CNCA 00C-003-2013 English PDF (CNCA00C-003-2013)
CNCA 00C-003-2013 English PDF (CNCA00C-003-2013)
See Chinese contents: CNCA 00C-003-2013
CNCA 00C-003-2013: China Compulsory Certification Implementation Rules - Manufacturing enterprise classification management, certification mode selection and determination
Serial No.. CNCA-00C-003
China Compulsory Certification Implementation Rules -
Manufacturing Enterprise Classification Management,
Certification Mode Selection and Determination
ISSUED ON. SEPTEMBER 24, 2013
IMPLEMENTED ON. OCTOBER 01, 2013
Issued by. Certification and Accreditation Administration of the People's Republic of China
Table of Contents
0. Introduction ... 4
1. Scope ... 4
2. Terms and definitions ... 4
2.1 Manufacturing enterprise classification management ... 4
2.2 Basic certification mode ... 5
2.3 Certification mode ... 5
3. Manufacturing enterprise classification management ... 5
3.1 Basic principles ... 5
3.2 Quality information related to the classification of manufacturing enterprises 6 3.3 Collection, analysis, evaluation, and preservation of information for manufacturing enterprise classification management ... 7
3.4 Determination and adjustment of classification management level of
manufacturing enterprises ... 8
3.5 Application of classification management results of manufacturing enterprises ... 8
3.6 Notification and transmission of results of classification management information of manufacturing enterprises ... 10
3.7 Supervision of classification management information of manufacturing enterprises ... 10
4. Selection and determination of certification mode ... 11
4.1 Certification elements and use ... 11
4.2 Determination of basic certification mode ... 12
4.3 Certification mode and manufacturing enterprise classification management ... 15
4.4 Selection and determination of certification mode based on risk control ... 17 Appendix -- Reference sample for four-level classification management of manufacturing enterprises ... 18
In accordance with the requirements of “Administrative Measures for China Compulsory Certification”, the certification body shall “implement classification management and effective follow-up inspection of certified products and their manufacturing enterprises, control and verify the consistency of the certified products and the type test samples, and that the quality assurance capability of manufacturing enterprises continues to meet certification requirements”. To avoid large deviations in the manufacturing enterprise classification management and certification mode selection when implementing compulsory certification by different certification bodies, this Implementation Rules is formulated to clarify relevant requirements, and to ensure that certification bodies, when preparing certification implementation detailed-rules and implementing compulsory certification and after-certification supervision, accurately grasp the basic working principles and requirements for manufacturing enterprise classification management and certification mode selection and determination.
This Rules specifies the following two parts.
(a) The basic requirements that the certification body shall meet when establishing the classification management mechanism for manufacturing enterprises;
(b) Based on the basic certification mode, the general requirements for the certification body to select and determine the certification mode for specific implementation according to the products produced by the manufacturing enterprise.
2. Terms and definitions
2.1 Manufacturing enterprise classification management
The manufacturing enterprise classification management referred to in this Implementation Rules means that, for the manufacturing enterprises of the same category of products, the certification body, based on the quality-related information such as the quality assurance capability of the manufacturing enterprise, the integrity and law-abiding status, and the quality status of the products produced, conducts comprehensive evaluation and classifies the manufacturing enterprises, to implement differentiated management of the products produced by different categories of manufacturing enterprises in terms of certification mode selection, unit classification principle, and after-certification supervision, etc., so as to achieve the goal of controlling certification risk, improving the quality and efficiency of certification activities, and ensuring that certified products continue to meet certification requirements.
and cooperation between the enterprise and the certification body during the test/inspection may also be used as reference information.
3.2.2 Quality information of certified products
The quality information of certified products includes information such as various product quality supervision and spot test results at national and provincial levels, as well as judicial decisions, appeal-complaint arbitrations, releases of China Consumers Association, media exposures, etc. related to products and enterprises which have obtained compulsory certification.
In principle, the certification body shall verify the quality information obtained by the society or obtain confirmation from the enterprise.
3.3 Collection, analysis, evaluation, and preservation of information for manufacturing enterprise classification management
The certification body shall establish a collection, analysis, evaluation, and preservation system of information for classification management of manufacturing enterprises, to ensure the effective operation of the classification management mechanism of manufacturing enterprises.
3.3.1 Collection of information
The certification body can refer to the relevant quality information collection channels listed in 3.2, to effectively track and collect the information of certified enterprise and product quality, and verify the accuracy of the information.
3.3.2 Analysis and evaluation of information
When the certification body analyzes and evaluates the collected quality information, it shall judge the effect and relational degree of the problems reflected by the relevant information on the conformity and consistency of product compulsory certification, and on the quality assurance capability of manufacturing enterprise, to evaluate and determine whether the consequences of occurrence of non-conformities have an impact on the classification level of the manufacturing enterprise.
3.3.3 Preservation of information
The certification body shall properly keep relevant files and supporting materials for the determination and adjustment for classification management level of manufacturing enterprise, and bear the corresponding obligations of confidentiality and responsibilities specified in laws and regulations.
The storage life of relevant files and supporting materials for the determination and adjustment for classification management level of manufacturing enterprise shall at least be longer than the duration of all the certificates obtained by the corresponding implementation body to conditionally accept the results of manufacturing enterprise supplier declaration of conformity, the certification body shall determine in combination with the certification risk control capability and the classification management results of the manufacturing enterprise.
According to the specific products and industry characteristics, the certification body can also, in combination with the certification risk control capability and the classification management results of manufacturing enterprises, reflect the differentiated certification requirements of the classification management of manufacturing enterprises in other links and elements of certification implementation and after-certification supervision. 3.6 Notification and transmission of results of classification management information of manufacturing enterprises
When the certification body accepts the application for certification, it shall, through the information platform of the CNCA, obtain the information on the certification of relevant manufacturing enterprises and products on its own. A notification and transmission mechanism for classification management information of manufacturing enterprises shall be established between certification bodies.
