Turning ISO 17034 Audits into a Success Strategy

Preparing for an ISO 17034 accreditation audit can feel overwhelming. Reference Material Producers (RMPs) often worry about what auditors will look for, how deep they’ll go, and whether their systems are ready.

The truth is, an audit doesn’t have to be stressful when your system is structured, your team is prepared, and your documentation tells a clear story of competence and control.

This guide walks you through every stage of the ISO 17034 audit process — from early planning to post-audit improvement — so you can pass the first time with confidence and build a culture that thrives beyond accreditation.

Understanding the ISO 17034 Audit Process

ISO 17034 audits serve one purpose: to verify that your reference-material production process is technically competent, traceable, and effectively managed.

There are three main types of audits:

• Internal audits — performed by your team to verify compliance and readiness.
• Accreditation audits — conducted by external bodies before granting or renewing accreditation.
• Surveillance audits — periodic checks that ensure you continue meeting ISO 17034 requirements.

The typical flow looks like this:

1. Document review – assessors evaluate your procedures, records, and QMS structure.
2. On-site assessment – they observe processes, check traceability, and interview personnel.
3. Closing meeting – findings are presented and discussed.

Pro Tip: Approach the audit as validation, not inspection. It confirms your system works as designed.

Pitfall: Treating the audit as a one-day event instead of a cycle of continuous improvement.

Pre-Audit Planning: Building the Right Foundation

Every successful audit starts months before the assessors arrive. Preparation ensures you have no surprises when it matters most.

Key pre-audit steps:

• Conduct a gap analysis against ISO 17034 clauses.
• Perform a full internal audit and close pending non-conformities.
• Hold a management review that evaluates resources, risks, and improvement actions.
• Verify that calibration certificates, training records, and production data are complete and current.

Pro Tip: Begin preparation at least three months in advance. It gives enough time to correct gaps, retrain staff, and verify records.

Pitfall: Waiting for the accreditation body’s notice before organizing your readiness activities.

Preparing Documentation and Objective Evidence

Documentation is your audit backbone. It shows how your quality system supports each ISO 17034 requirement.

Your evidence should include:

• Quality manual and policies.
• SOPs for production, testing, and characterization.
• Records of homogeneity, stability, and traceability.
• Calibration certificates and subcontractor approvals.
• Competence evaluations and training logs.

Organize your files logically — either by clause or process — and keep version control visible.

Pro Tip: Maintain a digital “audit package” with controlled access. It speeds up retrieval and keeps your presentation consistent.

Pitfall: Overloading assessors with excessive or duplicate documents. Clarity always outweighs volume.

Competence and Confidence — Preparing Your Team

Auditors don’t just assess documents; they assess people. Your team’s understanding of their roles is a strong reflection of your management system.

Prepare by:

• Reviewing each employee’s competence profile.
• Refreshing training on procedures and key tasks.
• Clarifying who will answer for which process area during the audit.

Example: During one assessment, a laboratory’s technician clearly explained the logic behind their homogeneity testing method. The auditor noted this as a strength because it demonstrated real competence, not memorized responses.

Pro Tip: Encourage openness. If someone doesn’t know an answer, they can refer to documented evidence — that shows control, not weakness.

Common Audit Non-Conformities and How to Avoid Them

Understanding where others often struggle helps you stay ahead.

Typical ISO 17034 audit findings include:

• Traceability gaps — missing or outdated calibration certificates.
• Weak production documentation — incomplete data on reference-material batches.
• Training gaps — competence not evaluated or outdated records.
• Document control issues — obsolete versions still in use.
• Weak internal audits — findings repeated from previous years.

Pro Tip: Review your previous audits for recurring patterns. Recurring minors indicate systemic weaknesses.

Pitfall: Focusing only on major findings. Consistently repeated “small” issues can jeopardize credibility.

Managing the Audit Day

Audit day runs smoother when everyone knows what to expect.

Here’s a simple structure:

1. Opening meeting — confirm scope, introduce team, and review schedule.
2. Assessment phase — provide requested documents, demonstrate processes, and facilitate site visits.
3. Interviews — staff explain their roles and show awareness of procedures.
4. Closing meeting — auditors summarize findings and discuss next steps.

Pro Tip: Assign one audit coordinator to record every question, document request, and observation. It keeps communication organized and ensures nothing gets missed.

Pitfall: Arguing findings in the moment. Take notes, stay professional, and address issues after reviewing the evidence.

Responding to Findings and Corrective Actions

Even strong systems receive findings. What matters is how you respond.

Follow this structure:

1. Review each finding carefully and cite the corresponding clause.
2. Analyze root cause using the 5 Whys or Fishbone method.
3. Plan corrective actions with clear responsibilities and deadlines.
4. Implement and verify that the action resolved the issue.

Pro Tip: Keep a Corrective-Action Log with status tracking. It demonstrates accountability and progress.

Pitfall: Closing findings too quickly without verifying effectiveness. Auditors revisit unresolved issues in the next cycle.

Post-Audit Follow-Up and Continuous Improvement

Once the audit concludes, use the findings to strengthen your system.

Post-audit steps include:

• Discussing results with your team and capturing lessons learned.
• Updating procedures or risk assessments based on feedback.
• Integrating findings into the next management review.
• Tracking recurring issues through KPIs or performance dashboards.

Pro Tip: Treat every audit as a learning opportunity. The insights often reveal hidden process inefficiencies or training needs.

Pitfall: Filing the audit report away and moving on. Use it as an action plan for the next six to twelve months.

FAQs

Q1: How often should internal audits be conducted?
At least once a year, or more frequently after major process or personnel changes.

Q2: What do auditors value most during ISO 17034 assessments?
Consistency, documented traceability, and a team that clearly understands its processes and responsibilities.

Q3: Can ISO 17034 and ISO/IEC 17025 audits be combined?
Yes. Many RMPs align them for efficiency, but you must keep each standard’s requirements traceable and distinct.

Conclusion — Pass the Audit, Strengthen the System

Passing your ISO 17034 audit on the first attempt isn’t about luck. It’s about preparation, structure, and control.

When your documentation is current, your people are confident, and your system consistently reflects competence, accreditation becomes a natural outcome — not a struggle.

Every audit is a mirror of how your organization works daily. Use it to validate your strengths, correct weaknesses, and prove to clients and regulators that your reference materials meet the highest global standards.

To simplify your preparation, you can use the complete ISO 17034 Audit Preparation Toolkit — it includes editable templates, checklists, and corrective-action logs designed to help you move from preparation to accreditation efficiently.