ISO/IEC 17025 — Standard

About the Standard

Scope title: competence of testing and calibration laboratories

ISO/IEC 17025 is a standard published by ISO/IEC Joint Technical Committees (ISO/IEC). Standards published jointly by ISO and IEC; conformity assessment (the 17000 series) and information technology standards fall in this group.

See the other 9 codes from ISO/IEC

Coverage areas

What Is ISO/IEC 17025?

ISO/IEC 17025 is the competence standard for testing and calibration laboratories. It is not a product or management system standard: it is the accreditation framework demonstrating that THE RESULT a laboratory produces is reliable. Whether a test report falls within an accredited scope is determined against this standard.

The standard consists of two bodies of requirements. The structural and resource requirements govern impartiality, confidentiality, personnel competence, equipment, facilities and externally provided services. The process requirements cover method selection and verification, sampling and handling, calculation of measurement uncertainty, traceability, quality control, reporting of results and complaint handling.

Two concepts sit at the centre of the standard. MEASUREMENT TRACEABILITY is the linking of a result to a national or international reference through an unbroken chain; every link carries its own uncertainty and the chain is documented. MEASUREMENT UNCERTAINTY expresses numerically the range within which the result is reliable. These two concepts are the technical difference separating an accredited report from a non-accredited one.

ACCREDITATION IS TIED TO SCOPE, and this is the most misunderstood point in the field. A laboratory being accredited does not mean every one of its tests is accredited; the list of methods in the scope document governs. A report issued for a test outside the scope is not considered accredited and cannot carry the accreditation logo.

The 2017 edition brought the process approach and risk-based thinking into the standard and required the laboratory to define its DECISION RULE explicitly when issuing a statement of conformity: how will measurement uncertainty be treated for results close to the tolerance limit?

Why Does This Standard Exist?

The problem of the reliability of laboratory results became critical as trade globalised. If a test carried out in one country is not accepted in another, the same product has to be retested in every market; that multiplies cost and time.

The solution was mutual recognition: laboratories are accredited against a common competence standard and accreditation bodies recognise one another. The ILAC mutual recognition arrangement is the roof of that structure; a report from a laboratory accredited by an ILAC member accreditation body is accepted in the other member countries.

Two concepts were decisive in the development of the standard. Traceability shows that a measurement is not arbitrary: a metre really is a metre because the chain links to the national metrology institute and from there to international recognition. Uncertainty makes honesty compulsory: no measurement is exact, and declaring how far a result could move is what makes the result usable.

The 2017 revision brought two important changes. The first was the decision rule requirement: if a laboratory issues a statement of conformity, it must define in advance how it takes uncertainty into account. The second was an emphasis on impartiality and risk management: pressures that could affect the laboratory's decisions (commercial, ownership, customer relationship) must be identified and managed.

we do water analysis and we are an accredited laboratory

Which Products Require It

Testing laboratories
Calibration laboratories
Organisations carrying out sampling activities
In-house laboratories within manufacturers (depending on scope)
Proficiency testing providers (together with the relevant standards)

Related Legislation and Schemes

Accreditation gains international acceptance through the ILAC mutual recognition arrangement
In Türkiye, accreditation is granted by TÜRKAK
Inspection bodies fall under ISO/IEC 17020, product certification under ISO/IEC 17065 and system certification under ISO/IEC 17021-1
Much legislation requires a test report to fall within an accredited scope
Proficiency testing providers fall under ISO/IEC 17043

How the Assessment Runs

1Defining the scopeThe methods, parameters, matrices and measurement ranges to be accredited are defined.
2Method verification and validationStandard methods are verified under the laboratory's conditions; in-house methods are validated.
3Establishing the traceability chainTraceability is established and documented through equipment calibration and reference materials.
4Uncertainty calculationAn uncertainty budget is established for each method; the contributions are identified and the combined uncertainty calculated.
5Quality controlInternal quality control (control charts, repeatability) and external quality control (proficiency testing) are operated.
6The accreditation assessmentThe accreditation body assesses documentation, the site and technical competence; periodic surveillance is maintained.

Neighbouring Standards and the Differences

ISO/IEC 17020
Inspection bodies. A different activity and a different accreditation scope; neither covers the other.
ISO/IEC 17065
Product certification bodies. They issue certificates using test results.
ISO 9001
A management system standard. It does not assess technical competence; it does not take the place of ISO/IEC 17025.
ISO/IEC 17043
Proficiency testing providers; the basis of a laboratory's external quality control.

What the Report Must Contain

To be usable, a report must carry the information below. An incomplete report may not be accepted in the supply chain or in an inspection even when its result is correct.

The accreditation scope and whether the report falls within it
The method applied and any deviations from the method
The measurement uncertainty and the approach to calculating it
Traceability information: the reference used and its calibration status
If a statement of conformity is given, the decision rule applied
Sample information: how it was taken, transported and accepted

Commonly Confused Points

Accreditation is tied to SCOPE. A laboratory being accredited does not mean every one of its tests is accredited; the list of methods in the scope document governs.
An ISO 9001 certificate does not take the place of ISO/IEC 17025; one is a management system and the other a technical competence assessment.
A calibration certificate without a statement of uncertainty does not meet the requirements of this standard.
If a statement of conformity is given, the decision rule must be defined; an undefined statement produces disputes for results close to the tolerance limit.
The accreditation logo cannot be used on reports outside the scope; doing so is a breach of accreditation.
Sampling is a separate accreditation scope; it cannot be assumed that sampling by a laboratory accredited for the test is also accredited.

Structure of the Code

Published by: ISO/IEC
Serial number: 17025
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Calibration

Related Tests and Services

Of the 15 pieces of content this code is referenced in, the 15 with their own published page are listed below.

Calibration · 15

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Basis: The structure of ISO/IEC 17025:2017 (structural, resource, process and management system requirements), the concepts of traceability, measurement uncertainty and the decision rule; the ILAC mutual recognition and TÜRKAK references; the scopes of the neighbouring accreditation standards.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Related Standards

Frequently Asked Questions About ISO/IEC 17025

Is your laboratory accredited?

The right question is: is the test I need within your accreditation scope? The scope document is defined by method, parameter and range, and whether the requested test falls within it is confirmed separately.

What is the difference between an accredited and a non-accredited report?

An accredited report is produced within a system independently assessed as having verified the method, established traceability and calculated uncertainty. Legislation often requires an accredited scope.

Why does uncertainty matter?

For results close to the tolerance limit, the decision depends on uncertainty. A conformity decision made without knowing the uncertainty cannot be defended.

We have an ISO 9001 certificate — is it sufficient for our laboratory?

It is not. ISO 9001 does not assess technical competence; laboratory accreditation is granted under ISO/IEC 17025.

Frequently Asked Questions

Is this standard mandatory for my product?

Whether it is mandatory depends on the product group, the target market and the applicable legislation. Once you tell us your product and market, we clarify in writing whether this standard is required.

How long does the test process take?

Duration depends on the scope of the standard, the number of specimens and current capacity. The exact duration is shared, together with the specimen and scope details, at the quote stage.

Do you issue certification against this standard?

Which activity is carried out under which accreditation scope is separately confirmed at the application stage. Up-to-date scope information is published on our corporate page.

What happens if the standard I need is not here?

The library is based on a continuously growing inventory. If you cannot find the code you are looking for, you can send it through the quote form; we will assess the relevant scope and get back to you.