American Association for Laboratory Accreditation

American Association for Laboratory Accreditation
Name	American Association for Laboratory Accreditation
Abbreviation	A2LA
Formed	1978
Type	Non-profit accreditation body
Headquarters	Frederick, Maryland
Region served	United States; international
Leader title	President
Leader name	Barry S. Brooks
Website	[Not displayed]

American Association for Laboratory Accreditation is a nonprofit organization that provides accreditation services to conformity assessment bodies, including testing laboratories, calibration laboratories, proficiency testing providers, and inspection bodies. Founded to support standardized measurement and quality systems, it operates within a network of standards committees, regulatory agencies, and international agreements. It interacts with numerous institutions to harmonize technical competence assessment and mutual recognition of conformity assessment results.

History

A2LA was established in 1978 amid discussions involving stakeholders such as the National Bureau of Standards and industrial consortia influenced by developments in International Organization for Standardization documents and American National Standards Institute debates. Early formative interactions included exchanges with the National Institute of Standards and Technology, the Food and Drug Administration, and state metrology offices while responding to demands from manufacturers represented by groups like the National Association of Manufacturers and the Chamber of Commerce. During the 1980s and 1990s, A2LA engaged with international fora including International Laboratory Accreditation Cooperation and the International Accreditation Forum, aligning programs with ISO/IEC 17025 and participating in mutual recognition arrangements alongside national bodies such as United Kingdom Accreditation Service, National Association of Testing Authorities (Australia), and Deutsche Akkreditierungsstelle. In the 2000s and 2010s, collaborations with regulatory agencies such as the Environmental Protection Agency and the Department of Defense shaped sector-specific schemes, while interactions with standards developers like ASTM International and American Society for Testing and Materials informed technical annexes. Recent history includes program expansion to fields associated with Clinical Laboratory Improvement Amendments, biomedical testing networks, and international trade agreements like the North American Free Trade Agreement and its successor instruments.

Organization and Governance

A2LA is governed by a board comprising representatives from accreditation committees, industry stakeholders, and technical experts, echoing governance models used by entities such as World Trade Organization advisory groups and United Nations-affiliated technical panels. Its administrative headquarters in Frederick, Maryland coordinates technical assessors, metrology experts, and training staff, liaising with standards bodies such as ISO committees and national metrology institutes like Physikalisch-Technische Bundesanstalt and National Physical Laboratory (United Kingdom). Funding streams mirror nonprofit accreditation models used by groups like National Voluntary Laboratory Accreditation Program and include fees, grants, and cooperative agreements with agencies like the National Institutes of Health and state health departments. Internal committees reflect sectoral interests found in organizations such as American Chemical Society, American Society for Microbiology, Institute of Electrical and Electronics Engineers, and American Petroleum Institute.

Accreditation Programs and Services

A2LA offers schemes comparable to programs operated by United Kingdom Accreditation Service and Canadian Association for Laboratory Accreditation including accreditation to ISO/IEC 17025 for testing and calibration, accreditation to ISO 15189 for medical laboratories, and accreditation for proficiency testing providers analogous to ISO/IEC 17043. Sectoral programs parallel initiatives by Food and Drug Administration-recognized laboratories, Centers for Disease Control and Prevention networks, and Department of Agriculture-affiliated testing facilities. Services extend to calibration traceability linking to national metrology institutes such as Bureau International des Poids et Mesures and to specialized proficiency testing comparable to offerings by European Cooperation for Accreditation partners. A2LA also administers recognition schemes that interact with certification bodies operating under frameworks like ISO 9001 and sector schemes used by American Petroleum Institute and National Fire Protection Association.

Standards and Assessment Process

The assessment methodology follows normative documents such as ISO/IEC 17025, ISO/IEC 17020, and ISO/IEC 17065, and uses technical checklists derived from committees like those convened under ANSI and ASTM International. Assessors trained by A2LA often possess expertise from institutions including National Institute for Occupational Safety and Health, Pharmaceutical Research and Manufacturers of America, and university laboratories affiliated with Johns Hopkins University and Massachusetts Institute of Technology. The process includes document review, on-site assessment, proficiency testing review, and corrective action follow-up, mirroring procedures used by International Accreditation Forum signatories and national bodies such as Japan Accreditation Board and Société Française d'Assurance Qualité. A2LA participates in witness assessments and interlaboratory comparisons similar to programs run by European Committee for Standardization and international comparison initiatives under the Bureau International des Poids et Mesures.

International Recognition and Partnerships

A2LA maintains mutual recognition arrangements and cooperative agreements with peers including International Laboratory Accreditation Cooperation, International Accreditation Forum, United Kingdom Accreditation Service, National Association of Testing Authorities (Australia), and regional cooperatives in Asia and Europe. Partnerships encompass engagement with trade-focused entities like World Trade Organization committees, technical cooperation with United Nations Industrial Development Organization, and liaison with regulatory frameworks in jurisdictions such as the European Union and Canada. These relationships facilitate cross-border acceptance of test reports and calibration certificates analogous to arrangements used by ILAC MRA and IAF MLA networks.

Impact and Criticism

Proponents credit A2LA with enhancing technical credibility for laboratories serving industries represented by American Petroleum Institute, Pharmaceutical Research and Manufacturers of America, and National Aeronautics and Space Administration, improving marketplace confidence similar to effects attributed to ISO-based accreditation systems. Critics, including commentators from trade associations and academic laboratories such as those associated with American Association for Clinical Chemistry and various university research centers, question cost barriers, scope limitations, and potential conflicts of interest echoing debates involving International Accreditation Forum policies and national oversight discussions in bodies like Congress and state legislatures. Debates also touch on harmonization challenges in sectors regulated by Food and Drug Administration and Environmental Protection Agency, and on comparisons with accreditation models used by European Cooperation for Accreditation members.

Category:Accreditation organizations