Introduction to ISO/TS16949 International Automotive Industry Quality System Technical Specification
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ISO/TS16949 International Automotive Industry Quality System Technical Specification Introduction The International Organization for Standardization (ISO) published an industry-specific quality system requirement in May 1999. Its full name is "Technical Specification ISO/TS16949 Quality Systems Automotive Suppliers Special Requirements for the Application of ISO 9001: 1994". This article provides a brief introduction to the requirements of the quality system from three aspects: background, objectives and structure, and article content. 1、 The publication of the ISO 9000 standard series and the global implementation of quality system certification activities based on ISO 90019002 have had a significant impact on the international automotive industry, as the background of the emergence of ISO/TS 16949. The global development trend and global procurement strategy of the automotive industry have led many large international automotive industry groups to early establish quality system requirements for their suppliers and begin auditing activities. After the publication of the ISO 9000 series of standards, several major automotive industry countries have developed their own unified quality system requirements for the automotive industry based on the ISO 9001 standard, and started certification activities similar to ISO 9000, including second party review and third-party registration. Among them, QS-9000 developed by the three major automobile companies in the United States and VDA6.1 developed by the German Automobile Industry Federation are familiar to China and have already carried out certification activities in China. In addition, countries such as France and Italy have also formulated similar documents. Many parts and material suppliers in the automotive industry have to supply many automobile manufacturers around the world at the same time, resulting in multiple requirements and certification issues. Based on the above situation, the relevant agencies of the automotive industry in the five countries of Germany, Italy, France, and Britain jointly established the International Automotive Task Force (IATF), in cooperation with the ISO/TC 176 Technical Committee, which began to coordinate in 1997, formed a draft in 1998, and officially announced it in the form of Technical Specifications (TS) in 1999 for temporary use by the automotive industry. According to ISO regulations, technical specifications will be reviewed every three years before deciding whether to convert to international standards. At the same time as the publication of this technical specification, the checklist, guidelines, certification plan, and IATF accreditation criteria of ISO/TS 16949 have also been passed. It can be said that the global unified certification scheme for the automotive industry has been formed, and the preparation work for certification has been actively carried out in Europe and America. ISO/TS 16949 will also have a significant impact on China's automotive industry, for the following reasons: 1. Many joint venture automobile factories and their supply networks in Europe and America in China are bound to accept the requirements and certifications of ISO/TS 16949; 2. ISO/TS 16949 is based on ISO 9001 and integrates advanced quality management requirements of the international automotive industry. It will provide an excellent opportunity for China's automotive industry, which is about to join the WTO, to improve its management and technical level, and to enhance its competitiveness. 2、 Objective and Structure 1 Objective The goal of this technical specification is to develop a basic quality system that can provide continuous improvement, emphasize defect prevention, reduce variation and waste in the automotive industry supply chain (network). On top of this basic requirement, there may also be special requirements from customers. The structure of the quality system document for this technical specification is shown in the following figure. From the figure, it can be seen that: ① ISO 90019002:1994 is the foundation of this technical specification, specifically reflected in the provisions of ISO/TS 16949, which are formed by adding supplementary provisions to the 20 elements of ISO: 9001:1994 (cited throughout the text). ② ISO 9001, ISO/TS 16949, and customer specific requirements are the basis for suppliers to develop quality system documents, and each one is important The references in this specification list a series of reference manual catalogs, including important tools and technologies such as FMEA, SPC, MSA, reliability, tooling equipment, production part approval procedures, experimental design, continuous improvement, project management, system audits, etc. Once referenced by technical specifications, they become a part of the specification requirements. These reference manuals have good operability. 3、 The content introduction of ISO/TS 16949 is as mentioned above. The entire specification cites ISO 9001:1994 and adds its own content after the provisions of each element. This article only provides a brief introduction to the supplementary parts. Due to the limited understanding level of the author, the introduction may not be appropriate. Readers in need should also read the original text. 1. Scope: This specification applies to the design/development, production, installation, and service of automotive related products, with special emphasis on the "site" of suppliers and subcontractors who provide production and maintenance parts. Point out that the design center and company headquarters cannot be independently certified. 