Last Updated on September 24, 2025 by Melissa Lazaro

Corrective Actions After an ISO 15189 2022 Audit

Let’s be honest—getting through an ISO 15189:2022 audit can feel like crossing the finish line. But in reality? The real work often starts after the auditor leaves.

In my experience helping over 150 labs through ISO 15189 accreditation and surveillance audits, here’s what I’ve noticed: most teams breathe a sigh of relief once the audit’s done… and then feel totally stuck when it’s time to deal with the findings.

You might be asking:

• How serious is this nonconformity?

• What do they actually expect in a corrective action plan?

• Are we supposed to fix everything immediately—or just respond on paper?

If that sounds familiar, you’re not alone. And the good news? You don’t need to panic, overreact, or guess your way through it.

In this article, I’ll walk you through exactly how to handle corrective actions after an ISO 15189:2022 audit—step by step. From understanding what the findings really mean, to writing a solid response, fixing the root cause, and proving to auditors that your lab is on it.

Let’s break it down together.

Understand the Types of Findings You May Receive

Here’s what I’ve seen trip up a lot of labs—they treat every finding the same. But not all audit findings carry the same weight, and if you don’t respond to each one the right way, you might waste time, overcorrect, or worse—miss the point entirely.

So, what kind of findings should you expect?

1. Nonconformities (Major or Minor)

These are the ones you have to respond to with a formal corrective action plan.

• Minor Nonconformities usually mean something’s not fully in line with the standard, but it’s not causing immediate risk.

• Major Nonconformities are more serious. They indicate a breakdown in the system—something that could affect test quality, patient safety, or regulatory compliance.

Example:
A lab received a minor for missing a few staff training sign-offs. But when another lab couldn’t provide any documented risk assessment process? That was flagged as a major.

2. Observations or Opportunities for Improvement (OFIs)

These aren’t “failures,” but they’re still important. Auditors may suggest ways to improve processes that technically meet the standard—but could be better.

Example:
One auditor noticed that two SOPs covered the same task in different ways. It wasn’t a nonconformity, but they noted it as an OFI. The lab later combined the SOPs—and reduced staff confusion.

3. Positive Notes (Yes, Really!)

Some auditors also highlight what you’re doing well. These aren’t findings—but they show where your system is working. Don’t ignore them. Use them to build confidence and recognize your team.

Why it matters:

When you know what each finding really means, you can:

• Prioritize your responses appropriately

• Avoid over-fixing or under-addressing issues

• Show auditors you understand the system—not just the standard

How to Analyze the Root Cause (Not Just the Symptom)

Let’s be real—this is where most labs rush it. The audit’s over, the report lands, and everyone scrambles to “fix” things. But without understanding why the issue happened in the first place, that fix probably won’t stick.

Here’s what I’ve seen work (and what I recommend every time):

1. Use the 5 Whys—Seriously, It Works

Ask “why” five times (or more if needed) to dig past the obvious.
For example:

• Why was the wrong result released?
  → Because the second review step was skipped.

• Why was it skipped?
  → Because the staff thought the LIMS auto-validated it.

• Why did they think that?
  → Because the SOP wasn’t clear.

Now we’re getting somewhere. That’s a system issue—not just a staff mistake.

2. Get Your Team Involved

Don’t solve it solo. The people closest to the issue usually know more than the report shows. Pull them into a short, honest discussion. Ask what happened, what they noticed, and what’s really getting in the way.

3. Avoid the “Just Retrain Them” Trap

This is a big one. I’ve seen too many labs default to retraining as the fix for everything. But if the issue was caused by a bad process, unclear instructions, or missing tools—training won’t solve it.

Example from the field:
A hematology lab kept making transcription errors. The default response was “retrain staff.” But after a proper root cause analysis, we found the LIMS interface was poorly designed. Once that changed, the errors stopped—no retraining needed.

What auditors expect:

They’re not just looking for what you fixed—they want to see you understood why it failed in the first place. That’s what separates a compliant lab from a confident, well-managed one.

Build a Clear, Actionable Corrective Action Plan

Once you’ve figured out the root cause, it’s time to show the auditor you’re serious about fixing it—and that starts with a smart corrective action plan. This is where your lab gets to demonstrate control, not just compliance.

Here’s what a strong plan should always include:

1. The Actual Fix (Based on the Root Cause)

This should tie directly to what caused the issue—not just the surface-level problem.
Example: If the root cause was “inconsistent SOPs,” then the action might be to review, revise, and consolidate procedures—not just tell staff to “be more careful.”

2. Assigned Responsibilities

Someone needs to own the fix—and not just “the quality team.” Be specific.
Who’s writing the new SOP? Who’s updating the LIMS? Who’s verifying the change worked? Put names, not just departments.

