Laboratory Accreditation
A2LA (American Association for Laboratory Accreditation) is the largest ISO/IEC 17025 accreditation body in the United States. Affinity QMS provides testing and calibration laboratories with the document management, CAPA, and audit infrastructure that A2LA assessors look for throughout the accreditation and reassessment cycle.
Overview
A2LA (American Association for Laboratory Accreditation) is a non-governmental, non-profit, public service membership society that accredits testing and calibration laboratories to international standards — primarily ISO/IEC 17025:2017, the international standard for testing and calibration laboratory competence. Founded in 1978, A2LA has grown to become the largest general-scope laboratory accreditation body in the United States, accrediting over 5,000 facilities across 140+ countries and covering more than 1,500 fields of testing.
A2LA is a signatory member of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), meaning that test reports issued by A2LA-accredited laboratories carrying the ILAC mark are recognized across all ILAC signatory countries without the need for re-testing. This international recognition is critical for laboratories that test products or materials destined for export, that serve multinational clients, or whose test data must be accepted by foreign regulatory authorities.
A2LA accreditation is required or strongly preferred across a wide range of regulated industries. Testing laboratories supporting medical device manufacturers (21 CFR Part 820 quality system), FDA-registered food facilities, pharmaceutical manufacturers, environmental monitoring, and government contract testing must often be A2LA-accredited as a condition of acceptance of their test results. Defense and aerospace supply chains frequently specify A2LA or NAVAIR-endorsed accreditation for supplier testing laboratories. Calibration laboratories serving regulated manufacturing environments often need A2LA accreditation to issue calibration certificates accepted by regulatory auditors.
A2LA conducts accreditation assessments using trained technical assessors — typically working laboratory scientists and engineers with domain expertise in the specific fields of testing being assessed. Assessors evaluate both the management system requirements of ISO/IEC 17025 (the "quality system" portion) and the technical competence requirements (the "technical" portion), ensuring that the laboratory's people, equipment, methods, and environment are genuinely capable of producing reliable results.
Accreditation Process
STEP 01
Submit an A2LA application defining the specific fields of testing or calibration for which accreditation is sought. A2LA assigns an accreditation officer and reviews the application for completeness. Laboratories define their scope precisely — method, analyte, matrix, and range — as this scope appears on the accreditation certificate.
STEP 02
A2LA conducts a desk-based review of the laboratory's quality manual and key quality system documents to verify that the management system is designed to meet ISO/IEC 17025 requirements before scheduling an on-site assessment. Significant deficiencies at this stage delay the on-site assessment until corrective documents are submitted.
STEP 03
A team of A2LA technical assessors visits the laboratory for a one-to-three-day on-site assessment, reviewing records, interviewing personnel, observing testing activities, and inspecting equipment and environmental conditions. Assessors document non-conformances (minor, major, or critical) requiring corrective action before accreditation can be granted.
STEP 04
Laboratories must submit documented corrective actions for all non-conformances identified during the on-site assessment, typically within 30–60 days. A2LA's accreditation officer reviews the corrective action responses for adequacy. Some non-conformances may require a follow-up desk review or on-site revisit before the accreditation decision is made.
STEP 05
Upon satisfactory resolution of all non-conformances, A2LA issues an accreditation certificate and publishes the laboratory's accredited scope on A2LA's public directory. The accreditation is valid for two years, after which a full reassessment is required. Annual surveillance may be required depending on scope and risk profile.
STEP 06
A2LA conducts reassessments every two years. Laboratories must maintain their quality management system, report significant changes (personnel, methods, equipment, facilities) to A2LA promptly per the A2LA R311 Significant Change policy, and participate in any required proficiency testing programs for their accredited scope.
Platform Mapping
| A2LA / ISO 17025 Requirement | Standard Reference | Affinity QMS Module | What It Does |
|---|---|---|---|
| Control of Management System Documents | ISO 17025 §8.3 | Document Control | Quality manual, procedures, work instructions, and forms with version control, approval workflows, controlled distribution, and access permission controls for laboratory personnel |
| Corrective Actions | ISO 17025 §8.7 | CAPA Management | Non-conforming work investigations, root cause analysis, corrective action plans, effectiveness monitoring, and complete records of all corrective action activities with links to non-conforming test results |
| Internal Audits | ISO 17025 §8.8 | Audit Management | Annual internal audit program planning, ISO 17025-mapped audit checklists, non-conformance tracking from audit findings, corrective action follow-up, and management review input preparation |
| Personnel Training and Competency | ISO 17025 §6.2 | Training Management | Competency-based training records for all testing and calibration personnel, method-specific authorization records, training effectiveness evaluations, and ongoing competency monitoring documentation |
| QMS Core and Management Review | ISO 17025 §8.9 | QMS Core | Management review scheduling, input and output records, quality objectives tracking, customer complaint management, and continual improvement activity documentation required by ISO 17025 management review clause |
Who This Is For
Quality Manager at a Testing Laboratory
The person responsible for maintaining A2LA accreditation needs a QMS that manages the quality manual, internal audit schedule, CAPA records, and personnel competency documentation without complex enterprise software. Affinity QMS is configured for ISO 17025 scope from day one.
