IVD and Laboratories
ISO/IEC 17025: Competence of Testing and Calibration Laboratories
ISO/IEC 17025 sets general requirements for the competence, impartiality and consistent operation of testing and calibration laboratories. Accreditation bodies use it to accredit laboratories for a defined scope of tests or calibrations. Device makers mostly meet it through their suppliers: the test labs and calibration providers whose results end up in design history files and production records.
At a Glance
- Standard
- ISO/IEC 17025
- Subject
- Competence of Testing and Calibration Laboratories
- Group
- IVD and Laboratories
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard covers impartiality and confidentiality, personnel, facilities and environmental conditions, equipment, metrological traceability, and externally provided products and services. Process requirements address method selection, verification and validation, sampling, handling of test items, technical records, evaluation of measurement uncertainty, assuring the validity of results, reporting, complaints and nonconforming work. The laboratory also needs a management system to support all of this.
Accreditation is granted for a scope. A lab can be accredited for some tests and not others, so the useful question isn't whether a supplier is accredited but whether the specific test or calibration you buy is on its accredited scope. Calibration certificates from accredited providers typically state traceability and measurement uncertainty, which a device maker needs to judge whether the calibration is fit for the tolerance being checked.
Device makers rely on accredited laboratories for electrical safety and EMC testing, biocompatibility and sterilization testing, package testing and calibration of production and test equipment. Some run in-house laboratories that seek accreditation themselves. Either way, under ISO 13485 and FDA's QMSR the device maker stays responsible for controlling these suppliers and for confirming results are suitable for how they're used.
Who It Applies To
- Test laboratories performing electrical safety, EMC, biocompatibility, sterilization or package testing
- Calibration providers for production, inspection and test equipment
- In-house testing and metrology laboratories at device manufacturers
- Device makers qualifying and monitoring outside laboratories as suppliers
What Auditors Check
Accredited Scope Check
Supplier files showing the specific tests or calibrations purchased are on the lab's accredited scope, or a justification where they aren't.
Calibration Certificate Review
Certificates reviewed on receipt for traceability, measurement uncertainty and as-found results.
Out-of-Tolerance Follow-Up
When a calibration finds equipment out of tolerance, an assessment of product measured since the last acceptable calibration.
Test Report Review
Evidence that test reports were checked against the protocol, sample identity and acceptance criteria before being relied on.
Supplier Monitoring
Ongoing evaluation of laboratory performance, including changes in accreditation status and any complaints.
In-House Laboratory Controls
For internal labs, method validation, personnel competence and equipment control records, whether or not the lab is accredited.
Related Services
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Questions
Do our test laboratories have to be ISO/IEC 17025 accredited?
It depends on the test, the market and how the results will be used. Even where it isn't required, accreditation for the specific test is strong evidence of competence and simplifies supplier qualification. Where you use a laboratory that isn't accredited, document how you established its competence.
Is an accreditation certificate enough for supplier qualification?
It's a strong input but not the whole picture. Check that the scope covers the tests you buy, include the laboratory in your supplier evaluation and monitoring, and review each report before relying on it.
What should we do when a calibration comes back out of tolerance?
Evaluate the effect on product and measurements made with that equipment since its last acceptable calibration, and record the decision and any action taken. Auditors may sample out-of-tolerance results to see whether that assessment actually happened.
Does an in-house laboratory need accreditation?
Not necessarily. Many device makers run internal labs under their QMS without accreditation. Accreditation can help where customers or programs expect it for specific tests, but the lab still needs validated methods, competent staff and controlled equipment either way.
ISO/IEC 17025
Check Your Quality System Against ISO/IEC 17025
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
