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Accreditation
Biological

Biological

A2LA's biological testing field covers biological, microbiological, and biochemical testing and measurement, including but not limited to the examination of foods, cannabis, and pharmaceuticals.

Program Requirements

ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories.
Optional Good Manufacturing Practices (cGMP) and Good Laboratory Practice (GLP) requirements.

Biological Subprograms

In addition to the general biological field, subprograms within this field have been developed in the following areas, each of which has associated with it additional, specific requirements for accreditation. Learn more:

Food and Pharmaceutical Testing Laboratory Accreditation Program
Veterinary Laboratory Accreditation Program
Cannabis Testing Laboratory Accreditation Program
Threat Agent Testing Laboratory (TATL) Accreditation Program
FDA ASCA Biocompatibility

FAQs

What resources are available to help me through the accreditation process?

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A2LA assigns a dedicated accreditation officer to…

What areas of my organization will the assessor review?

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An A2LA assessment includes a thorough examin…

What is a CAB?

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A Conformity Assessment Body (CAB) is defined in …

How does A2LA determine the number of assessors necessary to perform our assessment?

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The most important factor in determining the …

Does A2LA accredit organizations outside the U.S.?

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Yes, however, under A2LA’s multilateral recog…

How is "Laboratory Accreditation" different from "Quality Systems Registration and Certification"?

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Terms such as "quality system registration" or "a…

How long does it take to become accredited?

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In general, a well-prepared applicant can com…

What are the requirements for A2LA Accreditation?

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The requirements for which a CAB is normally asse…

What are the steps in the accreditation process and how should I prepare?

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A2LA has developed a short document entitled …

How much does A2LA accreditation cost?

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A2LA is one of the most transparent organizations…

What is "conformity assessment accreditation"?

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Conformity assessment accreditation is defined as…

What is the "scope of accreditation"?

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The list of specific tests, types of tests, calib…

Why isn't compliance with ISO/IEC 17025 enough for A2LA Accreditation?

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The introduction to ISO/IEC 17025 notes that accr…

When should we enroll in proficiency testing programs?

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Laboratories that intend to apply in the near fut…

What are the proficiency testing requirements for laboratories seeking accreditation?

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A2LA now publishes all proficiency testing (PT) r…

What are A2LA's Metrological Traceability Policies?

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A2LA's general Metrological Traceability Policy r…

Which calibration laboratories meet A2LA’s requirements?

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There are five accreditation bodies (ABs) in the …

How are exceptions to the A2LA Traceability Policy handled?

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Exceptions to the A2LA Traceability Policy ca…

What happens during the assessment if our calibration services are not accredited by an accreditation body recognized by A2LA?

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In general, A2LA's assessors will cite labora…

What if I have a conflict of interest with the assessor assigned to me?

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Before assigning any assessor, A2LA will submit a…

Once I have my assessment, how quickly can I expect to be accredited?

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Following your on-site assessment, the process ca…

How does A2LA maintain the confidentiality of my documents and status within the accreditation process?

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All A2LA staff, assessors, and technical experts …

What is a “quality management system”?

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A quality management system (QMS) is a compilatio…

What is a “standard”?

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A standard is a document that provides requiremen…

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