Conformity assessment has an essential property of delivering trust and serving development, which is considered as the certificate of compliance in quality management and market economy and a passport for international trade.
The conformity assessment work in China has been developing at a rapid pace since the reform and opening-up policy took effect in 1978, especially after the Certification and Accreditation Administration of China (CNCA) was established in 2001. In the past two decades, standardization has provided significant technical support for conformity assessment, and played a vital role in serving the national development of China and combating the crises caused by epidemics.
Conformity assessment in China
After the founding of the People's Republic of China in 1949, this country gradually started its national and international standardization work, and became a member of the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO) in 1957 and 1978 respectively.
As one of the priorities, certification and accreditation in China began in the 1980s. The certification system for electronic component products was established in 1981. Quality Certification Committee for Electronic Components of China (QCCECC), the first product quality certification body, was set up in the same year to carry out the quality certification of related electronic components based on the technical specifications of IEC.
Since the mid-1980s, certification systems were promoted on a wide scale for products such as household appliances, electronic entertainment devices, medical equipment, automobiles, food and firefighting products, with relevant administration work in the charge of multiple government departments. Later, the certification mechanisms for management system, personnel and service were gradually established as well.
In China, the introduction of certification and accreditation system has played a major role in facilitating international trade and improving product quality. However, there were existing problems, particularly the incompatible respective certification systems for domestic products and imported and exported products.
At the beginning of the 1990s, the two sets of management certification systems administrated by different government departments had led to repeated certification, labeling and even charges as well as different standards and procedures, which dissatisfied many domestic and foreign enterprises.
To fulfill the promises China made to join the World Trade Organization (WTO), and establish a harmonious certification and accreditation system, the State Council approved the establishment of CNCA in August 2001 to manage, supervise and coordinate the national certification and accreditation work in a unified mechanism. A year later, SAC/TC 261 on conformity assessment was set up, making the standardization of conformity assessment grow out of nothing.
In the past 20 years, SAC/TC 261, through conformity assessment standardization, has converted all the international standards developed by ISO’s committee on conformity assessment (ISO/ CASCO) into national standards, and developed a series of important innovative national standards in the areas such as inspection & testing and biosafety laboratory.
Serving the national development
Taking internationalization as a typical feature of conformity assessment, ISO and IEC have developed a series of standards and guides according to the best practices of conformity assessment by pooling the expertise and experience of conformity assessment professionals and users across the world. These standards developed by ISO/CASCO constitute the popular CASCO toolbox.
And identical conversion of the international standards developed by ISO/CASCO into national standards is the initial mission of the conformity assessment standardization work in China. Since SAC/TC 261 was established, it has determined its core tasks as active conversion of international standards and participation in international standards development. It has set a four-step development strategy, namely clear development and planning, active and comprehensive tracking, practical participation in international standards development, and innovative national standards at international level, showcasing the path of the introduction and internationalization of conformity assessment standardization.
In China, SAC/TC 261 has never stopped introducing international standards. In 2003, Chinese experts served as the members of the Chairman’s Policy and Coordination Group (CPC) in ISO/ CASCO. The 100% conversion rate of all international standards of ISO/CASCO was realized in 2010. To better promote the international conformity assessment work in China, ISO publications such as Building trust—The Conformity Assessment Toolbox, A guide to good practice—Principles and practices in product regulation and market surveillance, and Guidance for conformity assessment in government surveillance and application were published in Chinese in 2011, 2013 and 2015 respectively.
In 2016, an international workshop on certification of services was jointly held by SAC/TC 261 and ISO/CASCO in Shanghai. In 2018, several international experts from renowned standardization bodies such as AFNOR were appointed as foreign advisers in SAC/TC 261. All these have indicated one step after another forward in the introduction of conformity assessment standardization in China.
Internationalization is also a priority. The conformity assessment work in China has been upholding the spirit of pioneering, realizing multiple "first attempts" in its internationalization development. In 2012, a Chinese expert assumed the convenor of a working group in ISO/CASCO for the first time, contributing to the draft of ISO/IEC 17021-2015, Conformity assessment — Requirements for bodies providing audit and certification of management systems.
