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SAMR 75-2023 English PDF (SAMR75-2023)

SAMR 75-2023 English PDF (SAMR75-2023)

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SAMR 75-2023: Industrial product manufacturer implement regulations on supervision and management of quality and safety subject responsibilities
A manufacturer shall establish and improve the product quality and safety management system, implement the product quality and safety responsibility system, appoint quality and safety directors and quality and safety officers that are commensurate with the enterprise scale, product categories, and risk level in accordance with the law, and specify job responsibilities of the main persons in charge, quality and safety directors, and quality and safety officers of the manufacturer.
SAMR Order 75 [2023]
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Provisions on Supervision and Administration of Implementing Primary
Quality and Safety Responsibilities by Manufacturers of Industrial
Products
Order No. 75 of the State Administration for Market Regulation
“Regulations on the Supervision and Administration of Implementing Primary Quality and Safety Responsibilities by Manufacturers of Industrial Products” was adopted at the 6th executive meeting of the State Administration for Market Regulation on 27 March 2023. It is hereby promulgated and shall be implemented from 5 May 2023.
Director: Luo Wen
April 4, 2023
Provisions on Supervision and Administration of Implementing of
Primary Quality and Safety Responsibilities by Manufacturers of
Industrial Products
Article 1 In order to urge industrial product manufacturers (hereinafter referred to as manufacturers) to implement the primary product quality and safety responsibilities, strengthen the product quality and safety responsibilities of the main persons in charge, and regulate the behavior of quality and safety management personnel, in accordance with the Law of the People's Republic of China on Product Quality, the Standardization Law of the People's Republic of China, the Regulations of the People's Republic of China on Certification and Accreditation, the Regulation of the People's Republic of China on the Administration of Production Licenses for Industrial Products, and other laws and regulations, formulate these regulations. Article 2 Within the territory of the People's Republic of China, if manufacturers implement industrial product production license management and China Compulsory Certification management, as well as manufacture products involving personal health and the safety of life and property and having compulsory national standard requirements, these regulations apply to the lawful implementation of product quality and safety responsibilities and their supervision and management by the main persons in charge, quality and safety directors, and quality and safety officers of these manufacturers.
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Article 3 A manufacturer shall establish and improve the product quality and safety management system, implement the product quality and safety responsibility system, appoint quality and safety directors and quality and safety officers that are commensurate with the enterprise scale, product categories, and risk level in accordance with the law, and specify job responsibilities of the main persons in charge, quality and safety directors, and quality and safety officers of the manufacturer. The main persons in charge of the manufacturer shall be fully responsible for the product quality and safety work of the manufacturer, and establish and implement a long-term mechanism for the primary product quality and safety responsibility. The quality and safety directors and quality and safety officers shall assist the main persons in charge of the manufacturer to do a good job in product quality and safety management according to their job responsibilities. Article 4 The main persons in charge of a manufacturer shall support and ensure that the quality and safety directors and quality and safety officers carry out product quality and safety management work in accordance with the law. Before making major decisions involving product quality and safety, the opinions and suggestions of the quality and safety directors and quality and safety officers shall be fully listened to.
When a quality and safety director or quality and safety officer discovers that a product has any defect that endangers safety, or the production license or compulsory product certification certificate expires, he or she shall make veto suggestions such as stopping the production and sales of the corresponding product, and the main persons in charge of the manufacturer shall immediately organize analysis and research judgment and take disposal measures to eliminate hidden risks; if a defect is confirmed, the products shall be recalled in accordance with relevant national regulations.
Article 5 On the basis of appointing quality and safety officers in accordance with the law, the following manufacturers shall appoint quality and safety directors:
(1) Product manufacturers that implement industrial product production license management; (2) Product manufacturers that implement China Compulsory Certification management; (3) Other large and medium-sized manufacturers of industrial products that involve personal health and safety of life and property and have compulsory national standard requirements. Local market supervision and administration departments at or above the county level shall guide qualified manufacturers in their jurisdiction to appoint quality and safety directors based on the actual conditions of the region.
Article 6 Quality and safety directors and quality and safety officers shall have the following quality and safety management capabilities:
(1) Be familiar with laws and regulations, compulsory national standards related to industrial product quality and safety, and the quality management system of the manufacturer; Page 4 of 7
(7) Accept and cooperate with the supervisory inspections, defective product recalls, accident investigations, quality and safety tracing and other work carried out by the market supervision and management department, and actively address and correct the problems discovered during the inspection.
