英文质量手册(工程公司)
Quality Manual
Approval Page
Introduction
Quality Commitment of XX CORPORATION. (XX CORP) XX Corp. (hereafter referred to as XX CORP) always adheres to the service concept of “What XX CORP pursues is the success of client’s projects”, trying its best to provide quality and excellent projects and satisfactory service. To achieve our goal, we hereby make the following commitments:
We will establish one quality management system in line with Standard GB/T1 9001 idt ISO 9001. President, top management of the Company, will be responsible for active promotion and implementation of the system to ensure all laws, regulations and policies on quality of the Company understood by all employees and implemented in product realization.
XX CORP will set up organizations and documentation management system necessary for quality management system and appoint one deputy president responsible for the establishment, maintenance and supervision of the quality management system. The responsibilities on quality of relevant departments and personnel will be clearly defined, to ensure all quality-related issues are under someone's responsibility and everyone has his own responsibilities, so that the quality of products and service meets the requirements of the customer.
XX CORP will strengthen the contact with the customer, gather market information and know customer and market needs in a timely manner to satisfy increasing expectation of the customer and market and carry out customer needs evaluation to ensure smooth performance of the project contract.
XX CORP will strengthen the training over all employees, including the training on management abilities and responsibilities of management at all levels as well as operating procedure and expertise of production personnel to improve their professional quality; strengthen the education of the concept “taking customer as the focus” to provide excellent products for the customer by high-quality personnel.
XX CORP will make great effort to use new technologies, new processes, new equipment and new materials in the project; properly select qualified supplier and subcontractor, establish a more complete file and regularly evaluate the quality, price and service; continuously introduce advanced software and production equipment to build high-quality, cost-effective, energy-saving, safe and environment friendly project for the customer.
XX CORP will set up supervision and inspection mechanism for product realization process to find and identify improvement opportunities at any time; make improvement program and take corrective and preventive measures through survey and analysis of customer satisfaction; continuously improve the efficiency and effectiveness of the management system.
President of XX CORP will ensure the provision of adequate resources to perform such commitments.
President of XX CORP
Date: Dec. 15, 2010
Quality Policy of XX CORPORATION. (XX CORP)
Sincere Service Strive for Excellence
Innovative Development Continuous Improvement
Connotation of the quality policy:
a) Sincere Service: adhering to the quality-oriented philosophy, pursuing honest operation, observing national laws and regulations and relevant standards, thinking about the interests of the customers, satisfying customers’ requirements and abiding by the contract to guarantee the project and service quality and establish a good corporate reputation and social image, satisfy the customers with good reputation and quality service to win market gradually.
b) Strive for Excellence: establishing, implementing and maintaining the quality management system to realize quality control of the whole process by strict system, fine management, standard operation and meticulous service, implementing quality responsibility, assuring and optimizing resource allocation, improving employees’ quality and making efforts to design and build high-quality and excellent project.
c)Innovative Development: being never satisfied and brave in making innovation, vigorously promoting scientific and technological innovation and management innovation, promoting the application of new technologies, new processes, new materials, new equipment and advanced modern enterprise management methods, and continuously enhancing the quality assurance capacity, improving the project products quality and pushing the Company developing in an innovative manner.
d) Continuous Improvement: according to the changing situation, the needs of customers and the company management needs, continuously optimizing and improving the company's quality management system, processes, products and services, providing customers with satisfactory project products and services in a lasting and stable manner, enhancing its capabilities and improving the competitiveness of the company.
