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ISO/IEC 17025 – What Is It?

  • Info Test ADN
  • Aug 30
  • 3 min read

When you take a DNA test—whether for genealogy, health, or paternity—you want to be sure the results are reliable. One of the main guarantees lies in the accreditation of the laboratory according to strict standards.


Among them, ISO/IEC 17025 is a global benchmark for the technical competence of laboratories. This article clearly explains what this standard is: its origin, contents, usefulness in DNA laboratories, and especially how you, as a user, can verify that a laboratory holds it.


iso 17025

What Is ISO/IEC 17025?


ISO/IEC 17025 is an international standard that defines the general requirements for the competence of testing and calibration laboratories. It was developed by the ISO CASCO committee, incorporating aspects of the ISO 9001 management system while maintaining a specific technical focus on laboratories. It does not serve to “certify” a laboratory but to accredit it in order to prove its technical competence.


History and Structure of the Standard


Version Timeline


  • 1999: First publication under the name ISO/IEC Guide 25.

  • 2005: Major revision, aligned with ISO 9001 (2000 edition), emphasizing management involvement, continuous improvement, and customer communication.

  • 2017 (current version): Structured into eight detailed chapters (from scope definition to the management system), with an approach based on risks, impartiality, human resources, and traceability.


Purpose and Scope of Application


A Global Foundation of Trust

With ISO/IEC 17025, laboratories can demonstrate they are competent and capable of producing valid results, fostering national and international trust. This facilitates result recognition between countries, avoiding the need for repeat testing.


Broad Applicability

This standard applies to all types of laboratories—public, private, academic, industrial, etc.—engaged in testing, sampling, or calibration activities. While health labs may prefer ISO 15189, dedicated to medical laboratories, ISO 17025 remains a relevant benchmark for genetic labs.


Why ISO/IEC 17025 Is Crucial for DNA Testing


1. Technical Accuracy and Traceability


The standard specifically requires:

  • Validation of analytical methods and estimation of measurement uncertainties;

  • Sample traceability, from receipt to report generation;

  • Regular calibration of equipment, and management of maintenance and verifications;

  • Training and qualification of staff, with clear records.

This ensures that each step, from sample to report, is controlled and documented.


2. Impartiality, Quality, and Documented Systems


ISO/IEC 17025 also imposes:

  • Strict rules on impartiality, confidentiality, and conflict-of-interest management;

  • Establishment of a quality management system, including internal audits, corrective actions, and continuous improvement.


3. Recognition, Trust, and Acceptance


A laboratory accredited under this standard sends a strong signal to users:

  • Seriousness and rigor are demonstrated, inspiring trust from clients (patients, institutions, etc.);

  • In some contexts (legal, medical, administrative), only accredited laboratories are accepted.


How Does a Laboratory Obtain ISO/IEC 17025 Accreditation?


  1. Implementation of required systems (quality, technical, traceability, internal audits…) over a period of several months.


  2. Evaluation by a third-party accreditation body—such as COFRAC in France, ANAB, PJLA or A2LA in the U.S., NABL in India, etc.—based on ILAC requirements to ensure international mutual recognition.


  3. Audit report, with a list of anomalies (non-conformities), corrections, and then issuance of the accreditation certificate, generally valid for two years, with annual surveillance.


How Can You Verify That a Laboratory Is Accredited?


a) Search on Official Websites

  • In France, COFRAC publishes a list of ISO/IEC 17025-accredited labs with their exact accreditation scope.

  • Internationally, consult the websites of organizations like ANAB, NABL, or the ILAC directories.


b) Check the Laboratory’s Website

  • Look for the mention of ISO/IEC 17025:2017 accompanied by the accreditation body’s logo.

  • Ask for or download the certificate, usually available upon request or directly online.


c) Review the Documents

  • The certificate should specify the scope of competence (e.g., specific genetic tests).

  • Check that the certificate is up to date (validity, recent audits, not expired).


Comparative Insight: ISO 17025 vs ISO 15189


ISO 15189 is a standard dedicated to medical laboratories, focusing on contribution to patient care, turnaround times, emergency management, training of medical personnel, etc. It is more healthcare-oriented than ISO 17025.


By contrast, ISO 17025 is broader, focused on technical competence, test validation, traceability, and rigor—therefore often used for DNA tests that are not directly clinical analyses or depending on the context requirements.


Conclusion — For You, DNA Test Users


Choosing an ISO/IEC 17025 accredited lab means opting for:


  • Scientifically rigorous and reliable results;

  • Complete transparency and traceability of the process;

  • National and international recognition of the results;

  • And above all, assurance that everything has been done to ensure quality, from sample collection to report issuance.




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