ISO/IEC 17025: what it is, who needs it, and how accreditation works

What is ISO/IEC 17025?

ISO/IEC 17025:2017 is the international standard for the competence of testing and calibration laboratories, covering how a laboratory is run and how it produces valid results. Nobody certifies a laboratory to it. A national accreditation body assesses the laboratory against it and grants a scope of accreditation listing the tests or calibrations it covers.

The 2017 edition is the third. Its requirements come in five groups: general, for impartiality and confidentiality; structural; resource, for people, facilities, equipment, metrological traceability and bought-in services; process, from contract review and method validation to reporting, complaints and nonconforming work; and management system, met under option A from the standard's own clauses or under option B through a management system run in accordance with ISO 9001.

Who needs ISO/IEC 17025?

Contract testing and calibration laboratories serving pharma and device companies, whose customers ask for the scope of accreditation in supplier qualification before the first sample is sent

The standard becomes urgent when a customer's supplier audit asks for the scope of accreditation, when the accreditation body's assessment date lands and the last internal audit was a year ago, or when a new method goes live that the current scope does not cover.

ISO/IEC 17025 IN QUALIO

Qualio maps every method, training record and equipment record to its clause, so the assessor finds each one where the standard puts it

Qualio breaks ISO/IEC 17025 down clause by clause and maps your methods, training records, equipment and calibration records and corrective actions to the clauses they answer, beside ISO 9001 and ISO 15189 in the same library. It reassesses when a record changes and recommends a fix on each gap. Copilot drafts the update and your team approves it. Before the assessor's visit, you export the audit pack by clause.

Methods and procedures held as controlled documents for clause 7.2, with training assigned on the effective date of every revision for the competence records of 6.2

Equipment and calibration records for clauses 6.4 and 6.5, held as controlled documents, with calibration and maintenance run as workflows beside the procedures that govern them

Nonconforming work under 7.10 and complaints under 7.9, each an event traceable to the corrective action under 8.7 that closed it

Internal audit and management review run as events for 8.8 and 8.9, so the review reads the audit findings, complaints and open corrective actions as they stand

Standards that apply alongside ISO/IEC 17025

LaboratoriesISO 15189: The sibling standard for medical laboratories, built on ISO/IEC 17025 and adding requirements for the patient and the clinical use of results, so a clinical laboratory's accreditation is to ISO 15189
Management systemsISO 9001: The quality management system standard that clause 8 of ISO/IEC 17025 mirrors, and the management system a laboratory can run to meet that clause under option B
Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA's drug manufacturing regulation, whose laboratory controls in Subpart I govern the quality control lab's specifications, methods and release testing, inspected by the FDA whether or not the lab is accredited
Electronic records21 CFR Part 11: The FDA's rule for the electronic records and signatures a laboratory's technical records and test reports will be kept in
Medical devicesISO 13485: The device quality management system standard, which controls the measuring equipment a device company's own lab uses in 7.6 and the contract labs it buys testing from in 7.4, where the scope of accreditation is what gets asked for

LabPlex

LabPlex is a cannabis and hemp testing laboratory based in California.

Read the LabPlex story

“We needed something that was user-friendly, easy to onboard new team members, and easy to get up and running. Qualio has surpassed our expectations on those metrics.”

Stephana P.VP of Quality, Alphazyme

Guides and checklists for ISO/IEC 17025

Blog

How to get an ISO 17025 certification

Checklist

Audit readiness checklist: Be prepared to pass your next audit

Guide

Annex SL: the core of your ISO journey

Questions about ISO/IEC 17025

What is ISO 17025?

ISO/IEC 17025:2017 is the international standard for the competence of testing and calibration laboratories. It sets requirements for impartiality, people, facilities, equipment, methods, metrological traceability and the validity and reporting of results, with a management system behind them. A national accreditation body assesses a laboratory against it and grants a scope of accreditation.

Is there an ISO 17025 certification?

No. A laboratory is accredited to ISO/IEC 17025 by a national accreditation body, which assesses its competence to perform the tests or calibrations on its scope. Certification is a different thing: a certification body attesting that a management system conforms to a standard such as ISO 9001. The scope of accreditation is the document a customer asks a laboratory for.

How does ISO 17025 accreditation work?

The laboratory applies to a national accreditation body, such as UKAS, A2LA, ANAB or INAB, with the scope it wants. The body reviews the documentation, then sends assessors, with a technical assessor for each discipline, to witness tests and read records. Findings are closed, the scope is granted, and surveillance visits follow, with a full reassessment on a fixed cycle.

What is the difference between ISO 17025 and ISO 15189?

ISO 15189 is written for medical laboratories that examine patient samples. It builds on ISO/IEC 17025 and adds requirements around the patient: pre-examination and post-examination processes, turnaround times and clinical advice. A clinical laboratory is accredited to ISO 15189, and a testing or calibration laboratory serving pharma, device or environmental customers is accredited to ISO/IEC 17025.

Can we add ISO/IEC 17025 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every clause, so the procedures, training records and corrective actions that answer ISO 9001 or ISO 15189 count towards 17025 without being re-filed. The first assessment lists what is covered and what is new.

When is the accreditation assessment?

Bring the date and your methods. We will show you ISO/IEC 17025 assessed against them clause by clause, with the gaps listed and the audit pack exported the way the assessor reads it.

Book a demo Get started

Less time on audit prep. More time on quality.