American Association for Laboratory Accreditation

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The American Association for Laboratory Accreditation (A2LA) is an international non-profit, non-governmental, independent organization and accrediting body that provides accreditation and training services for numerous types of laboratories. The A2LA offers accreditation programs and training courses for the biological, chemical, clinical, energy, environmental, forensic, manufacturing, and mechanical industries, among others.[1][2]

History

The American Association for Laboratory Accreditation (AALA) was founded in 1978 by the American Council of Independent Testing Laboratories (ACIL), with financial support from the American Society for Testing and Materials (ASTM). The AALA (later dubbed the A2LA for convenience) was set up as a private sector alternative to the National Institute of Standards and Technology's (NIST) National Voluntary Laboratory Accreditation Program (NVLAP), itself established in 1976.[3][4]

NVLAP was originally borne from "a government-private effort to accredit laboratories for classes of technology to a government program that accredits laboratories on a product-by-product basis or an associated service basis where the product or the service is defined by standards and test methods."[4] The need for laboratory product-based verification resulted in the creation of NVLAP Type I accreditation programs, "whose usual objective is to assure that accredited laboratories exist to serve product assurance requirements imposed upon laboratory users."[4] Additionally, a need for service-based testing accreditation programs — focused heavily on labs themselves and their thoughts on standards and protocol rather than the end users— drove the creation of Type II programs. However, NIST eventually focused on Type I programs. The alternative A2LA placed more focus on Type II programs. [4][3]

By the spring of 1981, ACIL and the A2LA were stating their case that NIST's NVLAP be phased out, leaving private sector bodies such as the A2LA to handle testing laboratory accreditation with greater expedience and lower costs. They further suggested that NIST could still be involved, though as an entity that would accredit A2LA and other accrediting bodies. However, it wasn't until the publishing of the National Research Council's report "Standards, Conformity Assessment, and Trade: Into the 21st Century" and the subsequent passage of the National Technology Transfer and Advancement Act (NTTAA) in 1996 that a concerted effort began towards the goal of accrediting the accredited.[4] "Government recognition of private-sector accreditors will enable both regulatory and procurement agencies to eliminate the costs associated with operating federal accreditation, certification, and other conformity assessment programs," said the National Research Council, "while maintaining responsible oversight of regulatory and procurement enforcement."[5] However, rather than NVLAP disappearing, the A2LA and the International Council of Building Officials Evaluation Service (ICBO ES) joined NVLAP in October 2000 as officially recognized accreditation bodies by the National Cooperation for Laboratory Accreditation (NCLA). The NCLA, basing its accreditation programs on ISO/IEC 17025:1999 criteria, was created in part due to the confusing number of standards and accreditation programs, many which were viewed as redundant. NCLA signatory accredited bodies like the A2LA would be required to "treat the accreditations, test reports and certificates of the other signatories as technically equivalent."[6][7]

In February 1998, the A2LA accredited the thousandth lab in its history. By April 2003 that number had risen to 2000 labs.[8] In late June 2003, A2LA's technical manager Warren Merkel joined NIST as NVLAP's program director.[9]

On October 25, 2010, A2LA announced that it would be expanding accreditation programs into the field of forensic science, offering both a forensic testing lab option for compliance with ISO/IEC 17025 and a forensic inspection body (crime scene unit) option for compliance with ISO/IEC 17020.[10] The organization accredited its first forensic lab a little over a year later.[11]

Accreditation

The A2LA offer tens of different accreditation programs for laboratories and testing centers, each with their own varying requirements.[1] Application review, on-site assessments, quality review, and, if necessary, corrective action resolutions are conducted before the final review and accreditation decision. For most programs, the accreditation lasts for two years as long as the lab remains compliant and maintains obligations such as notification of significant changes to primary policies, resources, organization, and legal ownership.[12]

Compliance

After acceptance, the A2LA will use the renewal assessment process to ensure a lab's compliance with the body's accreditation standards. In the unusual case of a laboratory failing to pay fees or comply with the body's accreditation standards, the A2LA may choose to place the lab on suspension. Once on suspension, the affected lab must satisfy certain conditions before being able to again operate and eventually be reinstated. The reinstatement process may vary slightly by accreditation program; the ISO 15189 reinstatement process, for example, requires a three-member panel review and vote for or against reinstatement.[13] In extreme cases of non-compliance, the A2LA can also choose to completely revoke the lab's accreditation in a process called enforced withdraw.[14]

