If you’re moving from ISO Guide 34 to ISO 17034, internal audits are your best safety net. They catch weaknesses before the accreditation body does.
Most Reference Material Producers (RMPs) update their documentation, train staff, and tweak systems — but forget to test if it all actually works. That’s where internal audits come in. They tell you how ready your system really is, and where the gaps still hide.
By the end of this guide, you’ll know how to plan and run internal audits during transition so you can walk into your external assessment confident — not guessing.
Understanding the Role of Internal Audits in the Transition
Internal audits are more than a compliance box. They’re your dry run — your proof that every process aligns with ISO 17034’s stricter, measurable requirements.
Under ISO 17034, internal audits aren’t limited to checking paperwork. They now dig deeper into:
Technical competence and metrological traceability.
Homogeneity and stability verification.
Management system integration (Option A or B).
Evidence of improvement actions since your last ISO Guide 34 review.
Pro Tip: Run your audit like a mock external audit. Use the same level of questioning and clause-based evidence collection you’d expect from an accreditation assessor.
Common Pitfall: Auditing too early in the transition — when half your procedures are still in draft form. Always finalize key procedures first, then audit for effectiveness.
Planning the ISO 17034 Transition Audit Program
A strong internal-audit plan during transition keeps things organized and realistic.
Here’s how to build it:
List every updated procedure — highlight what changed.
Identify high-risk areas such as production, measurement traceability, and calibration.
Define objectives — are you checking conformity, readiness, or both?
Assign auditors who aren’t directly responsible for the areas they review.
Schedule at least two audits: one mid-transition and one final readiness check.
Pro Tip: Give each audit a focus. The first can assess document and process readiness. The second should simulate the accreditation audit — full-system scope.
Example: One RMP ran a “trial audit” three months before their ISO 17034 assessment. They discovered incomplete training records for new equipment — fixed them early and passed with zero major findings.
Conducting Effective Internal Audits Under ISO 17034
Once planning’s done, here’s how to conduct an audit that adds value — not just paperwork.
Review updated documents clause by clause.
Interview staff to confirm understanding of new procedures.
Check evidence of measurement traceability, calibration, and stability tests.
Document findings clearly and reference the exact clause.
Pro Tip: Use a clause-based checklist (covering Clauses 5 – 8). It keeps audits structured and makes report writing easier later.
Pitfall: Avoid vague findings like “procedure needs improvement.” Instead, say “Clause 7.5 — procedure SOP-P07 lacks evidence of calibration verification for equipment EQP-02.” Precision matters.
Evaluating Audit Findings and Prioritizing Corrective Actions
After the audit, it’s time to turn observations into action.
Classify findings: major, minor, or observation.
Assign responsibility: name the person, not just the department.
Set deadlines: realistic but firm.
Verify effectiveness: always close the loop.
Pro Tip: Track all findings in one shared sheet — internal and external — so your team can see progress at a glance.
Example: One RMP found recurring issues with document control. Using a “5 Whys” root-cause analysis, they traced it to untrained backup staff. A short refresher training solved it permanently.
Auditing Technical Competence and Traceability
This is where many internal audits fall short. ISO 17034 expects clear proof of technical competence.
Check for:
Staff training and qualifications tied to production tasks.
Validated measurement methods and uncertainty evaluations.
Calibration certificates with traceable standards.
Proper records for homogeneity and stability tests.
Pro Tip: Pair your Quality Auditor with a Technical Expert. You’ll get balanced findings — procedural compliance and scientific validity.
Reporting and Follow-Up During Transition
A good audit isn’t complete until it’s reported clearly.
Your internal-audit report should include:
Scope, objectives, and date.
Areas audited and personnel interviewed.
Summary of conformities and findings.
Corrective-action plan with deadlines.
Pro Tip: Add a “Transition Readiness Summary” — a table showing how compliant each ISO 17034 clause is (Fully / Partially / Not Yet). It becomes your accreditation body’s favorite page.
Common Pitfall: Closing findings too soon. Always check if the fix works, not just if a document was updated.
Using Internal Audits to Prove Readiness to Accreditation Bodies
Your final internal audit is your strongest piece of evidence. Accreditation assessors love seeing an honest, detailed self-assessment — it shows maturity and control.
Keep the following records ready:
Internal-audit schedule and checklist.
Audit reports with objective evidence.
Corrective-action tracking log.
Follow-up verification notes.
Pro Tip: Present your internal-audit summary at the opening meeting of your external audit. It immediately demonstrates proactive quality management.
FAQs — Internal Audits During ISO 17034 Transition
Q1. How many internal audits do we need before the external one? Ideally two — one mid-transition and another full-system audit before your accreditation body visit.
Q2. Can the same person who wrote the procedures audit them? No. ISO 17034 requires independence — assign auditors who weren’t involved in creating or implementing the procedure.
Q3. Can I reuse my old ISO Guide 34 audit checklist? Yes, but only after updating clause references and adding new requirements for traceability, competence, and uncertainty.
Conclusion — Turning Internal Audits Into a Transition Advantage
Internal audits aren’t just about ticking boxes — they’re how you prove control, competence, and consistency. When done right, they transform the ISO 17034 transition from guesswork into a confident, evidence-based process.
Every audit you run is a rehearsal for accreditation — one that sharpens your system and your team.
Next Step: Download the ISO 17034 Internal Audit Checklist and Corrective-Action Tracker to start assessing your readiness and closing gaps with precision.
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.