In October 2013, the 29th plenary meeting of ISO/CASCO was held in Beijing, which was the first of its kind in China. In 2015, a Chinese expert was nominated by SAC/TC 261 to be convenor of the working group for developing the first standard related to certification of services, ISO/IEC TR 17028:2017, Conformity assessment — Guidelines and examples of a certification scheme for services. In 2016, a meeting of ISO/CASCO/WG 45 was held in Shanghai for the first time.
In 2018, a book Conformity assessment in China in both Chinese and English was published by the committee, which summarized the working experience of conformity assessment in China in an allround manner and elaborated on the application and promotion of the CASCO toolbox in China. The prefaces of the book were written by Zhang Xiaogang, former ISO President, and Sergio Mujica, ISO Secretary-General. Dong Lequn, Chair of SAC/TC 261, introduced the system and practice of conformity assessment in China and shared the book with other participants at an international workshop on market surveillance held by ISO in 2019.
In 2020, Delivering supply chain confidence was published with the participation of Chinese experts in drafting, which included four cases from China, contributing Chinese experience to the promotion of supply chain confidence in the world.
So far, SAC/TC 261 is in charge of 82 currently effective national standards, achieving the full tracking of all international standards developed by ISO/CASCO and establishing a supporting certification and accreditation standards system for identically covered international standards and innovative national standards.
At present, many Chinese experts are the members of the Chairman’s Policy and Coordination Group (CPC), Strategic Alliance and Regulatory Group (STAR) and Technical Interface Group (TIG) in ISO/CASCO, who have participated in the development and revision of 45 international standards on conformity assessment, registered in 51 working groups for 90 times, assumed the convenors of 7 working groups, and led the development of important international standards such as ISO/IEC 17000:2020, Conformity assessment — Vocabulary and general principles.
Overcoming the crises related to epidemics
The first innovative national standard in the conformity assessment field, GB 19489-2004, Laboratories—General requirements for biosafety, was released in 2004 after the outbreak of severe acute respiratory syndrome (SARS) in China in 2003. Through the release of the standard, the national accreditation system for biosafety laboratory was officially established in China, providing an important institutional guarantee in improving biosafety management, solving hidden dangers in safety management, and preventing biosafety accidents in laboratories across China.
GB 19489-2004 has stood the fights against SARS and highly pathogenic avian influenza (HPAI), playing a prominent role in safeguarding the laboratory biosafety and managing the pathogenic microorganism laboratories in accordance with the law. The standard received the second prize of the first China Standards Innovation and Contribution Award in 2006.
The standard was later translated into English, and served as the reference material on the biosafety international standards developed by the World Health Organization (WHO) and European Committee for Standardization (CEN).In 2014, to help Sierra Leone fight against Ebola, the Chinese government assisted in the country’s construction of biosafety laboratories, making Chinese standards well recognized by applying their design, construction and admissive inspection. Thanks to the standard, biosafety laboratories have played a key role in scientific research, disease prevention and control, anti-terrorism actions and security with enormous benefits.
Based on such successful practice, SAC/TC 261 developed and released GB 27421-2015, Mobile laboratories — General requirements for biosafety. Taking a national sci-tech project as technical support, the standard specified the basic requirements for facility, equipment and safety management of biosafety protection horizontal mobile laboratories at first, second and third classes.
Various mobile laboratories constructed according to the standard have been highly praised for the important tasks such as epidemic control, disaster relief and anti-terrorism actions, fully reflecting the value of conformity assessment standards in laboratory biosafety and epidemic control. The standard also played a key role in the COVID-19 pandemic control, and received the second prize of China Standards Innovation and Contribution Award in 2020.
These typical successful cases have revealed the responsibilities of standards in fighting against the crises concerning epidemics and many fields including basic principles and requirements of conformity assessment, biosafety and quality management of laboratory as well as food safety. Over the past two decades, conformity assessment standardization has been catering to the life health and safety of people and the high-quality economic and social development in China.
(Chinese version provided by SAC/TC 261 on conformity assessment; edited and translated by Jin Jili)
供稿：全国认证认可标准化技术委员会（SAC/TC 261）；编译：靳吉丽
