Overview

The international standard against which testing and calibration laboratories are accredited. The third edition, ISO/IEC 17025:2017, was reviewed and confirmed in 2023 and remains current.

ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, is the standard laboratories are assessed against when they seek accreditation. It is the third edition, replacing ISO/IEC 17025:2005, and was reviewed and confirmed in 2023, so it remains the current edition. It applies to all organizations performing laboratory activities regardless of size or whether they are independent, part of a larger organization, or within a manufacturer.

The 2017 edition revised the scope to cover all laboratory activities — testing, calibration and the sampling associated with subsequent testing and calibration — rather than treating sampling as peripheral. It adopted the process approach used in ISO 9001, ISO 15189 and ISO/IEC 17021-1, introduced risk-based thinking in place of some prescriptive preventive-action requirements, and recognised the reality of modern laboratories by addressing computer systems, electronic records and electronically produced results and reports.

The requirements are organised into five substantive groups. General requirements cover impartiality and confidentiality. Structural requirements cover legal identity, management responsibility and defined scope of activities. Resource requirements cover personnel competence, facilities and environmental conditions, equipment, metrological traceability, and externally provided products and services. Process requirements — the technical heart of the standard — cover review of requests and contracts, selection and validation of methods, sampling, handling of test and calibration items, technical records, evaluation of measurement uncertainty, ensuring the validity of results, reporting, complaints, nonconforming work, and control of data and information management. Management system requirements can be met either by the standard's own Option A requirements or, under Option B, by operating a management system conforming to ISO 9001 that also satisfies the technical clauses.

Two technical concepts carry particular weight in assessment. Metrological traceability requires measurement results to be linked to appropriate references through a documented unbroken chain of calibrations, each contributing to measurement uncertainty. Measurement uncertainty must be evaluated for calibrations and, in defined circumstances, for tests, and taken into account when statements of conformity are made against a specification — the standard requires the laboratory to document the decision rule used when reporting pass or fail.

Conformity to ISO/IEC 17025 is normally demonstrated through accreditation rather than certification. National accreditation bodies assess laboratories against the standard for a defined scope of tests or calibrations, and mutual recognition arrangements under ILAC allow accredited results to be accepted across borders. Assessment involves technical assessors who examine the methods within the scope, witness testing, and review records, uncertainty budgets, traceability and proficiency testing performance — a deeper technical examination than a generic management system audit.

The standard interlocks with others: ISO 9001 may be used to satisfy management system requirements under Option B; ISO 15189 is the equivalent standard for medical laboratories and is now structurally aligned with ISO/IEC 17025:2017; and accredited calibration under ISO/IEC 17025 is how manufacturers operating ISO 9001, ISO 13485 or IATF 16949 satisfy their own equipment traceability requirements.

Purpose

To specify the general requirements for the competence, impartiality and consistent operation of laboratories, so that laboratory results are technically valid and can be relied on by customers, regulators and accreditation bodies.

Key Benefits

• Accreditation provides internationally recognised evidence of technical competence
• Results from accredited laboratories are accepted across borders under ILAC arrangements
• Establishes metrological traceability and documented measurement uncertainty for reported results
• Requires validated methods and ongoing assurance of the validity of results
• Impartiality and confidentiality requirements protect the credibility of reported results
• Covers electronic records, laboratory information management systems and electronic reporting
• Reduces the need for repeated customer or regulator audits of the same laboratory
• Option B allows an existing ISO 9001 system to satisfy the management system requirements
• Supports equipment calibration traceability needed by ISO 9001, ISO 13485 and IATF 16949 manufacturers

Key Requirements

• Maintain impartiality: identify risks to impartiality on an ongoing basis and eliminate or minimise them
• Maintain confidentiality of customer information obtained or created during laboratory activities
• Be a legal entity, or a defined part of one, with defined management responsibility and documented scope of activities
• Ensure personnel competence: define competence requirements, authorise personnel and keep records
• Control facilities and environmental conditions where they affect the validity of results
• Control equipment, including calibration, maintenance, intermediate checks and out-of-service handling
• Establish metrological traceability of measurement results through documented unbroken calibration chains
• Control externally provided products and services, including subcontracted laboratory activities
• Review requests, tenders and contracts, including method selection and customer notification of deviations
• Select, verify and validate methods appropriate to the laboratory activities
• Control sampling where the laboratory performs it, with a documented sampling plan and method
• Handle, transport, store and dispose of test and calibration items under controlled conditions
• Maintain technical records sufficient to allow repetition of the laboratory activity
• Evaluate measurement uncertainty and apply a documented decision rule for statements of conformity
• Ensure the validity of results through internal quality control and proficiency testing or interlaboratory comparison
• Report results accurately, clearly and unambiguously, including required content for test and calibration reports
• Handle complaints and nonconforming work, and control data and information management systems
• Operate a management system under Option A or Option B, including internal audit and management review

Who Needs This Standard?

Testing and calibration laboratories of every kind — materials and product testing, environmental and water analysis, food testing, pharmaceutical and chemical analysis, forensic laboratories, metrology and calibration providers, and in-house laboratories within manufacturers. It is required by regulators and customers in many sectors, and by manufacturers who need accredited calibration to support their own quality management systems.

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