I. History of Development
Conformity assessment in China (in this book referring to Mainland China) has progressively developed with the reform and opening-up. In 1957, China joined the International Electrotechnical Commission (IEC). In September 1978, China rejoined in the International Organization for Standardization (ISO). In April 1981, China established the electronic component product certification system and founded the first product quality certification body, the Quality Certification Committee for Electronic Components of China (QCCECC), which was designed to perform quality certification for relevant electronic components according to the IEC's technical specifications. Since the mid-1980s, China has promoted the certification system more extensively by successively establishing product certification systems in the fields of household appliances, electronic recreational devices, medical appliances, automobiles, food, fire safety products, and others, which are interconnected with multiple government administrations, and gradually established management system certification, personnel certification, and certification of service.
The introduction of the certification and accreditation system into China has played an important role in facilitating international trade and improving product quality on the domestic market yet has also been challenged by the co-existence of two certification systems. To fulfill the commitment of China to the WTO and build up a unified certification and accreditation system, in August 2001, the State Council established and authorized the CNCA to centrally manage, supervise, and comprehensively coordinate relevant certification and accreditation work nationwide.
In November 2003, the State Council developed and officially issued the Regulations of the People's Republic of China on Certification and Accreditation (hereinafter referred to as Regulations on Certification and Accreditation), which provides the legal basis for the new certification and accreditation legal system. Promoted by CNCA, the China National Accreditation Service for Conformity Assessment (CNAS) was set up together with the establishment of a centralized and unified accreditation system. Through the unification of product catalogs, applicable national standards, technical rules, and procedures, as well as symbols and charges, a unified China Compulsory Certification (CCC Certification) system was established nationwide. The China Certification and Accreditation Association (CCAA) was founded as a self-regulatory organization of the certification and accreditation sector in China.
In March 2018, the State Administration for Market Regulation (SAMR) was assembled based on State Council's institutional reform program, and the CNCA's duties were reassigned to SAMR to facilitate the centralized management of certification, accreditation, inspection, and testing activities.
After years of unremitting efforts, China has established a relatively complete certification and accreditation system with Chinese characteristics supported by laws, institutions, organizations, supervision, and standards, by referring to international certification and accreditation criteria, which provides assurance and technical support to the development of conformity assessment in China.
Legal system. The laws and regulations system for certification and accreditation centered around the Regulations on Certification and Accreditation has been formulated. By2019, certification and accreditation provisions have been clearly written into 19 laws, 17administrative regulations, and 14 policies.
Regulatory system. Based on international rules and national conditions, a practical institutional system has been developed to include certifications (including product, management system, and service), accreditations (for certification body, laboratory, and inspection bodies), qualification recognition of inspection and testing bodies, and registrations of import and export food producers. As of 2019, compulsory product certifications covered a total of 119 products in 21 major categories, whereas voluntary product certification covered a total of 3 major categories (product, service, and management system) and 49 sub-categories. The accreditation system branched out into 41 basic categories, 23 special categories, and 43 sub-categories. Lastly, the qualification of inspection and testing bodies spanned across 35 areas of expertise.
Organizational structure. Following the principles of "unified management and joint implementation", the State Administration for Market Regulation (SAMR) was assembled to serve as the centralized administrator, the coordinator for inter-ministerial conferences on certification and accreditation involving more than 20 ministries/commissions, the supervisor of local market regulatory authorities nationwide, and the executor of the organizational framework comprising certification/accreditation/inspection/testing bodies (see Figure 1).
Supervision system. A five-in-one supervision system has been established to incorporate laws and regulations, administrative supervision, accreditation restriction, industry self-regulation, and social supervision, to ensure the validity and credibility of certification and accreditation.
Standards system. The international standards for conformity assessment developed by International Organization for Standardization/Committee on Conformity Assessment (ISO/CASCO) have been identically adopted as Chinese national standards. By the end of October 2019, a total of 94 national standards and 165 industry standards on certification and accreditation have been published to unify and normalize the certification and accreditation activities.
International cooperative and mutual recognition system. By the end of 2019, China had joined in 21 international organizations for certification and accreditation and signed 14 multi-lateral and 123 bilateral mutual recognition agreements.
II. Main Activities
The conformity assessment in China has played a positive role in strengthening quality management, transforming government functions, promoting industrial trans-formation and upgrades, participating in international cooperation and competition, and more. Especially after China proposed the objective of modernizing the state governance system and governance capacity, conformity assessment has further developed in every aspect of China's economic development, mainly including certification, testing, inspection, verification, and accreditation activities. Some other activities of conformity assessment are also noticed in the extensive practice in China.
