Recommended Reading | Research and Discussion on ISO/CASCO Series Standards and Standard Systems

　　The International Organization for Standardization (ISO) is an independent non-governmental organization composed of members from national standard bodies of 168 countries, having developed more than 24,777 international standards to date. ISO has established three policy development committees: the Committee on Conformity Assessment (CASCO), the Consumer Policy Committee (COPOLCO), and the Developing Country Committee (DEVCO). Among them, ISO/CASCO is responsible for formulating and publishing policies or standards related to conformity assessment to guide global conformity assessment activities. The "Conformity Assessment Toolbox" is a series of international standards and documents related to conformity assessment developed by ISO/CASCO. These international standards and documents provide normative and operational tools for conducting conformity assessment activities. This article introduces the basic composition and functions of ISO/CASCO, analyzes the series of ISO/CASCO standards, the standard system, and the domestic adaptation situation, aiming to provide reference and guidance for the construction of China's laboratory accreditation standard system.

　　 1. Composition and Responsibilities of ISO/CASCO

　　ISO/CASCO is composed of representatives from ISO member national standard bodies, ISO technical committees (TCs), and other international organizations, including 95 participating members (P-members) and 45 observer members (O-members). ISO/CASCO is a liaison member of nine international organizations, including the International Bureau of Weights and Measures (BIPM), International Accreditation Forum (IAF), International Federation of Standards Users (IFAN), International Federation of Inspection Agencies (IFIA), International Certification Network (IQNet), International Laboratory Accreditation Cooperation (ILAC), International Personnel Certification Association (IPC), International Organization of Legal Metrology (OIML), and the International Union of Independent Laboratories (UILI). The main responsibilities of ISO/CASCO include:

　　(1) Responsible for researching and evaluating methods to determine whether products, processes, services, and management systems comply with relevant standards or other technical specifications;

　　(2) Developing international standards and guidelines related to testing, inspection, and certification practices for products, processes, and services, as well as the operation and acceptance assessment of management systems, testing laboratories, inspection bodies, certification bodies, and accreditation bodies;

　　(3) Promoting mutual recognition and acceptance of national and regional conformity assessment systems, and the appropriate use of international standards for testing, inspection, certification, and assessment.

　　ISO/CASCO jointly develops its documents with the International Electrotechnical Commission (IEC) and the European Committee for Standardization (CEN). By establishing globally recognized policies and international standards related to conformity assessment and conformity assessment systems, it enhances user confidence and promotes trade.

　　ISO/CASCO has three standing policy groups: the Chair Policy and Coordination Group (CPC), the Strategic Alliance and Regulatory Group (STAR), and the Technical Interface Group (TIG), as well as multiple technical working groups (WGs). CPC is the core working group of CASCO, mainly responsible for research on conformity assessment strategy issues, overall planning of CASCO work, standard interpretation, proposing policy recommendations, and ensuring policy implementation. STAR members include representatives from CASCO member bodies and industry and regulatory departments, mainly responsible for liaising with key economic sectors and government regulatory departments, collecting issues and needs, and identifying future research directions based on feedback from industry representatives. TIG coordinates with relevant ISO TCs on aspects of international standards involving conformity assessment, assisting CASCO in reviewing and ensuring ISO international standards remain neutral, guiding relevant TCs to develop industry conformity assessment requirements according to CASCO policies, and designing and establishing industry conformity assessment systems. The relationship between policy groups and technical working groups is shown in Figure 1.

　　 2. ISO/CASCO Standard System

　　As of May 2023, ISO/CASCO has developed and published a total of 37 international standards, with 4 standards under development. The series of standards in the Conformity Assessment Toolbox can be divided into three categories based on their function and role: foundational documents, general documents, and technical functional documents. Foundational documents include basic standards guiding the drafting and use of general and technical functional documents; general documents include documents used globally for conformity assessment activities, covering supplier declarations of conformity, accreditation, peer review, international mutual recognition, and good practice guidelines; technical functional documents include requirements for specific objects and various conformity assessment activities, involving laboratories, inspection bodies, verification and validation bodies, certification bodies, and labels and marks. The specific standard system framework is shown in Figure 2.

　　The ISO/CASCO standard system covers multiple fields such as inspection, testing, and certification. Among the 37 series standards, there are 2 foundational documents, 6 general documents, and 29 technical functional documents. The foundational documents mainly include conformity assessment vocabulary and guidelines for drafting normative conformity assessment documents; the general documents mainly include supplier declarations of conformity, accreditation body requirements, international mutual recognition agreements, and good practice guidelines; the technical functional documents mainly include capability requirements for laboratories, inspection bodies, verification and validation bodies, certification bodies, and general requirements for labels and marks. The ISO/CASCO series standards have a clear hierarchical structure, unified and standardized naming and structure, consistent standard structure and language description, ensuring the scientific rigor and strictness of the entire standard system. This facilitates users in searching and using the standards, promotes dissemination and understanding, and makes the standards more widely applicable.

