Last Updated on September 24, 2025 by Melissa Lazaro

How to Prepare for an ISO 15189 2022 Accreditation Audit ?

Let’s be real—getting ready for an ISO 15189:2022 accreditation audit isn’t just another box to tick. It’s a major milestone for any medical laboratory, and it can feel overwhelming, especially with the 2022 update bringing in some big changes.

I’ve spent over ten years helping labs—big and small—get audit-ready. From regional blood banks to university-affiliated diagnostics labs, I’ve seen it all. And I’ll tell you right now: the labs that succeed don’t just prepare documents, they build confidence in their systems.

So, if you’re a lab manager, quality officer, or just someone who’s been tasked with “making sure we’re ready,” you’re in the right place. This guide is going to walk you through everything I share with my own clients—from understanding the new standard, to organizing your team, to the little things auditors always catch.

Here’s what you’ll walk away with:

• A crystal-clear breakdown of what the 2022 version actually means for your lab

• Step-by-step strategies to prep like a pro (without the panic)

• Expert tips I’ve learned from real audits—what works, what doesn’t, and what most people miss

Sound good? Let’s dive in and get your lab ready—confidently, not just compliantly.

Understand What’s New in ISO 15189:2022 (Without the Jargon Overload)

Here’s what I’ve noticed—most labs start prepping for the audit without really understanding what changed in the 2022 update. And that’s where things start slipping.

So, what’s actually different?

The 2022 version isn’t just a rewording of the old one. It’s a mindset shift. Here’s the big stuff in plain English:

• Risk-based thinking is now front and center.
  You’re not just following procedures—you’re expected to understand why you do what you do, and how you’re managing risks at every step.

• More alignment with ISO/IEC 17025 and ISO 9001.
  If your lab also follows other standards, you’ll notice the language and structure feel more familiar. That’s intentional—to streamline things across the board.

• Tech and digital systems finally get the spotlight.
  With the rise of LIMS and remote processes, the standard now calls for more focus on data integrity, IT systems, and information security.

Why this matters:

I once worked with a diagnostic lab that assumed their 2012-based quality manual was “close enough.” By the time we did our first mock audit, they had over thirty documented gaps—just from not addressing the new structure and language.

Lesson? Even if your processes haven’t changed, your documentation and mindset need to.

Pro Tip 

Run a quick clause-by-clause comparison between 2012 and 2022 versions. It takes a couple of hours, but it’ll give you a clear picture of what’s new, what’s missing, and what needs reworking.

Run a Proper Gap Analysis (Not Just a Checklist Exercise)

Let’s be honest—too many labs treat gap analysis like a checkbox activity. Download a generic template, skim through it, and call it a day. But if you want to actually pass your ISO 15189:2022 audit, that approach just doesn’t cut it.

Here’s what works (and what I recommend to every client):

• Build or download a clause-by-clause matrix based on the new 2022 version.

• Assign different sections to team leads—quality, technical, IT, even admin staff.

• Review real implementation, not just documentation. Ask: Are we actually doing this? Or is it just written on paper?

Real example from the field:

I helped a clinical microbiology lab prep for their transition to the 2022 version. Instead of rushing it, we spent two days doing a focused, hands-on gap review. The result? We found twenty-three critical gaps—half of which had been overlooked in their internal review.

What impressed the auditors most was how our corrective actions directly mapped to each clause. They called it one of the most audit-ready QMS reviews they’d seen that year.

Use this mini checklist to guide your gap analysis:

• Do we have clear documentation mapped to each clause?

• Can we show evidence of implementation for every requirement?

• Are staff aware of process changes or just signing SOPs?

• Have we addressed IT security, risk, and leadership involvement?

Pro Tip

Don’t do this alone. Get your team involved. Cross-functional input helps uncover blind spots and shows auditors that your system is truly integrated—not just managed by the quality department.

