In 2017, after the joint research of 10 relevant international organizations responsible for quality management, industrial development, trade development, and regulatory cooperation, it was published in the book "Quality Policy-Technical Guidelines" issued by the United Nations Industrial Development Organization (UNIDO) in 2018 A new definition of quality infrastructure is proposed. The new definition points out that quality infrastructure is a system composed of organizations (public and private) and policies, relevant legal frameworks and practices required to support and improve the quality, safety and environmental protection of products, services and processes. At the same time, it is pointed out that the quality infrastructure system involves consumers, enterprises, quality infrastructure services, quality infrastructure public institutions, and government governance. It also emphasizes that the quality infrastructure system relies on measurement, standards, and accreditation (from conformity assessment). Listed separately), conformity assessment and market surveillance.
2. The concept of conformity assessment
According to the definition in the international standard ISO/IEC17000 "Conformity Assessment Vocabulary and General Principles", Conformity Assessment refers to "the confirmation that the requirements related to products, processes, systems, personnel or institutions are met". The "Conformity Assessment Builds Trust" jointly published by the International Organization for Standardization and the United Nations Industrial Development Organization pointed out that commercial customers, consumers, users, and government officials are concerned about the quality, environmental protection, safety, economy, reliability, compatibility, and availability of products and services. Features such as operability, efficiency, and effectiveness have expectations, and the process of proving that these features meet the requirements of standards, regulations, and other specifications is called conformity assessment.
Conformity assessment provides a means to meet these expectations in accordance with relevant standards, regulations, and other specifications. It helps to ensure that products and services are submitted as required or promised. In other words, conformity assessment builds trust, can meet the needs of market economy entities, and promote the healthy development of market economy.
——For consumers, consumers can benefit from conformity assessment, because conformity assessment provides consumers with a basis for choosing products or services.
——For enterprises, manufacturers and service providers need to determine whether their products and services meet the requirements of laws, regulations, standards and specifications and provide them according to customer expectations, so as to avoid losses in the market due to product failure.
——For regulatory agencies, they can also benefit from conformity assessment, because conformity assessment provides them with a means to implement laws and regulations and achieve public policy goals.
3. Main types of conformity assessment
Conformity assessment mainly includes four types: testing, inspection, certification, and accreditation. According to the definition in the international standard ISO/IEC17000 "Conformity Assessment Vocabulary and General Principles":
(1) Testing is "the activity of determining one or more characteristics of conformity assessment objects in accordance with procedures."
In layman's terms, it is an evaluation activity using equipment and equipment in accordance with technical standards and specifications, and the evaluation results are test data.
(2) Inspection (Inspection) is "the activity of reviewing product design, product, process or installation and determining its compliance with specific requirements, or determining its compliance with general requirements based on professional judgment";
In layman's terms, it is to rely on people's experience and knowledge to use test data or other evaluation information to make judgments on whether they meet relevant regulations.
(3) Certification is "third-party certification related to products, processes, systems or personnel";
In layman's terms, it refers to a conformity assessment activity in which a third-party certification body certifies that products, services, management systems, and personnel comply with relevant standards and technical specifications.
(4) Accreditation is "a third-party certification that officially shows that the conformity assessment body has the ability to perform specific conformity assessment tasks."
In layman's terms, it refers to the conformity assessment activities in which the accreditation body certifies the technical capabilities of the certification body, inspection body, and laboratory.
It can be seen from the above definition that the objects of inspection, testing and certification are products, services and corporate organizations (directly facing the market); and the objects of recognition are institutions engaged in inspection, testing and certification (indirectly facing the market).
4. Attributes of conformity assessment activities
According to the nature of the activities engaged in conformity assessment, it can be divided into three categories: first-party, second-party and third-party.
-The first party. Refers to the conformity assessment carried out by manufacturers, service providers and other suppliers, such as self-inspection and internal audit carried out by manufacturers to meet their own R&D, design and production needs.
-The second party. Refers to the conformity assessment implemented by the demander such as the user, consumer or purchaser, such as the inspection and inspection carried out by the purchaser on the purchased goods.
