Last Updated on September 24, 2025 by Melissa Lazaro

What ISO 15189 2022 Auditors Look for?

Let’s be honest—most labs prepping for ISO 15189:2022 feel like they’re guessing. You’ve got the SOPs. The quality manual is updated. The team’s been trained. But when the auditor walks through the door, there’s still that nervous question floating around: What exactly are they going to focus on?

In my experience helping over 150 labs pass ISO 15189 audits—many on their very first try—I can tell you this: it’s not just about having documentation. Auditors want to see if your system is actually working. They’re looking for evidence that your team understands your processes, that your risks are under control, and that you’re not just compliant—you’re committed.

If you’re a quality manager, lab director, or internal auditor wondering what to expect when your turn comes, you’re in the right place.

In this article, I’ll walk you through exactly what ISO 15189:2022 auditors look for—based on real audits I’ve guided labs through. No guesswork. No fluff. Just clear insights that’ll help you prepare smart and present your lab with confidence.

Let’s break it down together.

Understand the Role of an ISO 15189 Auditor

Here’s what I’ve noticed—many labs assume that auditors are there just to “check the documents.” And while yes, they’ll absolutely look at your paperwork, that’s just one piece of the puzzle.

So, what’s an auditor really doing during your ISO 15189:2022 assessment?

They’re not just hunting for mistakes. They’re evaluating how well your entire quality management system works—on paper and in practice.

In simple terms, they’re asking:

• Is your lab following ISO 15189:2022 requirements consistently?

• Are your processes traceable, controlled, and clearly understood by your team?

• Do your systems actually support quality results—or just look good in a binder?

Here’s how this plays out in real life:

I worked with a diagnostic lab in the Middle East that had beautifully organized documentation. Everything was version-controlled, color-coded, and formatted perfectly. But when the auditor started asking staff how they handled sample rejections or what their role was in the quality system, things fell apart. The disconnect between paper and practice triggered two major nonconformities.

What did the auditor say? “The system looks good—but the team’s not living it.”

What this means for you:

Expect your auditor to spend time:

• Reviewing your documents and records

• Observing your workflows in action

• Interviewing staff across different roles

• Cross-referencing your SOPs with real-time practice

They’re looking for alignment. Consistency. Confidence from your team—not perfection, but proof that your system works.

Top Areas Auditors Focus On in the 2022 Version

Now that we’ve covered what auditors are generally looking for, let’s get more specific. The 2022 update to ISO 15189 didn’t just tweak a few phrases—it shifted the whole approach. And auditors are adjusting their lens accordingly.

So, where do they focus most?

Here’s what I’ve consistently seen across labs preparing for ISO 15189:2022:

1. Risk-Based Thinking in Action

Auditors don’t just want to see a “risk register” sitting on a shelf. They want to know how your lab actually identifies, monitors, and controls risks as part of your daily work.

• Have you assessed risks related to equipment downtime?

• What happens if there’s a delay in your reagent supply chain?

• How do you prevent reporting errors during high-volume periods?

I once had an auditor ask a lab technician what they’d do if a power interruption happened during PCR analysis. That single question revealed gaps in both contingency planning and training.

2. Staff Competency and Ongoing Evaluation

Auditors want to see that your team isn’t just trained once and forgotten. They’ll ask:

• How often is competency assessed?

• Is there a documented method for evaluating performance?

• Can the team explain their role in the quality system?

Hint: a signed attendance sheet from last year’s training session isn’t enough.

3. Internal Audits and Management Reviews

Auditors look closely at your internal review mechanisms:

• Were the audits thorough or rushed?

• Are nonconformities tracked, analyzed, and resolved?

• Is your management review process meaningful—or just minutes on paper?

One auditor I worked with spent nearly an hour discussing a lab’s internal audit findings—because the follow-up actions weren’t clear. The lab had good intentions, but the lack of closure raised red flags.

4. Equipment and Calibration Records

Expect auditors to dig into:

• Maintenance logs

• Calibration certificates

• Equipment qualification documentation

They often compare what’s scheduled vs. what’s been done. Any gaps here? They’ll catch them.

5. Data Integrity and IT Controls

This is a growing focus. Auditors want to know:

• How secure is your lab’s data?

• Who has access to edit results?

• What’s the process for verifying digital entries?

More than once, I’ve seen labs marked down for not having a clear audit trail in their LIMS or failing to lock result fields after validation.

How Auditors Evaluate Implementation (Not Just Paperwork)

Let’s be real—having a beautifully written SOP doesn’t mean much if no one follows it. And auditors know this. That’s why under ISO 15189:2022, they’re not just reviewing documents—they’re checking how well your system is being lived out.

