When I first started guiding labs through ISO 17034 accreditation, one thing was clear — the terminology tripped people up more than the requirements themselves. Words like homogeneity, characterization, or uncertainty sound technical, but once you understand them, they actually make perfect sense.
This glossary breaks down the language of ISO 17034 into plain English. Whether you’re new to reference-material production or brushing up before an audit, you’ll see what each term means, why it matters, and how it fits into everyday work in your lab.
Core ISO 17034 Concepts Explained Simply
Before diving into procedures, it helps to get comfortable with the basics.
Reference Material (RM): A sample with a known property value, used to check or compare measurements. Think of it as your lab’s yardstick.
Certified Reference Material (CRM): A reference material that has gone through rigorous testing and certification — it’s traceable and includes a stated uncertainty.
Reference-Material Producer (RMP): The organization that designs, prepares, tests, and certifies reference materials under ISO 17034.
Metrological Traceability: The documented path linking your measurements to international or national standards through an unbroken chain of calibrations.
Example: When your CRM certificate says “traceable to NIST standards,” that’s traceability in action.
Pro Tip: Add these key definitions to your quality manual — it helps new staff learn faster and reduces confusion during audits. Pitfall: Don’t use “RM” and “CRM” interchangeably. Certification makes the difference between the two.
Technical Testing & Production Terms You’ll See in ISO 17034
Once you know the basics, the next set of terms describes how you actually prove your materials are reliable.
Characterization: Determining the true value of a property using testing or measurement — it’s the process that defines your CRM’s assigned value.
Homogeneity: Checking that all units in a batch are consistent. Every bottle or vial should behave the same.
Stability: Ensuring the material keeps its properties over time — months or even years after production.
Uncertainty: A quantitative expression of confidence in your measurement results. It’s not an “error,” it’s a calculated range showing how sure you are.
Example: If you produce 100 vials of a CRM, characterization finds the value, homogeneity confirms every vial is the same, stability keeps it valid next year, and uncertainty tells users how reliable that number is.
Pro Tip: Document each stage — auditors look for evidence of testing, not just statements. Pitfall: Don’t call uncertainty “error.” Errors are mistakes; uncertainty is part of good science.
Quality-Management and Accreditation Terms
ISO 17034 also speaks the language of management systems — here’s what those terms really mean.
Quality Management System (QMS): The structure that defines how you run your operation — from procedures to records to reviews.
Management Review: A regular check by leadership to ensure the QMS is still effective and improving.
Nonconformity: When something doesn’t meet a requirement or your own procedure. It’s not the end of the world — it’s a signal to investigate.
Corrective Action: The steps you take to fix the cause of a nonconformity so it doesn’t happen again.
Example: If your storage freezer failed and affected stability results, recording the event, fixing the cause, and reviewing preventive measures are all part of corrective action.
Pro Tip: Discuss nonconformities openly. Labs that treat them as learning moments grow stronger over time. Pitfall: Confusing “nonconformity” with “audit finding.” Assessors may note observations that aren’t actual nonconformities.
Accreditation and Recognition Terms
ISO 17034 connects your competence to global acceptance — here’s how that structure works.
Accreditation Body (AB): The independent organization (like SANAS, UKAS, or ANAB) that assesses your compliance and grants accreditation.
Scope of Accreditation: The specific materials, properties, or measurement methods covered by your accreditation certificate.
ILAC MRA (Mutual Recognition Arrangement): The international framework that ensures accredited CRMs are recognized worldwide.
Example: When your AB is part of ILAC MRA, a CRM certified under your name in one country is trusted by laboratories across the globe.
Pro Tip: Review and update your scope annually — it’s both a compliance task and a marketing opportunity. Pitfall: Forgetting to announce new scope expansions to customers; it’s one of the easiest ways to promote your progress.
Supporting Terms from Related Standards
ISO 17034 doesn’t exist in isolation — it overlaps with ISO 17025 and ISO 9001. Knowing these linked terms keeps your system consistent.
Validation: Proving a method works for its intended purpose.
Verification: Checking that a result or process meets predefined requirements.
Proficiency Testing (PT): Comparing your lab’s results with others to confirm competence.
Traceability Chain: The full series of calibration steps connecting your measurement to an international standard.
Example: If your weighing balance is calibrated to a national standard, that chain is your traceability path — it supports both ISO 17025 and ISO 17034 requirements.
Pro Tip: When integrating standards, map clauses side-by-side. It helps prevent duplicated procedures. Pitfall: Mixing up validation and verification — validation happens before routine use, verification confirms performance during use.
FAQs — Quick Clarifications
1. What’s the easiest way to teach these terms to new staff? Create a shared glossary in your QMS and update it after audits or training sessions. A short quiz in onboarding helps it stick.
2. Are ISO 17025 and ISO 17034 definitions the same? They overlap, but ISO 17034 adds production-specific terms like characterization, homogeneity, and stability.
3. Can I simplify definitions on CRM certificates? Yes, keep wording user-friendly — just ensure the full official definitions remain in your controlled documentation for traceability.
Conclusion — Speak ISO 17034 Fluently
Understanding ISO 17034 terms isn’t about memorizing jargon — it’s about speaking the language of trust and precision. When everyone in your team knows what these words mean, compliance becomes easier, communication smoother, and audits far less stressful.
I’ve seen labs transform once the terminology clicks — suddenly, people stop fearing audits and start owning their systems.
Next step: Download QSE Academy’s ISO 17034 Glossary PDF. It’s a ready-to-use reference you can print, share, or integrate into your QMS to keep your whole team on the same page.
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.