President of XX CORP
Date: Dec. 15, 2010
Table of Contents
1 SCOPE (4)
1.1 G ENERAL P RINCIPLE (4)
1.2 A PPLICATION (4)
2 NORMATIVE REFERENCE DOCUMENTS (4)
3 TERMS AND DEFINITIONS (4)
4 QUALITY MANAGEMENT SYSTEM (5)
4.1 G ENERAL R EQUIREMENTS (5)
4.2 M ANAGEMENT C OMMITMENT AND Q UALITY P OLICY (6)
4.2.1 Purposes (6)
4.2.2 Responsibility (6)
4.2.3 Content and Requirement of Management (6)
4.2.4 Relevant Document (8)
4.3 T AKING C USTOMER AS THE F OCUS (8)
4.3.1 Purposes (8)
4.3.2 Responsibility (8)
4.3.3 Content and Requirement of Management (8)
4.3.4 Relevant Document (9)
4.4 D OCUMENT R EQUIREMENTS (9)
4.4.1 General Principle (9)
4.4.2 Document control (9)
4.4.3 Record control (11)
5 MANAGEMENT RESPONSIBILITY (12)
5.1 P LANNING AND M ANAGEMENT OF Q UALITY O BJECTIVES (12)
5.1.1 Purposes (12)
5.1.2 Responsibility (12)
5.1.3 Content and Requirement of Management (12)
5.1.4 Relevant Document (13)
5.2 P LANNING OF Q UALITY M ANAGEMENT S YSTEM (13)
5.2.1 Purposes (14)
5.2.2 Responsibility (14)
5.2.3 Content and Requirement of Management (14)
5.3 O RGANIZATION AND RESPONSIBILITY (15)
5.3.1 Purposes (15)
5.3.2 Responsibility (15)
5.3.3 Content and Requirement of Management (15)
5.3.4 Relevant Document (17)
5.4 C ONSULTATION AND C OMMUNICATION (17)
5.4.1 Purposes (17)
5.4.2 Responsibility (17)
5.4.1 Purposes (17)
5.4.2 Responsibility (17)
5.4.3 Content and Requirement of Management (18)
5.4.4 Relevant Document (19)
5.5 M ANAGEMENT REVIEW (19)
5.5.1 Purposes (19)
5.5.2 Responsibility (19)
5.5.3 Content and Requirement of Management (19)
5.5.4 Relevant Document (20)
6 RESOURCE MANAGEMENT (20)
6.1 H UMAN R ESOURCES (20)
6.1.1 Purposes (20)
6.1.2 Responsibility (20)
6.1.3 Content and Requirement of Management (21)
6.1.4 Relevant Document (22)
6.2 I NFRASTRUCTURE (22)
6.2.1 Purposes (22)
6.2.2 Responsibility (22)
6.2.3 Content and Requirement of Management (22)
6.2.4 Relevant Document (23)
6.3 W ORK E NVIRONMENT (23)
6.3.1 Purposes (23)
6.3.2 Responsibility (23)
6.3.3 Content and Requirement of Management (24)
7 PRODUCT REALIZATION (24)
7.1 V ALIDATION OF P ROJECT R EQUIREMENTS (25)
7.1.1 Contract Clarification (25)
7.1.2 Contract Review (26)
7.2 P ROJECT P LANNING AND M ANAGEMENT (28)
7.2.1 Planning and Management of Project Items (28)
7.2.2 Planning and Management of Technical Development Project (29)
7.2.3 Planning and Management of Preceding Consulting Project (30)
7.2.4 Change Management (30)
7.2.5 Contractors and Suppliers (32)
7.2.6 Customer Property (33)
7.2.7 Control of Unqualified Products (34)
7.3 D ESIGN Q UALITY C ONTROL (35)
7.3.1 Design Planning (36)
7.3.2 Design Input (38)
7.3.3 Design Output (39)
7.3.4 Design Verification (40)
7.3.5 Design Review (41)
7.3.6 Design Validation (42)
7.3.7 Design alteration (43)
7.4 P ROCUREMENT Q UALITY C ONTROL (46)
7.5 M ATERIALS M ANAGEMENT AND Q UALITY C ONTROL (53)
7.6 C ONSTRUCTION Q UALITY C ONTROL (59)
7.7 M ANAGEMENT AT S TART-UP S TAGE (67)
7.7.1 Start-up Sub-contractor (67)
7.7.2 Start-up (68)
7.7.3 Construction Quality Warranty (69)
7.8 C OMPLETION A CCEPTANCE (69)
7.8.1 Purposes (69)
7.8.2 Responsibility (69)
7.8.3 Content and Requirement of Management (70)
7.8.4 Relevant Document (70)
8 MEASUREMENT ANALYSIS AND IMPROVEMENT (70)
8.1 C USTOMER S ATISFACTION (71)
8.1.1 Purposes (71)
8.1.2 Responsibility (71)
8.1.3 Content and Requirement of Management (71)
8.1.4 Relevant Document (72)
8.2 I NTERNAL AUDIT (72)
8.2.1 Purposes (72)
8.2.2 Responsibility (72)
8.2.3 Content and Requirement of Management (72)
8.2.4 Relevant Document (73)
8.3 A NALYSIS OF D ATA (73)
8.3.1 Purposes (73)
8.3.2 Responsibility (73)
8.3.3 Content and Requirement of Management (73)
8.3.4 Relevant Document (74)
8.4 C ORRECTIVE AND P REVENTIVE M EASURES (74)
8.4.1 Purposes (74)
8.4.2 Responsibility (74)
8.4.3 Content and Requirement of Management (74)
8.4.4 Relevant Document (75)
9 MANAGEMENT OF QUALITY MANUAL (75)
9.1 P URPOSES (75)
9.2 R ESPONSIBILITY (75)
9.3 C ONTENT AND R EQUIREMENT OF M ANAGEMENT (75)
10 APPENDIX (77)
1 S COPE
1.1 General Principle
This Manual makes regulations on the requirements of quality management
system of XX Corp. (XX CORP) (hereafter referred to as the Company), internally
serving as quality management standard and externally working as a proof for
quality assurance capacity.
