Element 2: Example of department/person responsible for the quality system: Manager representative/quality management department standard requirements brief description: ISO9001 standard requires enterprises to carefully plan how products meet quality requirements and form a complete set of quality system documents To guide various departments to operate according to regulations. Quality system documents usually include three levels: quality manual, procedure documents, work instruction documents and various forms. Element 3: Example of the department responsible for contract review: Brief description of business department standard requirements: The ISO9001 standard requires that enterprises should review orders before accepting them; they should also review orders when they are revised, and transmit revision information to all production-related parties in a timely manner. department. Element 4: Design control Examples of responsible departments: Design and development department Brief description of standard requirements: The ISO9001 standard requires companies to establish standardized product development and design processes. Element 5: Document and data control Example of responsible department: Office Brief description of standard requirements: Documents are "regulations" within the enterprise. Since the implementation of ISO9001 standards is essentially the "legalization" of enterprises, a large number of documents will be produced to guide the work of personnel at all levels. The ISO9001 standard requires enterprises to strictly manage documents so that all documents used on site are valid and approved by the corresponding authorized personnel. Element 6: Example of the department responsible for purchasing: Brief description of the standard requirements of the supply department: The ISO9001 standard requires that enterprises should take appropriate measures to control sub-suppliers (raw material suppliers, outsourcers); the purchase order issued should clearly indicate the specifications of the products ordered. Information must be reviewed and approved by personnel with certain authority before it can be issued. Element 7: Control of products provided by customers Examples of responsible departments: Supply department Brief description of standard requirements: The ISO9001 standard requires companies to verify products provided by customers and store them properly to avoid loss, damage or incompatibility. Element 8: Examples of departments responsible for product identification and traceability: Brief description of standard requirements for warehouse and field operation departments: ISO9001 standards require companies to properly conduct various products (raw materials, semi-finished products, finished products) in various locations (warehouses, workshops, etc.) identification to prevent confusion or misuse; in addition, if there are traceability requirements, the necessary historical records related to product production and circulation should be traceable. Element 9: Process control Examples of responsible departments: On-site operation department, equipment management department Brief description of standard requirements: Mainly refers to the control of the production process. The ISO9001 standard requires that enterprises should scientifically plan the production process; take effective measures to control each process, including controlling the "people" (operators), "machine" (machine equipment), and "materials" (materials) of the process. There are six major factors: "method" (work instructions), "environment" (production environment), and "test" (quality inspection). Element 10: Example of the department responsible for inspection and testing: Brief description of the standard requirements of the quality inspection department: ISO9001 standard requires enterprises to implement incoming inspection, process inspection, and final inspection; develop a full set of inspection standards, including incoming inspection standards for various raw materials and various processes Inspection standards and final product inspection standards; quality control personnel should strictly carry out inspections in accordance with the standards and make records; records should be properly kept. Element 11: Examples of departments responsible for testing equipment control: Brief description of standard requirements for quality inspection departments or measurement rooms: ISO9001 standards require companies to perform regular calibrations of testing equipment (such as appliances, meters, devices, etc.) at specified intervals to ensure that these equipment The test results are always accurate. Element 12: Examples of departments/persons responsible for inspection and testing status: Brief description of quality inspection department standard requirements: ISO9001 standards require enterprises to use appropriate identification methods to identify the qualified or unqualified status of products after inspection to prevent substandard products. misuse.

Element 13: Examples of departments responsible for the control of non-conforming products: Brief description of standard requirements for quality inspection departments and on-site operation departments: ISO9001 standards require enterprises to deal with non-conforming products. The processing methods include return, rework, concession release, downgrade use, scrap, etc.; The enterprise should designate personnel with corresponding authority to review non-conforming products at the corresponding level and decide how to deal with them; non-conforming products should be recorded. Element 14: Example of the department responsible for corrective and preventive measures: Brief description of the standard requirements of the quality management department: The ISO9001 standard requires that enterprises should have established channels to analyze the non-conforming information they have, and take corrective and preventive measures to eliminate the causes of non-conforming , to prevent the recurrence of nonconformities. This is the only way to continuously improve management levels. Element 15: Examples of departments responsible for handling, storage, packaging, protection and delivery: Brief description of standard requirements for warehouses, handling and transportation teams: ISO9001 standards require enterprises to have good control over the following processes: Handling - Prevent damage to goods during the handling process ; Storage - to prevent damage to the goods during storage. Packaging - the packaging process should be properly controlled; Protection - appropriate protection and isolation measures should be taken for certain special materials; Delivery - products should be ensured from the time they leave the factory to the time they are delivered. The quality of the product will not be compromised before it reaches the customer. Element 16: Quality record control Examples of responsible departments: Quality management department Brief description of standard requirements: Quality records are evidence to prove whether the operation of the ISO9001 management system is effective, objective evidence for internal audit supervision, and the basis for taking corrective and preventive measures in the future. The ISO9001 standard requires all departments of the enterprise to fill in quality records truthfully and accurately; quality records should be properly preserved and stored in categories for easy reference. Element 17: Examples of departments/persons responsible for internal quality audits: Management representatives and quality management department explanation: This is a very effective supervision method provided by the ISO9001 standard, which is used to supervise the implementation of the management system and constantly look for Problems arise, problems are corrected, and management is improved. This is unique to companies that implement ISO9001 and is also one of the advantages of ISO9001. What needs to be done is to establish internal audit procedures, train a group of competent internal auditors, and supervise the operation of the management system in accordance with prescribed procedures. Element 18: Training Examples of responsible departments: Personnel department Brief description of standard requirements: The ISO9001 standard places more emphasis on human factors. It requires that all personnel in the enterprise who are engaged in work that affects quality receive corresponding training. Element 19: Service Examples of responsible departments: Business departments or specialized service departments Brief description of standard requirements: The ISO9001 standard requires that enterprises should provide customers with a certain level of services when needed, and formulate procedures for service implementation, verification and reporting. Element 20: Statistical technology Examples of responsible departments/personnel: Quality management department Brief description of standard requirements: The adoption of statistical technology is the sublimation of quality management level.