0. Introduction

According to the requirements of the Provisions on Administration of China Compulsory Certification (CCC), certification bodies shall “implement classification management and effective follow-up inspection for certified products and their production enterprises, and control and verify the consistency between certified products and type-test samples and the continued conformity of the factory quality assurance capability with certification requirements”.

In order to avoid significant deviations in classification management of production enterprises and selection of certification modes when different certification bodies implement compulsory certification, these Implementation Rules are formulated to specify relevant requirements. This ensures that certification bodies accurately grasp the basic working principles and requirements for classification management of production enterprises and selection and determination of certification modes when preparing detailed rules for certification implementation, implementing compulsory certification and conducting post-certification surveillance.

1. Scope

These Rules specify the following two parts:

(a) The basic requirements that certification bodies shall meet when establishing a classification management mechanism for production enterprises;

(b) The general requirements applicable to certification bodies, based on the basic certification mode, for the selection and determination of the specific certification mode to be implemented for products manufactured by production enterprises.

2. Terms and Definitions

2.1 Classification Management of Production Enterprises

As referred to in these Implementation Rules, the classification management of production enterprises means that, for production enterprises manufacturing products of the same category, a certification body conducts a comprehensive evaluation based on quality-related information such as the factory quality assurance capability, its integrity and compliance status, and the quality status of the products manufactured. On this basis, the certification body classifies the production enterprises, thereby implementing differentiated management for products manufactured by different categories of production enterprises in areas such as selection of certification modes, principles for division of certification units and post-certification surveillance. The objective is to control certification risks, improve the quality and efficiency of certification activities, and ensure the continued conformity of certified products with certification requirements.

2.2 Basic Certification Mode

The basic certification mode refers to the combination of basic product certification elements determined on the basis of the inherent safety risk characteristics of the products and the production processes generally adopted by enterprises. It is predicated on the integrity and self-discipline, effective management and stable production of the production enterprise, and is aimed at ensuring the continued conformity of products with the requirements of compulsory certification standards.

The basic certification mode is specified in the compulsory certification implementation rules of specific products. Based on the actual classification management of production enterprises by the certification body, products manufactured by enterprises that meet conditions such as standardized management, integrity and compliant operation, and stable product quality shall be certified in accordance with the basic certification mode.

2.3 Certification Mode

As referred to in these Implementation Rules, the “certification mode” means the specific certification mode selected and determined by a certification body for implementation on products manufactured by a production enterprise.

In order to effectively control certification risks and improve the continued conformity of certification results, for certification objects for which it is not appropriate to implement certification using the basic certification mode, the certification body, based on its actual classification management of production enterprises, shall, through an assessment of the risks that may arise when nonconformities occur, select and add necessary certification elements step by step and strengthen surveillance requirements on the basis of the basic certification mode. The specific certification mode for implementation is thus determined.

In general, the higher the likelihood of nonconformity of the certification object and the more severe the consequences, the stricter its certification mode shall be.

3. Classification Management of Production Enterprises

3.1 Basic principles

The establishment of classification management of production enterprises shall be based on all information available to the certification body that is related to the quality of production enterprises and certified products.

The certification body shall establish measures and an implementation mechanism for classification management of production enterprises in accordance with the principle of “controlling certification risks, implementing differentiated management and improving certification effectiveness”. Classification management of production enterprises shall also reflect the principle of dynamic adjustment of classification levels of production enterprises, so as to promote continuous improvement in the management capability, self-discipline awareness and product quality of production enterprises.

The classification conditions and classification levels for classification management of production enterprises shall be specified in consideration of the characteristics of specific products and industries. In principle, the classification conditions and classification levels under the same implementation rules shall remain consistent. The classification management of production enterprises shall not set any discriminatory classification conditions with respect to the scale, production capacity or similar factors of production enterprises.

The classification level of a production enterprise shall be used solely as the basis for management of the production enterprise by the certification body. Enterprises shall not use the classification management results assigned to them by certification bodies in market promotion, publicity or other activities, as this would otherwise mislead consumers.

3.2 Quality Information Involved in Classification of Production Enterprises

The quality information involved in the classification of production enterprises shall at least include quality information obtained in all stages of certification implementation and quality information published or reflected by governments at all levels, society, the media, the public and other parties.