This Manual is applicable to the headquarters of the Company and the quality
management activities involved in preliminary consulting projects (project
proposals, project application report, feasibility study, environmental impact
review), technology development and transfer, general contract of the project
(design and development, procurement, construction management, start-up
services, project management contract) undertaken by it, and also serves as the
basis for internal and external audits.
This Manual is applicable to all departments of the Company headquarters
including the project teams.
1.2 Application
This Manual incorporates all terms of Quality Management System:
Requirements (GB/T 19001-2008 idt ISO 9001:2008). No deletion is made.
2 N ORMATIVE R EFERENCE D OCUMENTS
The articles contained in the following standards constitute the articles of this
Manual by quoting in this Manual. When this Manual is issued, all the versions are
valid. All standards are subject to revision, and parties using this Manual are
encouraged to investigate the possibility of applying the most recent version of the
standards listed below.
GB/T 19001-2008 idt ISO 9001:2008 Quality Management System:
Requirements
GB/T 19000-2008 idt ISO 9000:2005 Quality Management System: Basics &
Terminology
3 T ERMS AND D EFINITIONS
In addition to the reference of the definitions and terminologies stipulated in
Quality Management System: Basics & Terminology (GB/T 19000-2008 idt ISO
9000:2005) and Quality Management System: Requirements (GB/T 19001-2008
idt ISO 9001:2008), this Manual also uses the following terminologies and
abbreviations:
3.1 Company: CHINA HUANQIU CONTRACTING & ENGINEERING ORPORATION.
for short.
3.2 All departments including the project teams: President's Office, Strategy
(Research) and (Planning) Development Div., QHSE Management Div., Human
Resource Div., Finance, Property & Capital Operation Div., Business Div.,
International Business Div., Information Center, Contract & Legal Affairs Div.,
Process Div. (composed of Chemical Process Dept., Refinery Process Dept. and
Package Equipment Dept., the same below), Engineering Div. (composed of
Civil Dept., Electrical & Control Dept., Piping Dept., Mechanical Dept., the same
below), Project Management Div., Project Controls Div., Document Control Div.,
Construction Div., Procurement Div. (with Technology Import and Export and
International Tendering Center and Materials Dept. under it), Start-Up Div., QHSE
Center, Consulting Div., Patent and Technology Development Div., Administration
& Security Div., Audit Div. (Budget Office), CPC Affairs Div. (Corporate
Culture Div.), Project Teams set up in accordance with established projects.
3.3 Competent department: the unified management department of the element.
3.4 Auxiliary competent department: the auxiliary unified management department of
the element.
3.5 Joint administrative department: the department providing assistance in relevant
management.
3.6 Relevant departments: departments implementing element-related requirements.
3.7 QHSE management system: an integrated management system consisting of
Health, Safety and Environmental Management System (HSE-MS), Occupational
Health & Safety (OH&S) Management System, Environmental Management
System and Quality Management System and established in accordance with
Q/SY 1002.1, GB/T 28001 and GB/T 24001 and GB/T 19001.
4 Q UALITY M ANAGEMENT S YSTEM
4.1 General Requirements
Quality Management System is established and Quality Manual and relevant
procedure documents are formulated by the Company in accordance with the
requirements of Quality Management System: Requirements (GB/T 19001-2008
idt ISO9001:2008) and relevant national regulations and standards as well as
actual conditions. Documents of all departments concerned shall, in strict line with
quality management requirements of the Company, take Quality Manual and
procedure documents as guideline, up to the requirements of system documents
by a relatively independent way, so that they can be effective as an organic
component of the quality management system, realizing the goal of performance
improvement and continuous improvement.
-Determining the processes necessary for Quality Management System and its application in the headquarters of the Company.
-Determining the sequence of the processes and their interactions.
-Determining the principles and methods required to ensure effective operation and control of the processes.