Certification refers to a third-party attestation related to a product, a process, a system, or a person. It mainly includes management system certification, product certification, certification of service, and personnel certification. Management system certification mainly covers the certification of management systems of quality, environment, occupational health and safety, information security, IT service, food safety, energy, measurement, assets, road safety, event sustainability, intellectual properties, and more. Product certification encompasses compulsory product certification and voluntary product certification. China employs the compulsory certification system (CCC certification) for products related to safety, hygiene, health, environmental protection, and consumer protection. Voluntary product certification is classified into two modes, unified promotion at the national level and voluntary implementation at the organizational level. In the case of voluntary product certification uniformly promoted by the nation, the CNCA shall develop basic specifications, rules, marks, and more for certification. For product certification voluntarily carried out by organizations, a certification body may independently develop certification rules and marks upon registration with the CNCA. The certification of services as an emerging field has aggressively developed in China in recent years, now covering such areas as financial service, care for the elderly, healthcare, after sales services, sports facility services, information security services, logistics services, e-commerce services, car rentals, and energy management contracting (EMC) services. Personnel certification mainly refers to the national registration system for certification auditors.
Testing refers to determining one or more characteristics of an object of conformity assessment, according to the procedure. Testing laboratories may provide services as first-party, second-party, or third-party testing bodies. Testing laboratories in China mainly include non-profit governmental testing laboratories, for-profit commercial testing laboratories, and enterprise-owned testing laboratories.
Inspection refers to the examination of a product, process, service, or installation, or the examination of the design, and the determination of their conformity with specified requirements or general requirements on the basis of professional judgment. Inspection activities have an extraordinarily extensive coverage. Some inspection activities are readily visible, for example counting and weighing in import & export commodity inspections; some involve conformity judgment on the objects inspected on the basis of testing data as well as empirical and statistical analysis, for example in-service inspection of pressure vessels; some may seem to be very simple but are based on extremely profound empirical or technical accumulation, for example failure analysis of various mechanical parts, and damage identification in commodity inspection.
Validation and verification serve as an emerging form of conformity assessment activity. With the requirements of monitoring environmental issues such as greenhouse gas emissions and energy efficiency, conformity assessment mechanisms such as verification activities are progressively introduced into these new fields. In the process of constructing the carbon emission management and trading market in China, a third-party carbon emission verification system has been built up, in which third-party bodies carry out verifications on greenhouse gas emission data of the listed organizations under carbon emission management and issue third-party auditing reports.
Accreditation refers to the third-party attestation related to a conformity assessment body conveying a formal demonstration of its competence to carry out specific conformity assessment tasks. In China, a centralized and unified national approval system is implemented. The China National Accreditation Service for Conformity Assessment (CNAS) is the only national accreditation body in China that is lawfully designated and supervised by the CNCA. By 2019, CNAS had established an architecture of 14 basic accreditation systems, 32 special accreditation systems and 43 sub-theme accreditation systems for the accreditation of certification bodies, laboratories, and testing bodies.
Some other activities are also carried out according to basic procedures described in the conformity assessment functional approach in China. For example, hotels in China are assessed and rated according to the star rating standards. National tourist attractions in China are graded out of five, according to the quality rating of Chinese tourist attractions.
III. Working Mechanism
(I) Unified Management and Joint Implementation
Under the Regulations of the People's Republic of China on Certification and Accreditation and SAMR's authorities vested by the State Council, a unified supervision and management system on certification and accreditation featuring “unified management and joint implementation" was implemented in China.
“Unified management”: Qualification of certification and accreditation bodies are approved by CNCA, according to the law; the nationally promoted certification system is developed and implemented by the CNCA independently or jointly with other departments of the State Council; basic specifications and rules are drafted or developed and issued by the CNCA; certification and accreditation activities of the certification body and accreditation body as well as the implementation of related certification and accreditation systems are regulated by the CNCA; the local certification regulatory department is authorized by the CNCA to supervise and manage certification activities within its jurisdiction.
“Joint implementation”: The CNCA establishes a joint inter-ministerial conference system for nationwide certification and accreditation works, as authorized by the State Council; The CNCA approves the qualification of certification body and solicits for opinions from the relevant departments of the State Council if the function of the relevant department of the State Council is involved; the basic specifications and rules state that if the relevant department of the State Council is involved, it shall be developed by the CNCA jointly with the relevant department of the State Council; a compulsory product certification catalog is developed and adjusted by the CNCA jointly with the relevant department of the State Council, issued by the CNCA and implemented jointly with parties concerned; violations of certifications and accreditations, if the function of relevant department of the State Council is involved, shall be reported to the relevant departments in a timely manner; the certification should be accepted by departments from the perspective of industrial management.