So how do they do that?

Here’s what I’ve seen time and time again in real audits:

1. They Watch What Your Team Actually Does

Auditors will observe how samples are received, labeled, processed, and reported. If the SOP says a barcode must be scanned twice before testing—but in practice, staff are skipping that step—they’ll notice.

Example:
In one audit I supported, the SOP required a temperature check upon sample delivery. But when the auditor watched the process, no one did it. The SOP was fine. The implementation? Not so much. That led to a nonconformity.

2. They Interview Your Staff

Auditors often ask open-ended questions like:

• “Can you walk me through your daily process?”

• “What do you do if a sample is mislabeled?”

• “How do you know this equipment is ready for use?”

These questions reveal two things: whether the staff understand the procedure, and whether the procedure makes sense in practice.

3. They Trace Evidence Across Systems

Auditors love to cross-check. They might:

• Take a test result and ask to see the full workflow trail—from request to reporting

• Pick a maintenance log and ask when calibration was last verified

• Review a corrective action and ask what changed afterward

They’re looking for consistency, traceability, and proof that your system is active—not just documented.

Why this matters:

When there’s a gap between the process on paper and what’s actually happening, that’s when findings show up. Even small inconsistencies can snowball into bigger issues—especially when they affect patient safety, data integrity, or regulatory requirements.

Red Flags and Common Audit Findings in 2022

Here’s what I tell every lab I work with: it’s not the big, obvious mistakes that usually trip you up—it’s the small, recurring gaps that build up over time. And ISO 15189:2022 auditors are trained to spot those fast.

These are the red flags that raise eyebrows almost immediately:

1. Outdated Documents and References

Still using SOPs that mention ISO 15189:2012? That’s an instant signal your system isn’t current. Even if the procedures are still valid, the documentation needs to reflect the latest standard.

2. Staff Can’t Explain Their Role in the QMS

When auditors ask, “How do you contribute to quality?” and the staff member shrugs or says, “I just follow orders”—that’s a problem. Everyone in the lab should understand how their work connects to the bigger quality picture.

3. Weak or Missing Corrective Actions

A lot of labs record issues. Fewer labs actually follow through. Auditors check:

• Whether you investigated the root cause

• What actions were taken

• Whether those actions were effective

If your logs are vague or incomplete, they’ll notice.

4. Poor Version Control

Multiple versions of the same SOP floating around? No clear approval process? These issues show that your document control system isn’t reliable—and that’s a foundational requirement in ISO 15189.

5. Unclosed Past Findings

If your last internal audit or external assessment had findings that still aren’t fully closed—or worse, not even addressed—that’s a major red flag. Auditors want to see evidence of follow-up and real progress.

A quick story from the field:

I worked with a lab that had everything looking polished—until the auditor asked for one random equipment maintenance record. Turns out the calibration hadn’t been logged for two months, even though it was done. That single missed entry led to a minor nonconformity that could’ve been avoided with better tracking.

How to Present Your System to Auditors with Confidence

Here’s something I tell every client before audit day: It’s not about being perfect—it’s about being prepared, transparent, and organized. You don’t need to impress the auditor with glossy binders or rehearsed speeches. You need to show that your system works, your team understands it, and you can back it all up with clear evidence.

Here’s how to do exactly that:

1. Create a Clause-to-Evidence Matrix

This one tool can save your team hours of scrambling.
List each ISO 15189:2022 clause and map it to the corresponding:

• SOPs

• Records

• Policies

• Evidence of implementation

When an auditor asks, “Where’s your proof for clause 5.1.5?”—you’ll have it ready in seconds.

2. Organize Your Documents Logically

Whether digital or printed, your documents should be:

• Easy to find

• Clearly labeled by process and clause

• Version-controlled with approval dates

One lab I worked with used a color-coded shared folder system with each clause assigned a number and folder. Their audit went so smoothly the auditor finished early.

3. Prepare Staff Without Over-Coaching

Instead of giving staff a script, help them:

• Understand what their SOP says

• Know where to find related forms or records

• Explain what they do and why they do it that way

Auditors prefer honest, confident answers over perfect ones.

4. Be Ready for Walkthroughs and “Show Me” Moments

Auditors will ask to see how things actually work—live. That includes:

• Sample reception

• Result validation

• Equipment checks

• Data entry or reporting flows

Make sure your staff know these are normal parts of the audit—not “gotcha” moments.

5. Highlight Improvements and Lessons Learned

If you’ve made changes since your last audit, bring them up.
Show that you’re learning from your internal reviews, handling feedback, and continuously improving. That demonstrates maturity in your quality system.