The manufacturer shall formulate the Duties of the Quality and Safety Directors in accordance with the provisions of the preceding paragraph and in light of actual conditions. Article 8 A quality and safety officer is responsible to the quality and safety director or the main person in charge of the manufacturer in accordance with the requirements of his or her duties, and assumes the following responsibilities:
(1) Supervise and guide employees to implement job quality and safety regulations; (2) Check the implementation of raw material purchase control, production process control, product factory inspection, and other systems;
(3) Implement control over non-conforming products, urge employees to take effective measures to rectify quality problems, and report to the quality and safety director in a timely manner;
(4) Manage and maintain the manufacturer's product quality and safety files, and save relevant information as required;
(5) Accept and cooperate with the supervision and inspection, defective product recall, accident investigation, quality and safety tracing and other work carried out by the market supervision and management department, and truthfully provide relevant materials. The manufacturer shall formulate the Code of Conduct for Quality and Safety Officers in accordance with the provisions of the preceding paragraph and in light of actual conditions. Article 9 A manufacturer shall establish a dynamic management mechanism based on the prevention and control of industrial product quality and safety risks, implement self-inspection requirements based on the actual situation of the manufacturer, formulate a Quality and Safety Risk Management and Control List for Industrial Products, and establish and improve work systems and mechanism for daily control, weekly investigation, and monthly scheduling. Article 10 A manufacturer shall establish a daily quality and safety control system for industrial products. A quality and safety officer shall conduct daily inspections according to the Quality and Safety Risk Management and Control List for Industrial Products to form a Daily Quality and Safety Inspection Record for Industrial Products. For any hidden quality and safety risk discovered, preventive measures shall be taken immediately and the risk shall be reported to the quality and safety director or the main persons in charge of the manufacturer in a timely manner. If no problems are found, records shall also be kept, and zero-risk reporting shall be implemented. Page 5 of 7
Article 11 A manufacturer shall establish a weekly quality and safety investigation system for industrial products. A quality and safety director shall organize a hidden risk investigation at least once a week, analyze and judge the product quality and safety status based on the problems discovered during daily control, and form a Weekly Quality and Safety Investigation and Management Report for Industrial Products.
Article 12 A manufacturer shall establish a monthly quality and safety scheduling system for industrial products. The main persons in charge of the manufacturer shall listen to the management work report of the quality and safety director at least once a month, summarize the daily management of industrial product quality and safety, the investigation and management of hidden risks, and other conditions for the month, make scheduling arrangements for the key work of the next month, and form a Minutes of Monthly Quality and Safety Scheduling Meeting for Industrial Products.
Article 13 A manufacturer shall keep records for the appointment, adjustment, and performance of duties of the main persons in charge, the quality and safety directors, and quality and safety officers, the Duties of the Quality and Safety Directors, the Code of Conduct for Quality and Safety Officers, the Quality and Safety Risk Management and Control List for Industrial Products, the Daily Quality and Safety Inspection Record for Industrial Products, the Weekly Quality and Safety Investigation and Management Report for Industrial Products, the Minutes of Monthly Quality and Safety Scheduling Meeting for Industrial Products, and the opinions and suggestions put forward by quality and safety directors and quality and safety officers, and archive them for future reference. Article 14 The market supervision and management department shall conduct the supervision and inspections focusing on the establishment and implementation of a quality and safety responsibility system for industrial products and other management systems by the manufacturer, the hidden industrial product quality and safety risks discovered by the manufacturer during daily control, weekly investigation and monthly scheduling, and corrective actions.
Article 15 A manufacturer shall organize training and assessment on laws, regulations, standards and professional knowledge for quality and safety directors and quality and safety officers, and at the same time record and archive the training and assessment results for future reference. Personnel who fail the assessment are not allowed to serve as quality and safety managers in corresponding positions.
In accordance with the Guidelines for the Assessment of Quality and Safety Management Personnel in Industrial Product Manufacturers formulated by the State Administration for Market Regulation, local market supervision and administration departments at or above the county level organize random supervision and spot checks on the quality and safety directors and quality and safety officers of manufacturers within their jurisdictions and publish the results. No fees may be charged for supervision and spot checks.
If the manufacturer fails to pass any spot check, the manufacturer shall immediately take corrective measures.
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