A new ISO/IEC 17025 for laboratories

Significance of the topic

Revisions to ISO/IEC 17025 have direct operational and accreditation consequences for testing, calibration and sampling laboratories worldwide. The 2017 edition (with subsequent revisions reflected in guidance up to 2024) redefines scope, clarifies how measurement uncertainty and conformity decisions are handled, and embeds a risk-based approach into laboratory practice. For laboratories, accreditation bodies and stakeholders, understanding these changes is essential to maintain compliance, ensure valid results and align laboratory management with contemporary quality and metrological practices.

Objectives and overview of the revision

The revised standard was designed to harmonize ISO/IEC 17025 with the structural format of the ISO/IEC 17000 family, modernize terminology and address activities—such as sampling—that were previously less explicitly treated. The revision keeps the core technical and quality expectations for laboratories but reorganizes clauses, introduces explicit provisions for decision rules and risk management, and offers two management-system implementation routes to accommodate laboratories with existing ISO 9001 systems. A three-year transition period was provided to allow laboratories and accreditation bodies to adopt the new requirements.

Methodology and scope of the standard

The standard widens the definition of a laboratory to include entities that perform testing, calibration and sampling linked to subsequent calibration or testing (which may be performed elsewhere), thereby allowing accreditation of sampling as a standalone activity. Key methodological elements introduced or clarified include:

• The decision rule: laboratories must document how measurement uncertainty is considered when declaring conformity and must communicate and agree this rule with clients; statistical bases and guidance are referenced in international guides.
• Risk-based approach: the laboratory must identify, evaluate and act on risks and opportunities relevant to achieving its objectives; preventive action terminology is replaced by risk-oriented planning and improvement.
• Management system options: Option A (comply with clauses covering both management and technical requirements) or Option B (laboratories with an ISO 9001 system comply with the technical clauses of ISO/IEC 17025 plus selected management clauses).

Main changes and discussion

The most significant practical and structural changes include:

• Reorganized clause structure to align with the ISO/IEC 17000 series.
• Explicit treatment of sampling as an accreditable activity and requirement to account for sampling uncertainty in the measurement uncertainty budget.
• Mandatory documentation of the decision rule for conformity assessment and client agreement.
• Embedding of risk and opportunity assessment across relevant clauses (impartiality, nonconforming work, management review, etc.).
• Two management-system routes (A and B) to facilitate integration with ISO 9001 where applicable.
• Stronger emphasis on impartiality and confidentiality, with expanded treatment of liability.
• More detailed requirements for metrological traceability, supported by ILAC guidance, and for reporting of sampling activities.
• Higher expectations for validation tools and participation in proficiency testing programs to demonstrate competence.
• Enhanced controls for data and information management reflecting digital technologies and data integrity needs.
• Management review requirements broadened to include risk-based considerations and customer feedback; a formal quality manual is no longer mandatory.
• Greater control and definition of externally provided products and services (subcontracting), and adoption of the term laboratory management rather than top management, while the titles technical manager and quality manager are no longer mandated.

Practical guidance for laboratories (implementation)

To achieve a smooth transition laboratories should consider the following pragmatic steps:

• Obtain and study the revised standard to grasp its intent and new requirements.
• Create a cross-reference (gap) matrix mapping existing procedures to the new clauses.
• Perform a gap analysis combined with risk assessment to identify where new or revised procedures are required (e.g., decision rules, sampling procedures, data controls).
• Document a decision rule for conformity assessments and agree it with customers where relevant.
• Revise sampling protocols to capture reporting requirements and include sampling uncertainty in uncertainty budgets.
• Evaluate and, if needed, strengthen participation in proficiency testing and validation practices.
• Assess information management systems for data integrity, security and traceability; implement additional controls where necessary.
• Engage early with the national accreditation body to clarify expectations and timelines.
• Plan internal audits and management reviews focused on the new risk-based and impartiality provisions; provide staff training on new responsibilities.

Benefits and practical applications

The revision brings practical advantages for laboratories and users of laboratory services:

• Clearer eligibility for accreditation of sampling activities supports organizations involved solely in sampling operations.
• Risk-based planning focuses resources on activities with greatest impact on result validity and customer confidence.
• Stronger metrological traceability and decision-rule requirements improve transparency of conformity statements.
• Modernized data and information management provisions help laboratories adapt to digital workflows and enhance data integrity.
• Flexibility in management system implementation allows more efficient alignment with existing ISO 9001 systems.

Future trends and applications

Likely developments and opportunities emerging from this revision include:

• Evolution of proficiency testing schemes and validation tools to meet tighter competence demonstrations and decision-rule needs.
• Increased emphasis on metrological traceability frameworks and international agreements to support global comparability of results.
• Growth of guidance documents and sector-specific “cookbooks” to help laboratories interpret risk-based requirements and sampling accreditation.
• Further integration of digital quality management, laboratory information management systems and electronic reporting consistent with data control clauses.
• Expanded use of remote and hybrid assessment approaches by accreditation bodies, accompanied by harmonized regional and international peer-review practices.

Conclusion

The ISO/IEC 17025 revision updates the structure and several substantive expectations for laboratories without fundamentally altering the core technical competence requirements. Key emphases—sampling as an accreditable activity, documented decision rules, and a pervasive risk-based mindset—require laboratories to review procedures, enhance traceability and data controls, and communicate clearly with customers and accreditation bodies. With planned implementation and targeted changes, laboratories can convert the revised standard into an opportunity to strengthen scientific rigor and stakeholder confidence.

References

1. ISO/IEC Guide 98-4:2012, Uncertainty of measurement — Part 4: Role of measurement uncertainty in conformity assessment.
2. Williams A., Magnusson B. (Eds.), Eurachem/CITAC Guide: Use of uncertainty information in compliance assessment, 2nd Edition, 2021.
3. ILAC P10:07/2020, ILAC Policy on Metrological Traceability of Measurement Results.