ICS03.120.10
National Standard of the People's Republic of China
GB/T18305—2003/ISO/TS16949:2002 replaces GB/T18305—2001
Quality management systems
Particular requirements for the applicationof ISO 9001:2000 for automotive productionand relevant service part organizations(ISO/TS16949:2002,IDT)
2003-01-17 Issued
People's Republic of China
General Administration of Quality Supervision, Inspection and Quarantine
2003-06-01 Implementation
People's Republic of China
National Standard
Quality Management System
Particular requirements for the application of GB/T19001-2000 to organizations of automotive production parts and related repair parts GB/T18305-2003/ISO/TS16949:2002*
Published by China Standards Press
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ISO Foreword
About certification
Process approach…
Relationship with GB/T19004
0.3.1IATF Guidelines on ISO/TS16949,2002….0.4
Compatibility with other management systems
Objective of this standard…·
Normative references
Terms and definitions
3.1Terms and definitions for the automotive industry
4 Quality management system
4.1 General requirements
4.1.1 General requirements
bzxZ.net4.2 Document requirements
Quality manual
Document control
Engineering specifications
Record control
Record retention| |tt||5 Management responsibilities
5.1 Management commitment
5.1.1 Process efficiency
5.2 Customer focus
5.3 Quality policy
5.4 Planning.
5.4.1 Quality objectives
5.4.1.1 Quality ear tags
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
GB/T18305-2003/IS0/TS16949:2002V
..........
Note: In this catalogue, Songti characters represent the contents of GB/T19001, 2000, and Kaiti characters represent special requirements of the industry. 1
GB/T18305—2003/ISO/TS16949:20025.5.1 Responsibility and authority
5.5.1.1 Responsibility for quality
5.5.2 Management representative
5.5.2.1 Customer representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.1.1 Quality management system performance
5.6.2 Review input
5.6.2.1 Review input
5.6.3 Review output||tt ||6 Resource Management
6.1 Resource Provision
Human Resources
-Supplement
Capacity, Awareness and Training
Product Design Skills
Job Training
Employee Motivation and Empowerment
6.3 Infrastructure
Plant, Facility and Equipment Planning.
Emergency Plan
6.4 Working Environment
Safety of Personnel Related to Achieving Product Quality Cleanliness of Production Site
7 Product Realization
Planning of Product Realization
Planning of Product Realization
Acceptance criteria
Change control·
7.2 Customer-related processes
Determination of product-related requirements
, special characteristics specified by customers.
7.2.2 Review of product-related requirements
Review of product-related requirements
Organization manufacturing feasibility
7.2.3 Customer communication
Customer communication
7.3 Design and development
Supplement·
7.3.1 Design and development planning
Multi-party argumentation method
Design and development input||t t||7.3.2.1 Product Design Input
7.3.2.2 Manufacturing Process Design Input
7.3.2.3 Special Characteristics
7.3.3 Design and Development Output
7.3.3.1 Product Design Output - Supplement
7.3.3.2 Manufacturing Process Design Output...
7.3.4 Design and Development Review...
Design and Development Verification
7.3.6 Design and Development Confirmation
7.3.6.1 Design and Development Confirmation - Prototype Plan
Product Product approval process·
Supplement
Control of design and development changes·
Purchasing process…
Compliance with regulations·
Development of supplier quality management system
Customer-approved sources of supply·
Purchasing information·
Verification of purchased products
Quality of incoming products·
Monitoring of suppliers.
7.5 Production and service provision
Control of production and service provision.
Control plan
Work instructions·
Verification of work standards,|| tt||Preventive and predictive maintenance
Management of production tools
Production plan
Service information feedback
Service agreement with customers
Confirmation of production and service provision process
Confirmation of production and service provision process
7.5.3 Identification and traceability
7.5.3.1 Identification and traceability-
7.5.4 Customer property
-Supplement
7.5.4.1 Customer-owned production tools...
7.5.5 Product protection.
7.5.5. 1 Storage and inventory
7.6 Control of monitoring and measuring devices
7.6.1 Measurement system analysis...
Calibration/verification records
-Supplement
GB/T18305-2003/IS0/TS16949:200212
GB/T18305-2003/IS0/TS16949:20027.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
7.6.3.2 External laboratory
8 Measurement, analysis and improvement
8.1 General Principles..
Determination of statistical tools.