-Ensuring that President provides necessary resources in accordance with the requirements of Section 6 “Resource Management” of the Manual and acquires
information’s by consultation and communication, communication with customers
as well as monitoring and measuring results etc. to support the operation and
monitoring of such processes.
-Monitoring, measuring (when applicable) and analyzing such processes.
-Implement the measures provided in this Manual to ensure that they are operating with the mode of Plan - Do - Check - Action (PDCA) to achieve the
continuous improvement of the planned results and Quality Management System.
-Identifying completely the outsourcing process necessary but possible to make the project unqualified and seeing to corresponding control of such
process. Determining the control type and degree over the outsourcing process in
accordance with its potential impact over the capacity of providing products up to
requirements.
4.2 Management Commitment and Quality Policy
4.2.1 Purposes
President of the Company shall provide strong leadership and clear commitment
for the establishment, implementation and improvement of the quality
management system and make sure such commitments performed by all
employees.
The Company shall establish the quality policy, stipulating the principle and aim of
quality management and ensuring continuous and effective operation of the
quality management system.
4.2.2 Responsibility
4.2.2.1 President of the Company is responsible for providing evidence for the commitment to the establishment, implementation and continuous improvement of the quality management system and for the approval of management commitment and quality policy.
4.2.2.2 Management Representative is responsible for the implementation of management commitment and quality policy.
4.2.2.3 Strategy (Research) and (Planning) Development Div. is the competent department of management commitment and quality policy, responsible for the formulation of draft management commitment and quality policy.
4.2.2.4 CPC Affairs Div. (Corporate Culture Div.) is responsible for the publicity of management commitment and quality policy in the Company.
4.2.2.5 QHSE Management Div. is responsible for supervising the implementation of management commitment and quality policy in all departments concerned.
4.2.2.6 All departments concerned are responsible for incorporation of management commitment and quality policy into their objectives and their implementation, as well as the publicity and implementation of management commitment and quality policy in the department.
4.2.2.7 All employees shall carry out relevant requirements of management commitment.
4.2.3 Content and Requirement of Management
4.2.3.1 President of the Company shall provide evidence for the commitment to the establishment, implementation and continuous improvement of the quality management system by following activities:
-Communicating to the employees the importance of satisfying customers and meeting the requirements of laws and regulations;
-Formulating quality policy;
-Formulating quality objectives;
-Conducting management review;
-Providing resources.
4.2.3.2 Formulation and approval for issuance of management commitment and quality
policy
Strategy (Research) and (Planning) Development Div. is responsible for collecting
and proposing draft management commitment and quality policy from and for all
employees, rep orting it to leaders’ office meeting for discussion, which will be
approved by top management for issuance.
4.2.3.3 The following aspects should be considered when the management commitment is
developed:
- Ensuring to establish, operate, maintain and continuously improve quality management system;
- Reflecting the general purpose, strategic objective and direction of the Company;
- Related laws and regulations and other requirements and the requirements of the Group Company;
- Clear definition of the responsibilities for quality management of the leaders at each level;
- Production conditions, features and size suitable for the project;
- Expectations and requirements of interested parties;
- The language being simple, easy to be understood by the employees and the public.
4.2.3.4 The following aspects should be considered when Quality Policy is developed:
- The reflection of general tenet and direction of the Company;
- The basis of the Company’s commitments to satisfy customers’ requirements;
- Incorporation of commitments to continuous improvement and compliance with laws and regulations and other requirements;
- Compliance with general requirements of quality policy of the Corporation;
- Features and size of activities, products and services suitable for the Company;
- Provision of basic framework and guidance for the establishment and evaluation of quality objectives;
- The language being simple, easy to be understood by the employees and the public.
4.2.3.5 Management commitment and quality policy will be distributed in the form of
documents and be publicized by various ways until all personnel working for the
Company or on behalf of the Company understand and implement them. They
shall be implemented through the setting of objectives, establishment and
implementation of the quality system and process control, to ensure continuous
and effective operation of the quality management system.
4.2.3.6 Management commitment and quality policy can be accessible to the public and
be communicated to the parties concerned by relevant departments.
4.2.3.7 Management commitment and quality policy will be evaluated annually during the
management review to ensure its continuing suitability.
4.2.3.8 All departments concerned will implement management commitment and quality
policy during their activities and demonstrate their implementation through the
establishment and effective operation of the quality management system.
4.2.3.9 Upon significant changes in production and operation or request by management
review and customer, it is necessary to review and revise management
commitment and quality policy and inform related information.
