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GB/T 18305-2016: PDF in English (GBT 18305-2016) GB/T 18305-2016
Quality management systems - Particular requirements for the application of GB/T 19001--2008 for automotive production and relevant service part organizations
ICS 03.120.10
A00
National Standards of People's Republic of China
Replace GB/T 18305-2003
Quality management system car production and related services
Application of GB/T 19001-2008 special requirements
GB/T 19001-2008forautomotiveproductionandrelevantservice
(ISO /T S16949..2009, Qualitymanagementsystems-Particular
requirementsfortheapplicationofISO 9001..2008forautomotive
productionandrelevantservicepartorganizations, IDT)
2016-12-13 release.2017-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People 's Republic of China
China National Standardization Management Committee released
Directory
Preface Ⅴ
Notes on certification Ⅵ
Introduction Ⅶ
1 range 1
1.1 General 1
1.2 Application 1
2 normative reference document 1
3 Terms and definitions 2
3.1 Terms and definitions of the automotive industry 2
4 quality management system 3
4.1 General requirements 3
4.1.1 General requirements - Supplement 4
4.2 Documentation requirements 4
4.2.1 General 4
4.2.2 QUALITY MANUAL 4
4.2.3 File Control 4
4.2.3.1 Engineering specifications 5
4.2.4 Record control 5
4.2.4.1 Record keeping 5
Responsibilities 5
5.1 Management commitment 5
5.1.1 Process efficiency 5
5.2 Focus on the customer
5.3 Quality policy 6
5.4 Planning 6
5.4.1 Quality objectives 6
5.4.1.1 Quality Objectives --- Supplement 6
5.4.2 Quality management system planning 6
5.5 Responsibilities, authority and communication 6
5.5.1 Duties and competencies 6
5.5.1.1 Quality Responsibilities 7
5.5.2 Managerial Representative 7
5.5.2.1 Customer Representative 7
5.5.3 Internal communication 7
5.6 Management Review 7
5.6.1 General 7
5.6.1.1 Quality management system performance 7
5.6.2 Review input 8
5.6.2.1 Review input - add 8
5.6.3 Review Output 8
Resource Management 8
6.1 Resource provision 8
6.2 Human Resources 9
6.2.1 General 9
6.2.2 Competence, training and awareness 9
6.2.2.1 Product design skills 9
6.2.2.2 Training 9
6.2.2.3 Post training 9
6.2.2.4 Employee Incentives and Authorizations 9
6.3 Infrastructure 10
6.3.1 Planning of plants, facilities and equipment
6.3.2 Contingency plan 10
6.4 Working environment 10
6.4.1 Personnel safety related to compliance with product requirements
6.4.2 Production site cleaning 10
Product realization
7.1 Planning for product realization
7.1.1 Planning for product realization - Supplement 11
7.1.2 Acceptance criteria 11
7.1.3 Confidentiality 11
7.1.4 Change Control 11
7.2 Customer-related processes 11
7.2.1 Determination of product-related requirements 11
7.2.1.1 Special characteristics specified by the customer 12
7.2.2 Review of product-related requirements 12
7.2.2.1 Review of product-related requirements - Supplement 12
7.2.2.2 Organization Manufacturing Feasibility 12
7.2.3 Customer Communication 12
7.2.3.1 Customer Communication --- Supplement 13
7.3 Design and development
7.3.1 Planning for design and development 13
7.3.1.1 Multi-party demonstration method 13
7.3.2 Design and development input 13
7.3.2.1 Product design input 14
7.3.2.2 Manufacturing process design inputs 14
7.3.2.3 Special features 14
7.3.3 Design and development of outputs 14
7.3.3.1 Product design output --- Supplement 14
7.3.3.2 Manufacturing process design output 15
7.3.4 Design and development review 15
7.3.4.1 Monitoring 15
7.3.5 Design and Development Verification 15
7.3.6 Design and development confirmation 15
7.3.6.1 Product design confirmation --- Supplement 16
7.3.6.2 Sample plan 16
7.3.6.3 Product Approval Process 16
7.3.7 Control of design and development changes 16
7.4 Procurement 16
7.4.1 Procurement process 16
7.4.1.1 Compliance with laws and regulations 16
7.4.1.2 Development of supplier quality management system
7.4.1.3 Source of supply approved by the customer 17
7.4.2 Purchasing information 17
7.4.3 Verification of Purchased Products 17
7.4.3.1 Acceptance of conformity requirements for incoming products 17
