Category / Standard

ISO/IEC 17025: complete guide, articles and resources

Testing & Calibration Laboratories — expert articles, practical resources, and solutions to structure your certification project.

Version
ISO/IEC 17025:2017
Type
Accreditation standard
Articles
47 published
Definition

What is the ISO/IEC 17025 standard?

The ISO/IEC 17025 standard sets out the general requirements for the competence of testing and calibration laboratories. First published in 1999 and revised in 2017, it is the global benchmark for accrediting measurement laboratories.

The standard covers impartiality, confidentiality, structural and resource requirements (personnel, facilities, equipment), process requirements (methods, sampling, handling, validation, measurement uncertainty, metrological traceability), and management system requirements.

ISO 17025 accreditation is delivered in the US by A2LA, ANAB, IAS, and PJLA, in the UK by UKAS, and by equivalent bodies internationally. It is required for many regulated activities: environmental testing, food and pharmaceutical analysis, calibration, product testing, forensics, and clinical laboratory measurement (in addition to ISO 15189).

Who is ISO/IEC 17025 for?

The standard targets testing laboratories (chemical, microbiological, mechanical, electrical, environmental analysis) and calibration laboratories (metrology for mass, length, temperature, pressure, electrical quantities). It includes industrial labs, contract labs, government labs, and university labs.

Why get certified?

ISO 17025 accreditation gives international recognition to laboratory results (ILAC mutual recognition agreements), conditions access to many regulated markets, reduces duplicate testing between customers and suppliers, and structures measurement uncertainty control.

Version
ISO/IEC 17025:2017
Certified
Accredited by IAS, A2LA, ANAB, UKAS
Validity
Varies by accreditation
Avg. timeline
12 to 24 months
Articles & guides

All our articles on ISO/IEC 17025

Frequently asked questions

Everything you need to know about ISO/IEC 17025

Difference between ISO 17025 and ISO 9001?
ISO 9001 is a general quality management system (any activity). ISO 17025 is specific to measurement laboratories and adds strong technical requirements on metrological traceability, measurement uncertainty, method validation, and technical competence of personnel.
Difference between ISO 17025 and ISO 15189?
ISO 17025 covers all testing and calibration laboratories. ISO 15189 is specific to medical (clinical) laboratories, with additional requirements on clinical interpretation, patient sampling, and the patient-result-clinician chain.
How much does ISO 17025 accreditation cost?
For an SME laboratory, expect $10,000 to $40,000 for initial accreditation depending on scope and the number of methods. Internal costs (equipment, method validation, proficiency testing) are often higher than accreditation fees.
How long does ISO 17025 accreditation take?
Expect 12 to 24 months. The duration is long because all in-scope methods must be validated, the lab must participate in proficiency testing (PT), and a documentary then on-site assessment is required.
Difference between calibration and testing?
A calibration establishes the relationship between values indicated by a measuring instrument and true values (traceable to the metrological chain). A test determines a characteristic of a product or material according to a defined method. A single laboratory can be accredited for both.

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