External links

References

  1. 1.0 1.1 "Industry-Specific Accreditation Programs". American Association for Laboratory Accreditation. https://www.a2la.org/appsweb/industry.cfm. Retrieved 08 February 2016. 
  2. "A2LA Training Programs Overview". American Association for Laboratory Accreditation. https://www.a2la.org/training/index.cfm. Retrieved 08 February 2016. 
  3. 3.0 3.1 Young, Theodore R. (1982). "History of Laboratory Accreditation in the U.S.". In Locke, John W.. Laboratory Accreditation: Future Directions in the United States. National Bureau of Standards. https://books.google.com/books?id=5AwCHKSCJrkC&pg=PA28. Retrieved 08 February 2016. 
  4. 4.0 4.1 4.2 4.3 4.4 Hyer, Charles W., ed. (1998) (PDF). A Selective Review of Testing Laboratory Accreditation Movements in the United States. National Institute of Standards and Technology. http://gsi.nist.gov/global/docs/GCR%2098-740.pdf. Retrieved 08 February 2016. 
  5. International Standards, Conformity Assessment, and U.S. Trade Policy Project Committee; Board on Science, Technology, and Economic Policy; National Research Council (1995). Standards, Conformity Assessment, and Trade: Into the 21st Century. National Academy Press. pp. 256. doi:10.17226/4921. ISBN 9780309086479. http://www.nap.edu/catalog/4921/standards-conformity-assessment-and-trade-into-the-21st-century. Retrieved 08 February 2016. 
  6. O'Neil, Joe (02 October 2000). "National Cooperation for Laboratory Accreditation" (PDF). National Institute of Standards and Technology. http://www.a2la.org/press_releases/mranewsrelease2.doc.pdf. Retrieved 08 February 2016. 
  7. Robinson, Roxanne M.; Valentine, Daren C. (2001). "Chapter 13: Accreditation and Harmonization". In Singer, Donald C.. A Laboratory Quality Handbook of Best Practices. Milwaukee, WI: ASQ Quality Press. pp. 339–354. ISBN 0873894901. https://books.google.com/books?id=FQaOq7Tuc_cC&pg=PA339. Retrieved 08 February 2016. 
  8. Unger, Peter (December 2003). "Milestones of A2LA" (PDF). A2LA News (83). https://www.a2la.org/newsletters/a2lanews_dec2003.pdf. Retrieved 08 February 2016. 
  9. "NIST Selects New Chief of National Voluntary Laboratory Accreditation Program". National Institute of Standards and Technology. 10 June 2003. http://www.nist.gov/public_affairs/releases/nvlap.cfm. Retrieved 08 February 2016. 
  10. "A2LA Now Offers Accreditation for Forensic Examination" (PDF). American Association for Laboratory Accreditation. 25 October 2010. https://www.a2la.org/press_releases/release10232010_Forensic_Program.pdf. Retrieved 08 February 2016. 
  11. "A2LA Accredits First Forensic Examination Testing Laboratory" (PDF). American Association for Laboratory Accreditation. 17 November 2011. https://www.a2la.org/press_releases/first_forensics_lab_PR.pdf. Retrieved 08 February 2016. 
  12. "I105 – Typical Steps in Preparing for the Accreditation Process" (PDF). American Association for Laboratory Accreditation. 12 May 2015. pp. 6. http://www.a2la.org/applications/Preparing_for_Accreditation.pdf. Retrieved 15 February 2016. 
  13. "R901 – General Requirements: Accreditation of Clinical Testing Laboratories Meeting the ISO 15189 Requirements" (PDF). American Association for Laboratory Accreditation. 12 August 2014. pp. 29. https://www.a2la.org/requirements/15189_R901.pdf. Retrieved 15 February 2016. 
  14. "Suspensions and Withdrawals". American Association for Laboratory Accreditation. 2013. https://www.a2la.org/dirsearchnew/susdefinitions.cfm. Retrieved 15 February 2016.