What does A2LA mean in FDA

A2LA (American Association for Laboratory Accreditation) is an independent, nonprofit organization that provides third-party laboratory accreditation services. We evaluate and accredit labs that perform testing, inspection, and calibration activities to show competence in a specific field of expertise.

Working with A2LA helps organizations demonstrate they operate a competent laboratory through third-party accreditation, which gives customers confidence in the results produced by an accredited laboratory. Achieving compliance with national and international standards demonstrates an organization’s commitment to quality. Additionally, having an accredited lab can open up new business opportunities.

Becoming accredited by A2LA signals an organizations commitment to quality and helps enhance their reputation with customers and other stakeholders. Being accredited validates that their laboratory meets or exceeds the requirements of a recognized standard for performing testing, inspection, or calibration activities in a competent manner.

A2LA is recognized as a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement Services (MRA). This recognition ensures our accreditations will be accepted outside of the US Boarder in ILAC countries without further evaluation or assessment from another accreditation body. Some other notable international organizations recognizing our work include Asia Pacific Laboratory Accreditation Cooperation (APLAC), European Co-operation for Accreditation (EA), Interamerican Accreditation Cooperation (IAAC), Institute National de Metrologia Calibration y Normalizacion (INMETRO), Société française d'Accréditation (COFRAC) and Southern African Development Community Laboratories Accreditation Scheme (SADC LAS).

The laboratory must demonstrate its ability to meet strict technical requirements based on one or more of the following standards—ISO/IEC 17025 “General Requirements for the Competence of Testing and Calibration Laboratories”; ISO 15189 “Medical Laboratories - Requirements for Quality and Competence”; NFPA 1904 “Standard for Verification/Inspection & Maintenance Procedures for Fire Protection Equipment”; ISO/IEC 17043 “Conformity Assessment – General Requirements for Proficiency Testing”; EPA 3545B “Environmental Performance Validation Guidebook”; FDA Guidance 21 CFR Part 11 “Electronic Records/Electronic Signatures Rule”. Additionally, they must have operational systems in place appropriate to each scope applied for accreditation along with necessary facilities and resources to support this scope.

An application packet containing forms required necessary documents will be sent once payment has been received. After client review and submission we initially assess the documents submitted against relevant criteria such as scope of certification requested, size/complexity of operation, quality management system documentation etc.. This stage allows us identify any gaps or missing information before we conduct facility visits where we then verify capabilities, processes, procedures or documentation may not have been provided upon initial application submittal.

Once your application has been reviewed by our staff you will receive either a notice requesting additional information or confirmation for scheduling site visit(s). During this time our staff are available answer any questions you may have about process.

Once accredited your organization is required maintain compliance with applicable standard(s) within scope(s) being certified over life duration certification cycle which is usually 3 years depending on industry service type.

Yes there annual fees associated maintaining your certification status after initial assessment period these include Surveillance visits certificate maintenance etc., These fees are determined individually based on various factors such as industry type complexity number personnel involved etc.,

No typically only one audit visit required prior issuing certificate then yearly surveillance visits however assessments may recommended at any point time certain changes take place within your facility including personnel changes equipment additions etc.,