-Third party. Refers to the conformity assessment performed by a third-party organization independent of the supply and demand parties, such as product certification, management system certification, and various accreditation activities. Certification, accreditation, and the inspection and testing activities that provide proof to the society all belong to the third-party conformity assessment.
Compared with the first-party and the second-party conformity assessment, the third-party conformity assessment is implemented by an institution with independent status and professional ability in strict accordance with national or international standards and technical specifications, which has higher authority and credibility. Therefore, gaining universal recognition from all parties in the market can not only effectively guarantee quality and protect the interests of all parties, but also enhance market trust and promote trade facilitation.
5. Embodiment of conformity assessment results
The results of the conformity assessment are usually publicized to the public in written forms such as certificates, reports, and signs. Through this publicity proof, the problem of information asymmetry can be solved, and the general trust of related parties and the public can be obtained. The main forms are:
——Certificate and mark;
——Recognition certificate and logo;
——Inspection certificate and inspection report.
(2) Origin and development.
1. check. Inspection and testing have been accompanied by human production, life and scientific research activities. With the need for product quality control in production and trading activities, standardized, process-oriented, and standardized inspection and testing activities have developed day by day. In the latter part of the industrial revolution, inspection and testing technology and equipment have been highly integrated and complex, and inspection and testing institutions specializing in testing, calibration, and verification have gradually emerged. Inspection and testing itself has become a booming industry field. With the development of trade, there have been third-party inspection and testing institutions that provide quality services such as product safety testing and cargo identification to the society. For example, the Underwriters Laboratory (UL) established in 1894 in the United States, in trade exchanges and market supervision Plays an important role.
2. Certification. In 1903, the United Kingdom began to certify and apply the "kite" logo to rail products that passed inspections in accordance with the standards set by the British Engineering Standards Institute (BSI), becoming the world's earliest product certification system. In the 1930s, industrial countries such as Europe, the United States and Japan have established their own certification and accreditation systems, especially for specific products with higher quality and safety risks, and implemented compulsory certification systems one after another.
With the development of international trade, in order to avoid duplication of certification and facilitate trade, it is objectively necessary for countries to adopt uniform standards and rules for certification activities to achieve mutual recognition of certification results on this basis. In the 1970s, in addition to implementing certification systems within their own countries, European and American countries began to conduct mutual recognition of certification systems between countries, and then developed a regional certification system based on regional standards and regulations. The most typical regional certification system is the European Union's CENELEC (European Committee for Electrotechnical Standardization) certification of electrical products, and the subsequent development of the European Union CE Directive.
With the increasing globalization of international trade, the establishment of a universal certification system worldwide has become a general trend. In the 1980s, countries around the world began to implement international certification systems based on international standards and rules on a variety of products, such as the electrical product safety certification system (IECEE) established by the International Electrotechnical Commission (IEC). Since then, it has gradually expanded from the field of product certification to management systems, personnel certification and other certification fields, such as the ISO9001 international quality management system promoted by the International Organization for Standardization (ISO), and certification activities carried out in accordance with this standard.
3. Recognized. With the development of conformity assessment activities such as inspection, testing and certification, various conformity assessment agencies engaged in inspection, testing and certification activities have appeared one after another. The good and the bad are mixed, making users unable to choose, and even some institutions have harmed the interests of related parties, causing the government to standardize certification. Calls for behavior of institutions, inspection and testing institutions. In order to ensure the authority and impartiality of certification and inspection results, accreditation activities have emerged. In 1947, the first national accreditation body, Australia NATA, was established to first accredit laboratories. In the 1980s, industrialized developed countries successively established their own accreditation agencies. After the 1990s, some emerging countries have also established accreditation agencies.
With the origin and development, the certification system has gradually developed from product certification to management system certification, service certification, personnel certification and other types; with the origin and development, the accreditation system has gradually developed from laboratory accreditation to certification body accreditation, inspection agency accreditation and other types .
(3) Function and role.
The reason why certification, accreditation, inspection and testing is a basic system of the market economy, in a nutshell, is embodied as "one essential attribute, two typical features, three basic functions, and four outstanding functions".