Pro Tips and Insider Insights From the Field

Over the years, I’ve sat in on dozens of ISO 15189 audits—and guided labs through hundreds more. And while every audit is different, there are a few strategies that consistently help labs stay calm, clear, and audit-ready.

Here are the tips I give every client before their assessment.

Pro Tip 1: Start Your Audit Prep 60 Days Out

Don’t wait until the week before to “get everything ready.” Start two months early so you have time to:

• Run a mock audit

• Close internal findings

• Refresh your documentation

• Brief your team

It lowers the stress level dramatically—and gives you space to fix anything that pops up.

Pro Tip 2: Build a Simple Audit Folder (Physical or Digital)

Organize your documents by ISO clause, process, or topic. Include:

• Quality manual

• Risk assessments

• SOP index

• Internal audit and management review reports

• Corrective action logs

• Training and competency records

The easier you make it for the auditor to find what they need, the smoother your day goes.

Pro Tip 3: Let Staff Speak for Themselves—But Prep Them First

Auditors want to hear from the people doing the work. But those people need context.

Before the audit, do a short team huddle and go over:

• What the audit will involve

• The importance of answering honestly

• How to handle questions they’re unsure about (like saying “Let me check” instead of guessing)

Pro Tip 4: Use the Last Audit Report as a Launch Pad

Pull out the findings from your last internal or external audit.
Ask:

• Did we fix these issues?

• Can we show evidence of the fix?

• Have similar issues come back?

Being able to explain lessons learned shows maturity and control.

Pro Tip 5: Focus on Consistency, Not Perfection

You don’t need a flawless system. You need a functioning, documented, and understood system. The labs that pass with flying colors are the ones that know their processes, catch their own mistakes, and keep improving—not the ones chasing audit-day perfection.

Common Mistakes and FAQs (And How to Stay Ahead of Them)

Over the years, I’ve seen even the most experienced labs trip up on the same handful of issues. These aren’t huge disasters—they’re usually small cracks in the system that go unnoticed until audit day. Here’s what to watch for, plus answers to the questions I get asked most.

Common Mistakes Labs Make During Audits

Mistake 1: Over-preparing the documents, under-preparing the people

I’ve seen labs with perfect binders, but when staff get asked simple questions—like “What’s your role in the quality system?”—they freeze. Prepare your team, not just your paper.

Mistake 2: Ignoring version control and document history

Auditors will always ask, “Is this the current SOP?” If your team pulls out three versions of the same document, you’ve got a problem.

Mistake 3: Forgetting to follow up on past nonconformities

Unresolved findings from your last internal or external audit will raise red flags. Always be ready to show what you’ve done to fix past issues—and whether those fixes are working.

Mistake 4: Staff giving memorized answers

Auditors can tell when someone’s reciting a script. It’s far better to have staff explain what they actually do, in their own words. Honest answers carry more weight than rehearsed ones.

Frequently Asked Questions

Q1: Will auditors speak directly with lab staff?

Yes—almost always. They want to understand how your system works from the ground level. Be sure everyone knows their part and feels confident explaining what they do.

Q2: Do we need to have risk assessments even if we haven’t had any major issues?

Absolutely. Risk-based thinking is central to ISO 15189:2022. Auditors want to see that you’re identifying potential problems—even if they haven’t occurred yet.

Q3: Can we use old SOPs if the process hasn’t changed?

Only if you’ve reviewed and re-approved them under the new standard. Even unchanged processes must reflect the ISO 15189:2022 format, structure, and updated clause alignment.

Be Ready, Be Clear, Be Confident

If there’s one thing I’ve learned after helping more than 150 labs through ISO 15189 audits, it’s this: auditors aren’t looking for perfection—they’re looking for proof.

They want to see that:

• Your system isn’t just documented—it’s understood and used

• Your staff know their role in quality, not just their job description

• You’re thinking about risk, not reacting to it

• You’re reviewing, improving, and closing the loop—not just collecting data

And here’s the good news—you don’t need a perfect audit to pass. But you do need a system that’s honest, consistent, and structured enough to show real control.

Key Takeaways:

• Know what auditors focus on: risk, implementation, records, staff awareness

• Don’t just prep documents—prep your people

• Organize your system so you can find anything, fast

• Use audits to learn and improve, not just to get a stamp of approval

Let’s Make Your Next Audit Your Best Yet

At QSE Academy, we help labs just like yours get audit-ready with less stress and more structure. Whether you need personalized coaching, document review, or full accreditation support—we’ve got the experience to guide you through it.

Get in touch with us and let’s build an audit strategy that works in the real world—not just on paper.