　　 3. Domestic Alignment and Adaptation of ISO/CASCO Standards

　　The National Certification and Accreditation Standardization Technical Committee (SAC/TC 261) is the domestic counterpart committee of ISO/CASCO. The Accreditation and Testing Department of the State Administration for Market Regulation provides business guidance, and the secretariat is located at the China Certification and Accreditation Association (CCAA). SAC/TC 261 has achieved significant results in participating in and leading the development of international conformity assessment standards, translating and adapting international conformity assessment standards, promoting the implementation and application of the Conformity Assessment Toolbox series standards domestically, and researching and absorbing the latest international conformity assessment theories and achievements. The ISO/CASCO "Conformity Assessment Toolbox" series of international standards have basically been adapted into China's national standards. The National Standardization Administration has included the ISO/CASCO series standards in the "National Standard Classification" to facilitate enterprises and institutions in querying and using them.

　　As of now, SAC/TC 261 manages a total of 91 effective national standards and 249 industry standards. The current certification and accreditation standard system table divides certification and accreditation standards into four levels: the first level is "Basic General Standards for Certification and Accreditation," the second level includes "Basic Standards for Six Certification and Accreditation Activities," the third level further refines the "Second Level" activities, and the fourth level includes "Technical Requirements for Certification Objects" and "Testing Standards." The overall framework of the current certification and accreditation standard system basically meets the development needs of certification and accreditation in China. The scope covered by the standards is also basically consistent with the scope regulated by ISO/CASCO, serving as a refinement and supplement based on it. However, with the continuous updating and iteration of international and domestic certification, accreditation, and testing technologies, further refinement is needed in areas such as laboratory management and certification body management systems, and necessary supplementation, expansion, and improvement of the certification and accreditation standard system table.

　　 4. Insights for the Construction of China's Laboratory Accreditation Standard System

　　In March 2014, with the approval of the National Standardization Administration, SAC/TC 261 established the Laboratory Accreditation Sub-Technical Committee (SAC/TC 261/SC1), with the secretariat undertaken by the China National Accreditation Service for Conformity Assessment (CNAS). CNAS is responsible for the technical management of national standards for laboratory accreditation and assists the National Certification and Accreditation Standardization Technical Committee in undertaking the domestic counterpart work of the relevant ISO technical committees; it is responsible for the formulation and revision of national standards related to laboratory certification and accreditation, including basic standards, management standards, and competence assurance standards. The National Certification and Accreditation Administration is responsible for its daily management and business guidance.

　　There are currently 34 valid national standards managed by SAC/TC 261/SC1, among which 2 national standards are equivalent conversions of the ISO/CASCO series standards, namely GB/T 27020—2016 and GB/T 27043—2012, both of which are currently valid. According to the requirements of the National Standardization Administration Committee for TC to establish and continuously improve the standard system, it is necessary to further clarify the scope and boundaries of the laboratory accreditation standard system. Researching and establishing a relatively systematic and standardized laboratory accreditation standard system helps to guide the formulation and revision of national standards in this field, direct the preparation of standard formulation and revision plans, further regulate the management of inspection and testing institutions, improve the overall level of inspection and testing institutions in China, and provide strong support for participating in international competition. In the process of constructing the standard system, in addition to drawing on the experience of constructing advanced international standard systems such as ISO/CASCO, full consideration should also be given to the characteristics of existing standards in China and the trend of rapid development in the future. The expandability of the standard system should be considered. With the continuous improvement and development of inspection and testing technology levels and digital management levels, the corresponding accreditation technologies are also continuously improving and perfecting. Therefore, the framework of the standard system is not immutable but should be gradually expanded, deepened, and updated to ensure consistency and compatibility between domestic standards and advanced international standards, fully leveraging the role and advantages of accreditation in enhancing international trade facilitation and breaking down technical trade barriers.

　 　Conclusion

　　By analyzing and studying the ISO/CASCO series standard system, it can be seen that its standard formulation is scientific and rigorous, the standard system structure is reasonable, and the standard content hierarchy is clear. Although we have basically converted the ISO/CASCO series standards, further refinement is needed in subdivided fields such as laboratory management to build a clearer and more comprehensive standard system framework and form a scientific and systematic chain.

　　At present, the formulation and revision of laboratory accreditation standards are relatively scattered and lack focus. By studying and learning from the ISO/CASCO standard system and comparing it with the current status of laboratory accreditation standardization work in China, summarizing and classifying existing standards reveals gaps and deficiencies in the current standards. This can provide a scientific basis for constructing the laboratory accreditation standard system, preparing accreditation standard formulation and revision plans, and formulating relevant accreditation standardization measures.

　　With the development of market globalization and international trade, we should further improve the top-level planning of standards, promote the further improvement of the standard system, actively participate in the formulation and revision of international standards, promote the globalization and application of standards, and build a certification and accreditation standard system framework with Chinese characteristics to make important contributions to promoting international trade and industrial cooperation.