Update and Organize Your Documentation the Smart Way

Once you’ve run your gap analysis, here’s where most labs hit a wall—updating their documents. It’s not just about filling out templates or tweaking your SOPs. It’s about making sure your documentation actually reflects how your lab runs today, not how it ran five years ago.

What you need to focus on:

• Start with your Quality Manual. If it’s still based on the 2012 version, it’s outdated—period. Use it as your foundation, but don’t be afraid to rebuild where needed.

• Review and revise your SOPs, risk assessments, internal audit plans, and management review records. Make sure they align with the new clauses.

• Implement version control. Every document should clearly show the latest revision date, approval signatures, and where it applies in the standard.

A real-world misstep I’ve seen:

A well-equipped diagnostics lab I consulted had great processes—but their documentation told a different story. Their SOPs hadn’t been updated in over three years, and they still referenced ISO 15189:2012. It nearly cost them their accreditation. We had to launch a three-week document overhaul to get things back on track before their surveillance visit.

Documentation doesn’t need to be perfect, but it absolutely needs to be current and consistent.

Quick documentation wins:

• Use clause references on every document so auditors can trace compliance easily.

• Create a centralized document register or tracker—it helps during audits and internal reviews.

• Don’t just archive old SOPs—clearly mark them as superseded and store them properly.

Pro Tip

Index your documents by ISO 15189 clause. It makes audits smoother and shows the auditor you’ve built your system intentionally—not reactively.

Train Your Team for Audit Success

Now that your documents are in shape, it’s time to make sure your people are too. Because let’s face it—your lab could have the best paperwork in the world, but if your team freezes up during the audit, it’s going to show.

Here’s what strong audit prep really looks like:

• Tailored training, not just generic slides.
  Everyone should know how their specific role supports ISO 15189:2022. Your technical staff don’t need to know the full standard—but they do need to explain their process, how they follow SOPs, and what to do if something goes wrong.

• Hands-on mock audits.
  Don’t just rehearse “audit day” with the quality team. Involve the whole lab. Ask the same kinds of questions auditors do. Walk through real scenarios. Make it feel like the real thing.

• Confidence-building, not cramming.
  I’ve seen teams try to memorize answers—and it never goes well. Instead, help your staff understand why they do what they do. That way, they’re prepared to answer naturally and clearly.

What this looks like in action:

One hematology lab I worked with ran two full-day mock audits with role-playing. The lab assistants took turns acting as auditors, asking tricky questions and reviewing SOPs. When the actual auditor showed up, the team was calm, sharp, and ready. The audit wrapped up early—with only one minor finding.

What to cover in your audit training:

• Roles and responsibilities under ISO 15189

• How to handle auditor questions professionally

• Knowing where key documents are and how to access them

• What to do when you don’t know the answer (hint: don’t guess)

Pro Tip

Don’t train once and forget it. Build short refreshers into your monthly meetings or morning huddles. Ongoing awareness makes your team audit-ready all year—not just the week before.

Strengthen Your Internal Audit and Management Review

Here’s the truth—a weak internal audit is one of the biggest red flags for external auditors. If your lab isn’t finding and fixing its own issues, the assumption is that you’re not really managing your system—just coasting.

So how do you make your internal audit process actually useful?

• Audit against the new 2022 clauses, not just old habits.
  I’ve seen teams still using checklists from ISO 15189:2012. That’s a quick way to miss important updates. Update your tools, and make sure your audit scope includes things like risk-based thinking and data integrity.

• Dig deeper than compliance.
  Don’t just ask “Are we following the SOP?” Ask “Is the SOP effective?” and “Are there any risks or bottlenecks here?”

• Get fresh eyes involved.
  Have someone outside the process being audited do the review. Internal audits are way more powerful when the person asking questions isn’t already too close to the work.

Same goes for management review—it’s not just a formality.

This is your lab’s chance to look at the big picture:

• Are our quality goals being met?

• What trends are we seeing in errors or complaints?

• What’s changing in the industry that might affect us?

