Last Updated on September 25, 2025 by Melissa Lazaro

Introduction: Why Passing Your ISO 13485 Audit First Time Matters

Let’s be honest—ISO 13485 audits can feel intimidating. Between documentation, risk management, CAPA, and supplier controls, it’s easy to wonder if you’ve covered everything. I’ve guided medical device companies of all sizes through certification, and here’s what I’ve noticed: the difference between a smooth audit and a stressful one usually comes down to preparation.

Passing your ISO 13485 audit on the first try isn’t about perfection—it’s about proving your Quality Management System (QMS) is alive, effective, and consistently applied. The good news? Most audit findings are predictable. If you prepare smartly, you can avoid the common pitfalls that trip up so many companies.

This guide will walk you through the entire ISO 13485 audit process step by step—what to expect in Stage 1 and Stage 2, the most common non-conformities, how to run effective internal audits, and how to handle corrective actions if issues do come up. You’ll also find links to detailed guides and resources, including a free internal audit checklist you can download.

By the end, you’ll have a clear roadmap to approach your ISO 13485 audit with confidence—and a strong chance of passing the first time.

Understanding the ISO 13485 Audit Process

Before diving into preparation, it helps to understand how the ISO 13485 audit process is structured. Certification bodies typically split the audit into two stages:

Stage 1 – Readiness Review

• Focus: Are your documents complete and your QMS formally in place?

• The auditor checks things like your Quality Manual, procedures, internal audit records, and management reviews.

• Think of this as your rehearsal—it identifies gaps before Stage 2.
  For a deeper breakdown, see our guide on [ISO 13485 Stage 1 Audit Preparation].

Stage 2 – Implementation and Effectiveness

• Focus: Can you prove your QMS is working in practice?

• Auditors review records, interview employees, walk the production floor, and check processes like supplier control, training, and CAPA.

• This is the “real test” that determines if you get certified.
  For detailed tips, explore our [ISO 13485 Stage 2 Audit Checklist].

Both stages matter. Stage 1 ensures you’re ready, while Stage 2 validates that your system is robust and consistently applied. Together, they form the backbone of ISO 13485 certification.

Preparing for Stage 1: Documentation and Readiness

Stage 1 of the ISO 13485 audit is all about proving that your Quality Management System (QMS) is formally in place and ready for testing. Auditors want to see that you’ve covered the basics: documentation, internal audits, and management reviews.

Key areas to prepare:

• Quality Manual and procedures — Make sure every required document exists, is approved, and matches the standard.

• Internal audits — At least one full cycle should be complete, with findings recorded and corrective actions documented.

• Management reviews — Minutes should show that leadership has reviewed the QMS, set objectives, and taken decisions.

Pro Tip: Create a simple clause-by-clause matrix that maps ISO 13485 requirements to your procedures. Auditors love this because it shows nothing has been overlooked.

Common mistake: Treating Stage 1 as “just paperwork.” Auditors expect records that prove the QMS is more than theory—for example, evidence that management reviews actually led to decisions and follow-up actions.

For a step-by-step guide on getting Stage 1 right, check out our full article: [ISO 13485 Stage 1 Audit Preparation].

Preparing for Stage 2: Implementation and Evidence

Stage 2 is where the real test happens. Unlike Stage 1, which focuses on readiness and documentation, Stage 2 dives deep into whether your Quality Management System (QMS) is truly working in practice. Auditors will walk the floor, talk to employees, and request records to confirm that your processes match what’s written in your procedures.

Key areas auditors will test:

• Employee competence — staff should know the quality policy and how their role connects to it.

• Production and process controls — records like DMRs, DHRs, and validated processes must be complete and consistent.

• Supplier management — proof that critical suppliers are qualified, monitored, and re-evaluated.

• Risk management integration — risk files updated with complaints, CAPAs, and changes.

• CAPA and nonconformities — not just logged, but investigated, corrected, and checked for effectiveness.

Pro Tip: Be ready to “show and tell.” If auditors ask about a batch, pull up the corresponding records immediately. Quick access builds confidence that your QMS is in control.

For a detailed breakdown of what to expect in Stage 2, see our full resource: [ISO 13485 Stage 2 Audit Checklist].

Common Non-Conformities in ISO 13485 Audits (and How to Avoid Them)

No matter how well-prepared you are, most companies get written up for something. The good news? Audit non-conformities are highly predictable. Year after year, auditors flag the same weak spots.