(II) Joint Inter-ministerial Conference
To coordinate and promote certification and accreditation work, the joint inter-ministerial conference system for certification and accreditation work was established by the Chinese government in April, 2002. Its major responsibilities include: studying and raising opinions and suggestions for the national working guideline and policies of certification and accreditation, studying key issues in national laws, regulations, and standards related to certification and accreditation, studying and raising suggestions and measures for readjusting and regulating certification market orders and strengthening certification supervisory management, studying key issues in international cooperation about certifications and accreditations, and WTO member obligations. It is a coordinated system for all departments of the Chinese government to discuss and coordinate certification and accreditation affairs. It is composed of 22 members (see Table 2) with the head of the CNCA as the convener, who shall convene at least one plenary meeting every year. With the development of certification and accreditation, another 11 institutions have been invited to participate in the joint inter-ministerial conference system.
Following the principle of “unified management and joint implementation”, the CNCA has progressively improved the inter-ministerial coordination mechanism and established the information exchange platform to promote the harmonious development of certification and accreditation.
For example, the Ministry of Railways and the CNCA jointly issued the Administrative Measures for Railway Product Certification in May 2012, which further outlined the management requirements for the admissible system of railway product certification, so that product certification becomes one of the main admission management modes of special railway products. Both the compulsory product certification and the voluntary product certification are recognized for railway product certification. The admissible catalog of railway product certifications (hereinafter referred to as “the Admissible Catalog”) is formulated, adjusted, and published by the Ministry of Railways, which manages the voluntary product certification. Railway products under the compulsory product certification management which are listed in the Admissible Catalog shall not be used in the railway field prior to having obtained certification according to the law. The certification body and testing body engaged in compulsory product certification shall be designated by the CNCA. The certification body engaged in product certification covered in the Admissible Catalog shall be approved by the CNCA and confirmed by the Ministry of Railways. For another example, in August 2015, the CNCA, together with six ministries and commissions such as the National Development and Reform Commission (NDRC), issued the Administrative Measures for Testing and Certification of the Electronic Tendering System, which clearly outlined the procedure, method, supervisory management, and other matters relating to the testing and certification of electronic tendering and bidding system, which provides the basis and assurance for the comprehensive development of testing and certification.
In 2016, 32 ministries and commissions, including 22 member organizations, under the coordination of the joint inter-ministerial conference platform, jointly issued “The Thirteenth Five-Year Plan” for the Development of Certification, Accreditation, Inspection, and Testing Development (2016-2020), raising the objectives and tasks of certification, accreditation, inspection, and testing development in China in 2016-2020.
(III) Annual Working Conference
To implement national policy requirements, the CNCA organizes and holds the National Certification and Accreditation Working Conference to review and summarize achievements in certification and accreditation work for the year and comprehensively deploys the work objectives and main tasks for the next year. To carry out the spirit of this annual conference, special meetings, including working conferences of certification bodies, working conferences for qualification approval of inspection and testing bodies, working conferences for the accreditation of conformity assessment bodies, and the plenary of the China Certification and Accreditation Association (CCAA) are respectively held to develop the annual working plans in all fields.
For example, the National Certification and Accreditation Working Conference was held in Beijing on January 16, 2018, to convey the spirit of the 19th National Congress, carry out the requirements of the National Quality Supervision Inspection and Quarantine Working Conference, summarize certification and accreditation work since the 18th National Congress of the CCP, and set general goals for certification and accreditation work for the next three years. In accordance with the deployments of the meeting, five themed initiatives will be carried out in 2018, including the certification upgrading action of a million enterprises, the action of high-end certification quality benefiting people, the action of certification servicing for local sectors, the “Chinese certification, global recognition" action, and the certification problem-addressing action. This year's certification work will focus on eight aspects: establishing a quality certification system, promoting quality improvement, strengthening law enforcement and supervision, optimizing system supply, improving the sectoral environment, consolidating infrastructure, furthering international cooperation, and strengthening the Party's leadership. The Conference received participation from members of the joint inter-ministerial meeting on national certification and accreditation work, specially invited guests, and representatives from certain certification bodies and certified organizations.