4.2.4 Relevant Document
Quality Management Commitment of XX CORPORATION. (XX CORP)
Quality Policy of XX CORPORATION. (XX CORP)
4.3 Taking Customer as the Focus
4.3.1 Purposes
Top management and all employees shall aim to enhance customer satisfaction,
identify and determine customer needs and expectations, take timely corrective
and preventive measures to prevent the occurrence of non-conformities through
the effective operation of QHSE management system and customer satisfaction
survey and to continuously improve QHSE management system to ensure that
customers’ requirements are met.
4.3.2 Responsibility
4.3.2.1 Top management shall take customer as the focus to carry out the quality
management system in an effective manner.
4.3.2.2 Project Management Div., the competent department of taking customer as the
focus, is responsible for organizing to determine the quality requirements of the
customer of the contracted project, including requirements for product and quality
management, and for organizing to monitor the customer’s satisfaction.
4.3.2.3 Consulting Div., QHSE Center and Patent and Technology Development Div. are
all auxiliary competent departments of taking customer as the focus, respectively
responsible for organizing to determine the quality requirements of the customer
of preliminary consulting projects, environmental impact review project and
technology development project, including requirements for product and quality
management, and for monitoring their satisfaction.
4.3.2.4 Business Div., the joint administrative department of taking customer as the focus,
is responsible for organizing to determine the requirements of domestic
customers.
4.3.2.5 International Business Div., the joint administrative department of taking customer
as the focus, is responsible for organizing to determine the requirements of
overseas customers.
4.3.2.6 All departments concerned are responsible for identifying and satisfying the
requirements of the customer, collecting customer’s feedback and taking timely
corrective and preventive measures to enhance customer satisfaction.
4.3.3 Content and Requirement of Management
4.3.3.1 Top management shall aim to enhance customer satisfaction and strengthen all
employees’ awareness of taking customer as the focus.
4.3.3.2 Business Div., International Business Div., Project Management Div.,
Consulting Div., QHSE Center and Patent and Technology Development Div. shall
ensure the confirmation of customer’s requirements in accordance with 7.1.1 in
this Manual.
4.3.3.3 Project Management Div., Consulting Div., QHSE Center and Patent and
Technology Development Div. shall measure and analyze the customer
satisfaction in accordance with 8.1 in this Manual, to know about customer’s
comments on the Company.
4.3.3.4 All departments concerned shall identify and satisfy customer’s requirements
through the implementation of all processes of the quality management system,
take corresponding corrective measures based on customer’s feedback and
continuously improve the quality management system to enhance the customer
satisfaction.
4.3.4 Relevant Document
HQCM-QMc-0100-14 Customer Satisfaction Evaluation Procedure
4.4 Document Requirements
4.4.1 General Principle
The Company will establish and keep quality management system documents
in written form or by other media, including:
- Documented management commitment, quality policy and quality objectives;
- Quality Manual, including the description of the scope of the quality management system and interaction between elements and processes of the quality
management system as well as documented procedures for establishing quality
management system or its reference;
- Quality management system procedure documents;
- Supporting documents of the quality management system (including rules, regulations, technical documents, work instructions, quality plans, specifications,
guidelines, templates, forms etc.);
- Applicable external documents, including laws and regulations, quality management requirements of the Corporation and other requirements;
- Quality records.
4.4.2 Document control
4.4.2.1 Purposes
It aims to make clear the requirements for document control by the management
system to ensure that the information in the document is accurate and the
document can communicate intention and unify actions. Record, as one special
document, will be controlled in accordance with the requirements of 4.3.3 in the
Manual.
4.4.2.2 Responsibility
4.4.2.2.1 QHSE Management Div. is the competent department of document control and is
responsible for preparing QHSE System Document Control Procedures and
stipulating the management requirements of quality system documents and
materials.
4.4.2.2.2 Contract & Legal Affairs Div. is auxiliary competent department of document
control and is responsible for preparing Management Procedures for Applicable
Laws, Regulations, Standards and Specifications and organizing the formulation
and management of quality management rules.
4.4.2.2.3 Document Control Div. is auxiliary competent department of document control and
is responsible for preparing Project Document Control Procedures and
supervising and inspecting the management of project document control.
4.4.2.2.4 President's Office of the Company is responsible for the distribution management
of internal and external administrative documents.
4.4.2.2.5 Other departments and each project team are responsible for the control of quality
system documents and materials within the business scope of the departments
and the project.