The most common non-conformities include:

• Document control — outdated procedures still in use or missing approvals.

• Risk management — files not updated with complaints or product changes.

• CAPA and nonconformity handling — weak root cause analysis or no effectiveness checks.

• Supplier controls — lack of documented re-evaluation or performance monitoring.

• Training and competence — staff can’t explain the quality policy or their role in the QMS.

• Internal audits and management reviews — rushed, incomplete, or missing evidence of follow-up actions.

Real-life example: I once worked with a company that had excellent documentation but missed re-evaluating a critical supplier for over two years. The auditor flagged it as a major non-conformity because it posed a direct risk to product quality. The company fixed it by introducing a supplier scorecard and an annual re-approval process—turning a gap into a long-term improvement.

For a full breakdown of the top audit findings and how to prevent them, explore our detailed guide: [Top ISO 13485 Audit Non-Conformities].

The Role of Internal Audits in ISO 13485

If there’s one thing that consistently separates well-prepared companies from those that struggle, it’s the quality of their internal audits. ISO 13485 requires you to run them at planned intervals, but the real value is in using them to spot issues before an external auditor does.

Why internal audits matter:

• They ensure every clause of ISO 13485 is covered during your audit cycle.

• They highlight weak spots—so you can fix them early, not under audit pressure.

• They provide management with real visibility into how effective the QMS is.

💡 Pro Tip: Use a checklist to keep your internal audits consistent and comprehensive. It’s much easier to track findings and prove coverage when you’ve followed a structured template.

👉 To make this easier, we’ve created a free resource: [ISO 13485 Internal Audit Checklist Download].

Internal audits aren’t just about compliance—they’re your best rehearsal before the certification body arrives.

Corrective Actions for ISO 13485 Audit Findings

Even with the best preparation, audit findings happen. What matters isn’t whether you have them—it’s how you respond. Corrective actions are your chance to prove that your QMS doesn’t just record problems, but actually learns from them.

The corrective action process usually follows five steps:

1. Contain the issue – take immediate action to prevent further impact.

2. Investigate root cause – dig deeper than symptoms using methods like the 5 Whys.

3. Plan corrective actions – define what will be done, by whom, and by when.

4. Implement and document – show clear evidence of changes made.

5. Verify effectiveness – prove the fix worked with data or follow-up audits.

Pro Tip: Auditors are often more impressed by a strong corrective action system than by a company with no findings at all. It shows maturity and continuous improvement.

For detailed guidance, check out our article: [ISO 13485 Corrective Actions for Audit Findings].

Handled well, corrective actions can turn an audit finding into a positive reflection of your system’s strength.

FAQs on Passing Your ISO 13485 Audit

Q1. Can you fail an ISO 13485 audit?
Yes. If major non-conformities are found—like missing risk management or no CAPA process—certification will be delayed until they’re corrected. Minor findings alone usually won’t block certification, as long as you submit corrective actions within the required timeframe.

Q2. How long does the full ISO 13485 audit process take?
Most companies can complete Stage 1 and Stage 2 within a few months. Stage 1 often takes 1–2 days, while Stage 2 can take 2–5 days depending on your size and scope. Corrective actions, if needed, may add extra time.

Q3. Do internal audits need to cover every clause of ISO 13485?
Yes. Over the course of your internal audit cycle, every requirement of the standard must be checked. Some organizations do this all at once, while others spread it out across the year.

Conclusion: Key Takeaways for Passing Your ISO 13485 Audit First Time

Passing your ISO 13485 audit on the first attempt doesn’t come down to luck—it comes down to preparation. If your documentation is in order, your processes are implemented consistently, and your team understands their role in quality, you’ll give auditors the confidence they’re looking for.

The roadmap is straightforward:

• Use internal audits to spot gaps early.

• Treat Stage 1 as your readiness check.

• Approach Stage 2 with solid evidence and staff involvement.

• Be aware of common non-conformities and avoid the traps.

• Handle corrective actions with root cause analysis and effectiveness checks.

In my experience, organizations that prepare this way rarely face major setbacks. Instead, they walk into audits confident, with fewer surprises and a smoother path to certification.

👉 Your next step: Download the [ISO 13485 Internal Audit Checklist] and review our detailed guides on [Stage 1 Preparation], [Stage 2 Checklist], [Top Non-Conformities], and [Corrective Actions]. Together, they’ll give you a complete toolkit to approach your audit with confidence—and pass the first time.