3.2.1 Quality Information Obtained During Certification Implementation

Quality information obtained during certification implementation includes information on production enterprises and product quality obtained by the certification body in all stages of certification implementation before certificate issuance and post-certification surveillance.

Quality information obtained during certification implementation before certificate issuance may come from the conformity of samples with standards, the level of factory quality assurance capability and other aspects. In respect of the conformity of sample testing with standards, consideration may be given to such aspects as the authenticity of the samples obtained and the severity of nonconformities in the test results. With respect of the level of factory quality assurance capability, consideration may be given to the management and control of raw materials, parts and components used for product manufacture and their suppliers, the extent to which production equipment and human resource allocation meet requirements, the stability of continuous production, and the enterprise’s quality control and inspection capabilities.

Quality information from post-certification surveillance may come from the consistency of samples obtained during follow-up inspection after certification, the continued conformity of the factory quality assurance capability, and the conformity of sampling testing/inspection results with standards.

The enterprise’s correction of nonconformities in testing/inspection, and its communication and cooperation with the certification body during testing/inspection, may also be used as reference information.

3.2.2 Quality Information on Certified Products

Quality information on certified products includes information such as the results of various product quality supervision sampling inspections at national and provincial levels, as well as information such as judicial decisions, complaint and appeal arbitration, releases by consumer associations and media exposure related to products and enterprises that have obtained compulsory certification.

In principle, the certification body shall verify quality information obtained from society or obtain confirmation from the enterprise.

3.3 Collection, Analysis and Evaluation, and Retention of Information for the Classification Management of Production Enterprises

The certification body shall establish a system for the collection, analysis, evaluation, and retention of information for classification management of production enterprises, so as to ensure the effective operation of the classification management mechanism for production enterprises.

3.3.1 Collection of Information

The certification body may refer to the relevant quality information collection channels listed in 3.2 to effectively track and collect quality information on certified enterprises and products, and verify the accuracy of the information.

3.3.2 Analysis and Evaluation of Information

When analyzing and evaluating the collected quality information, the certification body shall determine the impact and degree of relevance of the issues reflected by the relevant information on the conformity and consistency of complusory certification and on the factory quality assurance capability, in order to evaluate and determine whether the consequences of nonconformities will affect the classification level of the production enterprise.

3.3.3 Retention of Information

The certification body shall properly retain files and supporting materials related to the determination and adjustment of classification management levels of production enterprises, and shall assume the corresponding confidentiality obligations and responsibilities prescribed by laws and regulations.

The retention period for files and supporting materials related to the determination and adjustment of classification management levels of production enterprises shall be at least longer than the duration of all CCC certificates obtained by the corresponding production enterprise.

3.4 Determination and Adjustment of Classification Management Levels of Production Enterprises

3.4.1 Basic Requirements

The certification body shall publish, as public documents, the level information and the conditions for determination and adjustment related to classification management of production enterprises.

After analyzing and evaluating the classification management information of production enterprises, the certification body shall review the decision on determination and adjustment of the production enterprise’s classification level.

The certification body shall determine the certification mode applicable to compulsory certification of the product according to the classification level of the production enterprise, and shall inform the certification applicant of necessary plans and information before certification implementation. During certification implementation, if relevant quality information affects the result of the production enterprise’s classification level, the certification body shall adjust the certification mode in a timely manner.

For a production enterprise applying for certification for the first time and for which no quality information has yet been obtained, the certification body shall determine its classification level for initial certification and the corresponding certification mode according to the results of certification risk assessment.

After the classification management level of the production enterprise has been determined or adjusted, the production enterprise or, where necessary, relevant parties shall be informed.

3.4.2 Reference Example

These Implementation Rules provide an example of four-level classification management of production enterprises and set out relevant principles for determining and adjusting classification levels of production enterprises in order to realize dynamic management.

Different certification bodies may select, add or reduce different classification level information and conditions for determination and adjustment according to different products.

For the contents of the reference example, see the Annex.

3.5 Application of Classification Management Results of Production Enterprises

The purpose of classification management of production enterprises is to implement differentiated certification management for production enterprises at different levels. When designing certification schemes, certification bodies shall apply the results of classification management of production enterprises at least in the following aspects.