Knowledge of basic statistical concepts………
8.2 Monitoring and measurement
Customer satisfaction
Customer satisfaction
Internal audit
Supplementary…
Quality management system audit
Manufacturing process audit…
Product audit
Internal audit plan
Qualification of internal auditors
Monitoring and measurement of processes
Monitoring and measurement of manufacturing processes…
Monitoring and measurement of products
Layout inspection and functional test·.
Appearance Project
Nonconforming Product Control
Nonconforming Product Control
Control of Reworked Product
Customer Notification
Customer Special…
8.4 Data Analysis
Analysis and Use of Data…
8.5 Improvement:
Continuous Improvement
Continuous Improvement of the Organization
Improvement of the Manufacturing Process….
Corrective Action
Problem Solving…
Impact of Corrective Action
8.5. 2.4 Test/analysis of rejected products
8.5.3 Preventive measures
Appendix A (Normative Appendix) Control plan
A.1 Stages of control plan
Elements of control plan
References
GB/T18305-—2003/IS0/TS16949:2002 This standard is equivalent to ISO/TS16949:2002 "Quality management system-Particular requirements for the application of ISO9001:2000 to automobile production parts and related repair parts organizations".
This standard has made technical revisions to GB/T18305-2001 (idtISO/TS16949, 1999) "Quality system requirements for automotive suppliers". When this standard is released, it replaces GB/T18305-2001. The main changes of this standard are as follows:
1. Due to the release and implementation of GB/T19001--2000 (idtISO9001:2000) "Quality Management System Requirements", the original GB/T18305-2001 based on GB/T19001--1994 (idtISO9001:1994) has been structurally adjusted. The main body of the standard has changed from the original 20 elements to 8 major clauses; 2. The "Appendix A (Appendix to the standard) Terms and definitions" in the original GB/T18305-2001 has been cancelled, and part of the content has been adjusted to Chapter 3 of the new standard:
3. The "Appendix C (Suggestive Appendix) Special Characteristics" in the original GB/T18305--2001 has been cancelled. The purpose of this standard is to The Song font in the catalog represents the content of GB/T19001-2000 "Quality Management System Requirements", and the Kai font represents the special requirements of the industry.
Appendix A of this standard is a normative appendix.
This standard is proposed and coordinated by the National Technical Committee for Automotive Standardization and the National Technical Committee for Quality Management and Quality Assurance Standardization. The drafting units of this standard: China Automotive Technology Research Center, China Standards Research Center. The main drafters of this standard: Li Zhiying, Yu Hongtao, Zheng Yuanhui, Li Renliang, Wang Weidong. GB/T18305—2003/ISO/TS16949:2002ISO Foreword
The International Organization for Standardization (ISO) is a worldwide federation composed of national standardization bodies (ISO member bodies). Formulating country The work on international standards is usually done by ISO technical committees. Each member body interested in a subject identified by a technical committee has the right to participate in the work of that committee. International organizations (official or unofficial) in liaison with ISO take part in the work. ISO maintains a close collaboration with the International Electrotechnical Commission (IEC) on electrotechnical standardization. The development of international standards conforms to the relevant provisions of Part 3 of the ISO/IEC Directives. The main task of the technical committee is to develop international standards. The draft international standard adopted by the technical committee is submitted to the member bodies for voting. A draft international standard must be approved by at least 75% of the voting member bodies before it can be officially published as an international standard. In other cases, especially when there is a pressing market demand for such a document, , the technical committee may decide to publish other forms of standardization documents:
-ISO Public Specification (ISO/PAS) indicates that there has been consensus among technical experts within an ISO working group and can be accepted for publication if 50% of the members of the higher-level committee vote in favor. -ISO Technical Specification (ISO/TS) indicates that there has been consensus among the members of the technical committee and can be accepted for publication if 2/3 of the members of the committee vote in favor.
For ISO/PAS or ISO/TS, a review is conducted after three years to determine whether it should be confirmed, revised to an international standard or withdrawn within another three years. In the case of ISO/PAS or ISO/TS being confirmed, it is reviewed again after six years to determine whether it should be converted to an international standard or withdrawn.