One group of labs I worked with turned this into a powerful strategic session. They pulled in data from five different sites and used their management review to standardize how they handled critical test results. That change alone helped reduce turnaround times by nearly 20 percent.

Key items to bring into your management review:

• Nonconformance trends and root causes

• Status of corrective actions

• Feedback from staff and patients

• Opportunities for improvement and resource needs

Pro Tip

Don’t wait until just before the audit to do your internal audit and management review. Aim to complete them at least six to eight weeks ahead so you have time to fix anything that comes up—and show auditors real follow-through.

Address Risks, Opportunities, and Corrective Actions

This is where a lot of labs get stuck. They either overcomplicate risk management with unnecessary tools or treat it like a checkbox task. But ISO 15189:2022 expects labs to think critically about how they manage uncertainty—and show they’re doing something about it.

So, what does that actually look like?

• Start simple with what you know.
  You don’t need fancy software. Use a basic risk register or even a spreadsheet to list potential issues—delayed results, equipment downtime, sample contamination—and how you’re reducing them.

• Get the team involved.
  The best risk assessments I’ve seen come from team brainstorming. Your staff know where the problems are. Tap into that insight.

• Document opportunities too.
  A lot of labs forget this. If you’ve improved a turnaround time, streamlined a process, or introduced a new system—that’s a positive change worth recording. ISO 15189 wants to see that you’re not just reacting to problems, but also looking ahead.

Real-world experience:

One genetics lab I worked with had a recurring issue with delayed courier pickups. Instead of just logging a nonconformance every time, they did a root cause analysis, changed providers, and built in a backup process. During the audit, they walked the auditor through the entire corrective action trail—problem, analysis, fix, and follow-up. The auditor actually complimented them on how proactive their system was.

What to track and show during your audit:

• Identified risks and how they’re being managed

• Records of preventive actions and follow-up

• Opportunities logged and linked to improvement actions

• Corrective actions with clear root cause analysis

Pro Tip

Don’t just close nonconformances—analyze them. Always ask “Why did this happen?” and “How can we make sure it doesn’t happen again?” That’s what auditors want to see: action with insight, not just paperwork.

Final Pre-Audit Checks and External Audit Readiness

So you’ve updated your documents, trained your team, reviewed risks, and completed your internal audits. Now comes the last stretch before the big day—and it’s all about tying everything together with intention.

Here’s how to run a solid pre-audit readiness check:

• Schedule a full internal review at least two weeks before the actual audit.
  Treat it like a dress rehearsal. Walk through each clause of ISO 15189:2022 and make sure you’ve got matching evidence ready to go.

• Set up your evidence folders—digital or physical.
  Make it easy for the auditor to find what they’re looking for. Use a clear structure, label everything by clause, and make sure staff know where to find documents if asked.

• Prep your front-line team.
  Run quick refreshers on how to answer auditor questions naturally. Remind them it’s okay to say, “I’m not sure, let me find someone who can help,” rather than guessing.

One thing that sets confident labs apart:

They don’t panic during audits. Why? Because they’re organized. One client of mine created a simple ISO 15189 audit binder—one tab for each clause, with evidence, training records, and process maps. It didn’t just help them—it impressed the auditor and made the whole process smoother for everyone.

Your last-minute readiness checklist:

• Internal audit and management review completed

• Document control and versioning up to date

• Risk assessments and corrective actions ready to show

• Evidence folders indexed and accessible

• Staff know what to expect and who handles what on audit day

Pro Tip

Assign an “audit day lead”—usually your quality manager or someone confident with the system. Their job is to guide the process, help field questions, and keep things running smoothly while the auditor’s on-site.

Expert Tips From the Field: What Actually Works

In my experience working with medical labs across different countries and specialties, it’s the small, strategic habits—not just big systems—that make the biggest difference during ISO 15189:2022 audits. Here are a few go-to tips I share with every client:

Tip 1: Create a Clause-to-Evidence Matrix

Map every clause of ISO 15189:2022 to your internal documents, SOPs, and records. This matrix becomes your audit roadmap—and saves time when an auditor asks, “Where’s your evidence for this requirement?”