When the same manufacturing enterprise applies for certification at two or more certification bodies at the same time, and one of the certification bodies discovers that the certified products and enterprise have potential safety hazards and need to be monitored in a key manner, the certification body shall promptly inform other certification bodies of the relevant information, if necessary, send a copy to the CNCA.
When the same manufacturing enterprise converts the certificate between different certification bodies, the certification body which accepts the new application shall take the initiative to obtain the relevant enterprise quality information and verify the classification management situations of the manufacturing enterprise with the previous certification body. The previous certification body shall provide truthfully.
3.7 Supervision of classification management information of manufacturing enterprises
The certification body shall establish a rigorous and reasonable classification management system for manufacturing enterprises. The CNCA shall, in combination with daily management and special supervision, verify the classification management of manufacturing enterprises.
inspection may be selected for evaluation, to simplify the certification plan and shorten the time it takes for the product to enter the market. The certification elements of after- certification supervision may focus on the use of production on-site/market sampling test or inspection, and after-certification follow-up inspection, to improve the self-discipline and management awareness of quality control by manufacturing enterprises before the products enter the market.
220.127.116.11 Higher risk products
The determination of higher risk product grade is mainly based on the following factors. (a) General product maturity (Standard system needs to be improved, not fully integrated with international standards);
(b) The industry is less regulated. The proportion of small enterprises/workshop enterprises is larger;
(c) Product process control is more complicated, or the quality depends on the quality of raw materials. The production control assurance capability is low;
(d) The place where the product is used is relatively unfixed, and the environment is less safe and reliable. There are many opportunities for direct contact between the product and general consumers. General consumers can install, operate, and use it by themselves;
(e) When the product does not meet the standard, there is a greater possibility of serious personal and property damage.
In principle, products with the above three or more characteristics are higher risk products. When determining the basic certification mode for higher risk products, combined with the actual characteristics of products and production, more comprehensive certification elements can be used in the certification mode before certification, to achieve effective control of certification risks. The certification elements of after-certification supervision may focus on the use of production on-site/market sampling test or inspection, after-certification follow-up inspection, and if necessary, may consider appropriately increasing the frequency and requirements of sampling test or inspection and after-certification follow-up inspection, to ensure continuous conformity of management capability of manufacturing enterprise and quality of certified products.
4.2.2 Operability and economy of certification
When determining the basic certification mode, attention shall be paid to the actual characteristics of products and production which determine the operability and economy of certification activities, which may include.
(a) Characteristics of production and processing of products and key links affecting manufacturing enterprise and there are risks in product quality management, it is necessary for the certification body to add certification elements in the certification mode for specific implementation, to control certification risks.
4.3.1 Lack of integrity in manufacturing enterprises
The integrity and self-discipline of manufacturing enterprises is the basis for the implementation of compulsory product certification.
For manufacturing enterprises with a lack of integrity, the certification body may, in the certification mode for specific implementation, select any necessary certification elements, to control and promote the continuous conformity of certification results with certification requirements. In terms of the selection and determination of certification mode, it may consider.
(a) Aiming to ensure that real certification information of manufacturing enterprise can be obtained, such as.
OBTAIN authentic test samples by market/production on-site sampling and other methods;
CONDUCT initial factory inspection/follow-up inspection/flight inspection without prior notice.
(b) Aiming to increase the probability of finding non-conformity, such as. INCREASE the frequency of after-certification supervision;
INCREASE the coverage of test/inspection, to raise the probability of finding non-conformity.
(c) Targeting the punishment of lack of integrity, such as.
AVOID using design verification, using factory testing resources, and other simplified methods to implement certification.
4.3.2 Risks in manufacturing enterprise quality management
The quality assurance capability of manufacturing enterprise is an important condition for maintaining the continuous validity of compulsory product certification. If the quality assurance capability cannot meet the compulsory product certification requirements, it will directly lead to risks and hidden dangers of product quality.
For manufacturing enterprises with risks in quality assurance capability, the certification body shall take targeted measures, and add necessary certification elements in the certification mode for specific implementation, to promote the gradual improvement of quality management capability of manufacturing enterprise. In terms of the selection and Appendix -- Reference sample for four-level classification
management of manufacturing enterprises
This example uses Category A, Category B, Category C, and Category D to represent the four-level classification management of manufacturing enterprises.
(1) Category A
This level is determined by the certification body on the comprehensive risk evaluation of the collected quality information and relevant information provided by the manufacturing enterprise. The basis for the evaluation includes at least the following. (a) Initial factory inspection and after-certification follow-up inspection in the recent 2 years have not found serious non-conformity item;
(b) After-certification supervision test has not found non-conformity item. All national and provincial level product quality supervision spot test results are concluded as “qualified”;
(c) When necessary, the enterprise shall have a good independent design capability; and the enterprise’s own testing resources obtain the qualification recognized according to ISO/IEC 17025 standard by the certification body that is mutually recognized by the ILAC agreement;
(d) Other information related to the manufacturing enterprise and the quality of certified products.
(2) Category B
Manufacturing enterprises except Category A, C, and D.
(3) Category C
When one of the following problems arises, the classification level of manufacturing enterprise shall be adjusted to Category C.
(a) The conclusions of initial factory inspection and after-certification follow-up inspection are judged as “on-site verification”;
(b) Media expose there is a problem with the quality of the product and it is of the enterprise responsibility, but it does not involve suspending or revoking the certification;
(c) Based on the comprehensive evaluation to quality information of manufacturing enterprise and certified products, the certification body believes that the level shall