Here’s something I’ve learned after years of helping Reference Material Producers (RMPs) prepare for ISO 17034 accreditation: most internal audits fail not because teams don’t care, but because they lack structure. They’re following scattered notes, mixing ISO 9001 and ISO 17025 requirements, and hoping it’s “close enough.”
That’s exactly why we created this ISO 17034 Internal-Audit Checklist—a step-by-step guide that walks you through each clause, ensures your audit covers everything accreditation bodies look for, and helps you uncover improvement opportunities long before assessment day.
By the end of this guide, you’ll know:
How to use the checklist effectively.
What to look for in each ISO 17034 clause.
How to transform audit results into real performance gains.
Understanding the Purpose of an ISO 17034 Internal Audit
An internal audit isn’t just a compliance exercise—it’s your mirror. It shows you how well your quality system actually works in practice.
When I work with RMPs, the first thing I emphasize is this: the goal isn’t to “pass the audit”; it’s to find weaknesses before an external auditor does. That mindset changes everything.
A solid ISO 17034 internal audit helps you:
Verify that your QMS processes are effective.
Check that your team consistently applies procedures.
Identify risks before they lead to nonconformities.
Pro tip: Plan audits around your production cycles, not just your calendar. It keeps findings relevant and actionable.
Common pitfall: Some RMPs treat audits like one-off projects. That’s a mistake. The best labs build auditing into their yearly rhythm—it becomes part of how they improve, not just a checkbox exercise.
Key Sections of the ISO 17034 Internal-Audit Checklist
The checklist is structured clause by clause, so you don’t miss critical areas. Each section guides you through evidence to review and questions to ask.
Here’s what’s inside:
Management & Organization: Roles, responsibilities, and authority structure.
Personnel Competence: Training, qualifications, and continuous competence verification.
Subcontracting & Equipment Control: How you manage suppliers and calibrations.
Production of Reference Materials: From planning to homogeneity testing.
Metrological Traceability: How you ensure all measurements trace back to recognized standards.
Quality Assurance & Data Control: Review of test data, calculations, and reporting.
Records & Document Control: Version control, storage, and retention.
Pro tip: Adapt checklist questions to your material type—what applies to a chemical RM might differ for a physical or biological one.
What I’ve seen go wrong: Some teams copy ISO 9001 questions into their audits. The result? Gaps in traceability, homogeneity, or measurement uncertainty—three areas that ISO 17034 inspectors care deeply about.
How to Conduct an ISO 17034 Internal Audit Using the Checklist
A checklist is only as effective as how you use it. Here’s the process I guide clients through:
Define scope and timing. Focus each audit on key processes rather than the whole QMS at once.
Select trained auditors. They must be independent of the work being audited.
Review past findings. Look at previous audit results and ensure follow-up actions were completed.
Perform the audit. Use the checklist to evaluate clause-by-clause compliance. Gather objective evidence—not opinions.
Record results. Note what’s compliant, partially compliant, or non-conforming.
Report findings clearly. Include supporting data, not vague comments.
Pro tip: Combine your ISO 17034 and ISO/IEC 17025 audits where possible. You’ll reduce duplication and save valuable time.
Example: One client integrated both systems into a single checklist and cut total audit time by nearly half.
Pitfall to avoid: Writing “compliant” without showing proof. Always attach evidence—records, calibration logs, or procedure references.
Reviewing Audit Findings and Planning Corrective Actions
Audits are pointless if findings sit in a folder. This is where the real improvement starts.
Classify each finding:
Non-conformities: Violations of ISO 17034 requirements.
Observations: Minor deviations that need monitoring.
Opportunities for improvement: Positive suggestions to strengthen processes.
Link every issue to the exact clause. That’s how you build traceability and clarity.
Pro tip: Use root-cause analysis—not guesswork—to plan corrective actions. Ask “why” five times until you get to the real cause.
Example: One RMP kept facing documentation errors. The root cause wasn’t “carelessness”—it was that no one trained staff on new version-control software.
Pitfall: Rushing to close non-conformities without verifying effectiveness. Always follow up after 30–60 days to check if the problem truly disappeared.
Customizing and Downloading the ISO 17034 Internal-Audit Checklist
You can download the editable checklist directly in Excel or Google Sheets format. Once downloaded, personalize it to match your processes, terminology, and document structure.
Here’s how to customize it effectively:
Add your internal process numbers beside each clause.
Insert columns for evidence references, comments, and responsible persons.
Highlight high-risk areas to prioritize during audits.
Pro tip: Keep a master version under document control so everyone uses the latest revision.
Common mistake: Forgetting to update the checklist after a procedure change or new revision of ISO 17034. Outdated audit tools create confusion and missed findings.
Integrating the Checklist into Continuous Improvement
An internal audit should never end with the final report—it should feed directly into management reviews and improvement projects.
Track trends:
Which clauses produce repeat findings?
Which areas show consistent improvement?
What risks are emerging from audit data?
Pro tip: Visualize findings using charts or dashboards. It helps management see progress instantly.
Example: One RMP discovered recurring issues with subcontractor evaluations. Tracking them graphically helped justify vendor qualification upgrades—reducing errors by 30%.
Audits become powerful when you treat them as a feedback engine, not a punishment tool.
FAQs
Q1: How often should we conduct ISO 17034 internal audits? At least once a year. However, if you’ve had significant process changes or new RM types, add targeted audits in between.
Q2: Can we use one checklist for both ISO 17034 and ISO/IEC 17025? Yes—if it’s mapped correctly. Many labs successfully merge overlapping sections like competence, traceability, and data control.
Q3: Do accreditation bodies accept customized audit checklists? Absolutely. In fact, they prefer it. Customization shows your understanding of ISO 17034 and proves your audit isn’t a copy-paste exercise.
Conclusion — Turn Audits into Opportunities
Internal audits don’t have to feel like paperwork. With the right checklist, they become one of your best improvement tools.
Our ISO 17034 Internal-Audit Checklist helps you stay compliant, identify issues early, and build confidence before accreditation day.
I’ve seen RMPs go from scattered notes to structured, data-driven audits in just a few weeks using this template.
Now it’s your turn— Download your ISO 17034 Internal-Audit Checklist and start auditing with clarity and confidence.
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.
