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CNCA 00C-003-2013 PDF in English


CNCA 00C-003-2013 (CNCA00C-003-2013) PDF English
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CNCA 00C-003-2013: PDF in English

CNCA 00C-003-2013
[Attachment 1]
Serial No.. CNCA-00C-003
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 
0. Introduction
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.
1. Scope
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.
3.5.6 Others
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.
4.2.1.2 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
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.