ISO/IEC 17025 sets the requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. The current edition is ISO/IEC 17025:2017, published November 29, 2017; the previous edition was withdrawn after a three-year transition that ended in late 2020.
Laboratories are not certified but accredited: an accreditation body assesses the lab's technical competence for a defined scope of tests or calibrations and lists that scope publicly.
Accreditation under a body that is a signatory to the international mutual recognition arrangement (now operated by Global ACI, formed when ILAC and IAF merged on January 1, 2026) means results are accepted across borders.
In writing, the standard expects a description of the management system (either built on ISO 9001 principles or a certified ISO 9001 system), impartiality and confidentiality commitments, personnel competence and authorization records, method validation and verification records, measurement uncertainty evaluations, equipment calibration and traceability records, sampling and handling procedures, quality control and proficiency testing participation, procedures for nonconforming work, complaints, corrective actions, internal audits, and management reviews.
Voluntary in principle, but mandated by many regulators and customers: environmental and drinking water testing (state and EPA programs), forensic laboratories, calibration suppliers to regulated manufacturers, product safety testing for certification marks, and laboratories supplying data to FDA, defense, or automotive customers.
Many contracts and regulations simply require accredited results.
Application scope with tests, methods, and measurement ranges; management system documentation and impartiality risk analysis; organization and personnel competence, authorization, and training records; facilities and environmental condition monitoring; equipment inventory, calibration certificates, and metrological traceability; method selection, validation, and verification records; measurement uncertainty budgets; sampling plans and sample handling records; technical records and reports for selected jobs; proficiency testing and interlaboratory comparison results; quality control data and control charts; nonconforming work, complaints, and corrective action records; internal audit and management review records; witnessed performance of tests or calibrations during the assessment.
Where the requirement sits: 8.2, 8.3 management system documentation and document control; 8.4 records; 6.2 personnel
On January 1, 2026 the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) merged into Global Accreditation Cooperation Incorporated (Global ACI), which now operates a single mutual recognition arrangement covering laboratory accreditation as well as management system and product certification.
Existing recognitions carried over, so an accreditation from any former ILAC MRA signatory keeps its international standing. Expect certificate wording and logos to change over time.
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ISO 9001 Quality Policy and Documented Information: who needs it, what goes in it, how often it is reviewed and who signs it off. Run exactly that in AllyMatter, alongside every other policy your company keeps.
How it works
Every document is approved by someone other than its author, versioned, distributed to the people it covers and acknowledged by name. Sign it where a signature is what the standard wants, send a set out together as a package, and export a dated record of who read which version when an assessor asks.
The written policies this standard turns on live here, with every version and every acknowledgment on the record.
A specialist consultant ecosystem exists, often former assessors and laboratory quality managers. Consultants run gap analyses, write the management system and technical procedures, help with method validation and measurement uncertainty, set up proficiency testing, run internal audits, and prepare the scope application and assessment.
Engagements often run six to twelve months because technical records take time to accumulate.
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Accreditation bodies themselves (not certification bodies), using lead assessors plus technical assessors expert in the lab's disciplines. In the US the main general-purpose bodies are A2LA, ANAB, PJLA, and NIST's NVLAP for specific programs.
Accredited by Peer evaluation among accreditation bodies under the Global ACI mutual recognition arrangement (formerly the ILAC MRA); accreditation bodies are assessed against ISO/IEC 17011.
Public register of assessors: ilac.org ↗
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AllyMatterPolicy management tool, the policy and acknowledgment layerPublisher of this siteDocument control for quality systems; ISO 9001, 13485 and AS9100 shops.
Controls, evidence and audit workflows, with a policy module inside.
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From the publisher
Approve the policies ISO 17025 asks for, keep every version, and record a named acknowledgment from each person who has to read them.