——"An essential attribute": transfer trust and serve development.
The market economy is essentially a credit economy, and all market transactions are the common choice of market entities based on mutual trust. With the increasing complexity of social division of labor and quality and safety issues, the objective and fair evaluation and verification of market transaction targets (products, services, or corporate organizations) by a third party with professional capabilities has become a necessary link in market economic activities. Obtaining third-party certification and accreditation can significantly increase the trust of all parties in the market, thereby solving the problem of information asymmetry in the market and effectively reducing market transaction risks. After the birth of the certification and accreditation system, it was quickly and widely used in domestic and international economic and trade activities to convey trust to consumers, enterprises, governments, society and the world. In the process of continuous improvement of the market system and market economy system, the characteristics of certification and accreditation of "transmitting trust and service development" will become increasingly apparent.
——Two typical characteristics: marketization and internationalization.
One is the characteristics of marketization. Certification and accreditation originate from the market, serve the market, develop in the market, and widely exist in market transactions such as products and services. It can transmit authoritative and reliable information in the market, establish a market trust mechanism, and guide the market to survive the fittest. The use of certification and accreditation measures by market entities can achieve mutual trust and mutual recognition, break market and industry barriers, promote trade facilitation, and reduce institutional transaction costs; the use of certification and accreditation measures by market supervision agencies can strengthen quality and safety supervision and optimize market access and affairs. Interim and ex-post supervision to standardize market order and reduce supervision costs.
The second is the characteristics of internationalization. Certification and accreditation is an internationally accepted economic and trade rule under the framework of the World Trade Organization (WTO). Certification and accreditation is generally accepted as a common method to regulate the market and facilitate trade, and to establish unified standards, procedures and systems. Mainly reflected in: First, international cooperation organizations have been established in many fields, such as the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation Organization (ILAC), etc. . Their purpose is to establish an internationally unified standard and certification and accreditation system to achieve "one inspection, one test, one certification, one accreditation, and universal access". Second, a full range of certification and accreditation standards and guidelines have been established internationally, and they have been issued by international organizations such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). At present, 36 international standards for conformity assessment have It is generally adopted by various countries. At the same time, the World Trade Organization’s Agreement on Technical Barriers to Trade (WTO/TBT) also regulates national standards, technical regulations and conformity assessment procedures, establishing reasonable goals, minimizing the impact on trade, transparency, national treatment, international standards and The principle of mutual recognition in order to minimize the impact on trade. Third, certification and accreditation methods are widely used internationally. On the one hand, they are used as market access measures to ensure that products and services meet the requirements of regulations and standards, such as the EU CE Directive, Japan PSE certification, China CCC certification and other compulsory certification systems; some international market purchases Systems such as the Global Food Safety Initiative (GFSI) also use certification and accreditation as a procurement access condition or evaluation basis. On the other hand, as a measure of trade facilitation, double and multilateral mutual recognition is adopted to avoid repeated testing and certification, such as the testing and certification system for electronic and electrical products established by the International Electrotechnical Commission (IECEE),
Mutual recognition arrangements such as the electronic component quality qualification assessment system (IECQ) and the explosion-proof electrical product certification system (IECEX) cover more than 90% of the world's economies, which greatly facilitates global trade.
——Three basic functions: quality management "physical examination certificate", market economy "letter of credit", and international trade "passport".
Certification and accreditation, as the name suggests, is to evaluate the conformity of products, services and their corporate organizations and issue publicity certificates to the society to meet the needs of market entities for various quality characteristics. As government departments reduce the "certificate" of access restrictions, the function of the "certificate" to enhance mutual trust and convenience among market entities is becoming more and more indispensable.
