ISO 17025 Certification & Accreditation USA

Standard status

ISO/IEC 17025:2017

The current edition, published in November 2017 and confirmed by ISO in 2023. The 2005 edition is superseded. No amendment or newer edition has been published.

Current standard: ISO/IEC 17025:2017General requirements for the competence of testing and calibration laboratories.
Previous edition: ISO/IEC 17025:2005Superseded.
Structure: Clauses 4 to 8General, structural, resource, process and management system requirements.
Accreditation bodies: ISO/IEC 17011Requirements for accreditation bodies that accredit labs.

Official records: ISO/IEC 17025:2017 (opens in a new tab) · IEC webstore (opens in a new tab)

ISO and IEC publish the standard. They do not issue certificates or accredit laboratories.

Decision guide

Which ISO 17025 recognition does your laboratory need?

Four questions. The result is a cautious starting point, not a regulatory decision. Confirm with whoever set the requirement.

Credentials

Laboratory accreditation vs ISO 17025 certification

They are not equivalent. A requirement for accreditation is never met by a certification certificate.

Accreditation and certification compared
	Laboratory accreditation	ISO 17025 certification
Who grants it	An accreditation body (for example A2LA, ANAB, NVLAP)	A certification body
What is assessed	Management system and technical competence for listed methods, ranges and capabilities	Conformity of the laboratory’s system to the standard, as defined by the certification scheme
Output	Accreditation certificate plus a published scope (methods, ranges, CMCs, sites)	A certificate
International recognition	Through the accreditation body’s signatory status (ILAC MRA, now Global Accreditation Cooperation)	No laboratory accreditation recognition
Accredited reports	Reports for in-scope activities can carry the accreditation body’s mark	Reports are not accredited
Meets a requirement for “accredited”?	Yes, within scope	No

What an IAS certificate does not do

It is not laboratory accreditation and has no accredited scope of methods, ranges or CMCs.
It does not make test reports or calibration certificates accredited.
It does not carry ILAC MRA or Global Accreditation Cooperation recognition.
It does not satisfy CPSC, FDA LAAF, FDA ASCA or other programs that require accreditation.
UQAS accredits IAS as a certification body. It does not accredit client laboratories.

The basics

Understanding ISO/IEC 17025 laboratory competence

Technically valid results come from competent people, suitable methods and equipment, controlled conditions, traceable measurements and continuous checks.

ISO/IEC 17025 covers impartiality and confidentiality, personnel competence, methods, equipment, measurement uncertainty, metrological traceability, quality control, proficiency testing, reporting and technical records, plus a management system.

Not a guarantee Conformity does not mean every result is error-free.
Scope-specific Accreditation covers only listed activities.
Not product approval An accredited lab does not certify or approve the products it tests.

Requirements

Explore ISO/IEC 17025:2017 requirements — clauses 4 to 8

Summaries in our own words; they do not reproduce the standard. Check clause titles against your copy.

Laboratory activities

Testing, calibration and sampling

Each has its own technical requirements. Calibration is not the same as adjustment, and not every lab samples.

Testing, calibration and sampling compared
	Testing	Calibration	Sampling
Purpose	Determine characteristics or performance of an item	Establish the relationship between an instrument’s indication and reference values, with uncertainty	Select or collect a portion for later testing or calibration
Typical activities	Chemical analysis, tensile tests, EMC measurements	Calibrating thermometers, gauges, balances, multimeters	Field soil sampling, water sampling, lot sampling
Method requirements	Standard, modified or laboratory-developed test methods	Calibration procedures and methods	Sampling plan and method
Equipment	Test equipment suitable for the method	Reference standards and working standards	Sampling tools and containers
Traceability	Needed where equipment affects the result	Central: results traceable to SI through calibration chain	Applies to measurements made during sampling
Uncertainty	Evaluated where relevant; sometimes estimated from method data	Evaluated and reported on certificates	Sampling can add uncertainty to later results
Technical records	Raw data, conditions, analyst, equipment	Readings, reference values, conditions, uncertainty	Location, date, plan used, conditions, deviations
Output	Test report	Calibration certificate	Sampling records, often included in the test report

Laboratory workflow

From customer request to technically valid report

A general illustration, not a validated method.

Measurement uncertainty

Understanding measurement uncertainty

A fictional calibration of a digital thermometer at 100 °C in a liquid bath. Change the inputs to see how contributors combine. Educational only: not an approved uncertainty budget or an accredited CMC.

Type A Evaluated statistically from repeated readings.
Type B Evaluated from other information: certificates, specifications, resolution.
Standard uncertainty (u) Each contributor expressed as one standard deviation.