2 Referenced Standards This specification references three international standards, namely ISO 8402:1994, ISO 9001:1994, and ISO/IEC 17025. And explain that subsequent versions of the first two standards will not be applicable. This means that if a new version of ISO9001 appears, it will not temporarily affect the specification. 3 Terminology and Definitions: This specification adopts the terminology definitions of ISO 8402:1994, and also defines some specific terms in the appendix, such as: product realization, on-site, final piece comparison, full size inspection, multi-party argumentation methods, benchmarking, and so on. 4 Quality System Requirements 4.1 Management Responsibilities 4.1.1 Quality Policy Under the quality policy, three specific requirements have been added: 4.1.1.1 Objectives, 4.1.1.2 Customer Satisfaction, and 4.1.1.3 Continuous Improvement. It is stipulated that long-term and short-term goals and measurement methods should be established and achievable within the specified time frame. The regulations should have a documented procedure for determining customer satisfaction, supported by objective data, and documented. It is pointed out that continuous improvement of quality, service, cost, and technology should be reflected in the quality policy. Improvement needs should be determined, improvement plans should be implemented, and improvement and corrective and preventive measures should be emphasized as activities at different levels. Improvement is to further reduce variation, reduce costs, and improve services on a qualified basis. 4.1.2 Organizational Responsibilities and Authorities 4.1.2.1 In this section, two sub clauses have been added: 4.1.2.1.1 Customer Representative and 4.1.2.1.2 Quality Responsibilities. It is stipulated that suppliers should designate appropriate individuals to represent customer needs during internal meetings to discuss quality requirements. Managers who have the responsibility and authority to take corrective measures should be able to promptly receive notification of non conformities. The personnel responsible for quality should have the right to stop production if necessary. 4.1.2.2 Resources In this paragraph, add the clause 4.1.2.2.2 on shift resources, which stipulates that personnel responsible for quality should be designated for each shift in the production process. 4.1.2.3 The management representative has not added any content in this paragraph. In 4.1.2, in addition to the above content, 4.1.2.4 Organizational Interface has also been added. The regulations should establish a management system for each stage from concept development to production based on the customer's prior quality planning reference manual or project management manual. Multiple argumentation methods should be used for decision-making. It also specifically stipulates the use of language and information transmission methods used by customers. 4.1.3 Management Review In this paragraph, add supplementary provision 4.1.3.2 Management Review Supplement. The review should include all elements and operational status. The review should be integrated with continuous improvement. To monitor and evaluate the completion of quality objectives and the cost of poor quality. Require sufficient review frequency. At the back of element 4.1, the specification has added four sub clauses: 4.1.4 Business Plan, 4.1.5 Analysis and Use of Company Level Data and Materials, 4.1.6 Employee Incentive, Authorization, and Satisfaction, and 4.1.7 Impact on Society. In 4.1.4 of the business plan, it is stipulated that there should be a formal document of the business plan, which should be based on the relevant content requirements of the business plan, develop basis and methods, track and revise. Indicate that the business plan does not provide third-party review. In 4.1.5, it is stipulated that the rise of quality, operational capacity, and current quality level should be documented. These data should be compared with competitors or equivalent competitors, and compared with the progress of business goals. In 4.1.6, it is stipulated that there should be a process of promoting employees to achieve quality goals and continuous improvement, including enhancing the quality awareness of personnel at all levels. At the same time, a process should be established to measure employee satisfaction and their understanding of quality objectives. 4.1.7 has two specific provisions. 4.1.7.1 Product Safety. The regulations should emphasize the focus on product safety in the quality policy and implementation, reduce potential risks, implement them in design and process control, and enhance personnel's safety awareness. 4.1.7.2 Regulations. The regulations should include a process to ensure compliance with government, safety, and environmental regulations. 4.2 Quality system 4.2.1 General provisions have not been added. 4.2.2 All requirements of the quality system program specifications should be explained in the system documents, but it is not necessary to write each one as a separate program document. 4.2.3 Quality planning lists the content of ISO 9001's 4.2.3 as 4.2.3.1 and adds 4.2.3.2 quality plan requirements. The regulations should establish a quality plan that includes customer requirements and references to appropriate technical specifications. In element 4.2, five sub clauses have been added: 4.2.4 Product Implementation, 4.2.5 Factory, Facility and Equipment Planning, 4.2.6 Tooling Management, 4.2.7 Process Improvement, and 4.2.8 Quality System Operation Status. 4.2.4 Product implementation is a significant supplement to quality planning, including 10 detailed requirements. Firstly, it is stipulated that a "product realization" procedure should be established to ensure timely delivery of products according to customer requirements. The method of product implementation can be advanced quality planning (as stipulated in QS-9000 in the United States) or project management (as stipulated in VDA in Germany). The relevant requirements for the entire process of product realization were described in detail from 4.2.4.1 to 4.2.2.10. 