One is the "physical examination certificate" of quality management. Certification and accreditation is a process of using a variety of quality management methods to diagnose and improve whether a company's production and operation activities conform to standards and specifications in accordance with the requirements of standards, regulations, etc. It is an effective tool to strengthen overall quality management. Through certification and accreditation activities, it can help companies identify key links and risk factors for quality control, continuously improve quality management, and continuously improve product and service quality. To obtain certification, an enterprise needs to go through multiple evaluation links such as internal audit, management review, factory inspection, measurement calibration, product type test, etc. After obtaining the certificate, it also needs to conduct regular post-certification supervision, which means a full set of "physical examinations" that can continue to ensure the management system Effective operation of the system, thereby effectively strengthening quality management.
The second is the "Letter of Credit" of the market economy. The essence of market economy is credit economy. Certification, accreditation, inspection and testing can transmit authoritative and reliable information in the market, help establish a market trust mechanism, improve market operation efficiency, and guide the market to survive the fittest. Obtaining third-party authoritative certification is a credit carrier that proves that a business organization has the qualifications to participate in specific market economic activities and that the goods or services it provides meet the requirements. For example, ISO9001 quality management system certification is a basic condition for bidding and government procurement at home and abroad, usually for companies that participate in bidding. For specific requirements such as environment and information security, ISO14001 environmental management system certification, ISO27001 information security management system certification, etc. As a qualification condition, the government procurement of energy-saving products and the national "Golden Sun" project take energy-saving product certification and new energy certification as access conditions. It can be said that certification, accreditation, inspection and testing provide market entities with credit certificates, solve the problem of information asymmetry, and play an irreplaceable role in transmitting trust for market economic activities.
The third is the "passport" for international trade. Due to the characteristics of internationalization, all countries advocate "one inspection and testing, one certification and recognition, international mutual recognition", which can help enterprises and products to enter the international market smoothly, and play a role in coordinating international market access in the global trading system. , Promoting trade facilitation and other important functions are institutional arrangements that promote the opening of mutual markets in the multilateral and bilateral trade systems. In the multilateral field, certification and accreditation is not only an international rule for promoting trade in goods under the framework of the World Trade Organization (WTO), but also an access condition for some global procurement systems such as the Food Safety Initiative and the Telecommunication Union; in the bilateral field, certification and accreditation are both a free trade area (FTA). ) The convenient tool to eliminate trade barriers under the framework is also an important topic of trade consultations and negotiations between governments on market access and trade balance. In many international trade activities, certification certificates or test reports issued by well-known international organizations are used as prerequisites for trade procurement and as a necessary basis for trade settlement. Not only that, but many countries have market access negotiations between countries. Regarding certification, accreditation, inspection and testing as an important content, it is written into the trade agreement.
——Four prominent roles: improving market supply, serving market supervision, optimizing the market environment, and promoting market opening.
Certification and accreditation are "imported products" in our country. my country's certification and accreditation system began at the beginning of reform and opening up in the 1970s and 1980s. It has developed with the development of my country's market economy and can be roughly divided into three stages:
1. Pilot and initial stage of certification and accreditation (1978-1991)
-Certification field. In 1978, my country rejoined the International Organization for Standardization and began to understand that certification is an effective means of evaluating, supervising, and managing product quality. In 1981, my country joined the International Electronic Component Certification Organization and established China’s first product certification body—China Electronic Components Certification Committee, which marked the beginning of my country’s formal use of foreign certification systems.
From the mid-1980s to the early 1990s, my country has successively established a series of product certification systems for household appliances, electronic entertainment equipment, medical equipment, automobiles, food, and fire-fighting products.
——Recognition field. In 1980, the former National Bureau of Standards and the former National Import and Export Commodity Inspection Bureau jointly sent a delegation to participate in the International Laboratory Accreditation Conference (ILAC), and international accreditation activities began to sprout in my country. In 1985, the laboratory accreditation system began to be implemented.
2. Full implementation stage of certification and accreditation (1991-2001)
In May 1991, Order No. 83 of the State Council formally promulgated the "Regulations on the Administration of Product Quality Certification of the People's Republic of China", marking that my country's quality certification work has entered a new stage of comprehensive and standardized implementation from the pilot.
-Certification field. At this stage, in addition to the comprehensive establishment and implementation of product certification, important progress has also been made in the field of management system certification, and certification systems such as ISO9001 quality management system, ISO14001 environmental management system, and OHSAS18001 occupational health and safety management system have been established successively.