ISO/TS16949:2002 was jointly developed by the International Automotive Task Force (IATF) and the Japan Automobile Manufacturers Association (JAMA) with the support of ISO/TC176, Quality Management and Quality Assurance Committee. The 1999 edition of ISO/TS16949 is cancelled through technical revision and replaced by the second edition of ISO/TS16949. The text in the box is the original text of ISO9001:2000. The part outside the box is the industry-specific supplementary requirements. In this technical specification, "shall" means requirement. "should" means suggestion. The paragraphs marked with NOTE are guidelines for understanding and interpreting the relevant requirements. Wherever the word "suchas" is used, any suggestions given are for guidance only. Appendix A is an appendix to the standard and constitutes a part of this standard. GB/T18305-2003/ISO/TS16949:2002 Notes on certification
Certification of this technical specification in accordance with the IATF certification scheme, including customer-specific requirements (if any), will be recognized by IATF customer members (see "Rules for Obtaining IATF Recognition"). Detailed information can be obtained from the following supervisory bodies under the IATF in each region. AssociazioneNazionaleFra IndustrieAutomobilistiche(ANFIA)Web site:anfia.it
[email protected]International Automotive OversightBureau(IAOB)Web siteiaob.org
e-mail:
[email protected]Federation des Industries des Equipements pour Vehicules(FIEV)Comité des Constructeurs Francais d'Automobiles(CCFA)Web site:
[email protected]Society of MotorManufacturers and Traders Ltd.(SMMT Ltd,)Web site:smmt.co.uk
e-mail:quality@smmt,co.uk
Verband der AutomobilindustrieQualit?tsmanagement Center (VDA, QMC)Web site:vda-qmc.de
[email protected]GB/T18305—2003/IS0/TS16949:20020.1 General
GB/T19001:2000, Quality Management System RequirementsIntroduction
0.1 General
The adoption of a quality management system should be a strategic decision for an organization. The design and implementation of an organization's quality management system is influenced by various needs, specific objectives, the products provided, the processes used, and the size and structure of the organization. It is not the purpose of this standard to unify the structure or documentation of a quality management system. The quality management system requirements specified in this standard are in addition to the product requirements. "Note" is a guide to understanding and explaining the relevant requirements. This standard can be used internally and externally (including certification bodies) to assess the ability of an organization to meet customer, legal and regulatory requirements and the organization's own requirements.
The formulation of this standard has taken into account the quality management principles set out in GB/T19000 and GB/T19004. 0.2 Process approach
GB/T19001:2000, Quality Management System Requirements 0.2 Process approach
This International Standard encourages the use of a process approach in the establishment, implementation and improvement of the effectiveness of a quality management system to enhance customer satisfaction by meeting customer requirements.
For an organization to operate effectively, a number of interrelated activities must be identified and managed. The activities that transform inputs into outputs through the use of resources and management can be considered processes. Usually, the output of one process directly forms the input to the next process. The application of a system of processes within an organization, together with the identification and interaction of these processes and their management, can be referred to as the "process approach". The advantage of the process approach is the continuous control of the links between individual processes in the system of processes and the combination and interaction of processes.
When the process approach is applied in a quality management system, it emphasizes the importance of the following aspects: a) understanding and meeting requirements;
the need to consider processes from a value-added perspective;
obtaining results on process performance and effectiveness;
d) continually improving processes based on objective measurements. The process-based quality management system model shown in Figure 1 shows the process links proposed in Chapters 4 to 8. This presentation reflects the important role played by the customer in specifying input requirements. Monitoring of customer satisfaction requires evaluation of information about the customer's perception of whether the organization has met their requirements. Although this model covers all the requirements of this standard, it does not reflect each process in detail. NOTE In addition, a method called "PDCA" can be applied to all processes. The PDCA model can be briefly described as follows: P-Planning: Establish the necessary objectives and processes to provide results based on customer requirements and organizational policies; D-Implement: Implement the process
C-Check: Monitor and measure processes and products according to policies, objectives and product requirements, and report the results; A-Action: Take measures to continuously improve process performance.
