Accreditation for Testing Laboratories

Scope categories

Accreditation is granted for explicitly defined test methods, activities, and locations. Below are the principal scope categories available under this program.

Category	Examples	Typical standards
Chemical & materials	Metals composition, polymer analysis, water chemistry	ASTM E3, ISO 11885
Mechanical & physical	Tensile strength, hardness, impact resistance	ASTM E8, ISO 6892
Electrical & EMC	Dielectric strength, EMI emissions, surge immunity	IEC 61000, CISPR 32
Environmental & climate	Temperature cycling, humidity, salt spray	IEC 60068, ASTM B117
Biological & microbiological	Sterility, endotoxin, biocompatibility	ISO 11737, USP <71>
Non-destructive testing	Radiography, ultrasonic, magnetic particle	ISO 9712, ASNT SNT-TC-1A
Food & agriculture	Pesticide residues, nutritional analysis, contaminants	ISO 17025, Codex methods

Core requirements

Applicant laboratories must demonstrate compliance with all structural, resource, and process requirements of ISO/IEC 17025:2017, including:

Management system — Quality manual, document control, internal audits, and management reviews (Clause 8)
Structural requirements — Legal entity, defined responsibilities, impartiality safeguards (Clause 4)
Resource requirements — Competent personnel, suitable facilities, calibrated equipment, metrological traceability (Clause 6)
Process requirements — Method validation/verification, sampling, measurement uncertainty, result reporting (Clause 7)
Impartiality — Documented risk assessment, conflict-of-interest controls, and separation from commercial pressures

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Key metrics

Cycle: 4-year accreditation period
Surveillance: Annual on-site assessments
PT participation: Required for every sub-scope
Assessment team: 1 Lead + 1–3 Technical Assessors
Decision timeline: ≤ 30 days after assessment report

Required documentation

A complete application includes the following documentation. Incomplete submissions will be returned for correction before review begins.

Document	Description	ISO Ref.
Quality manual	Policies, objectives, organizational structure, and scope statement	Clause 8.2
Procedures index	List of SOPs covering all accredited test methods	Clause 7.2
Personnel records	CVs, qualifications, competency assessments, and authorization matrices	Clause 6.2
Method validations	Validation or verification studies for each test method in scope	Clause 7.2.2
Equipment list	Inventory with calibration status, intervals, and traceability chain	Clause 6.4
Uncertainty budgets	Measurement uncertainty evaluations for quantitative methods	Clause 7.6
PT records	Proficiency testing results from the last 2 cycles	Clause 7.7
Internal audit reports	Most recent audit cycle with findings and corrective actions	Clause 8.8
Management review minutes	Most recent management review with decisions and actions	Clause 8.9
Impartiality declaration	Risk assessment, COI policy, and signed declarations from key staff	Clause 4.1

Proficiency testing requirements

Proficiency testing (PT) is mandatory for every accredited sub-scope. IAC requires laboratories to:

Participate in at least one PT round per sub-scope per year
Use PT providers accredited to ISO/IEC 17043 wherever available
Evaluate results using z-scores or equivalent statistical analysis
Document corrective actions for any result with |z| > 3.0
Maintain records for a minimum of two full accreditation cycles (8 years)

Where formal PT programs are unavailable, laboratories may propose inter-laboratory comparisons (ILCs) for IAC review.

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Assessor qualifications

All technical assessors assigned to this program must hold:

Degree in a relevant science or engineering discipline
Minimum 5 years of testing laboratory experience
Completed IAC Lead Assessor training (40 hours)
Current knowledge of ISO/IEC 17025:2017
No conflicts of interest with the applicant

Assessment process

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1. Document review

The assessment team reviews all submitted documentation against ISO/IEC 17025 requirements. A document review report is issued within 4 weeks, identifying any gaps or requests for additional information.

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2. On-site assessment

A 2–5 day on-site visit covering facilities, equipment, personnel interviews, witness testing, and record review. Nonconformities are classified as Major (systemic) or Minor (isolated).

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3. Corrective action

Major nonconformities must be resolved within 90 days; minor within 60 days. Evidence of correction is reviewed by the lead assessor before the case advances.

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4. Accreditation decision

The Accreditation Committee reviews the assessment report and corrective action evidence. Decisions are made within 30 days and are independent from the assessment team.

Fees and timelines

Fees depend on the number of test methods in scope, number of locations, and technical complexity. Key fee components for testing laboratories:

Application fee: USD 2,500 (non-refundable)
Document review: USD 3,000–5,000
On-site assessment: USD 1,800/day × assessor days
Annual surveillance: USD 2,000–4,000
Scope extension: USD 1,500 per additional sub-scope

Typical initial assessment timeline: 12–20 weeks from complete application to decision.

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Get a quote

Exact fees depend on your scope and organizational complexity. Contact us for a personalized fee estimate before applying.

Full fee schedule → Request a quote →

Frequently asked questions

Does accreditation include certification of products?

No. IAC accredits the laboratory's competence to perform specific tests. It does not certify products, systems, or organizations. Accredited test results provide confidence that the laboratory produced them competently, but the pass/fail determination remains with the applicable standard or specification.

Can we add or modify scope after initial accreditation?

Yes. Scope extensions follow a documented review process that includes submitting method validation evidence, personnel qualifications, and, in some cases, a supplemental on-site assessment. Scope reductions can be processed during any surveillance visit.

How is impartiality ensured during assessments?

The assessment function and the decision function are structurally separated. Assessors are screened for conflicts of interest before assignment. The Accreditation Committee makes grant/deny decisions without participation from the assessment team, and the Impartiality Committee provides independent oversight.

What happens if we fail a proficiency test?

A single unsatisfactory PT result does not automatically affect accreditation status. The laboratory must investigate root cause, implement corrective action, and report to IAC within 30 days. Repeated unsatisfactory results may trigger a focused surveillance assessment or partial scope suspension.

Can multi-site laboratories be accredited?

Yes. Multi-site laboratories are assessed under IAC's multi-site policy, which requires a central management system review plus sampling of permanent and temporary sites. All sites performing accredited testing must be assessed within the accreditation cycle.

Is flexible scope available?

IAC offers flexible scope accreditation for laboratories that can demonstrate competence to adapt validated methods to similar analytes, matrices, or parameters. Flexible scope requires an approved internal validation framework and is subject to surveillance verification.

How long does the full process take?

From complete application to accreditation decision, the typical timeline is 12–20 weeks. This includes document review (3–4 weeks), on-site assessment scheduling (2–4 weeks), the assessment itself (2–5 days), corrective action (up to 90 days if needed), and committee decision (up to 30 days).