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The Journal of the Japanese Society for Clinical Microbiology |
Biblioraphy Information
| ArticleTitle |
Importance of international standardization of microbiological testing |
| Language |
J |
| AuthorList |
Yoshikazu Ishii |
| Affiliation |
Department of Microbiology and Infectious Diseases, Toho University School of Medicine |
| Publication |
J.J.C.M.: 33 (4), 255-259, 2023 |
| Received |
June 28, 2023 |
| Accepted |
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| Abstract |
The International Organization for Standardization (ISO) develops its standards documents in Technical Committees (TCs) made up of experts from around the world. ISO standard documents are compiled on the basis of expert advice, defining the terminology used and the scope of application, and outlining requirements that reflect the latest expert knowledge. The introduction of these documents ensures that products and services of the same quality can be provided ISO consists of more than 300 technical committees (TS), of which ISO/TC 212 is responsible for 'Clinical laboratory testing and in vitro diagnostic testing systems'. diagnostic testing systems" and is divided into five Working Groups (WGs). Of these, WG 1 and WG 4 are responsible for the development of standards documents for 'Quality and competence in the medical laboratory' and 'Microbiology and molecular diagnostics' respectively. The most important document for which WG1 is responsible is ISO 15189: 2022 'Medical laboratories - Specific requirements for quality and competence'. The documents for which WG4 is responsible are very diverse, ranging from microbiological tests to pathological tests and molecular biological tests such as the Liquid biopsy. It has recently formed a Joint Working Group (JWG) with ISO/TC276 to develop ISO/TS 5798 'In vitro diagnostic test systems - Requirements and recommendations for the detection of SARS-CoV-2 using nucleic acid amplification methods was published. WG4 is also active and has published a number of standards documents; the participation of young researchers and medical professionals is required to continue its activities, as Japan's contribution is expected from ISO/TC212. |
| Keywords |
International Organization for Standardization, technical committee, requirement, recommendation |
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