ISO/IEC 17025:2017

What It Covers

What a laboratory must show to be accredited as competent, impartial and consistent in its testing, calibration or sampling, and therefore able to produce results others can rely on.

Who It Applies To

Testing and calibration laboratories of every kind, first-, second- or third-party, that seek accreditation or whose customers or regulators require it.

Key Requirements

• Impartiality and confidentiality managed as risks, with commitments from management (clause 4).
• Competent personnel, suitable facilities, calibrated equipment, and metrological traceability (clause 6).
• Methods verified or validated, with measurement uncertainty evaluated (7.2, 7.6).
• Validity of results assured through monitoring such as proficiency testing (7.7).
• Reports that are accurate and unambiguous, with decision rules agreed when conformity is stated (7.8, 7.1.3).

Structure at a Glance

Requirements Checklist

Work down the list with the evidence in hand. The PDF has a column for noting where each item is evidenced.

1. Risks to impartiality identified and addressed on an ongoing basis (4.1).
2. Scope of laboratory activities defined and matched to the accreditation scope (5.3).
3. Competence requirements defined, with authorization of personnel for specific activities (6.2).
4. Environmental conditions monitored where they affect results (6.3).
5. Equipment calibrated where it affects results, with intermediate checks planned (6.4).
6. Metrological traceability to SI units established and documented (6.5).
7. External providers of products and services evaluated and approved (6.6).
8. Decision rule agreed with the customer when conformity statements are requested (7.1.3).
9. Methods verified before use, and non-standard methods validated (7.2).
10. Measurement uncertainty evaluated for each calibration and, where relevant, each test (7.6).
11. Validity of results monitored, including proficiency testing or interlaboratory comparisons (7.7).
12. Reports contain the required information and identify any opinions and interpretations (7.8).
13. Nonconforming work managed, with recall of results where needed (7.10).
14. Data and information management systems validated before use (7.11).
15. Internal audits and management reviews performed at planned intervals (8.8, 8.9).

Implementation Roadmap

1. 1. Scope Define the activities and methods to be accredited, and choose Option A or Option B for the management system.
2. 2. Resources Confirm competence and authorization, equipment calibration and traceability, and environmental control.
3. 3. Methods and uncertainty Verify or validate each method, and build its uncertainty budget.
4. 4. Results assurance Set up proficiency testing, intermediate checks, and the decision rule for conformity statements.
5. 5. System and assessment Internal audit, management review, then a pre-assessment before the accreditation body visits.

How It Fits with Other Standards

ISO/IEC 17020 covers inspection bodies and ISO 15189 medical laboratories in the same family. The GUM sets how uncertainty is evaluated, ISO 10012 how a user organization manages its measurements, and NIST or another national metrology institute anchors traceability.

Findings We See Most Often

• Measurement uncertainty not evaluated, or incomplete (7.6).
• Metrological traceability not demonstrated for a calibration supplier (6.5).
• Method verification records missing for a standard method (7.2.1).
• Monitoring of the validity of results not planned or reviewed (7.7).

Related Standards

• ISO 10012:2026Measurement Management Systems
• GUM · Guide 98-3Measurement Uncertainty
• ISO/IEC 17020:2026Inspection Bodies
• ISO 15189:2022Medical Laboratories
• NIST TraceabilityCalibration Traceability
• AIAG MSAMeasurement Systems Analysis