3.5.1 Determination of Certification Mode

The implementation rules for  compulsory certification specify only the basic certification mode. Certification bodies shall, in combination with their certification risk control capability and the results of classification management of production enterprises, add certification elements step by step in the detailed rules for certification implementation and determine the certification modes specifically implemented for production enterprises with different capabilities and levels.

3.5.2 Division of Certification Units

The implementation rules for compulsory certification specify only the basic requirements for division of units. Certification bodies shall, in combination with their certification risk control capability and the results of classification management of production enterprises, make the requirements for division of certification units stricter and more detailed step by step in the detailed rules for certification implementation , so as to reduce certification risks.

3.5.3 Use of Production Enterprises’ Testing Resources

Where the implementation rules for compulsory certification allow laboratories to use an enterprise’s own testing resources to conduct testing, including type testing and surveillance sampling testing, the certification body shall, in combination with its certification risk control capability and the results of classification management of production enterprises, specify in the detailed rules for certification implementation the conditions and requirements for using enterprise’s testing resources to conduct testing.

3.5.4 Post-Certification Surveillance Scheme

When designing a post-certification surveillance scheme for certified enterprises, the certification body shall determine the following in combination with its certification risk control capability and the results of classification management of production enterprises:

(a) different certification elements used in post-certification surveillance;

(b) different methods of follow-up inspection after certification;

(c) different frequencies of follow-up inspection after certification;

(d) others.

3.5.5 Use of Supplier’s Declaration of Conformity

Where the implementation rules for compulsory certification or relevant management links, such as revision of the standards used as the basis for certification, allow a certification implementation body to conditionally accept the results of a production enterprise’s supplier’s declaration of conformity, the certification body shall make the determination in combination with its certification risk control capability and the results of classification management of production enterprises.

3.5.6 Others

According to the characteristics of specific products and industries, the certification body may also, in combination with its certification risk control capability and the results of classification management of production enterprises, reflect differentiated certification requirements for classification management in other stages and elements of certification implementation and post-certification surveillance.

3.6 Notification and Transmission of Classification Management Information Results of Production Enterprises

When accepting a certification application, the certification body shall proactively obtain certification information on the relevant production enterprise and products through the CNCA information platform. Certification bodies shall establish a mechanism for notification and transmission of classification management information of production enterprises.

Where the same production enterprise applies for certification with two or more certification bodies at the same time, and one certification body finds that a certified product or enterprise has safety hazards requiring specific monitoring, that certification body shall promptly notify the other certification bodies of the relevant information and, where necessary, copy CNCA.

Where the same production enterprise transfers a CCC certificate between different certification bodies, the certification body accepting the new application shall proactively obtain relevant enterprise quality information and verify the classification management situation of the production enterprise with the original certificate-issuing body; the original certificate-issuing certification body shall provide the information truthfully.

3.7 Supervision of Classification Management Information of Production Enterprises

Certification bodies shall establish rigorous and reasonable systems for the classification management of production enterprises. CNCA shall inspect the classification management of production enterprises in conjunction with routine management and special supervision.

4. Selection and Determination of Certification Modes

4.1 Certification Elements and Their Use

A certification mode consists of certification elements such as type testing, inspection of factory quality assurance capability and product consistency, follow-up inspection after certification, sample testing or inspection from the production, sample testing or inspection from the open market, and design appraisal.

4.1.1 Type Testing

Type testing is mainly used for products that require certification evaluation to be completed on the basis of testing.

4.1.2 Inspection of Factory Quality Assurance Capability and Product Consistency

Inspection of factory  quality assurance capability and product consistency conducted by a certification body before certificate issuance may also be called initial factory inspection. Initial factory inspection may be carried out with or without prior notification to the production enterprise.

4.1.3 Follow-up Inspection after Certification

Follow-up inspection after certification, also referred to as follow-up inspection, is one of the certification elements of “post-certification surveillance”. Follow-up inspection may be carried out with or without prior notification to the production enterprise. Based on the results of classification management of production enterprises, the certification body may arrange the frequency and requirements of follow-up inspection in a differentiated manner in the certification scheme.