4.4.2.3 Content and Requirement of Management
4.4.2.3.1 Establish and maintain Control Procedures of QHSE System Documents to
control the establishment, review, approval, publication, issuance, storage,
retrieval, modification and invalidation of documents and materials required for
Quality Management System, so as to ensure:
a) Documents shall be approved before publication to ensure completeness and
applicability of the documents;
b) The documents are evaluated or updated regularly and approved again.
Modification of the documents is approved by original approval department. In
case of designating other departments for examination and approval, it is required
to acquire all related background information.
c) The modification and current revised status of the documents are identified.
d) Effective version of corresponding document is available in relevant places where
Quality Management System operates;
e) Documents shall remain legible and easily recognizable;
f) External documents required for planning and operating the planned quality
management system are identified and controlled over the distribution.
g) When new document published, the document to be replaced shall be identified,
and the invalid document or obsolete document shall be removed timely. When
the obsolete document needs to be maintained, it shall be properly marked;
h) The path of retrieving documents and materials is specified to facilitate the
retrieval.
4.4.2.3.2 Establish Management Procedures for Applicable Laws, Regulations, Standards
and Specifications, clearly defining the management of such processes as
identification, access, distribution and update of applicable laws, regulations,
standards, specifications and other requirements.
4.4.2.3.3 Establish Project Document Control Procedures, clearly defining the scope,
responsibility and control requirements of project document control, including the
management of project records; Project Document Control Procedures shall in
line with the requirements of QHSE System Document Control Procedures,
Procedures for Applicable Laws, Regulations, Standards and Specifications and
QHSE Records Management Procedures.
4.4.2.3.4 Each department, in accordance with the requirements of QHSE
System Document Control Procedures and Procedures for Applicable Laws,
Regulations, Standards and Specifications, clearly defines the management
responsibilities of document control and takes effective control of the documents
of the Department, applicable laws, regulations, standards and specifications
as well as other external documents. Department document is numbered by
applying the document numbering principle of company.
4.4.2.3.5 A Project Team takes control of project documents and records in
accordance with Project Document Control Procedures. If the customer has other
requirements which do not violate regulations, standards and the contract, the
Project Team can make suitable modification over Project Document Control
Procedures based on the requirements of the customer and prepare the
document control rules for the project, which will be implemented after being
approved by the director of Document Control Div. and the Project Manager.
4.4.2.3.6 Documents shall be used and stored in proper media.
4.4.2.3.7 For any documents having confidential requirements, they will be treated
according to the confidentiality provisions of the Company.
4.4.2.4 Relevant Document
HQCM-QHc-0100-04 Control Procedures of QHSE System Documents
HQCM-QHc-0100-01 Management Procedure for Applicable Laws, Regulations
and Standard Specifications
HQPM-QMc-0100-01 Project Document Control Procedures
HQCM-QHc-0100-07 QHSE record management procedure
4.4.3 Record control
4.4.3.1 Purposes
It aims to take effective control of quality records, to provide objective evidence for
guaranteeing compliance with the requirements of quality management and
qualified products as well as effective operation of the quality management
system.
4.4.3.2 Responsibility
4.4.3.2.1 QHSE Management Div. is the competent department of record control and is
responsible for preparing QHSE Records Management Procedures, stipulating
the control requirements for the quality management system records and
supervising and inspecting the control of the quality records of the Company.
4.4.3.2.2 Document Control Div. is auxiliary competent department of record control and is
responsible for stipulating the control requirements for system document record
and supervising and inspecting the control of the quality records of the project. 4.4.3.2.3 Each department and each Project Team. shall take charge of the management
and control of records of its own department and project.
4.4.3.3 Content and Requirement of Management
4.4.3.3.1 Establishing and maintaining the QHSE Record Management Procedure, and
specifying the control needed by the identification, depositing, protection, retrieval,
keeping period and disposal of records.
a) Records to be controlled include: quality management system operation record,
product conformity record and audit and review result record etc.
b) Record should have clear handwriting, explicit identification, complete items and
real content, and should be filled in timely and be traceable.
c) Records shall be clear, identifiable, retrievable and accessible.
d) Records shall be stored in a suitable environment to prevent damage,
deterioration and loss.
e) Records shall be protected during use, transfer and lending to prevent damage.
f) Keeping department and period, disposal method and authority should be
specified for records.
4.4.3.3.2 Each department and each Project Team explicitly record the management
responsibilities of control in their documents according to the requirements of the
QHSE Record Management-procedure of the company, and carry out control over
the records of its own department and its own project according to requirements.
