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Scientific research laboratories are a crucial component and fundamental technological guarantee for implementing scientific and technological innovation. The data they produce serves as the basis for scientific achievements, and their quality directly impacts the reliability and scientific validity of those achievements. However, scientific research laboratories face challenges such as the difficulty in replicating research data and assessing its reliability. How to regulate the management of scientific research laboratories and ensure the reliability and reproducibility of research data is a major challenge currently facing the scientific community.
It is understood that laboratory accreditation is an internationally recognized and advanced quality management method. The international standard ISO/IEC 17025, "General requirements for the competence of testing and calibration laboratories," is widely applicable to testing and calibration laboratories. However, scientific research laboratories are diverse, with different operating models and critical control points compared to testing/calibration laboratories. To date, there is no precedent worldwide for accrediting scientific research laboratories.
To ensure the quality of research results and the technological innovation capabilities of scientific research laboratories, the China National Accreditation Service for Conformity Assessment (CNAS) has made the development of a scientific research laboratory accreditation system a key task during the 13th Five-Year Plan period. In July of this year, Hou Jianguo, Secretary of the Party Leadership Group of the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), visited the Secretariat of the National Accreditation Service for Conformity Assessment (CNAS) and fully affirmed the research on accreditation of scientific research laboratories. He requested that the accreditation system for scientific research laboratories be promoted by finding a suitable entry point in the national science and technology system reform, thereby making laboratory data management more standardized.
With the support of AQSIQ and the Certification and Accreditation Administration of China (CNCA), CNAS undertook the "Research on Good Practices for Scientific Research Laboratories" science and technology support project and launched the "Research on Key Technologies for Scientific Research Laboratory Accreditation" "13th Five-Year Plan" National Key Research and Development Program. Relying on a senior advisory think tank composed of several academicians, CNAS, in conjunction with dozens of research institutions and universities such as the Chinese Academy of Sciences and Beijing University of Science and Technology, has made concerted efforts to research key technologies for scientific research laboratory accreditation and has formulated the national standard for scientific research laboratories, "Good Practices for Scientific Research Laboratories" (draft). Currently, "Good Practices for Scientific Research Laboratories" has passed the project evaluation by the expert group of the National Standardization Administration.
Without international experience to refer to, CNAS has dared to innovate and overcome difficulties, initially establishing a scientific research laboratory management system oriented towards process control of scientific research data quality. This system, starting from the characteristics of scientific research laboratories, identifies key control points for ensuring the quality of scientific research data. On the one hand, it focuses on the research process of scientific research laboratories, establishing a scientific evaluation technical indicator system; on the other hand, it identifies risk sources, safeguarding the bottom line of laboratory safety, and playing a guaranteeing and supporting role in process control, data quality, and alignment with industry standards.
It is understood that the next step for CNAS is to carefully review previous achievements, striving to complete 2 to 3 demonstration accreditation reviews of scientific research laboratories in 2017, and striving to complete the approval of the national standard "Good Practices for Scientific Research Laboratories" in 2018, formally launching the scientific research laboratory accreditation system; and accrediting approximately 10 high-end scientific research laboratories in 2019, continuously promoting the adoption of the scientific research laboratory accreditation system by relevant parties.
Laboratory accreditation signifies a sound laboratory management system, standardized process control and testing technologies, which will play a vital role in safeguarding the organization of scientific research, the output of major scientific research results, and industrialization. It is hoped that the accreditation work of scientific research laboratories in my country can steadily advance in the future, breaking through key technologies and enhancing the scientific and technological content.