Value-added activities
Information flow
GB/T18305--2003/ISO/TS16949:2002Maintenance and improvement of quality management system
Management responsibilities
Resource management
Testing,
Analysis, improvement| |tt||Figure 1 Relationship between process-based quality management system model 0.3 and GB/T19004
GB/T19001:2000, quality management system requirements 0.3 and GB/T19004
GB/T19001 and GB/T19004 have been developed as a pair of coordinated quality management system standards. They complement each other but can also be used separately. Although the two standards have different scopes, they have similar structures to facilitate their application as a pair of coordinated standards.
GB/T19001 specifies quality management system requirements and can be used within the organization or for certification or contractual purposes. In terms of meeting customer requirements, GB/T19001 The focus is on the effectiveness of the quality management system. Compared with GB/T19001, GB/T19004 provides guidance for a wider range of objectives for the quality management system. In addition to effectiveness, the standard also pays special attention to continuously improving the overall performance and efficiency of the organization. GB/T19004 recommends guidance for those organizations whose top management hopes to go beyond the requirements of GB/T19001 by pursuing continuous improvement in performance. However, use for certification or contracts is not the purpose of GB/T19004.
Note: The knowledge and application of the eight quality management principles mentioned in GB/T19000--2000 and GB/T19004--2000 should be disseminated and implemented by the top management within the organization.
0.3.1IAT F Guidance on ISO/TS16949:2002 GB/T18305-2003/IS0/TS16949:2002 The IATF Guidance on ISO/TS16949:2002 is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application of the requirements of this standard. This 1ATF guidance document is not intended for certification or contractual purposes. 0.4 Compatibility with other management systems
GB/T19001:2000, Quality management system requirements 0.4 Compatibility with other management systems
: For the benefit of users, this standard is close to GB/T24001-1996 to enhance the compatibility of the two standards. This standard does not include requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, financial management or risk management. However, this standard enables organizations to combine or integrate their own quality management system with relevant management system requirements. 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 Objective of this standard
The objective of this standard is to establish a quality management system that continuously improves the supply chain, emphasizes defect prevention, and reduces variation and waste. This standard, combined with applicable customer-specific requirements, specifies the basic quality management system requirements for customers who sign this document. This standard is intended to avoid multiple certification audits and provide a common approach to establishing a quality management system for automotive production parts and related repair parts organizations.2002 IATF Guidance on ISO/TS16949:2002 is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application of requirements in accordance with this standard. This 1ATF guidance document is not intended for certification or contractual purposes. 0.4 Compatibility with other management systems
GB/T19001:2000, Quality Management System Requirements 0.4 Compatibility with other management systems
: For the benefit of users, this standard is close to GB/T24001-1996 to enhance the compatibility of the two standards. This standard does not include requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, financial management or risk management. However, this standard enables organizations to combine or integrate their own quality management system with relevant management system requirements. Organizations may change their existing management systems in order to establish a quality management system that meets the requirements of this standard. 0.5 Objective of this standard
The objective of this standard is to establish a quality management system that continuously improves, emphasizes defect prevention, and reduces variation and waste in the supply chain. This standard, combined with applicable customer-specific requirements, specifies the basic quality management system requirements for customers who sign this document. This standard is intended to avoid multiple certification audits and provide a common approach to establishing a quality management system for automotive production parts and related repair parts organizations.2002 IATF Guidance on ISO/TS16949:2002 is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application of requirements in accordance with this standard. This 1ATF guidance document is not intended for certification or contractual purposes. 0.4 Compatibility with other management systems
GB/T19001:2000, Quality Management System Requirements 0.4 Compatibility with other management systems
: For the benefit of users, this standard is close to GB/T24001-1996 to enhance the compatibility of the two standards. This standard does not include requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, financial management or risk management. However, this standard enables organizations to combine or integrate their own quality management system with relevant management system requirements. Organizations may change their existing management systems in order to establish a quality management system that meets the requirements of this standard. 0.5 Objective of this standard
The objective of this standard is to establish a quality management system that continuously improves, emphasizes defect prevention, and reduces variation and waste in the supply chain. This standard, combined with applicable customer-specific requirements, specifies the basic quality management system requirements for customers who sign this document. This standard is intended to avoid multiple certification audits and provide a common approach to establishing a quality management system for automotive production parts and related repair parts organizations.
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