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The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
In 1968, 31 clinicians and laboratory scientists representing 15 organizations convened to establish a formal consensus process for standardization. In 1977, CLSI received accreditation from the American National Standards Institute (ANSI) as a voluntary consensus standards organization. Around the same time, CLSI became the home of the National Reference System for the Clinical Laboratory (NRSCL), a collection of reference systems intended to enhance the comparability of test results, consistent with medical practice needs.
CLSI is a global association with over 1,500 member organizations and individual members, along with more than 2,000 volunteers. Until 2005, CLSI was known as the National Committee for Clinical Laboratory Standards (NCCLS). [1]
CLSI documents are developed by committees consisting of experts in medical testing or related aspects. Each CLSI committee produces consensus documents related to a specific discipline.
CLSI's core focus is the development of globally applicable voluntary consensus standards and guidelines for the clinical laboratory. This is achieved through an accredited consensus process.[ citation needed ]
CLSI relies on more than 2,000 volunteers. Volunteers and mentors also collaborate with CLSI's Global Health Partnerships to help establish laboratory quality management systems in resource-limited countries.
CLSI provides direct assistance in Sub-Saharan Africa to combat HIV/AIDS and other infectious diseases. With grants from the US-based PEPFAR (President's Emergency Plan for AIDS Relief) program administered by a cooperative agreement from the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), CLSI has been actively involved in improving essential laboratory services. CLSI has provided technical assistance in Côte d'Ivoire, Democratic Republic of the Congo, Dominican Republic, Ethiopia, Georgia, Ghana, Kazakhstan, Kenya, Kyrgyzstan, Malawi, Mali, Mozambique, Namibia, Nigeria, Peru, Rwanda, Tajikistan, Tanzania, Ukraine, Vietnam, and Zambia.[ citation needed ]
CLSI participates in the development of international standards as the Secretariat of ISO Technical Committee (TC) 212, clinical laboratory testing and in vitro diagnostic test systems. This responsibility was delegated to CLSI by the American National Standards Institute (ANSI), an ISO member body. CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.
The American National Standards Institute is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international standards so that American products can be used worldwide.
The International Organization for Standardization is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes.
A biological hazard, or biohazard, is a biological substance that poses a threat to the health of living organisms, primarily humans. This could include a sample of a microorganism, virus or toxin that can adversely affect human health. A biohazard could also be a substance harmful to other living beings.
The National Institute of Allergy and Infectious Diseases is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
The United States President's Emergency Plan For AIDS Relief (PEPFAR) is a United States governmental initiative to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease. Launched by U.S. President George W. Bush in 2003, as of May 2020, PEPFAR has provided about $90 billion in cumulative funding for HIV/AIDS treatment, prevention, and research since its inception, making it the largest global health program focused on a single disease in history until the COVID-19 pandemic. PEPFAR is implemented by a combination of U.S. government agencies in over 50 countries and overseen by the Global AIDS Coordinator at the United States Department of State. As of 2023, PEPFAR has saved over 25 million lives, primarily in sub-Saharan Africa.
The InterNational Committee for Information Technology Standards (INCITS),, is an ANSI-accredited standards development organization composed of Information technology developers. It was formerly known as the X3 and NCITS.
The Institute of Electrical and Electronics Engineers Standards Association is an operating unit within IEEE that develops global standards in a broad range of industries, including: power and energy, artificial intelligence systems, internet of things, consumer technology and consumer electronics, biomedical and health care, learning technology, information technology and robotics, telecommunication, automotive, transportation, home automation, nanotechnology, information assurance, emerging technologies, and many more.
ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Material in the standard also forms the basis for accreditation from an accreditation body.
The Standards Council of Canada (SCC) (French: Conseil canadien des normes (CCN)) is a Canadian crown corporation with the mandate to promote voluntary standardization in Canada. The SCC is responsible for:
In microbiology, the minimum inhibitory concentration (MIC) is the lowest concentration of a chemical, usually a drug, which prevents visible in vitro growth of bacteria or fungi. MIC testing is performed in both diagnostic and drug discovery laboratories.
The Association of Home Appliance Manufacturers or AHAM represents the manufacturers of household appliances and products/services associated with household appliances sold in the United States. AHAM also develops and maintains technical standards for various appliances to provide uniform, repeatable procedures for measuring specific product characteristics and performance features.
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212. ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff. While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
The Accredited Standards Committee X9 is an ANSI accredited standards developing organization, responsible for developing voluntary open consensus standards for the financial services industry in the U.S.
Sousan S. Altaie is Scientific Policy Advisor for the Office of In Vitro Diagnostic Devices in the United States. She joined the Food and Drug Administration in the Center for Drug Evaluation and Research in the Division of Anti-infective Drug Products as a primary reviewer in 1995. Six years later she joined the FDA's Center for Devices and Radiological Health as the Chief of Immunology and Molecular Diagnostics Branch. She is actively working as a member of the Global Harmonization Task Force (GHTF) and International Organization for Standardization (ISO) working groups. She was appointed the CDRH Critical Path Coordinator in 2004 and is actively involved in the Agency's Critical Path initiative. She has served as an observer, advisor and full member of various committees and subcommittees of the Clinical and Laboratory Standards Institute (CLSI).
The Nordic Institute of Dental Materials AS (NIOM AS) is a Nordic Cooperative Body for dental biomaterials. The Institute’s activities in research, materials testing, standardisation and research-based consulting are directed towards dental health services and health authorities in the Nordic countries. The Institute is owned jointly by NORCE and the Norwegian Ministry of Health and Care Services. Activities are financed by the Nordic Council of Ministers and the Nordic ministries for health services. Materials testing and consulting services also generate income. As a joint Nordic resource center, NIOM collaborates with dental schools and research institutions and provides services to government health authorities, dental professionals, and the public in the Nordic countries in the field of dental biomaterials.
The United States Military HIV Research Program was initiated by the United States Congress in 1986, in reaction to the threat of lost effectiveness of U.S./Allied troops due to HIV infection. The mission of MHRP is to develop an HIV-1 vaccine, provide prevention, care, and treatment, and conduct meaningful HIV/AIDS research for the global community through the President's Emergency Plan for AIDS Relief (PEPFAR). It is centered at the Walter Reed Army Institute of Research (WRAIR), and has established five international research sites in Africa and Asia. MHRP also partners with the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Thailand. MHRP works closely with The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), most notably in the development of the RV144 HIV vaccine in Thailand. MHRP is the largest research program supported by the HJF.
NSF is a product testing, inspection, certification organization with headquarters in Ann Arbor, Michigan. NSF also offers consulting and training services worldwide.
Makerere University Walter Reed Project (MUWRP) was established in 2002 for the primary purpose of HIV vaccine development and building of vaccine testing capability in Uganda. It is one of the 5 international research sites established by the Department of Defense (DoD) United States HIV Research Program (MHRP), a program centered at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. MUWRP's main facility is centrally located in Kampala, near the Makerere University College of Health Sciences where the MUWRP laboratory is located. The main facility includes the clinic, administrative, and data offices.
The Infectious Diseases Institute (IDI), established within Makerere University, is a Ugandan not-for-profit organization which aims to strengthen health systems in Africa, with a strong emphasis on infectious diseases; through research and capacity development. In pursuit of its mission both in Uganda and Sub-Saharan Africa, IDI provides care to People Living with HIV (PLHIV) and other infectious diseases, builds capacity among healthcare workers through training and ongoing support, maintains a focus on prevention, and carries out relevant research.
ASME B5 refers to a technical committee of the American Society of Mechanical Engineers and the standard they maintain which deals with machine tools.
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