For a production enterprise obtaining certification for the first time, where the certification scheme does not involve the initial factory inspection stage, the certification body may generally conduct the first follow-up inspection within three months after certification or at the time of first production.

4.1.4 Sample Testing or Inspection from the Production

Sample testing or inspection from the production is also called factory sample testing or inspection. Factory sample testing or inspection may be implemented before certification or as an element of post-certification surveillance.

4.1.5 Sample Testing or Inspection from the Open Market

Sample testing or inspection from the open market means sample testing or inspection conducted by a certification body on products that have obtained CCC certificates and have been released from the factory, sold or imported; it shall be used as an effective means of post-certification surveillance.

For products that need post-certification surveillance through sample testing or inspection from the open market, the certification body shall design a scheme to ensure that a certain proportion of certified products can be sampled from the market for testing or inspection.

4.1.6 Design Appraisal

Design appraisal is an evaluation activity that, in accordance with relevant standards, uses verification comparison and verification assessment to demonstrate that a product conforms to the requirements of the standards used as the certification basis. Depending on the reliability of the determination results, design appraisal may replace all or part of the type testing items.

4.2 Determination of Basic Certification Modes

The basic certification mode is determined comprehensively on the basis of product risk grading and consideration of factors such as certification operability and economy. The basic certification mode is studied and determined by the technical expert group for compulsory certification and is published through the certification implementation rules of specific products.

4.2.1 Product Risk Grading

Products in the CCC Catalogue are classified into general-risk products and higher-risk products.

4.2.1.1 General-Risk Products

The determination of the level of general-risk products is mainly based on the following factors:

(a) the product is relatively mature, with complete safety standards that are capable of alignment with international standards;

(b) the industry is relatively standardized and enterprises with strong awareness of self-discipline account for a large proportion;

(c) the capability to ensure quality control in product production is relatively good;

(d) the place of use of the product is relatively fixed and the environment is relatively safe and reliable, the product has fewer opportunities for direct contact with ordinary consumers, and it is generally installed, operated and used by professionals;

(e) when the product does not conform to standards, the possibility of serious harm to persons and property is relatively small.

In principle, products with three or more of the above characteristics are general-risk products.

When determining the basic certification mode for general-risk products, consideration may be given to corresponding simplification of certification elements before certification. In combination with the actual characteristics of the product and its production, one or both of type testing and initial factory inspection may be selected for evaluation, so as to simplify the certification scheme and shorten the time for the product to enter the market. For certification elements of post-certification surveillance, priority may be given to sample testing or inspection from the production or open market and follow-up inspection after certification, so as to improve the production enterprise’s self-restraint and management awareness regarding quality control before the product enters the market.

4.2.1.2 Higher-risk products

The determination of the level of higher-risk products is mainly based on the following factors:

(a) the product maturity is moderate; the standard system needs to be improved and is not fully aligned with international standards;

(b) the industry is less standardized, and small enterprises/workshop-type enterprises account for a relatively large proportion;

(c) product process control is relatively complex or quality depends on the quality of raw materials, and the capability to ensure production control is relatively low;

(d) the place of use of the product is relatively unfixed, the safety and reliability of the environment are insufficient, the product has more opportunities for direct contact with ordinary consumers, and ordinary consumers may install, operate and use it by themselves;

(e) when the product does not conform to standards, the possibility of serious harm to persons and property is relatively high.

In principle, products with three or more of the above characteristics are higher-risk products.

When determining the basic certification mode for higher-risk products, in combination with the actual characteristics of the product and production, consideration may be given to using more comprehensive certification elements in the certification mode before certification, so as to effectively control certification risks. For certification elements of post-certification surveillance, priority may be given to production-site/market sample testing or inspection and follow-up inspection after certification; where necessary, consideration may be given to appropriately increasing the frequency and requirements of sample testing or inspection and follow-up inspection after certification, so as to ensure the continued conformity of the management capability of the production enterprise and the quality of certified products.

4.2.2 Certification Operability and Economy

When determining the basic certification mode, attention shall be paid to the actual characteristics of products and production that determine the operability and economy of certification activities, which may include:

(a) characteristics of product production and processing and key links affecting quality control;

(b) product upgrading and lifecycle;

(c) characteristics of the product itself;

(d) other characteristics.