Combined (u_c) Root sum of squares, plus correlation terms where inputs are correlated.
Expanded (U = k × u_c) The coverage factor k depends on the distribution and effective degrees of freedom; it is not automatically 2.
Reporting Usually two significant figures, with k and coverage probability stated.

Fictional uncertainty budget. All values in °C; sensitivity coefficients are 1.
Contributor	Type	Distribution	Input
Reference standard	B	Normal	U k
Repeatability	A	Normal	s n
Resolution	B	Rectangular	Digit
Bath uniformity	B	Rectangular	±
Reference stability	B	Rectangular	±

Correlation between reference standard and stability (r)0 means independent. Set only if there is a technical reason.

Coverage factor kCheck the effective degrees of freedom shown below before choosing k.

Metrological traceability

How measurement results are linked to reference standards

Traceability is a property of a measurement result, not of an instrument. It needs an unbroken chain of calibrations, each with stated uncertainty, usually to SI units.

Arrangements depend on the measurand and method; reference materials can also provide traceability. A calibration sticker alone does not establish traceability.

Methods

Method verification vs validation

Verification confirms you can run an established method. Validation shows a method is fit for purpose. Neither has a universal sample size.

Verification and validation compared
	Verification	Validation
Purpose	Show the lab can perform an established method and achieve its stated performance	Show a method is fit for its intended use
When required	Standard methods used as published	Non-standard, laboratory-developed or modified methods, and standard methods used outside their intended scope
Performance characteristics	Those needed to confirm performance, e.g. precision, bias, limit of quantitation where relevant	A broader set, e.g. selectivity, range, linearity, limits, robustness, uncertainty
Records	Verification plan, data, comparison with method performance, conclusion	Validation plan, data, evaluation against requirements, statement of fitness
Acceptance criteria	From the method and the customer’s needs	Set before the study from intended use
Technical review	Reviewed and approved by competent personnel	Reviewed and approved by competent personnel
Sample size	Set by the lab with justification; no universal number	Set by the lab with justification; no universal number

Choose a description to see which usually applies.

Personnel

Demonstrating laboratory technical competence

Education, training, experience and skills are evaluated, then people are authorized for specific activities. A training certificate is not authorization to perform a method.

Equipment

Managing laboratory equipment

Calibration intervals are set from technical evidence, not one rule for all equipment. Maintenance is not calibration.

Controlling conditions that affect results

Conditions must suit the actual methods. There are no universal temperature or humidity limits; the method, equipment and item set them.

Temperature, where it affects the measurement
Humidity, for example for hygroscopic samples or electrical tests
Vibration, for example for balances and dimensional measurement
Dust and cleanliness, for example for trace analysis
Electrical supply quality for sensitive instruments
Contamination and cross-contamination, for example in microbiology
Segregation of incompatible activities
Access control to protect items and results
Storage conditions for samples, reagents and reference materials

Validity of results

How laboratories demonstrate ongoing validity of results

PT and ILC participation must suit the lab’s activities and accreditation requirements. There is no universal frequency or single provider. PT providers are often accredited to ISO/IEC 17043.

Ways to monitor validity
Method	Objective	Typical evidence	Interpretation
Proficiency testing (PT)	Compare performance with other labs on the same samples	PT reports, z-scores or other performance statistics, investigations	A questionable result triggers investigation even if not a failure
Interlaboratory comparison (ILC)	Compare results between labs where no PT scheme fits	Comparison plan, results, evaluation	Design and evaluation criteria must be justified
Reference materials	Check bias against known values	QC records with certified or in-house reference values	Reference material must suit the matrix and range
Replicate measurements	Check precision	Duplicate results, range charts	Shows precision, not bias
Control charts	Spot trends and shifts over time	Charts with rules and actions	Rules and limits are set by the lab
Blanks and recovery checks	Detect contamination and matrix effects	Blank and spike results	Common in chemistry and microbiology
Intermediate equipment checks	Confirm equipment stays in calibration between calibrations	Check records	Act when results drift

Internal quality control explorer

Decision rules

Understanding pass/fail decisions in laboratory reporting

A fictional measured value near an upper specification limit. Compare three illustrative decision rules. The rule to use is set by regulation, specification or agreement with the customer; there is no single mandatory rule.

Reports and certificates

What information belongs in laboratory reports?

Fictional examples with no accreditation marks. Uncertainty reporting differs between test reports and calibration certificates, and an accredited lab’s report does not approve a product.