4.4.3.3.3 Records can be stored by way of various information platforms.
4.4.3.3.4 Records from any parties concerned shall be controlled and managed in
accordance above requirements and filed as required.
4.4.3.4 Relevant Document
HQCM-QHc-0100-07 QHSE record management procedure
HQPM-QMc-0100-01 Project Document Control Procedures
5 M ANAGEMENT R ESPONSIBILITY
5.1 Planning and Management of Quality Objectives
5.1.1 Purposes
It aims to set quality objectives for the Company according to its management
commitment and quality policy, divide and implement it at related functions and
levels, set specific objectives and take effective control and management of it, to
ensure the realization of quality objectives of the Company.
5.1.2 Responsibility
5.1.2.1 President of the Company is responsible for approving quality objectives and
ensuring its realization.
5.1.2.2 QHSE Management Div. is the competent department of quality objectives and is
responsible for formulating quality objectives for the Company, dividing it to
relevant functional departments and carrying out supervision, inspection and
review on the implementation of quality objectives.
5.1.2.3 Project Management Div. is auxiliary competent department of quality objectives
and is responsible for carrying out supervision, inspection and review on the
implementation of quality objectives in the Project Teams.
5.1.2.4 All departments concerned are responsible for formulating quality objectives for
the department in combination with actual conditions of the department and
based on quality objectives of the Company, and carrying out self-inspection.
5.1.3 Content and Requirement of Management
5.1.3.1 Establish and keep Objectives Management Procedures and clearly define the management requirements for formulation, division and review of quality
objectives. Determine quality objectives of the Company according to actual conditions of the Company and the requirements of the Corporation and divide them step by step at each functional levels.
5.1.3.2 Formulation and approval for issuance of quality objectives
Quality objectives of the Company is drawn up by QHSE Management Div. and examined by the competent leader. Further revised and improved quality objectives will be reported to leaders’ office meeting for discussion and then be
approved by President for issuance.
5.1.3.3 Basis of quality objectives:
- Feasibility and advance of the technologies considered;
- Necessary items to meet the product requirements, customer’s expectation and requirements, laws, regulations and other requirements;
- business management and competition requirements, market conditions, economic conditions;
5.1.3.4 Formulation requirements of quality objectives:
a) Quality objectives shall be specific and targeted;
b) Quality objectives shall be measurable.
c) Quality objectives shall be formulated respectively and documented for each
quality-related function and level;
d) Quality objectives shall be formulated for all processes (including management
activities, resource provision, product realization, measurement, analysis and
improvement) of the quality system;
e) Quality objectives of the Company shall be formulated by giving considerations to
the following requirements:
- Collecting, counting and analyzing the actual implementation and completion of the quality objectives in recent years;
- Analyzing relevant laws, regulations and economic and technical policies, forecasting the production and operation situation for the next year;
- Studying the relevant requirements of the Group Company and the customers as well as the Company's medium-term and long-term development planning. 5.1.3.5 Implementation and review of quality objectives
5.1.3.5.1 All departments concerned divide quality objectives of the Company and
formulate quality objectives for the department and corresponding specific
implementation plan and control measures, and then put them into practice.
5.1.3.5.2 Each department and each Project Team. shall check the completion of the
quality objectives of its own department and its own project every six months and
submit the result to QHSE Management Div.;
5.1.3.5.3 organizes to complete statistical summary on the fulfillment of quality objectives of
the Company every six months.
5.1.3.5.4 QHSE Management Div. regularly organizes to carry out review on the fulfillment
of quality objectives of all departments concerned every year and reports the
review results to the competent leader.
5.1.3.6 After review of quality objectives by management review meeting every
year, when quality objectives need to be modified, QHSE Management Div. will
organize relevant departments for discussion and carry out corresponding
modification based on Objectives Management Procedures.
5.1.4 Relevant Document
HQCM-QHc-0100-02 Objective Management Procedure
QHSE Objectives of the Company
5.2 Planning of Quality Management System
5.2.1 Purposes
It aims to plan the quality management system of the Company to ensure the
realization of quality policy and quality objectives.
5.2.2 Responsibility
5.2.2.1 President of the Company is responsible for proposing requirements and
providing organization and resource assurance for planning of the quality
management system.
5.2.2.2 Management Representative is responsible for organizing the planning of the
quality management system.
5.2.2.3 QHSE Management Div. is the competent department of quality management
system planning and is responsible for assisting Management
Representative with the organization of quality management system planning. 5.2.2.4 All departments are responsible for coordinating with Management
Representative and QHSE Management Div. in the planning of the quality
management system.
