ISORegulatory IntelligenceStandard
ISO/IEC 17025:2017

General requirements for the competence of testing and calibration laboratories

The international standard for laboratory competence, impartiality and consistent operation. Published November 2017 as the third edition, replacing ISO/IEC 17025:2005, it is the standard against which testing and calibration laboratories are accredited worldwide.

LAST REVISED
November 2017
PRODUCT AREAS
ApiSolid DoseSterileBiotechDevicesFood
SCOPE & APPLICABILITY

Any organisation performing laboratory activities — contract testing laboratories, calibration providers, and in-house laboratories seeking accreditation.

KEY REQUIREMENTS
  • 01Demonstrated competence for each method within the accredited scope
  • 02Metrological traceability to SI units or certified reference materials
  • 03Method validation or verification appropriate to the method's status
  • 04Management of risks to impartiality, and control of laboratory information systems
IMPLEMENTATION TIPS
›Read the accreditation schedule, not the certificate — the certificate tells you the laboratory is accredited, the schedule tells you for what
›Where a contract laboratory performs GMP testing, qualify it against GMP as well as accreditation, and say so in the quality agreement
›Confirm the accreditation body is an ILAC MRA signatory if the result has to be accepted in another jurisdiction

ISO/IEC 17025:2017: frequently asked questions

Quick answers to common questions about ISO/IEC 17025:2017.

What is ISO/IEC 17025:2017?

ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories — is a standard issued by the International Organization for Standardization. The international standard for laboratory competence, impartiality and consistent operation. Published November 2017 as the third edition, replacing ISO/IEC 17025:2005, it is the standard against which testing and calibration laboratories are accredited worldwide.

Who does ISO/IEC 17025:2017 apply to?

Any organisation performing laboratory activities — contract testing laboratories, calibration providers, and in-house laboratories seeking accreditation.

What are the key requirements of ISO/IEC 17025:2017?

ISO/IEC 17025:2017 requires, among other things: Demonstrated competence for each method within the accredited scope; Metrological traceability to SI units or certified reference materials; Method validation or verification appropriate to the method's status; Management of risks to impartiality, and control of laboratory information systems.

When was ISO/IEC 17025:2017 last updated?

The current version of ISO/IEC 17025:2017 dates from November 2017.

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