7.4.3.2 Monitoring of suppliers 17
7.5 Production and service provision 18
7.5.1 Control of production and service provision 18
7.5.1.1 Control Plan 18
7.5.1.2 Assignment Guide 18
7.5.1.3 Verification of job preparation 18
7.5.1.4 Preventive and predictive maintenance 18
7.5.1.5 Management of Production Tooling 19
7.5.1.6 Production plan 19
7.5.1.7 Service Information Feedback 19
7.5.1.8 Service Agreement with Customer 19
7.5.2 Confirmation of production and service delivery process
7.5.2.1 Confirmation of production and service delivery process - Supplement 20
7.5.3 Identification and traceability 20
7.5.3.1 Identification and traceability - Supplement 20
7.5.4 Customer property 20
7.5.4.1 Customer-owned production tooling 20
7.5.5 Product protection 20
7.5.5.1 Storage and Stock 20
7.6 Control of monitoring and measuring equipment 21
7.6.1 Measurement system analysis 21
7.6.2 Calibration/Verification Record 21
7.6.3 Laboratory requirements 21
7.6.3.1 Internal laboratory 21
7.6.3.2 External laboratory 22
Measurement, analysis and improvement
8.1 General 22
8.1.1 Determination of statistical tools 22
8.1.2 Basic knowledge concept knowledge 22
8.2 Monitoring and measurement
8.2.1 Customer Satisfaction 22
8.2.1.1 Customer Satisfaction - Supplement 23
8.2.2 Internal Audit 23
8.2.2.1 Quality Management System Audit 23
8.2.2.2 Manufacturing process audit 23
8.2.2.3 Product review 23
8.2.2.4 Internal Audit Plan 23
8.2.2.5 Qualifications of Internal Auditors 24
8.2.3 Monitoring and measuring of the process
8.2.3.1 Monitoring and measurement of manufacturing processes
8.2.4 Monitoring and measuring of products
8.2.4.1 Full-size inspection and functional testing
8.2.4.2 Appearance Item 25
8.3 Nonconforming product control 25
8.3.1 Nonconforming product control --- Supplement 25
8.3.2 Control of rework products 25
8.3.3 Customer notice 25
8.3.4 Customer License 25
8.4 Data Analysis
8.4.1 Analysis and use of data
8.5 Improvements 26
8.5.1 Continual improvement
8.5.1.1 Continual improvement of the organization
8.5.1.2 Improvement of manufacturing process
8.5.2 Corrective action 26
8.5.2.1 Solve the problem 27
8.5.2.2 error prevention 27
8.5.2.3 Corrective action impact 27
8.5.2.4 Test/analysis of rejected products
8.5.3 Precautionary measures 27
Appendix A (Normative Appendix) Control Plan 28
A.1 Phase of the control plan
A.2 Elements of the control plan 28
Reference 30
Preface
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 18305-2003 "Quality management system Automobile production parts and related maintenance parts Organization applications
GB/T 19001-2000 special requirements ", and GB/T 18305-2003 compared to the main technical differences.
--- According to GB/T 19001-2008 (ISO 9001..2008, IDT) "quality management system requirements" to adjust the relevant content.
This standard uses the translation method equivalent to ISO /T S16949..2009 "Quality management system Automobile production parts and related services
Application of ISO 9001..2008 special requirements ".
This standard is proposed by the Ministry of Industry and Information Technology of the People's Republic of China.
This standard by the National Automotive Standardization Technical Committee (SAC/TC114) centralized.
This standard drafting unit. China Automotive Technology Research Center, Tianjin Huacheng Certification Center.
The main drafters of this standard. Zhang Jianwei, Zheng Yuanhui, Duan Min, Liu Yunxia, Yang Xueyong, Yu Fang, Li Zhengxin, Gao Xiaohong.
This standard replaced the previous version of the standard release.
--- GB/T 18305-2001, GB/T 18305-2003.
A description of the certification
In accordance with the IATF certification program to obtain the technical specifications of the certification, including customer special requirements (if any), will be IATF customers into
(See "Rules for the approval of IATF").
Details can be obtained from the following IATF supervisors under the various regions.
AssociazioneNazionaleFilieraIndustrieAutomobilistiche (ANFIA)
InternationalAutomotiveOversightBureau (IAOB)
IATF-France
Society ofMotorManufacturersandTradersLtd. (SMMTLtd.)