Management system

Clause 8: Option A and Option B

Option B suits labs with an ISO 9001-based system that supports ISO/IEC 17025. It does not need ISO 9001 certification, and ISO 9001 certification never gives ISO/IEC 17025 accreditation. Technical requirements in clauses 4 to 7 always apply.

Option A: The lab meets 8.2 to 8.9 directly: documentation, document control, records, risks and opportunities, improvement, corrective action, internal audits and management review.
Option B: The lab maintains a management system in line with ISO 9001 that can support and demonstrate the requirements of clauses 4 to 7, and at least the intent of 8.2 to 8.9.

Data integrity

Maintaining reliable laboratory records and information

No particular LIMS is required, and a LIMS does not become accredited. These controls are separate from ISO 27001 certification.

Sampling and handling

Maintaining sample identity and integrity

Sampling requirements apply only where sampling is part of the lab’s activities. Calibration labs rarely sample, and forensic chain of custody is not needed everywhere.

Sampling plan, where sampling is part of the lab’s activities
Unique identification of each sample
Recorded condition on receipt
Transport conditions that protect integrity
Storage that prevents deterioration or contamination
Sample preparation records
Chain of custody, where the work requires it (for example forensic or legal samples)
Retention and disposal
Records of deviations from the sampling plan

Accreditation pathway

How to obtain ISO/IEC 17025 laboratory accreditation

Twelve typical steps with an accreditation body. IAS does not perform accreditation assessments.

IAS ISO 17025 certification — a separate pathway

IAS’s ISO 17025 certification service, its issuer, any accreditation of IAS for it, its assessment process, certificate wording and customer-acceptance limits are under documentary verification. Until verified, this page does not describe it as a service you can buy. When described, it will be shown as certification only: it does not produce laboratory accreditation, accredited reports or international laboratory recognition.

Accreditation bodies

Understanding US laboratory accreditation options

Examples of bodies that accredit labs in the US. Each covers different programs and disciplines; check its current scope and recognition in its own directory. Listing is not a recommendation.

US laboratory accreditation bodies
Body	Full name	Relevant programs	Link
A2LA	American Association for Laboratory Accreditation	Testing and calibration accreditation to ISO/IEC 17025, among other programs	Official site (opens in a new tab)
ANAB	ANSI National Accreditation Board	Testing and calibration accreditation to ISO/IEC 17025, among other programs	Official site (opens in a new tab)
NIST NVLAP	National Voluntary Laboratory Accreditation Program	Federal program accrediting testing and calibration labs to ISO/IEC 17025 in specific programs	Official site (opens in a new tab)
PJLA	Perry Johnson Laboratory Accreditation, Inc.	Testing and calibration programs, including several regulatory programs	Official site (opens in a new tab)
IAS, Inc.	International Accreditation Service, Inc. (iasonline.org)	Laboratory accreditation programs. A different organization from Integrated Assessment Services LLC	Official site (opens in a new tab)

NIST lists A2LA, ANAB and NVLAP as accreditation bodies for its MRA designations: NIST: Accreditation bodies and MRAs (opens in a new tab). Integrated Assessment Services LLC is not International Accreditation Service, Inc.

International recognition

How to verify laboratory accreditation and international recognition

Accreditation bodies are assessed against ISO/IEC 17011 by their peers. Since January 1, 2026, the former ILAC and IAF arrangements have been run by Global Accreditation Cooperation Incorporated.

APAC: Global Accreditation Cooperation replaces IAF and ILAC (opens in a new tab)

Accreditation body Check it is a signatory for the relevant activity in the current directory.
Scope Check the lab’s methods, ranges and sites in its published scope.
Report marking Only in-scope results can carry accreditation claims.
Validity Check the certificate is current.
Regulators Recognition does not mean every regulator accepts every report.
Certification bodies A certificate from a certification body carries no laboratory accreditation recognition.

Regulatory context

ISO 17025 in US regulatory and commercial testing

Some programs require or accept accreditation with specific recognition and scope. Accreditation alone does not authorize a lab for any program, and accredited reports do not give FDA approval, FCC authorization, CE marking or product certification. General information, not legal advice.

Compared

ISO 17025 vs ISO 15189 vs ISO 9001

Not interchangeable. ISO 9001 certification does not demonstrate technical competence.