Tip 2: Do a ‘Walkthrough Audit’

Take an hour each week to literally walk through your processes from start to finish. Watch how samples move, how staff handle tasks, and how documentation flows. You’ll catch small issues before an auditor does—and that’s the point.

Tip 3: Treat Audit Prep as a Team Sport

Get everyone involved. Your quality manager can’t do it alone, and auditors know when a system is only owned by one person. Labs that prepare as a team consistently perform better during audits and have fewer findings.

Tip 4: Build Your Audit Binder (or Digital Folder) Early

Organize all your key documents by clause at least a month ahead of time. I recommend having a tab for each of the following: policies, SOPs, risk assessments, corrective actions, internal audit, and management review.

Tip 5: Practice the “Pause and Clarify”

During mock audits, teach your team this skill: if they don’t understand a question, they can pause, clarify, and then answer. It shows confidence and helps avoid saying something unclear or incorrect under pressure.

Common Mistakes to Avoid (And What to Do Instead)

Even experienced labs trip up when it comes to ISO 15189 audits. After supporting dozens of labs through this process, I’ve seen the same few mistakes pop up again and again. Here’s what to watch for—and how to steer clear of them.

Mistake 1: Updating documents but not your actual processes

It’s easy to change an SOP on paper. But if your team isn’t following that version—or worse, doesn’t even know it changed—you’ve got a gap. Always follow up document updates with training or a quick team walkthrough.

Mistake 2: Doing the internal audit too close to the real one

If you do your internal audit just days before the external one, you won’t have time to act on what you find. Auditors want to see that you’ve not only identified issues, but actually addressed them.

Mistake 3: Treating risk management like a formality

A list of risks is not enough. You need to show how you’re managing them—what controls you’ve put in place, what you’re monitoring, and how often.

Mistake 4: Overpreparing your staff with scripts

Memorized answers make auditors nervous. Train your team to speak confidently about their actual work—not rehearsed lines. It comes across more honest, and frankly, more impressive.

Frequently Asked Questions

Q: How long does it really take to prepare for an ISO 15189:2022 audit?
A: It depends on your starting point, but most labs need around three to six months of focused preparation. If you’re transitioning from ISO 15189:2012 and already have a strong QMS, it could be quicker.

Q: Do we need a separate risk register, or can it be part of our quality system?
A: Either works, as long as your risks are clearly documented, regularly reviewed, and tied to actual actions. The format doesn’t matter—clarity does.

Q: What happens if we get nonconformities during the audit?
A: It’s not the end of the world. What matters is how you respond. Have a plan ready to identify root causes, implement corrective actions, and show that you’ve closed the loop within the required timeline.

Wrapping It Up: Be Ready, Not Rushed

Let’s bring it all together. Preparing for an ISO 15189:2022 accreditation audit isn’t just about getting your paperwork in order—it’s about building a lab culture that’s confident, capable, and clear on what matters.

Here’s what we’ve covered:

• What’s new in the 2022 version and why it matters

• How to run a meaningful gap analysis

• Smart documentation updates that actually reflect your lab’s work

• Training your team so they’re ready, not rehearsed

• Strengthening your internal audits and management reviews

• Addressing risks and corrective actions the way auditors expect

• Tying it all together with a calm, organized pre-audit strategy

If there’s one thing I’ve learned after helping over a hundred labs navigate this journey, it’s that preparation builds confidence—not just compliance. When your team understands what they’re doing and why it matters, the audit becomes less stressful and a lot more productive.

And if you’re feeling overwhelmed or unsure where to start—don’t go it alone. That’s exactly what we help labs with every day.

Want to take the stress out of audit prep?

Reach out to us at QSE Academy and let’s talk. Whether you need a document review, a full implementation plan, or just honest guidance—we’ve got you covered.

You’ve got this. And we’re here if you need a hand.