Standard status
- Current published edition
- ISO/IEC 17025:2017 (third edition, published November 2017)
- Scheme type
- Testing and calibration laboratories
ISO/IEC 17025 is the international standard for testing and calibration laboratories. It states its own purpose as the competence, impartiality and consistent operation of laboratories, and those three words are the fairest short description of what it requires. It is not a management standard alone: it combines management system requirements with detailed technical requirements covering the people, equipment, methods and conditions that determine whether a result can be relied on. A laboratory accredited to it produces test reports and calibration certificates that a third party can trust without repeating the work. ASCB offers accreditation to ISO/IEC 17025.
Does an accredited test report mean the product is approved?
No, and this is the most common misunderstanding among purchasers. Accreditation to ISO/IEC 17025 concerns the laboratory, not the item it tested. A test report from an accredited laboratory says the result was produced by a laboratory independently assessed against the international standard. It does not say the tested product is approved, certified or compliant, unless the report itself carries a statement of conformity, which is a separate and defined activity. Where one is given, the decision rule, meaning how measurement uncertainty is accounted for in deciding pass or fail, must be defined and agreed with the customer before the work is done, and the report must identify which results the statement covers, which specifications are met or not met, and which decision rule was applied. Product certification is a different scheme, under ISO/IEC 17065.
Can a laboratory be certified to ISO/IEC 17025?
No. ISO/IEC 17025 is an accreditation standard, not a certification standard. A laboratory's competence against it is assessed by an accreditation body, not certified by a certification body. Certificates of this kind are occasionally issued by certification bodies operating to ISO/IEC 17021-1, but what such a certificate covers is the laboratory's management system, which in substance is an ISO 9001 check. The standard is explicit about how far that reaches: a laboratory already operating an ISO 9001 management system is treated as fulfilling the intent of the management system clause only. The clauses carrying the technical requirements apply in full regardless, and ISO 9001 does not address them. A management system certificate is therefore not accreditation and does not speak to the technical substance of ISO/IEC 17025.
What ISO/IEC 17025 requires
General requirements
The laboratory must be impartial, identifying and managing threats to impartiality on an ongoing basis rather than declaring it once, and must protect the confidentiality of the information it holds.
Structural requirements
A defined legal identity, organizational structure, and clear responsibilities and authorities for the people who manage, perform and verify work that affects results. The laboratory must also define and document the range of activities for which it conforms, and claim conformity only for that range. That requirement is where the defined scope comes from, and it is why the scope is the thing a purchaser should read.
Resource requirements
Competent personnel with documented and monitored authorization for the tasks they perform; facilities and environmental conditions that do not compromise results; equipment that is calibrated, verified and controlled; metrological traceability, meaning a documented unbroken chain of calibrations linking results to an appropriate reference and, where achievable, to the International System of Units; and control over externally provided products and services, including subcontracted work, reference materials and calibration providers.
Process requirements
Review of requests and contracts so the laboratory only accepts work it can competently perform; selection, verification and validation of methods; sampling where it is in scope; handling of items so identity and integrity are preserved; technical records sufficient to reconstruct a result; evaluation of measurement uncertainty; ongoing monitoring of the validity of results, typically through quality control, proficiency testing and interlaboratory comparison; clear and unambiguous reporting, including the rules on statements of conformity and opinions; handling of complaints and of nonconforming work; and control of data and information systems.
Management system requirements
A management system supporting consistent operation, with document and record control, actions to address risk, improvement, corrective action, internal audit and management review. The standard allows two routes to this clause: one that sets the requirements out directly, and one under which a laboratory already operating an ISO 9001 management system is treated as fulfilling the intent of the clause. The technical requirements apply in full either way.
Why seek ASCB accreditation against ISO/IEC 17025
ASCB assesses a laboratory against the requirements of ISO/IEC 17025 on a periodic, risk-based basis, sampling records, equipment, personnel authorizations and live testing or calibration activity. For a laboratory and the users of its results, that means independent third-party assessment against the international standard for testing and calibration laboratories, applied on its own terms; accreditation granted for a defined scope, so the schedule states exactly which tests and calibrations are covered, which is what makes accreditation useful to a purchaser rather than a general badge; a recognized basis for reliance on results across supply chains, regulators and customers, without the need to repeat work; public verifiability, since ASCB publishes its register of accredited bodies, so a purchaser can confirm a laboratory's accreditation and the scope it holds; and delivery by an established international accreditation body operating to ISO/IEC 17011 for more than 30 years; organizations certified by ASCB-accredited bodies operate in 140+ countries.
Where ISO/IEC 17025 sits among the standards
ISO/IEC 17025 is one of a family of conformity assessment standards. The most closely related are:
• ISO/IEC 17000: the conformity assessment vocabulary and principles; it defines the shared terms this standard uses.
• ISO/IEC 17020: inspection bodies; inspection turns on professional judgment rather than measurement alone.
• ISO/IEC 17021-1: management system certification bodies; a different activity, certifying management systems rather than producing results.
• ISO/IEC 17065: product, process and service certification bodies; a product certificate is not a test report.
• ISO 17034: reference material producers; they produce the certified reference materials laboratories rely on for traceability.
• ISO/IEC 17043: proficiency testing providers; they run the schemes laboratories use to evidence the ongoing validity of results.
• ISO 15189: medical laboratories; purpose-built for clinical testing, where ISO/IEC 17025 is the general laboratory standard.
• ISO 9001: quality management systems; the management system clause aligns with it, and ISO/IEC 17025 adds the technical requirements ISO 9001 does not address.
How to apply
How to apply for ISO/IEC 17025 accreditation, including the process, the fees and the application documents, is set out on Become Accredited.