VerbandderAutomobdustdustrieQualitätsmanagementCenter (VDA-QMC)
introduction
0.1 General
GB/T 19001-2008, Quality management system requirements
introduction
0.1 General
The adoption of a quality management system is a strategic decision for the organization. The design and implementation of an organization's quality management system is governed by the following factors
Impact.
a) the organization's environment, the changes in the environment and the risks associated with the environment;
b) the changing needs of the organization;
c) the specific objectives of the organization;
d) the products provided by the organization;
e) the process used by the organization;
f) the size and organizational structure of the organization.
The structure or document of a unified quality management system is not the purpose of this standard.
The quality management system requirements specified in this standard are complementary to the product requirements. "Note" is a guide to understanding and describing the requirements.
This standard can be used for internal and external (including certification bodies) to assess the organization to meet customer requirements, applicable to the product laws and regulations and
The ability to organize their own requirements.
The development of this standard has taken into account the principles of quality management as set forth in GB/T 19000 and GB/T 19004.
0.2 process method
GB/T 19001-2008, Quality management system requirements
0.2 process method
This standard encourages the use of process methods in establishing and implementing a quality management system and improving its effectiveness by meeting customer requirements,
Enhance customer satisfaction.
In order for the organization to function effectively, a number of interrelated activities must be identified and managed. Build your conversions by using resources and management
For the output of a group or a group of activities can be regarded as a process. Typically, the output of a process directly forms the input of the next process.
In order to produce the desired results, the application of the system within the organization, together with the identification and interaction of these processes,
And the management of these processes can be called "process approach".
The advantage of the process approach is the continuous connection between the individual processes in the process system and the combination and interaction of the processes
control.
When applying the process approach in a quality management system, it emphasizes the importance of.
a) understand and meet the requirements;
b) the need to consider the process from the perspective of value-added;
c) the results of the process performance and effectiveness;
d) Continuously improve the process on an objective basis.
The process-based quality management system model shown in Figure 1 shows the process links presented in Chapters 4 through 8.
The figure reflects the important role of the customer when specifying the input requirements. The monitoring of customer satisfaction requires the organization to the customer about the group
Whether the information has been met to meet the requirements of the information. Although this model covers all the requirements of this standard, but not in detail anti
Reflect the process.
Note. In addition, the method known as "PDCA" can be applied to all processes. The PDCA model can be summarized as follows.
P --- planning. according to the requirements of customers and the organization's approach, to provide results to establish the necessary goals and processes;
D - implementation. implementation process;
C - Check. Monitor and measure processes and products according to the guidelines, objectives and product requirements, and report the results;
A --- Disposal. Take measures to continuously improve process performance.
Figure 1 Process-based quality management system model
0.3 relationship with GB/T 19004
GB/T 19001-2008, Quality management system requirements
0.3 relationship with GB/T 19004
GB/T 19001 and GB/T 19004 are quality management system standards, these two standards complement each other, but can also be used alone.
GB/T 19001 specifies the quality management system requirements, can be used internally for the organization, can also be used for certification or contract purposes.
GB/T 19001 is concerned with the effectiveness of the quality management system in meeting customer requirements.
At the time of publication of this standard, GB/T 19004 is in the process of revision. The revised GB/T 19004 will be organized for the complex, to be
Seek a continuous and successful management guide in a higher and ever-changing environment. Compared with GB/T 19001, GB/T 19004 off
Note the broader scope of quality management; meet the needs and expectations of all stakeholders through the system and continually improve the organization's performance. however,
GB/T 19004 is not intended for certification purposes, laws and regulations and the purpose of the contract.
Note. The eight managers should be informed and supervised by the top management of the eight quality management principles mentioned in GB/T 19000-2008 and GB/T 19004
Knowledge and its application.
0.4 Compatibility with other management systems
GB/T 19001-2008, Quality management system requirements
0.4 Compatibility with other management systems
For the convenience of users, this standard in the revision process to take into account the contents of GB/T 24001-2004 to enhance the two standards
The compatibility. Appendix A shows the correspondence between GB/T 19001-2008 and GB/T 24001-2004.
This standard does not include specific requirements for other management systems, such as environmental management, occupational health and safety management, financial management or wind
Risk management specific requirements. However, this standard enables the organization to coordinate its own quality management system with the relevant management system requirements
Or integration. In order to establish a quality management system that meets the requirements of this standard, the organization may change the existing management system.