ISO/IEC 17025, ISO 15189 and ISO 9001 compared
	ISO/IEC 17025:2017	ISO 15189:2022	ISO 9001:2026
Intended organization	Testing and calibration labs	Medical labs	Any organization
Technical competence	Core focus	Core focus, for medical examinations	Not assessed
Methods	Verification and validation required	Verification and validation required	Not specific
Measurement uncertainty	Required where relevant	Required for quantitative results where relevant	Not required
Metrological traceability	Required	Required	Not required
Management system	Clause 8, Option A or B	Clause 8	Whole standard
Usual recognition	Accreditation	Accreditation	Certification
Typical evidence	Validation, uncertainty, QC, PT, reports	Pre-/post-examination, QC, EQA, reports	Processes, customer focus, improvement

ISO 15189 · ISO 9001 certification · ISO 13485 certification

Cost and time

What influences ISO 17025 assessment costs?

Accreditation fees are set by each accreditation body; certification fees are set differently and are not comparable. No prices or assessment days are given here.

How long does it take?

Preparation depends on scope definition, method verification and validation, uncertainty, traceability, competence, PT availability, management system, internal audit and corrective action. External time depends on the body’s review, scheduling and decision. No fixed timeline, such as six to twelve months, applies to every lab.

Preparation: your work, at your pace
Application review: set by the body
Assessment scheduling: depends on assessor availability
Corrective action: depends on findings
Decision: set by the body

Credential verification

Checking accreditation and certification credentials

Two organizations called IAS

Integrated Assessment Services LLC (IAS USA, this website) is a certification body. International Accreditation Service, Inc. (iasonline.org) is a separate organization that accredits laboratories. Its accreditations, Global Accreditation Cooperation recognition and accredited-lab directory do not belong to Integrated Assessment Services.

Laboratory accreditation: Accreditation body, its recognition for the activity, the lab’s scope (methods, ranges, CMCs, sites) and validity, checked in the body’s directory.
Certification: Certification body, its accreditation, the certificate scope and validity. IAS certificates: IAS certificate search.
Wording: “Accredited to ISO/IEC 17025” and “certified to ISO 17025” are different claims.

Impartiality

Professional integrity and independence

No consultancy IAS does not implement lab systems, write methods, uncertainty budgets or validation reports, or run gap analyses for labs it may certify.
No accreditation IAS does not accredit labs or assess on behalf of accreditation bodies.
Confidentiality We do not ask for test data or proprietary methods in this enquiry.
Independent decisions Made by people not involved in the assessment.
Training is separate Training does not make any outcome more likely.

FAQ

ISO 17025 questions

51 answers separating accreditation, certification, training and regulatory approval.

What is ISO/IEC 17025?

The international standard for the competence, impartiality and consistent operation of testing and calibration laboratories, including sampling linked to later testing or calibration.

What is the latest ISO 17025 edition?

ISO/IEC 17025:2017, published in November 2017 and confirmed by ISO in 2023. The 2005 edition is superseded.

Is ISO 17025:2026 published?

No. ISO/IEC 17025:2017 is current.

Who needs ISO 17025?

Labs whose customers, regulators or markets ask for demonstrated testing or calibration competence, usually through accreditation.

What is laboratory accreditation?

Formal recognition by an accreditation body that a lab is competent to perform specific activities listed in its scope.

What is ISO 17025 certification?

A certificate from a certification body about a lab’s system. It is not laboratory accreditation and does not give accredited status to reports.

What is the difference between certification and accreditation?

Accreditation assesses technical competence for a published scope and can carry international recognition. Certification does not, and cannot meet a requirement for accreditation.

Can IAS issue laboratory accreditation?

No. Integrated Assessment Services is a certification body, not a laboratory accreditation body.

Is Integrated Assessment Services the same as International Accreditation Service?

No. International Accreditation Service, Inc. (iasonline.org) is a separate organization that accredits labs. Its accreditations and recognitions do not belong to Integrated Assessment Services.

What is a scope of accreditation?

The document that lists the activities, methods, items, ranges and, for calibration, measurement capabilities that are accredited.

What laboratories can apply?

Testing labs, calibration labs and organizations doing sampling linked to testing, of any size.

Can a calibration laboratory obtain ISO 17025 accreditation?

Yes, for the calibrations, ranges and capabilities assessed by the accreditation body.

Can a testing laboratory obtain accreditation?

Yes, for the tests and methods in its scope.

Does ISO 17025 cover sampling?

Yes, where sampling is part of the lab’s activities and is linked to later testing or calibration.

Is ISO 17025 legally mandatory in the USA?

Not in general. Some federal and state programs require accreditation for specific testing.

What is the difference between testing and calibration?

Testing determines characteristics of an item. Calibration relates instrument indications to reference values, with uncertainty.

What are ISO 17025 clauses 4–8?