4.2.2.1 Characteristics of Product production and Processing and Key Stages Affecting Quality Control

Production enterprises of products in the CCC Catalogue are mostly engaged in industrial processing, manufacturing and assembly production. For processing, assembly and manufacturing, the main quality control links affecting certification risk control may include procurement quality, the production process and others.

(a) Procurement quality control

For products with simple processes that are mainly produced by purchasing parts and components for assembly, procurement quality is an important stage in controlling product quality. For such products, effective verification of the product’s continued conformity with the certification requirements can be achieved by controlling procurement and supplementing it with finished-product testing.

Certification elements related to procurement quality control and finished-product testing mainly include type testing, product consistency verification, and testing and inspection of samples taken from the production site/market.

(b) Production Process Control

For products for which production processes, equipment and personnel in the production process have a significant impact on quality, the production process is an important stage in controlling product quality. For such products, it is necessary to impose strict requirements on the enterprise’s own quality assurance capability in order to achieve the product’s continued conformity with certification requirements.

Certification elements related to production process control are mainly inspection of enterprise quality assurance capability and follow-up inspection after certification.

(c) Combined influence of multiple stages

For most higher-risk products in the catalogue of compulsory certification, factors affecting product quality and continued conformity with certification requirements may come from the combined influence of multiple stages such as procurement quality and production process.

Therefore, analysis shall also be conducted for specific products to determine certification elements related to product quality control.

4.2.2.2 Product Upgrading and Lifecycle

Product upgrading and lifecycle will affect the operability or economy of certification implementation.

(a) For electronic products such as mobile phones and computers, upgrading is rapid and the lifecycle is short, and production enterprises need to ensure that products enter the sales market as soon as possible. In combination with the characteristics of such products, consideration may be given to compressing pre-certification elements as much as possible in the basic certification mode, while combining classification management information of production enterprises and controlling product conformity through effective post-market surveillance.

(b) For products such as low-voltage switchgear assemblies, industrial electrical appliances and agricultural machinery products, their designs are relatively mature and stable, and both the upgrading cycle and lifecycle are relatively long. In combination with the characteristics of such products, priority may be given to certification elements related to conformity assessment of product production and design, while strengthening control of the factory quality assurance capability and product consistency after certification.

4.2.2.3 Other Reference Factors Such as Product Characteristics

Relevant characteristics to be considered may include the following:

(a) whether product production has seasonal characteristics and whether the product can be produced continuously, in batches and stably over a long period;

(b) product testing costs, which may include the cost of a single product, testing costs and transportation costs;

(c) certification status of key raw materials, components and parts used in the product, hereinafter referred to as key parts, such as obtaining  China Compulsory Certification or voluntary certification of parts that can be recognized for compulsory certification;

(d) other factors.

4.3 Certification Modes and Classification Management of Production Enterprises

The prerequisite for determining the basic certification mode is that the production enterprise is honest and self-disciplined, effectively managed and stable in production, while the certification mode actually used by the certification body may be further adjusted based on classification management of production enterprises. In the process of classification management evaluation of production enterprises, if there is evidence or information proving that the production enterprise lacks integrity or that there are risks in product quality management, the certification body needs to add certification elements in the specific certification mode for implementation to control certification risks.

4.3.1 Lack of Integrity of Production Enterprises

Integrity and self-discipline of production enterprises are the basis for implementing China Compulsory Certification.

For production enterprises lacking integrity, certification bodies may select any necessary certification elements in the specific certification mode for implementation, so as to control and promote the continued conformity of certification results with certification requirements. In selecting and determining the certification mode, consideration may be given to:

(a) aiming to ensure that true certification information of the production enterprise can be obtained, for example:

① obtaining authentic test samples by taking samples from the market or production site and other means;

② conducting initial factory inspection, follow-up inspection or unannounced inspection without prior notice.

(b) aiming to increase the probability of discovering existing nonconformities, for example:

① increasing the frequency of post-certification surveillance;

② increasing the coverage of testing/inspection to improve the probability of discovering nonconformities.