0.5 The objectives of this standard
The goal of this standard is to establish continuous improvement in the supply chain, emphasizing the prevention of defects, reducing the deterioration and waste of quality management system.
This standard, in combination with the applicable customer special requirements, specifies the basic quality management system requirements for signing this document.
This standard is intended to avoid multiple certification audits and to provide a quality management system for automotive production parts and related service pieces.
Common method.
Quality management system car production and related services
Application of GB/T 19001-2008 special requirements
1 Scope
1.1 General
GB/T 19001-2008, Quality management system requirements
1 Scope
1.1 General
This standard specifies the quality management system requirements for organizations with the following requirements.
a) the need to demonstrate that it has the ability to provide products that meet the requirements of the customer and the applicable laws and regulations;
b) through the effective application of the system, including the effective application of the system's continuous improvement process, and ensuring compliance with customer requirements and application
Of the laws and regulations required to enhance customer satisfaction.
Note 1. In this standard, the term "product" applies only to.
a) products that are expected to be made available to customers or customers;
b) any expected output resulting from the product implementation process.
Note 2. Legal and regulatory requirements may be called statutory requirements.
This standard and GB/T 19001-2008 combined, provides a quality management system requirements for automotive-related product design and open
Hair, production; related, also applies to the installation and service.
This standard applies to the organization of the customer requirements of the production and/or service parts manufacturing site.
Support functions, whether on site or on the outside (eg design center, corporate headquarters and distribution center), because of their support for the site
Role and constitute part of the on-site audit, but can not be a separate certification of this standard.
This standard applies to the entire automotive supply chain.
1.2 Application
GB/T 19001-2008, Quality management system requirements
1.2 Application
All requirements set forth in this standard are generic and are intended for use in all types, organizations of different sizes and for the provision of different products.
If any of the requirements of this standard are not applicable due to the nature of the organization and its products, it may be considered for deletion.
If the deletion is made, it should be limited to the requirements of Chapter 7 of this Standard, and such deletion does not affect the organization's ability to meet customer requirements
And the applicable laws and regulations of the product's ability or responsibility, or can not claim to comply with this standard.
This standard only allows the organization to have no product design and development responsibilities in the case of deletion of 7.3 related to the content.
It is not allowed to delete the design of the manufacturing process.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 19000-2008 Quality management system foundation and terminology (idtISO 9000..2005)
3 terms and definitions
GB/T 19001-2008, Quality management system requirements
3 terms and definitions
This standard uses the terms and definitions established in GB/T 19000.
The term "product" that appears in this standard may also refer to "service".
3.1 Terms and definitions of the automotive industry
GB/T 19000-2008 Definitions and the following terms and definitions apply to this document.
3.1.1
Control plan
A description of the system and process documentation required to control the product (see Appendix A).
3.1.2
Design responsibility of the organization designresponsibleorganization
The right to establish new product specifications, or to change the existing product specifications of the organization.
Note. This liability includes testing and verification of design performance within the scope of the customer's application.
3.1.3
Error prevention
Design and development of products and manufacturing processes to prevent the manufacture of substandard products.
3.1.4
Laboratory laboratory
Inspections, tests or calibrations, including, but not limited to, chemical, metallographic, size, physical, electrical, or reliability tests.
3.1.5
Laboratory range laboratoryscope
Controlled documents, including.
- specific tests, evaluations and calibrations to which the laboratory is qualified;
--- a list of equipment used to carry out the above activities;
- a list of methods and standards for carrying out the above activities.
3.1.6
Manufacturing
The following production or processing.
--- production materials;
--- production or service pieces;
---assembly;
- heat treatment, welding, painting, plating or other surface treatment.
3.1.7
Predictive maintenance predictivemaintenance
Based on process data, by predicting possible failure modes to avoid maintenance activities.
3.1.8
Preventive maintenance
Measures to plan for the elimination of equipment failure and unplanned outages of production as an output of the manufacturing process design.
3.1.9
Additional shipping premiumfreight
Additional costs or expenses incurred outside the agreed delivery of the contract.
Note. may result from method, quantity, unplanned or delayed delivery.
3.1.10
External place remotelocation
Support the site and there is no production process of the place.
3.1.11
Site
Where the value-added manufacturing process takes place.