4 General (impartiality, confidentiality), 5 Structural, 6 Resource, 7 Process and 8 Management system requirements.

What are personnel competence requirements?

Defined competence for each function, training, evaluation, authorization for specific activities and ongoing monitoring.

What is metrological traceability?

A property of a measurement result linking it to a reference, usually SI units, through an unbroken chain of calibrations with stated uncertainties.

What is measurement uncertainty?

A parameter describing the spread of values that could reasonably be attributed to the measured quantity.

How is an uncertainty budget developed?

List the sources, quantify each as a standard uncertainty, apply sensitivity coefficients, combine them (allowing for correlation), then expand with a justified coverage factor.

What is a Calibration and Measurement Capability?

A CMC is the best calibration capability an accredited calibration lab can offer to customers under normal conditions, published in its scope.

What is method verification?

Showing that the lab can perform an established method and achieve its stated performance.

What is method validation?

Showing that a method is fit for its intended use, needed for non-standard, lab-developed or modified methods.

What is proficiency testing?

Evaluation of a lab’s performance against criteria through interlaboratory comparisons run by a PT provider, often accredited to ISO/IEC 17043.

What is an interlaboratory comparison?

Organizing and evaluating tests on the same or similar items by two or more labs.

What is internal quality control?

Routine checks such as reference materials, replicates, blanks and control charts to monitor the validity of results.

What is a decision rule?

A rule describing how measurement uncertainty is taken into account when stating conformity with a specification.

What is a statement of conformity?

A statement in a report that a result meets or does not meet a specification, made using an agreed decision rule.

Does an accredited test report mean the product is certified?

No. It reports test results; product certification is a separate process.

What must appear on a calibration certificate?

Among other things, the results with units, measurement uncertainty, traceability evidence, conditions and the authorizing person.

Are all laboratory methods automatically accredited?

No. Only activities listed in the scope are accredited.

Does ISO 9001 certification replace ISO 17025 accreditation?

No. ISO 9001 does not assess technical competence.

What is the difference between ISO 17025 and ISO 15189?

ISO/IEC 17025 is for testing and calibration labs; ISO 15189 is for medical labs and includes patient-related requirements.

What is the difference between ISO 17025 and ISO 9001?

ISO/IEC 17025 adds technical competence requirements such as validation, uncertainty and traceability.

What are Option A and Option B?

Option A: the lab meets clause 8.2–8.9 directly. Option B: the lab has an ISO 9001-based system that supports the ISO/IEC 17025 requirements. Option B does not need ISO 9001 certification.

What documents are required?

Documented information the system needs, including impartiality, methods, technical records, uncertainty evaluations, QC and PT records, reports and management system records.

Do laboratories require a LIMS?

No. Data must be controlled, whether on paper, spreadsheets or a LIMS.

What happens during accreditation assessment?

Document review, on-site assessment, witnessing of methods and review of records by lead and technical assessors.

Do all accreditation bodies use Stage 1 and Stage 2?

No. Each accreditation body sets its own assessment process. Stage 1 and Stage 2 are typical of management system certification.

What happens when nonconformities are found?

The lab corrects them and provides evidence within the body’s time limits before a decision.

How much does ISO 17025 accreditation cost?

It depends on the accreditation body, scope, methods, sites and assessor time. Check the body’s fee schedule.

How long does assessment take?

It depends on readiness, scope and scheduling. We do not promise a timeline.

Can multiple sites be included?

Yes, where each site’s activities are assessed and listed.

Can an accreditation scope be extended?

Yes, through the accreditation body’s scope extension process.

Can existing accreditation be transferred?

Some accreditation bodies accept transfers under their own rules.

How can laboratory accreditation be verified?

Check the accreditation body’s directory for the lab, its scope and validity.

What is international accreditation recognition?

Mutual recognition between accreditation bodies. The ILAC and IAF arrangements are now run by Global Accreditation Cooperation Incorporated, operational since January 1, 2026.

Does ISO 17025 accreditation satisfy FDA or CPSC requirements?

Not automatically. Each program sets its own recognition, scope and acceptance rules.

Can IAS provide ISO 17025 training?

Training is delivered through EAS. The ISO/IEC 17025 Lead Auditor course (PR355) is CQI-IRCA certified. Training is not technical authorization and not accreditation.

How can I submit a laboratory technical enquiry?

Use the enquiry form on this page. Start by telling us which recognition you need.

Related training and resources

Training is delivered by EAS. The ISO/IEC 17025 Lead Auditor course (PR355) is CQI-IRCA certified. Course completion is not technical authorization or accreditation.

ISO 17025 Certification in USA