During this period, the most influential certification systems were the former National Bureau of Technical Supervision (Quality and Technical Supervision Bureau)’s “Great Wall Mark” certification system focusing on national product safety access and the former National Bureau of Import and Export Commodity Inspection (Entry-Exit Inspection). Quarantine Bureau) "CCIB Mark" certification system for the safe access of imported goods.
——Recognition field. The former National Bureau of Quality and Technical Supervision has successively established the National Accreditation Committee of China Quality Management System Certification Body (CNACR), China National Registration Board for Certification Personnel (CRBA), China National Laboratory Accreditation Board (CNACL) and China National Accreditation Board for Product Certification Body ( CNACP) to carry out the accreditation work in the domestic market; the former National Import and Export Commodity Inspection Bureau (Entry-Exit Inspection and Quarantine Bureau) successively established the China National Accreditation Board for Import and Export Enterprise Certification Bodies (CNAB) and China National Accreditation Board for Import and Export Laboratories (CCIBLAC) ) To carry out the accreditation work in the import and export field.
3. The establishment and implementation of a unified certification and accreditation system (2001-present)
After my country introduced an international certification and accreditation system, under the planned economic system at the time, different departments implemented them in their respective industries, which objectively caused a series of malpractices such as separate governance, multiple management, and repeated certification. Most prominently, due to the division of the domestic and foreign markets at that time, two different certification systems were implemented for domestic and imported products, which did not conform to the internationally accepted principle of national treatment. This issue became the focus of negotiations during the "WTO accession" negotiations. In the Protocol of my country's "Accession to the WTO", the Chinese government made a commitment to establish a unified product certification system, involving as many as 23 items of certification, accreditation, inspection and testing. In August 2001, in order to meet the needs of my country’s entry into the WTO and the improvement of the socialist market economy system, the Party Central Committee and the State Council decided to merge the former State Quality and Technical Supervision Bureau and the State Entry-Exit Inspection and Quarantine Bureau to form the General Administration of Quality Supervision, Inspection and Quarantine, and the establishment of the State Administration of Quality Supervision, Inspection and Quarantine. Certification and Accreditation Administration, this signifies that my country has established a unified certification and accreditation management system.
——Unification of management departments: CNCA, as the certification and accreditation supervision and management department of the State Council, is responsible for unified management, supervision and comprehensive coordination of national certification and accreditation work.
——Unification of laws and regulations: In November 2003, the State Council promulgated and implemented the "Regulations on Certification and Accreditation", which established a certification and accreditation management system that not only conforms to internationally accepted rules, but also conforms to my country's actual conditions.
——Unified certification system: With the compulsory product certification system as the core, a unified national certification system has been established. In May 2002, the country formally implemented a new compulsory product certification system, the core of which is to achieve the "four unifications" (ie, unified product catalog, unified applicable national standards, technical rules and implementation procedures, unified Logo, unified fee standard), to replace the "CCIB logo" certification and the "Great Wall logo" certification.
——Unified accreditation system: In August 2002, a centralized and unified accreditation system was established on the basis of the original import and export and domestic accreditation systems; in March 2006, in order to adapt to the requirements and changes of international accreditation organizations, the Chinese certification agency The National Accreditation Board and the National Accreditation Board for Laboratories merged to form the China National Accreditation Service for Conformity Assessment (CNAS) as the only national accreditation body.
In March 2018, in accordance with the "Deepening Party and State Institutional Reform Plan" of the Central Committee of the Communist Party of China, the State Administration for Market Supervision was established to be responsible for the comprehensive market supervision and management, unified management of inspection and testing, certification and accreditation and other tasks. The responsibilities of the National Certification and Accreditation Administration Committee are transferred to the State Administration of Market Supervision and Administration, and the brand is reserved to the outside world. It fully reflects the great importance of the Party Central Committee and the State Council on certification and accreditation inspection and testing work, indicating that certification and accreditation inspection and testing work has entered a new era.
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