A new ISO/IEC 17025 for laboratories

Importance of the Topic

ISO/IEC 17025:2017 introduced a major revision of the general requirements for the competence of testing and calibration laboratories. The update aligns the standard with the newer ISO/IEC formats and places greater emphasis on risk-based thinking, metrological traceability, and clarity in roles and responsibilities. For laboratories, accreditation bodies and stakeholders across testing, calibration and sampling sectors, understanding these changes is essential to maintain accreditation, ensure valid results, and support regulatory and commercial conformity assessment.

Objectives and Overview of the Revision

The revision aimed to modernize the standard structure, clarify scope (including explicit recognition of sampling as an accreditable standalone activity), and harmonize terminology and requirements with the ISO/IEC 17000 series. Primary goals were to support consistent implementation by laboratories and accreditation bodies, strengthen impartiality and confidentiality provisions, and promote a risk-based approach to management and technical activities.

Key Changes Introduced

• Restructured layout aligned with ISO/IEC 17000-series format.
• New definition of "laboratory" to include entities performing testing, calibration or sampling associated with subsequent calibration or testing, enabling accreditation of sampling-only bodies.
• Explicit requirement to document and apply a decision rule that accounts for measurement uncertainty when stating conformity.
• Requirement to identify and address risks and opportunities across laboratory activities rather than prescribing preventive actions.
• Two management system options: Option A (compliance with ISO/IEC 17025 clauses 4–7 and 8.2–8.9) or Option B (use of ISO 9001 system with compliance to clauses 4–7 of ISO/IEC 17025).
• Greater emphasis on impartiality and confidentiality, broader treatment of liability, and detailed requirements for metrological traceability in line with ILAC P10.
• Standards for sampling as a distinct activity, including reporting and incorporation of sampling uncertainty into measurement uncertainty.
• More demanding requirements for expression of opinions/interpretations, validation tools, participation in proficiency testing, and control of data/information management.
• Removal of mandatory quality manual; use of the term "laboratory management" instead of "top management"; de-emphasis on prescribed job titles such as "technical manager" or "quality manager" in favour of assigned competent personnel.

Methodology and Practical Implementation Guidance

The standard itself does not prescribe procedural minutiae but requires laboratories to apply a risk-based approach and to document decisions that affect conformity assessment. Key methodological points laboratories must address include:

• Documenting a decision rule with its statistical basis and communicating it to customers; guidance is provided by ISO/IEC Guide 98-4 and Eurachem/CITAC publications.
• Ensuring metrological traceability of measurement results per ILAC P10 and related international agreements.
• Including sampling uncertainty in overall uncertainty budgets and meeting specific reporting requirements for sampling activities.
• Maintaining robust data and information management controls to reflect modern technologies and digital workflows.

Main Results and Discussion (Implications for Laboratories)

The standard maintains the core technical competence expectations but reframes management requirements to be more flexible and risk-focused. Laboratories can expect accreditation assessments to scrutinize how risks and opportunities are identified and managed, how decision rules are applied, and how sampling-related activities and uncertainties are handled. The strengthened position on impartiality, confidentiality and liability means management systems and contractual arrangements need clearer documentation. Participation in proficiency testing and validation of methods are expected to be demonstrably effective, and data management will receive greater attention during assessments.

Benefits and Practical Applications

• Recognition of sampling as an accreditable activity expands the scope of bodies that can obtain accreditation, improving confidence in upstream sample collection processes.
• Decision rules and explicit treatment of measurement uncertainty lead to clearer, more defensible conformity decisions.
• Risk-based planning focuses resources on activities that affect result validity and customer requirements, enhancing efficiency and relevance of quality efforts.
• Stronger traceability and data management provisions support comparability of results and regulatory acceptance.

How Laboratories Can Achieve a Smooth Transition

1. Obtain and study the revised standard to understand its philosophy and specific provisions.
2. Create a cross-reference table between existing procedures and the new clauses to identify gaps.
3. Perform a gap analysis combined with a risk assessment to prioritise procedural changes.
4. Update or create procedures for decision rules, sampling documentation, data management and handling of risks and opportunities.
5. Communicate with the national accreditation body about expectations and timelines.
6. Plan and execute internal audits and management reviews focused on the revised requirements.

Future Trends and Potential Uses

• Digitalisation and advanced information management will drive further evolution of data control requirements and remote assessment practices.
• Greater harmonisation of decision rules and approaches to uncertainty in conformity assessment is likely, supported by guidance documents and interlaboratory schemes.
• Expanded accreditation of sampling organisations and service providers will improve end-to-end quality assurance for many supply chains.
• Proficiency testing and method validation schemes will evolve to address complex measurements, composite sampling and interpretation of results.
• Integration with ISO 9001 and other management frameworks will continue, enabling flexible accreditation pathways for diverse laboratory models.

Conclusion

ISO/IEC 17025:2017 modernises laboratory accreditation requirements by embedding risk-based thinking, recognising sampling as a distinct activity, and clarifying expectations on decision rules, traceability and information management. The technical competence requirements remain intact but the management system approach is more flexible. Laboratories that proactively map existing systems to the revised clauses, conduct risk-focused gap analyses, and engage with accreditation bodies will achieve a smoother transition and benefit from improved clarity and relevance of their conformity assessment processes.

References

• ISO/IEC Guide 98-4:2012. Uncertainty of measurement — Part 4: Role of measurement uncertainty in conformity assessment (also published as JCGM 106).
• Williams A., Magnusson B. (Eds). Eurachem/CITAC Guide: Use of uncertainty information in compliance assessment. 2nd Edition, 2021.
• ILAC P10:07/2020. ILAC Policy on Metrological Traceability of Measurement Results.