan XXX Appliances Limited Organization Chart. 4. Authority & Responsibility 4.1 This manual is issued under the authority of the President. 4.2 It is the responsibility of the Director of Quality, who is the designated Management Representative, to ensure that the principles of this manual, the Quality Policy, quality objectives, customer requirements, applicable regulatory requirements, and quality management system requirements are promoted, com-municated to and understood by all XXX employees. 5. Terms & Definitions 5.1 Corrective Action A process improvement methodology aimed at identifying and eliminating the causes of known non-conformities to prevent their recurrence. A problem solving process.
ISO 9001:2000 QUALITY MANUAL WOLSTENHOLME INTERNATIONAL LIMITED CONTENTS 1.0 Scope of the Quality Management System at Wolstenholme International Limited 1.1 Statement of Quality Policy 2.0 Quality Management System Documented Procedures 2.1 Document Control 2.2 Control of Quality Records 2.3 Internal Quality Audits 2.4 Control of Nonconforming Product 2.5 Corrective Action 2.6 Preventative Action 3.0 Quality Management System Processes and Interrelations 3.1 Organisation Charts 3.2 Responsibilities 3.3 Interrelation of Processes 3.4 Processes 1.0 Scope of the Quality Management System at Wolstenholme International Limited
Wolstenholme International Limited is a Company with a long-standing successful history of supplying metal powders, pastes, pellets, varnish, offset ink, flexography ink and other related products for use in a large range of applications, on a worldwide basis. The scope of the Quality Management System encompasses all activities on the Darwen Site. The Metallic Powders Operation at Darwen is responsible for the manufacture and supply of metal powders and pigments mainly in aluminium, copper and brass (bronze) based alloys, for use in printing, inks, plastics and other industrial and engineering applications. The Ink Operation at Darwen is responsible for the manufacture of a wide range and type of printing ink, 'one-pack' gold ink, varnish and related printing products. All production processes at Darwen are validated before leaving the site and as such sub-clause 7.5.2 is excluded. The overall operation at Darwen is controlled by the Ink & Print business unit and the Industrial business unit. Technical Service and Research and Development are vital to the future development of the Company, together with understanding and developing new products and applications for our customers. The manufacturing, technical and administration functions of the Company are based in Darwen, Lancashire, England and employ some 210 staff at that location. Through the application of Quality Management Systems and Company wide training programmes, Wolstenholme International Ltd. is committed to ensuring continuous improvements to both its processes and product technology.
Quality Management System Policy Manual ISO 9001:2015 11-8-17 Date Printed: _______________
1. Quality Management System Scope COMPANY NAME establishes this quality policy manual to implement and maintain a quality management system meeting the requirements of ISO 9001:2015, to ensure customer satisfaction in the manufacturing of stamped, formed, machined and fabricated metal parts, weldments, subassemblies and painting of metal parts to customer and COMPANY NAME specifications 1.1. Non-applicable Clauses of ISO 9001: 1.1.1. 8.3 Product Design & Development of Products & Services – COMPANY NAME is a custom manufacturer and designs are provided by our customers. 2. Quality Policy Statement COMPANY NAME is committed to continually improving all products and services to achieve our customer’s expectations. We do this by: 1) Living our values, 2) Providing opportunities for employee involvement, motivation and training, 3) Developing, documenting and following processes. 3. Quality Objectives COMPANY NAME’s quality management system objectives are to enable COMPANY NAME to be our customers’ first choice by: 1) Achieving satisfactory ratings on quality, delivery and other key metrics tracked and reported by our customers through their formal supplier evaluation and performance systems, 2) Achieving a level of 700 ppm as tracked through COMPANY NAME’s RA system for customers without a formal supplier evaluation system for quality, 3) Achieving a 95% on-time delivery to the COMPANY NAME warehouse for customers without a formal supplier evaluation system for delivery. Policy Manual Revisions Log Date 3/22/17 8/7/17 Summary of Revisions Rewrite of Quality Policy Manual to meet ISO 9001:2015. 1. Revised 4.2 to include “employees”, “owners” and “regulators”. Made By JGV JGV 2. Added Figure 2 to support to support the COMPANY NAME QMS Process Flow 11-8-17 Updated to clarify risk, inputs, out puts and KPI’s for Support and Management Process in QMS Process Reference page (page 6) JGV Management Approval Name: Title: Signature: Date: Paul Gintner President