4.2.4.1 Measurement refers to quality risk, cost, lead time, critical path, and other aspects. The regulations should clarify the measurement of appropriate stages in the product implementation process, analyze and report to managers. 4.2.4.2 The review cycle specifies the conduct of a status review at the appropriate stage of product implementation to take necessary measures and coordinate with the design phase. 4.2.4.3 The multi-party argumentation method points out that the multi-party argumentation method should be adopted for the process of product implementation, including the development and review of specificity, FMEA, and control plans. 4.2.4.4 Tools and technical regulations shall use the tools and technologies specified in the customer's reference manual for advanced product quality planning and control plans, or technologies with similar effects. PFMEA should address all special characteristics. Error prevention technology should be used. Conduct capability research on new processes. The objectives and acceptance criteria for process capability, reliability, maintenance convenience, and availability should be included. 4.2.4.5 When specified in the contract, computer-aided design should ensure the availability of CAD/CAE resources and capabilities that are compatible with customers. 4.2.4.6 Special Characteristics Regulations: Identify the special characteristics of products or processes that have a significant impact on safety, government regulations, coordination, performance, function, appearance, etc. according to the symbols specified by the customer. It specifies the requirements for determining and controlling special characteristics. 4.2.4.7 Feasibility Review stipulates that when conducting a product contract review, production feasibility (including quality, quantity, price, delivery time, etc.) should be studied and reviewed, and records should be kept. 4.2.4.8 The management regulations for process design should establish and maintain a documented procedure for process design. The content is specified in 4.2.4.8.1 Process Design Input, 4.2.4.8.2 Process Design Output, and 4.2.4.8.3 Process Verification. 4.2.4.9 The control plan specifies the content, type, method, review, and update of the control plan in this paragraph. 4.2.4.10 The approval procedure for products stipulates that at the end of product implementation, after process confirmation, and before formal supply, product and process approval must be carried out according to the procedures specified by the customer. This regulation also applies to subcontractors. Emphasize that all changes should be verified and approved by the customer. 4.2.5 The planning regulations for factories, facilities, and equipment should adopt a multi-party argumentation method to develop plans for factories, facilities, and equipment. The layout of the factory should comply with the principles of lean production. Methods and measurement standards for evaluating work efficiency should be developed. 4.2.6 Tooling management regulations should provide technical resources for the design, manufacturing, and verification of tools and measuring tools. A system for tooling management should be established and implemented. 4.2.7 Process improvement stipulates that continuous improvement should be extended to priority special characteristics. Once again, it is emphasized that improvement efforts should be aimed at preventing defects, rather than identifying them. If countable data is used and the result is not zero defects, then the "improvement" taken in this case is a corrective measure. 4.2.8 Regulations on the Operation Status of the Quality System: Evaluate the operation status of the quality system and keep records to provide evidence for the achievement of the goals specified in the quality plan, business plan, and customer satisfaction. The evaluation results should be applicable to corrective measures and continuous improvement. 4.3 Contract Review 4.3.1 General Provisions without Supplementary Content 4.3.2 Review Change the "Review" number of ISO9001 4.3.2 to 4.3.2.1. Add 4.3.2.2 Review - Supplementary sub clause. It is stipulated that suppliers should establish a process for determining cost elements or prices, and cost data is not provided for third-party review. 4.3.3 Contract revision without supplementary content 4.3.4 Record without supplementary content 4.4 Design control 4.4.1 General rules without supplementary content. The planning of design and development in 4.4.2 has been supplemented with the skills required in 4.4.2.1 and research and development in 4.4.2.2 after the original provisions. The supplier shall ensure the qualification of the design team and specify the applicable skills that the design department should master, such as geometric dimensions and tolerances, quality function deployment, manufacturability and assembly, value engineering, experimental design, FMEA, finite element analysis, solid modeling, simulation technology, CAD/CAE, reliability engineering plan, etc. The regulations should be able to communicate with research and development institutions, establish channels, and ensure innovation in products and processes. 4.4.3 There is no supplementary content for organizational and technical interfaces. 4.4.4 Design input: The original ISO9001 clause is numbered as 4.4.4.1, and two clauses, 4.4.4.2 Reliability Objectives and 4.4.4.3 Information Utilization, are added. It is stipulated that product life, reliability, durability, and maintainability goals should be included in the design input. It is necessary to establish a comprehensive utilization system for obtaining information