Over the years, I’ve helped dozens of Reference Material Producers (RMPs) prepare for ISO 17034 accreditation. And here’s what I’ve noticed: most audit findings are not surprises. They’re patterns.
Every audit reveals the same weak points—missing calibration traceability, incomplete records, or staff who can’t quite explain their own procedures. The good news? Once you know what these patterns look like, you can prevent them long before an auditor steps in.
In this guide, we’ll walk through the most common ISO 17034 audit non-conformities, why they happen, and how to fix them using practical strategies that actually work in real labs.
What Counts as a Non-Conformity Under ISO 17034
Before you can fix findings, you need to understand how they’re classified.
Auditors usually group findings into three categories:
Major non-conformities — serious issues that indicate a failure of the system.
Minor non-conformities — isolated lapses or inconsistencies.
Observations or opportunities for improvement (OFIs) — suggestions for better alignment or performance.
A major might look like missing calibration traceability for key instruments. A minor could be a single outdated SOP.
Pro Tip: Always map findings directly to ISO 17034 clauses. It helps you understand their context and decide which to fix first.
Common pitfall: Dismissing everything as “minor.” Small issues that repeat across processes often reveal a much larger system weakness.
Metrological traceability is the foundation of ISO 17034 compliance—yet it’s where most RMPs stumble.
Here’s what typically goes wrong:
Calibration certificates are expired or missing.
Reference standards lack documented traceability to SI units.
Measurement equipment was calibrated by non-accredited labs.
Traceability isn’t about paperwork—it’s about confidence in your measurement results.
Pro Tip: Create a simple “traceability map” that links every measurement or calibration to its reference standard and the corresponding ISO/IEC 17025 certificate.
Example: One RMP failed its initial audit because their balances were calibrated by a supplier that wasn’t ISO/IEC 17025 accredited. After switching vendors and documenting the traceability chain, the issue never came up again.
Pitfall: Assuming “any calibration certificate” is enough. Auditors look for recognized accreditation and valid traceability chains.
Non-Conformity #2: Weak Production and Characterization Records
If traceability is the backbone, then records are the nervous system of your QMS.
Many audit findings stem from incomplete or disorganized production records, such as:
Missing batch data or characterization logs.
Poorly documented homogeneity and stability studies.
Unclear traceability between raw data and the final certified values.
Pro Tip: Use standardized templates for every production stage—planning, testing, and certification. It ensures consistency and makes retrieval effortless.
Example: During one audit, a lab couldn’t link its raw stability data to the certified value. The process was sound, but documentation gaps led to a non-conformity. A simple traceability matrix fixed that permanently.
Pitfall: Keeping critical data in personal folders or untracked drives. Auditors expect all controlled records to live inside the QMS—not on someone’s laptop.
Non-Conformity #3: Competence and Training Gaps
This one’s a silent killer in many audits. On paper, everyone looks qualified. In reality, auditors start asking questions and staff freeze.
Typical red flags:
No formal competence matrix.
Training records missing for newly hired analysts.
No documentation proving technical evaluations or witnessed competence.
Pro Tip: Build a live competence tracker that lists every employee, their role, training history, and next evaluation date. Link it directly to the relevant ISO 17034 clauses.
Example: An RMP received a major non-conformity because two technicians were performing homogeneity tests without documented training. Once they implemented a structured training plan and competence evaluation form, the issue was resolved and even praised at their next audit.
Pitfall: Thinking experience equals competence. Without objective records, it doesn’t count in an audit.
Non-Conformity #4: Poor Document and Record Control
Document control is one of those areas that feels simple—until it isn’t.
Auditors often find:
Outdated SOPs still in use.
Missing revision histories or uncontrolled documents in circulation.
Records without approval signatures or revision tracking.
Pro Tip: Keep all controlled documents in one central repository—digital or hard copy—and restrict editing rights. Automatic version control prevents chaos.
Example: One client reduced confusion by assigning each SOP a unique ID linked to the process owner. During the audit, the assessor complimented how easy it was to verify document currency.
Pitfall: Allowing staff to keep personal copies of old procedures “just in case.” That’s how outdated methods sneak back into practice.
Non-Conformity #5: Weak Internal Audits and Corrective-Action Follow-Up
Here’s the irony: the internal audit—meant to catch problems early—is often the weakest link.
Common mistakes include:
Using a generic ISO 9001 checklist instead of an ISO 17034-specific one.
Closing findings without verifying effectiveness.
Repeating the same non-conformities year after year.
Pro Tip: Conduct clause-by-clause internal audits and use trend analysis to identify recurring weaknesses.
Example: A materials producer once had six repeat findings over three years. When we redesigned their checklist around ISO 17034 clauses and added a “verification of correction” step, those issues disappeared by the next audit.
Pitfall: Treating internal audits as paperwork instead of performance reviews. The goal isn’t to tick boxes—it’s to find real gaps before the assessors do.
How to Address and Prevent Non-Conformities Before the Next Audit
When you do receive findings, how you respond determines your credibility.
Follow a simple four-step corrective-action process:
Identify and describe the issue clearly. Include the clause reference.
Analyze the root cause. Use tools like the 5 Whys or a Fishbone diagram.
Implement corrective and preventive actions. Assign responsible persons and deadlines.
Verify effectiveness. Re-audit or review evidence after implementation.
Pro Tip: Turn every finding into a team learning session. Update SOPs, retrain staff, and review lessons during management meetings.
Example: One RMP created a monthly “quality huddle” to discuss recent findings and updates. Within six months, their repeat non-conformities dropped by 70 %.
Pitfall: Rushing to close findings without proving the fix worked. Quick isn’t the same as effective.
FAQs
Q1: Which ISO 17034 clauses cause the most non-conformities? Clauses 5 (Personnel Competence), 6–7 (Equipment & Subcontracting), and 9–10 (Metrological Traceability & Production) show up most often in audit reports.
Q2: Are minor non-conformities a big deal? Individually, no—but repeat minors indicate weak systems. Over time, they can trigger major findings or delay accreditation.
Q3: How quickly should we close non-conformities? Most accreditation bodies expect closure within 30–90 days. Always provide objective evidence, like revised records or training proofs.
Conclusion — Turn Audit Findings into Continuous Improvement
Every non-conformity tells a story. It’s not about failure—it’s feedback.
The most successful RMPs I’ve worked with don’t fear audit findings; they use them to strengthen their systems, train their people, and refine their data integrity.
When you understand the most common ISO 17034 non-conformities and fix their root causes, audits become smoother, predictable, and far less stressful.
Ready to get ahead of your next audit? Download your ISO 17034 Non-Conformity Checklist Template today and start tracking, correcting, and preventing issues before they appear on your report.
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.
