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Subject: Determine the general requirements for establishing, implementing, and maintaining a quality management system and the general requirements for document management
Excerpt: English text from the archived bilingual edition · Chinese edition
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Determine the general requirements for establishing, implementing, and maintaining a quality management system and the general requirements for document management
Applicable to the management of our company's quality management system and documents
1) Responsible for the establishment, implementation and maintenance of the leadership quality management system
2) Approved quality manuals and quality guidelines and quality objectives
1) ensure the establishment, implementation and maintenance of the processes required for the quality management system
2) Report to the general manager the performance of the quality management system and any improvement needs
3) Ensure that our company meets the formation and improvement of customer awareness
4) External liaison on matters related to the quality management system
1) Responsible for the normal operation of the quality management system
2) Responsible for the management of quality management system documents
Our company has established a quality management system based on the company's actual management requirements and ISO9001:2008 requirements, formed appropriate documents, implemented and maintained, and evaluated its effectiveness, suitability and adequacy, and continued to improve. To this end, our company should meet the following requirements
1) Determine the processes required for the quality management system and prepare corresponding documents. These processes include management activities, resource management, product and service implementation and monitoring, measurement and improvement of large processes, and sub-processes of quality activities
2) Determine the sequence of processes and their inter-interface relationships, ensure input, output and required resources, information, and develop control methods and guidelines to support the operation of the process and monitor the process
3) Manage the process through identification, monitoring, measurement and analysis, and use the various methods including statistical methods to obtain the necessary information to achieve continuous improvement
4) At present, the transportation process of some of our products is outsourced. Implement control in accordance with Clause 7.4 of this manual, sign the transportation agreement, and clarify the control requirements. The type and extent of outsourcing process control can be affected by the potential impact of the outsourcing process on the company's ability to provide products that meet the requirements, the degree of sharing of outsourced process control, etc., to ensure control of the outsourcing process, and does not exempt it from meeting customer and legal requirements. Responsibility
4.2.1 Our company forms system documents according to the requirements of the quality management system, and implements and continuously improves to ensure the effective operation of the system
1) Quality Manual (including quality policy and quality objectives and procedures). The scope of the quality management system coverage and the description of the deletion; the quality management system procedures that form the document; the interaction between the quality management system processes
2) Manage files. Common implementation rules for the quality management system of each post, such as various management systems, quality records, and foreign documents
4.2.3 The quality management system documents should be compatible with the actual management of our company, and have operability, and should be reviewed regularly for their effectiveness, suitability and adequacy. Execute the File Control Program
4.2.4 The quality management system documentation determines the quantity and level of detail based on the size of the company and the type of activity, the complexity of the process and its interactions, and the capabilities of the personnel
4.2.5 The carrier of the file is paper, or it can be a disk or a picture, etc., and it should be effectively controlled
4.2.6 Records established to provide evidence of compliance with the requirements and effective operation of the quality management system shall be controlled. The Record Control Procedure is prepared to define the controls required for the identification, storage, protection, retrieval, retention and disposal of records
4.3 To ensure the above requirements, the following procedure documents are specially formulated

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Compare wording, tone and information order across complete passages. Positions, prices, policies, exams and statistics retain their original context and should be verified before practical use.