5.2.3 Content and Requirement of Management
5.2.3.1 President of the Company is responsible for proposing requirements and
providing assurance so that:
a) The quality management system is planned to meet the requirements of quality
objectives, indicators and Section 4.1 in this Manual;
b) The management system is complete during planning and implementing the
modification of the quality management system.
c) The quality management system is planned, including the modification of the
quality management system and organization and resource assurance is
provided.
5.2.3.2 Management Representative organizes all departments to plan the quality
management system according to the requirements of President.
5.2.3.3 QHSE Management Div. coordinates with Management Representative in
formulating quality management system plan and carrying out supervision and
inspection over its implementation.
5.2.3.4 All departments plan quality management on business, formulate corresponding
plan and carry out supervision and inspection over its implementation.
5.2.3.5 The planning of the quality management system shall reflect the requirements of
quality policy, quality objectives and Section 4.1 in this Manual.
5.2.3.6 The quality management system shall reflect systematic management of
processes by “PDCA”, as shown below:
5.3 Organization and responsibility
5.3.1 Purposes
To ensure effective implementation of quality management, it is required to clearly define and communicate responsibilities and authorities of each quality management department and its personnel, to ensure effective operation of the quality management system.
5.3.2
Responsibility 5.3.2.1
President is responsible for approving the establishment and responsibilities of organizations of the Company. 5.3.2.2 Human Resource Div., the competent department for organization and
responsibilities, shall be responsible for setup of organization, defining corresponding responsibilities and authorities, and organizing inspection and examination to the fulfillment of those responsibilities.
5.3.2.3 Project Management Div., the auxiliary competent department for organization and responsibilities, shall be responsible for definition of organization and responsibilities.
5.3.2.4 QHSE Management Div. is the joint administrative department of organizations and responsibilities and is responsible for determining the responsibilities and division of work among production departments.
5.3.2.5 Each department and each Project Team. shall be responsible for defining of organizations of its own department and its own project as required, developing responsibilities of each post, checking and examining the fulfillment of responsibilities.
5.3.3 Content and Requirement of Management
5.3.3.1
Organization 5.3.3.1.1 Principle of organization setup
a) Meet requirements of quality management, and adhere to the “simplified, efficient
and unified" principle;
Operation mode of quality management system
ISO14001质量手册英文版模板(2008版)
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
ISO9001：2015全套文件英文版(含质量手册及全套程序文件)
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 .. (15)
质量手册翻译中英文对照解析
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
ISO13485：2016质量手册英文版(修改公司名及程序名就可直接套用)
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.
ISO9001质量手册英文版(ISO9001QualityManual)
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.
ISO9001：2015质量手册-英文版
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
ISO17025：2017质量手册英文版
Quality Manual Reference Standard ISO/IEC 17025:2017 Issue Number 01 Issue Date 01–08–2018 Copy Number Total Pages Issued To Address Prepared By Approved By Issued By Name Designation Quality Manager CEO Quality Manager Prepared By Approved By Issued By Page 1 of 59
Prepared By Approved By Issued By Page 3 of 59 Chapter → 1.0 General Information 1.1 Table of contents Chapter No. Subject Amend ment No. Page No. ISO/IEC 17025 Clause Ref. 1 Cover page, table of contents, amendment record sheet and glossary of terms (abbreviation) 00 1 – 6 ========== 2 Authorization statement and laboratory profile and context of organization 00 7 – 9 ========== 3 Control and distribution 00 10 – 11 ========== 4.0 General requirements 4.1 Impartiality 00 12 – 13 4.0 4.2 Confidentiality 00 14 5.0 Structural requirements 00 15 – 20 5.0 6.0 Resource requirements 6.0 6.1 General 00 21 6.2 Personnel 00 21 – 22 6.3 Facilities and environmental conditions 00 23 6.4 Equipment 00 24 – 26 6.5 Metrological traceability 00 27 6.6 Externally provided products and services 00 28 – 29 7.0 Process requirements 7.0 7.1 Review of requests, tenders and contracts 00 30 – 31 7.2 Selection, verification and validation of methods 00 32 – 34 7.3 Sampling 00 35 7.4 Handling of test or calibration items 00 36 7.5 Technical records 00 37 7.6 Evaluation of measurement uncertainty 00 38 7.7 Ensuring the validity of results 00 39 – 40 7.8 Reporting of results 00 41 – 43 7.9 Complaints 00 44 7.10 Nonconforming work 00 45 7.11 Control of data – Information management 00 46
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