3.1.12
Special characteristics
Products that may affect the safety or regulatory compliance, coordination, function, performance, or subsequent process product characteristics or manufacturing process parameters.
4 quality management system
4.1 General requirements
GB/T 19001-2008, Quality management system requirements
4 quality management system
4.1 General requirements
The organization shall establish a quality management system in accordance with the requirements of this standard, form it in a document, implement it and maintain it, and continue to improve its
Efficiency.
The organization shall.
a) the process required to determine the quality management system and its application throughout the organization (see 1.2);
b) determine the order and interaction of these processes;
c) identify the required guidelines and methods to ensure that the operation and control of these processes are effective;
d) ensure that the necessary resources and information are available to support the operation and monitoring of these processes;
e) monitor, measure (when applicable) and analyze these processes;
f) implement the necessary measures to achieve the planned results and continuous improvement of these processes.
The organization shall manage these processes in accordance with the requirements of this International Standard.
If the organization chooses to outsource any process that will affect the product's compliance, the control of these processes should be ensured. Outsource this kind of
The type and extent of program control should be defined in the quality management system.
Note 1. The processes required for the above quality management system include processes related to management activities, resource provisioning, product realization, and measurement, analysis and improvement.
Note 2. The "outsourcing process" is a process for the quality management system to be selected by the organization and implemented by the outside party.
Note 3. The organization ensures that the control of the outsourcing process does not relieve it of its obligations to meet all customer requirements and laws and regulations. Control of the outsourcing process
The type and extent can be affected by the following factors.
a) the potential impact of the outsourcing process on the ability of the organization to provide products that meet the requirements;
b) the degree of sharing of outsourcing process control;
c) the ability to achieve the required control by applying 7.4.
4.1.1 General requirements --- Supplement
Ensure that the control of the outsourcing process should not relieve the organization of the responsibility to meet all customer requirements.
Note. See 7.4.1 and 7.4.1.3.
4.2 Documentation requirements
General rules
GB/T 19001-2008, Quality management system requirements
4.2 Documentation requirements
General rules
The quality management system documentation should include.
a) the quality policy and quality objectives of document formation;
b) quality manual;
c) the documented procedures and records required by this standard;
d) Documents identified by the organization to ensure the effective planning, operation and control of its processes, including records.
Note 1. The "documented procedures" of this standard require that the procedure be established, documented, and implemented and maintained. A file can be included
Requirements for one or more programs. The requirements for a documented program can be included in multiple files.
Note 2. How much of the quality management system files of different organizations can differ from the level of detail depends on.
a) the size of the organization and the type of activity;
b) the complexity of the process and its interactions;
c) the ability of the person.
Note 3. The document may be of any form or type of medium.
4.2.2 Quality Manual
GB/T 19001-2008, Quality management system requirements
4.2.2 Quality Manual
The organization shall prepare and maintain a quality manual, which includes.
a) the scope of the quality management system, including any details of the deletion and the justification (see 1.2);
b) the documented procedures or references to the quality management system;
c) the expression of the interaction between the quality management system processes.
4.2.3 File Control
GB/T 19001-2008, Quality management system requirements
4.2.3 File Control
The documents required for the quality management system should be controlled. Records are a special type of document that should be entered in accordance with 4.2.4
Line control.
A documented procedure should be developed to define the controls required for.
a) in order to make the document fully and adequately approved prior to the release of the document;
b) review and update the documents as necessary and approve them again;
c) to ensure that changes to the document and the current revision status are identified;
d) ensure that the relevant version of the applicable document is available at the point of use;
e) ensure that the document remains clear and easy to identify;
f) to ensure that the external documents required for the planning and operation of the quality management system identified by the organization are identified and controlled for their distribution;
g) to prevent the unintended use of obsolete documents and, if for some purpose, to retain obsolete documents, make appropriate
Logo.
4.2.3.1 Engineering specifications
The organization shall have a process to ensure timely review, issuance and implementation of all customer engineering standards/specifications at the time required by the customer
And its changes. Timely review should be carried out as soon as possible, not more than two working weeks.
The organization shall keep records of the date of implementation of each change in production. Implementation should include updates to the document.
Note. When the design records refer to these specifications or documents that govern the production approval process (eg, control plan, FMEAs, etc.), these standards /
The specification changes require updating of the customer's production approval record.
4.2.4 Record control
GB/T 19001-2008, Quality management syst......
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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