Terminology

Laboratory and regulatory terminology:

A2LA
Established in 1978 as a non-profit, public service, membership society, A2LA accredits testing and calibration laboratories, inspection bodies, proficiency testing providers and reference material producers. AAALAC AAALAC is a private nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program. AAALAC stands for the “Association for Assessment and Accreditation of Laboratory Animal Care.” AAMI Association for the Advancement of Medical Instrumentation (AAMI) Standards for Medical Instrumentation. AIHA American Industrial Hygiene Association ( AIHA ) Laboratory accreditation programs based on international standards administered by the American Industrial Hygiene Association ANSI The American National Standards Institute (ANSI) is an organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system

AOAC
AOAC is an international not-for-profit scientific association that provides accreditation, proficiency testing, assessment of methods and certification. AOAC “Official Methods of Analysis” have been defined as “official” by regulations promulgated for enforcement of the Food, Drug, and Cosmetic Act (21 CFR 2.19), recognized in Title 9 of USDA-FSIS Code of Federal Regulations, and in some cases by the US environmental Protection Agency

ASTM
American Society for Testing and Materials ( ASTM )International is a voluntary standards development organization for technical standards for materials, products, systems, and services.

BP
British Pharmacopoeia ( BP )is standards for medicinal substances and pharmaceutical products in the UK.

CAB
Conformity Assessment Body (CAB) in accordance with the US-EU mutual recognition agreement.

CLIA
The U.S. Center for Medicare and Medicaid Services ( CMS )regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total CLIA covers approximately 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations has the responsibility for implementing the CLIA Program. Codex Alimentarius The Codex Alimentarius are International standards for foods and agriculture

DAR
Deutscher Akkreditierungs Rat ( DAR ) Germany Standards and Accreditation System

DEA
US Drug Enforcement Administration ( DEA ).

DIN V 55394-1/2:2000
European Standards for laboratories providing for Proficiency testing by interlaboratory comparisons DIN EN 45003:1995 Calibration and testing laboratory accreditation systems – General requirements for operation and recognition

EP
European Pharmacopoeia ( EP )is standards for medicinal substances and pharmaceutical products in the EU

EPA
US environmental Protection Agency (EPA ) . EPA’s drinking water standards program has established health based standards for more than 80 contaminants. Laboratories in the US analyzing drinking water compliance samples must be certified by EPA or the State.

FDA
US Food and Drug Administration ( FDA )

FHSA
US Federal Hazardous Substances Act ( FHSA )

GLP
Good Laboratory Practices ( GLP ) are US Food and Drug Administration regulations for Bioresearch Monitoring.

GMP
Good Manufacturing Practices (cGMP) are US Food and Drug Administration regulations for manufacturing and testing pharmaceuticals and food products.

IEEE
Institute of Electrical and Electronics Engineers, Inc. ( IEEE ) is a non-profit, technical professional association with consensus-based standards in the computer engineering, biomedical technology and telecommunications, to electric power, aerospace and consumer electronics areas.

ISO 9000
ISO is a network of national standards institutes from 146 countries working in partnership with international organizations, governments, industry, business and consumer representatives. The ISO 9000 family is primarily concerned with “quality management”.

ISO 17025
ISO is a network of national standards institutes from 146 countries working in partnership with international organizations, governments, industry, business and consumer representatives. The ISO 17025 are the General requirements for the competence of testing and calibration laboratories

NATA
NATA is the Australia’s Government-endorsed provider of accreditation for laboratories and similar testing facilities. NATA is also Australia’s GLP compliance monitoring authority for Good Laboratory Practice (GLP) and represents Australia on the OECD GLP Working Group; NCCLS NCCLS is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community.

NELAC
National environmental Laboratory Accreditation Conference ( NELAC ) is a US voluntary association of State and Federal agencies. NELAC’s purpose is to establish and promote mutually acceptable performance standards for the operation of environmental laboratories. NELAP The US EPA’s National environmental Laboratory Accreditation Program (NELAP) office provides support to NELAC and evaluation of the accrediting authority programs.

NVLAP
National Voluntary Laboratory Accreditation Program (NVLAP) NVLAP is part of the Standards Services Division within the US NIST (National Institute of Standards and Technology ) Technology Services. Fields of Accreditation include Calibration Laboratories, Chemical Calibration, Dosimetry, Electromagnetic Compatibility and Telecommunications, environmental, Fasteners and Metals Information Technology Security Testing, Product Testing SCC
Standards Council of Canada ( SCC )

UKAS
The United Kingdom Accreditation Service is the sole national accreditation body recognised by the UK government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services. Accreditation by UKAS demonstrates the competence, impartiality and performance capability of these evaluators.

USDA
US Department of Agriculture

USP
US Pharmacopeia are standards established by the The United States Pharmacopeial Convention, Inc. to ensure the quality of medicines for human and veterinary use

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