(c) aiming to punish lack of integrity, for example:

avoiding the use of simplified methods for certification implementation, such as design appraisal and the use of factory testing resources.

4.3.2 Risks in Quality Management of Production Enterprises

The quality assurance capability of a production enterprise is an important condition for maintaining the continued validity of  China Compulsory Certification. When the quality assurance capability cannot meet the requirements of compulsory certification, it will directly lead to risks and hidden dangers in product quality.

For production enterprises whose quality assurance capability involves risks, certification bodies shall take targeted measures and add necessary certification elements in the specific certification mode for implementation, so as to promote the gradual improvement of the quality management capability of production enterprises. In selecting and determining the certification mode, consideration may be given to:

(a) aiming to promote improvement of the quality assurance capability of production enterprises, for example:

① adding certification elements closely related to the quality assurance capability of production enterprises, including inspection of enterprise quality assurance capability and product consistency, and follow-up inspection after certification;

② where necessary, increasing the coverage of testing/inspection or the frequency of post-certification surveillance.

(b) aiming to verify the true status of the quality assurance capability of production enterprises, for example:

① conducting initial factory inspection, follow-up inspection or unannounced inspection without prior notice;

② obtaining authentic test samples through production-site or market sample and other means;

③ increasing the inspection and evaluation of the enterprise’s procurement control capability and testing capability.

4.4 Selection and Determination of Certification Modes based on Risk Control

In the specific process of implementing compulsory certification, certification bodies shall, as far as possible, grasp differences in management capability and quality control requirements among different production enterprises, comprehensively consider factors of certification operability and economy, and, on the premise that risks are controllable, reduce costs and shorten time for enterprises with “excellent management capability, honest and compliant operation, and good product quality”, promote enterprises to enhance their awareness of self-responsibility, and encourage honesty and trustworthiness.

Certification bodies shall regularly evaluate the selection, use and effects of certification modes, and make improvements and refinements where necessary.

Annex Reference Example for Four-Level Classification Management of Production Enterprises

This example uses Class A, Class B, Class C and Class D to represent four-level classification management of production enterprises.

(1) Class A

This level is determined by the certification body through comprehensive risk assessment of the collected quality information and relevant materials provided by the production enterprise. The basis for assessment shall include at least the following aspects:

(a) no moajor nonconformities have been found in initial factory inspection and follow-up inspection after certification within the past two years;

(b) no nonconformities have been found in post-certification surveillance testing, and the results of various product quality supervision sampling inspections at national and provincial levels are all “qualified”;

(c) where necessary, the enterprise shall have good independent design capability, and its own testing resources shall be accredited to ISO/IEC 17025 by an accreditation body that is a signatory to the ILAC mutual recognition arrangement;

(d) other information related to the quality of the production enterprise and certified products.

(2) Class B

Production enterprises other than Class A, Class C and Class D.

(3) Class C

The classification level of a production enterprise shall be adjusted to Class C when one of the following problems occurs:

(a) the conclusion of initial factory inspection or follow-up inspection after certification is determined as “on-site verification”;

(b) product quality problems are exposed by the media and are the responsibility of the enterprise, but do not involve suspension or withdrawal of the CCC certificate;

(c) the certification body considers, based on comprehensive evaluation results of quality information related to the production enterprise and certified products, that adjustment to Class C is necessary.

(4) Class D

The classification level of a production enterprise shall be adjusted to Class D when one of the following problems occurs:

(a) the conclusion of initial factory inspection or follow-up inspection after certification is determined as “failed”;

(b) the result of post-certification surveillance testing is that a safety item is nonconforming;

(c) inspection and/or surveillance sampling is refused without justifiable reason;

(d) the enterprise is exposed by the media and is at fault, and the impact on product safety is significant, which may lead to direct suspension or withdrawal of the CCC certificate;

(e) in the results of various product quality supervision sampling inspections at national and provincial levels, the relevant compulsory certification testing items are “nonconforming”;

(f) the CCC certificate is suspended or withdrawn because other compulsory certification requirements cannot be met;

(g) the certification body considers, based on comprehensive evaluation results of quality information related to the production enterprise and certified products, that adjustment to Class D is necessary.

The above example is for reference only.