Lab Director Pursuing Initial A2LA Accreditation
Testing and calibration laboratories pursuing A2LA accreditation for the first time need a QMS infrastructure in place before the document review stage. Affinity QMS provides the quality manual template, document control workflows, and internal audit structure that A2LA assessors will review in Stage 1.
Contract Lab Serving Regulated Industries
Contract testing laboratories serving pharmaceutical, medical device, food, or environmental regulatory clients face increasingly rigorous audit-readiness expectations from their customers in addition to A2LA assessors. Affinity QMS supports both the A2LA management system requirements and the customer-specific quality requirements that regulated-industry labs manage simultaneously.
Common Questions
What is the difference between A2LA, ANAB, PJLA, and other accreditation bodies?
All of the major US laboratory accreditation bodies — A2LA, ANAB (ANSI National Accreditation Board), PJLA (Perry Johnson Laboratory Accreditation), IAS (International Accreditation Service), and others — accredit laboratories to ISO/IEC 17025:2017 and are signatories to the ILAC MRA. Accreditation from any ILAC-signatory body carries equivalent international recognition. The differences are in scope specialization, industry focus, cost, and service model. A2LA is the largest and oldest general-scope accreditation body in the US, with deep experience across environmental, materials, biological, chemical, calibration, and forensic testing. ANAB has strength in food safety, construction materials, and inspection body accreditation. PJLA is smaller and often preferred by laboratories seeking more personalized service. Most customers and regulators accept accreditation from any ILAC-signatory body; specific customer contracts may specify a particular body.
How much does A2LA accreditation cost?
A2LA accreditation fees include an application fee, an annual fee (based on the number of accredited fields and total revenue), and assessment fees (travel and per-diem costs for assessors). For a small laboratory with a limited testing scope, total first-year costs including assessment are typically $5,000–$15,000. For a large multi-scope laboratory, costs can reach $30,000 or more annually. The annual fee structure means that maintaining accreditation has ongoing costs beyond the initial assessment. A2LA publishes its current fee schedules on its website; contact A2LA directly for a cost estimate specific to your laboratory's scope and size. Preparation costs — building the quality management system before the document review — are where Affinity QMS delivers significant savings compared to hiring a consultant to build quality system documentation from scratch.
How often does A2LA assess accredited laboratories?
A2LA requires a full reassessment every two years for all accredited laboratories. In addition, A2LA may require an interim surveillance assessment (desk-based or on-site) for laboratories that: (1) have significant scope expansions, (2) had major non-conformances at the previous assessment, (3) have been the subject of customer complaints, or (4) fall into A2LA's risk-based surveillance triggers. Laboratories must also report "significant changes" per A2LA's R311 policy — changes to key personnel, facilities, major equipment, or testing methods that could affect the technical validity of accredited testing — and A2LA may conduct an unannounced or short-notice visit in response to reported changes.
What do A2LA assessors typically focus on during an on-site assessment?
A2LA technical assessors focus on two categories of requirements: management system requirements and technical competence requirements. Management system findings commonly involve document control deficiencies (unauthorized document versions in use, missing approval signatures), internal audit program gaps (no evidence of completed audits, findings not closed), corrective action records (root cause not identified, effectiveness not verified), and personnel competency records (no documented evidence of training or authorization for specific methods). Technical competence findings involve method validation documentation, measurement uncertainty estimates, equipment calibration and traceability records, and proficiency testing participation. Assessors pay particular attention to whether the quality system records are genuine evidence of system operation — not just documentation that was created in preparation for the assessment but never used between assessments.
How long does it take to close a non-conformance after an A2LA assessment?
A2LA typically allows 30 days to submit corrective action documentation for non-conformances identified during an assessment. For minor non-conformances, a well-documented corrective action response (root cause identification, corrective action taken, evidence of implementation, measures to prevent recurrence) is typically resolved by desk review within two to four weeks of submission. Major non-conformances may require objective evidence of implementation (photos, revised records, test data) and can take 60–90 days to fully close if the corrective action involves infrastructure changes or new testing data. A2LA will not issue the accreditation certificate or extend accreditation until all non-conformances are closed to the assessor's satisfaction. Affinity QMS's CAPA module tracks non-conformance status, due dates, and evidence submission in a structured workflow designed to meet these timelines.
Does A2LA accreditation require participation in proficiency testing?
Yes. ISO/IEC 17025 requires laboratories to participate in proficiency testing (PT) or interlaboratory comparisons as a means of monitoring the validity of their test results. A2LA's policy (A2LA P102) specifies PT participation requirements: laboratories must participate in PT for every field of testing on their accredited scope at least once per accreditation period (every two years), and PT providers must be A2LA-accredited PT providers or otherwise qualified per ISO/IEC 17043. PT results and the laboratory's responses to unsatisfactory PT results are reviewed during reassessment. Affinity QMS tracks PT participation records, PT results, and any corrective actions taken in response to unsatisfactory PT results within the CAPA and Document Control modules, providing complete evidence of PT compliance during A2LA reassessments.
Related Resources
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