Understanding the Link Between ISO 17034 and ISO/IEC 17025
Over the past decade helping laboratories and reference-material producers prepare for accreditation, I’ve noticed one recurring confusion: people often think ISO 17034 and ISO/IEC 17025 are interchangeable. They’re not.
Both sit at the heart of measurement reliability—but they serve very different masters. ISO/IEC 17025 ensures your testing and calibration results are trustworthy. ISO 17034 ensures your reference materials—the very things that make those results traceable—are fit for purpose.
By the end of this guide, you’ll know exactly which one fits your organization, how they connect, and what mistakes to avoid if you ever plan to hold both accreditations.
Understanding the Core Purpose of Each Standard
Here’s what I tell every new client: start with purpose before paperwork.
ISO/IEC 17025 is built for testing and calibration laboratories. Its goal is to prove you can produce technically valid results—consistently and competently. Think of it as proof that your lab’s measurements are right.
ISO 17034, on the other hand, is all about the production of reference materials. It makes sure those materials are homogeneous, stable, and traceable, so anyone using them gets reliable calibration or validation results.
Pro Tip: If your main business is producing certified reference materials (CRMs), ISO 17034 is the right path. If you’re testing or calibrating, ISO/IEC 17025 is your standard.
Common pitfall: Some labs try to stretch ISO/IEC 17025 to cover reference-material production. It doesn’t. That’s like trying to use a thermometer to weigh something—it’s simply the wrong tool.
Scope and Application Differences: Who Needs Which Standard
Here’s the simple breakdown I share during training sessions:
Organization Type
Relevant Standard
Main Objective
Testing/Calibration Lab
ISO/IEC 17025
Produce valid measurement results
Reference-Material Producer
ISO 17034
Ensure reliable certified reference materials
Dual-Role Lab (testing + RMP)
Both
Combine traceable measurements and certified material production
If you only test or calibrate samples, ISO/IEC 17025 accreditation is enough. But if you’re characterizing or certifying materials for others to use, you need ISO 17034.
Example: A calibration lab that starts producing its own in-house standards for sale now crosses into ISO 17034 territory.
Pro Tip: Map your processes early. If you have steps involving material characterization, stability studies, or value assignment—those fall under ISO 17034.
Pitfall: Many labs only realize this gap when auditors flag it. By then, documentation updates become a scramble.
Management and Technical Requirements Compared
At a glance, both standards share familiar sections—management systems, resources, equipment, and technical procedures. But dig deeper, and the differences jump out.
ISO/IEC 17025 focuses on test method validation, equipment calibration, and measurement uncertainty. ISO 17034 adds layers on homogeneity, stability, and characterization studies.
Pro Tip: If you’re already ISO 17025-accredited, use that as your foundation. Many of your procedures—document control, internal audits, management reviews—can carry over.
Example: One of my clients simply expanded their ISO 17025 quality manual with a new section dedicated to reference-material production. That small change made dual compliance achievable without reinventing the wheel.
Pitfall: Assuming the documents are identical. ISO 17034 demands extra technical records—stability testing data, value-assignment reports, uncertainty budgets—specific to reference-material work.
Competence and Personnel Requirements
People often underestimate this part. ISO/IEC 17025 expects analysts and technicians to be competent in performing tests and calibrations. ISO 17034 goes further—it expects staff who can design characterization studies, evaluate homogeneity, and assign reference values using sound metrological principles.
Pro Tip: Cross-train your analysts in both measurement and statistics. A team that understands both sides will spot data anomalies before they turn into audit findings.
Example: In one dual-accredited lab I supported, we had to re-define job descriptions so statisticians were recognized as technical personnel—not just “support staff.” That small clarification eliminated recurring nonconformities.
Common mistake: Forgetting to document competence evaluations specific to ISO 17034. Accreditation bodies will ask for proof that your team knows not just how to measure—but how to certify.
Quality Assurance, Measurement Traceability, and Uncertainty
Both standards share one obsession: traceability. But how they handle it differs.
ISO/IEC 17025 ensures every test or calibration result traces back to recognized standards. ISO 17034 ensures the reference material itself maintains that traceability over time. That’s why it adds requirements for stability monitoring, homogeneity checks, and uncertainty evaluation tied to the assigned values.
Pro Tip: Integrate interlaboratory comparisons into your routine. It not only boosts confidence in your results but also demonstrates continuous verification of assigned values.
Example: One RMP client scheduled annual homogeneity re-testing of key CRMs. That proactive approach earned commendation from assessors during accreditation.
Pitfall: Skipping ongoing stability monitoring. Too many producers focus on initial characterization but ignore long-term checks—an easy way to lose accreditation credibility.
Integration Strategies: How to Align ISO 17025 and ISO 17034
If you operate both testing and reference-material functions, integration isn’t optional—it’s smart management.
Start by mapping overlapping clauses. Build a single quality management system that addresses both sets of requirements. Then tailor supporting procedures—production planning, material certification, equipment control—so they meet the extra depth required by ISO 17034.
Pro Tip: Use clause mapping as your project roadmap. It helps you see where one standard supports the other, and where you’ll need new controls.
Example: One of our dual-accredited labs merged both scopes under a shared calibration traceability system. They reduced document duplication by 40% and audit time by nearly half.
Common mistake: Treating the accreditations separately. When two systems run in silos, inconsistencies creep in—and assessors will spot them immediately.
FAQs — Clarifying Common Questions
1. Can one accreditation cover both ISO 17025 and ISO 17034? No. Each has its own accreditation scope and assessment process. However, some accreditation bodies conduct combined audits to streamline evaluation if you apply for both.
2. If my lab produces in-house reference materials, do I need ISO 17034? Not necessarily. If those materials are used only internally and not distributed as certified reference materials, ISO 17025 validation may suffice. But once you supply them externally, ISO 17034 becomes mandatory.
3. How long does it take to expand from ISO 17025 to ISO 17034? Typically 6–12 months, depending on how mature your quality system is and how ready your technical documentation (like characterization and stability data) are.
Conclusion — Choosing the Right Path for Your Laboratory
Here’s the bottom line:
ISO/IEC 17025 proves your measurements are valid.
ISO 17034 proves your reference materials are trustworthy.
If your lab handles both, integrating them under one management system isn’t just efficient—it’s strategic.
Over the years, I’ve guided dozens of laboratories through this exact journey, and the ones who planned integration early always achieved faster, smoother accreditation.
Next step: Explore QSE Academy’s ISO 17025 and ISO 17034 implementation toolkits. They give you ready-to-use templates, checklists, and project plans to simplify the dual-standard process and get you audit-ready faster.
Melissa Lavaro is a seasoned ISO consultant and an enthusiastic advocate for quality management standards. With a rich experience in conducting audits and providing consultancy services, Melissa specializes in helping organizations implement and adapt to ISO standards. Her passion for quality management is evident in her hands-on approach and deep understanding of the regulatory frameworks. Melissa’s expertise and energetic commitment make her a sought-after consultant, dedicated to elevating organizational compliance and performance through practical, insightful guidance.
