After years of helping labs and reference-material producers get accredited, I’ve noticed the same confusion pop up again and again. People mix up ISO 17034 with ISO/IEC 17025, think it’s only for big national labs, or assume it’s “just more paperwork.”
The truth? ISO 17034 is one of the most misunderstood — yet most valuable — accreditations in metrology and testing.
In the next few minutes, we’ll unpack the biggest myths I hear every week and explain what’s really true about this standard — so you can see whether it’s something your organization should take seriously.
This one comes up constantly, and it’s simply not true.
ISO/IEC 17025 proves that your testing or calibration is technically sound. ISO 17034 proves that your reference materials themselves are characterized, homogeneous, stable, and traceable. They focus on two very different things.
Example: One lab I worked with assumed their ISO 17025 certificate was enough for their CRM line. When their customers asked for ISO 17034 documentation, they realized there was a gap — no proof of stability studies, no uncertainty budget for assigned values.
Pro Tip: Use ISO 17025 to validate how you measure, and ISO 17034 to validate what you produce. Both standards complement each other perfectly.
Pitfall: Assuming one accreditation covers both. Accreditation bodies treat them as distinct scopes — and auditors will, too.
Myth #2 — “Only Large or National Labs Need ISO 17034”
Size doesn’t matter — competence does.
Some of the most successful accredited producers I’ve seen are small teams of five or six people. Accreditation helped them compete with major institutions by proving reliability, not reputation.
Example: A small regional RMP I guided through accreditation became the go-to supplier for local calibration labs simply because they were the only accredited option in their niche.
Pro Tip: Start small. You don’t need 50 CRMs in your scope — begin with one product line, master the process, and expand gradually.
Pitfall: Waiting until you’re “big enough.” By the time you think you’re ready, competitors will already be accredited and preferred by clients.
Myth #3 — “ISO 17034 Is Just a Quality-System Requirement”
If you think ISO 17034 is just documentation, you’re missing the point. It’s about technical competence — understanding your material’s behavior over time, measuring uncertainty correctly, and ensuring stability and homogeneity.
Example: During one implementation, we discovered a CRM batch losing stability over six months. Because the lab followed ISO 17034’s monitoring requirements, they caught the issue early and avoided distributing a compromised material.
Pro Tip: Treat the standard as a technical framework first, administrative second. The procedures and forms only make sense when they reflect real data and decisions.
Pitfall: Copying generic ISO 9001 procedures. ISO 17034 goes much deeper into measurement science — you can’t shortcut it with templates alone.
Myth #4 — “Accreditation Is Too Expensive for What You Get”
I understand the hesitation — accreditation isn’t free. But when you look at the return, the cost makes sense fast.
Accredited producers spend less time defending their data, face fewer client audits, and close contracts faster because buyers already trust the ILAC logo.
Example: A CRM producer I worked with calculated that one year of accreditation cost less than the time and resources spent handling client audits before accreditation.
Pro Tip: Measure your ROI in reduced audit days, faster client approvals, and new opportunities. Accreditation almost always pays for itself within the first year.
Pitfall: Only looking at upfront fees. The real savings come from time, credibility, and repeat business.
Myth #5 — “It’s Only Needed if You Sell Certified Reference Materials”
Even if your reference materials never leave your building, ISO 17034 principles can still improve your lab’s reliability.
Internal materials used for calibration, validation, or proficiency testing benefit from the same rigor — you just might not need full accreditation yet.
Example: One calibration lab I advised didn’t sell CRMs but aligned their internal procedures with ISO 17034 anyway. Their next ISO/IEC 17025 reassessment had zero nonconformities — assessors noted how well their traceability records were structured.
Pro Tip: You can adopt ISO 17034’s technical practices without pursuing accreditation immediately. It’s a smart stepping-stone for future growth.
Pitfall: Assuming internal use equals exemption from quality rules. Traceability still matters — whether you sell materials or not.
FAQs — Fast Answers to Common Questions
1. Is ISO 17034 mandatory for CRM producers? Not by law, but many regulators and clients now require accredited CRMs for official testing or calibration. In practice, it’s becoming the expectation.
2. How long does ISO 17034 accreditation take? Most producers complete the process in six to twelve months, depending on documentation readiness and how much characterization data you already have.
3. Can one audit cover both ISO 17025 and ISO 17034? Yes, many accreditation bodies offer combined audits, which saves time and cost — as long as both scopes are clearly defined.
Conclusion — The Truth About ISO 17034
Here’s what I’ve learned after helping dozens of producers: ISO 17034 isn’t a burden — it’s a blueprint for trust, precision, and professional growth.
It strengthens your reputation, simplifies compliance, and opens doors that paperwork alone never could.
If you’re serious about producing reliable reference materials — whether for clients or your own lab — ISO 17034 isn’t optional. It’s the mark of competence the world recognizes.
Next step: Download QSE Academy’s ISO 17034 Myth-Busting Checklist or explore our Implementation Toolkit to see exactly where you stand — and what it would take to get accredited confidently.
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.
