Why ISO 17034 Accreditation Matters for Producers and Labs
After years of guiding testing labs and reference-material producers toward accreditation, I’ve noticed one question that keeps coming up: “Do we really need ISO 17034?”
It’s a fair question. The line between testing, calibration, and reference-material production isn’t always clear. Some labs produce in-house materials; others manufacture certified reference materials (CRMs) for global use. Knowing where you fit is the first step to deciding if accreditation makes sense.
In this guide, you’ll see exactly who ISO 17034 is for, how to tell if your organization qualifies, and why some labs gain a major credibility boost just by pursuing it.
Understanding What ISO 17034 Covers (Before Deciding if You Need It)
ISO 17034 is the international standard that defines what it means to be a competent Reference Material Producer (RMP).
Think of it as the rulebook for anyone making materials used to calibrate instruments, validate methods, or ensure traceability in measurements. It verifies that your reference materials are homogeneous, stable, and metrologically traceable—the backbone of reliable testing everywhere.
Now, here’s where many teams get tripped up: ISO/IEC 17025 (for labs) and ISO 17034 (for RMPs) overlap but serve different purposes. ISO 17025 proves your testing or calibration is valid. ISO 17034 proves your reference materials themselves are valid.
Pro Tip: If you make materials that help others measure, validate, or calibrate—ISO 17034 applies to you. Pitfall: Relying only on ISO 17025 for reference-material work. It doesn’t cover the production side, and assessors will flag it instantly.
Organizations That Must Hold ISO 17034 Accreditation
Here’s who absolutely falls under ISO 17034’s umbrella:
National Metrology Institutes that provide certified standards to labs worldwide.
Commercial reference-material producers selling CRMs for calibration or validation.
Academic and government labs producing and distributing materials beyond internal use.
Specialized industry labs—pharma, food, or environmental—selling or sharing custom standards with clients or partners.
Example: I once worked with a university chemistry lab that made calibration standards for nearby hospitals. Once they began distributing those materials, ISO 17034 accreditation became non-negotiable.
Pro Tip: If your reference materials influence results outside your organization, accreditation isn’t optional—it’s a professional requirement.
When Internal Labs Should Consider ISO 17034 Accreditation
Not every lab that produces its own standards needs ISO 17034, but many still benefit from aligning with it.
If you’re a QA/QC or calibration lab creating in-house reference materials for internal use, formal accreditation might not be mandatory—but implementing the standard’s structure improves traceability, data reliability, and audit readiness under ISO/IEC 17025.
Pitfall: Waiting until a client asks for a CRM certificate. By then, it’s often too late to prepare the documentation. Pro Tip: Adopt ISO 17034 practices early—especially material characterization and record control. Even partial alignment streamlines audits and boosts confidence in your internal results.
Regulatory and Market Drivers That Make ISO 17034 a Must-Have
Here’s what’s changing the game: recognition and trust.
Across ILAC, EA, and APAC regions, ISO 17034 is the gold standard for CRM producers. Regulators, accreditation bodies, and customers are increasingly refusing to accept reference materials that don’t come from accredited RMPs.
In industries like pharmaceuticals, forensics, food safety, and environmental testing, ISO 17034 accreditation isn’t just good practice—it’s often the ticket to market access.
Example: A water-testing lab in Europe couldn’t sell its custom CRMs until it gained ISO 17034 accreditation. Once accredited, its materials were accepted under EU recognition schemes, opening contracts that were previously out of reach.
Pro Tip: Think of accreditation as a marketing edge. It says, “We don’t just claim quality—we prove it.”
Determining If Your Organization Is Eligible for ISO 17034
Before applying, you need to be sure your organization meets the standard’s baseline requirements:
A defined production process for reference materials.
Validated methods for characterization and testing.
Competent staff qualified to assign values and evaluate uncertainty.
A functioning quality management system—often adapted from ISO/IEC 17025.
Example: A calibration lab I worked with reused about 70 % of its ISO/IEC 17025 documentation—policies, procedures, training records—and simply added sections covering stability studies and characterization.
Pro Tip: Start with a gap analysis. It reveals whether your processes already align or if you need to build new systems before applying. Pitfall: Applying prematurely. Accreditation bodies will defer applications that lack real, validated production data.
Benefits of Pursuing ISO 17034 Accreditation
The value of ISO 17034 goes far beyond compliance paperwork. Accredited RMPs enjoy:
Global recognition under ILAC MRA agreements.
Instant credibility with regulators, clients, and auditors.
Reduced client audits—because your accreditation already proves competence.
Stronger internal control and fewer repeat investigations.
Pro Tip: Use your accreditation in proposals and marketing materials. It’s a silent credential that speaks volumes about trust and technical excellence.
Example: One producer I helped saw a 30 % increase in repeat orders once customers realized their CRMs were ISO 17034-certified—because it removed validation work for buyers.
FAQs — Clarifying Who Really Needs ISO 17034
1. Do I need ISO 17034 if I only make in-house calibration standards? Not always. If your materials never leave your lab, you can align your internal procedures with ISO 17034 principles without full accreditation.
2. Can ISO 17025 accreditation substitute for ISO 17034? No. ISO 17025 demonstrates competence in testing or calibration—not in producing and certifying reference materials.
3. How do I know if accreditation is worth it? If external clients, regulators, or partners depend on your reference materials, accreditation pays off quickly in trust, recognition, and fewer re-audits.
Conclusion — Is ISO 17034 Right for You?
ISO 17034 isn’t just for large national labs—it’s for any organization producing reference materials that others rely on. Even internal labs can benefit from adopting its structure to tighten control and consistency.
In my experience, the decision often comes down to one question: Do your materials influence decisions beyond your own lab? If yes, ISO 17034 is the standard that protects your reputation.
Next step: Perform a simple readiness check or explore QSE Academy’s ISO 17034 Implementation Toolkit. You’ll get the gap-analysis template, documentation structure, and action plan you need to move confidently toward accreditation.
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.