3. A Realistic Deadline

Auditors don’t expect you to fix everything overnight. But they do want to see you’ve set a timeline that makes sense—and that you’re tracking it.

4. Verification of Effectiveness

This is what a lot of labs miss. Don’t just say the action is “done.”
Show that the issue hasn’t come back. That could mean:

• A follow-up internal audit

• Reviewing performance data

• Asking staff for feedback on the new process

A simple structure that works:

A quick success story:

One client of mine used a corrective action log like the one above and shared it with their whole team during weekly huddles. They didn’t just close issues—they built a habit of improvement. During the next surveillance audit, the auditor called it “one of the best tracking systems they’d seen all year.”

Document Everything (The Right Way)

Let’s be real—if you can’t show it, it didn’t happen. That’s the golden rule when it comes to ISO 15189 corrective actions. You might’ve done everything perfectly, but if you can’t present clear, traceable documentation? The auditor has no choice but to flag it.

Here’s how to stay audit-proof and organized without drowning in paperwork:

1. Give Each Finding a Unique Reference ID

It sounds small, but it makes a huge difference—especially when you’re dealing with multiple findings. A simple system like “INT-2024-04” (for internal finding, April 2024) helps you track, sort, and reference issues later.

2. Create a Central Corrective Action Log

Don’t scatter notes across email threads, spreadsheets, and notebooks. Use one shared document or software to track:

• Finding summary

• Root cause

• Action taken

• Person responsible

• Status

• Verification method

• Supporting evidence (file links, reports, screenshots, etc.)

3. Keep Audit Trails Clean and Accessible

Auditors might ask for:

• The original audit report

• The related SOPs before and after revision

• Training records linked to changes

• Screenshots from your LIMS or equipment logs

• Meeting minutes showing decisions made

You don’t need to overdo it—but you do need to be able to say, “Here’s what we did, here’s how, and here’s proof it worked.”

Real-life tip:

I helped a pathology lab organize all their corrective action documents into folders by ISO clause. Each folder had a summary sheet, evidence, and status updates. During the next surveillance audit, they found every document in seconds—and the auditor praised their system clarity.

Use Corrective Actions to Strengthen Your QMS

Let’s be honest—most labs see corrective actions as something they have to do after an audit. But here’s the truth: the smartest labs use them as a springboard for real improvement. Why just close a finding when you can use it to make your whole system stronger?

Here’s how to make your corrective actions count beyond compliance:

1. Feed Trends into Your Management Review

If you’re seeing similar issues pop up across departments—say, repeated delays in reporting or recurring documentation errors—that’s something leadership should see. Bring it into your management review and use it to guide decisions.

Example:
One lab noticed that 60% of its findings over the past year involved poor communication during shift handovers. They turned that insight into a QMS project, redesigned the handover process, and saw incident rates drop by 40%.

2. Prioritize Internal Audits Based on Past Findings

Don’t just audit everything once a year. Look at your corrective action trends. If equipment maintenance or staff competency keeps showing up in findings, those areas need more attention—not less.

3. Track Opportunities for Improvement, Too

Corrective actions aren’t just for fixing problems. If an auditor gave you a great suggestion, or if your internal team spotted a smarter way to do something—log it. Assign it. Act on it. That’s how you evolve from “compliant” to “consistently improving.”

4. Share Lessons Across the Team

Instead of keeping findings and fixes locked in the quality office, turn them into teachable moments. Use them in staff training, morning huddles, or process improvement meetings. The goal? Build a culture where feedback turns into action.

What auditors love to see:

Evidence that you’re not just closing issues, but learning from them. If you can show how a small nonconformity led to a system-wide improvement, you’re speaking their language.

Pro Tips and Insider Insights From the Field

Over the years, I’ve worked with labs of all sizes—from small clinics to national reference centers—and when it comes to corrective actions, a few key strategies always make the difference. These aren’t theories—they’re practical habits I’ve seen work again and again.

Pro Tip 1: Don’t Wait for the Report—Start Right After the Audit

As soon as the auditor shares verbal findings during the closing meeting, start jotting them down. That way, you’re not scrambling when the final report comes in, and you’ve already got a head start on your responses.

Pro Tip 2: One Problem, One Root Cause

Avoid the urge to pile multiple issues into one corrective action. Each finding deserves its own cause analysis—even if the fix overlaps. This makes your system more traceable and easier to audit.

Pro Tip 3: Build a Corrective Action Template You Actually Use

Don’t reinvent the wheel each time. Use a standard form or spreadsheet that includes:

• Finding reference

• Root cause

• Action plan

• Owner

• Deadline

• Effectiveness review
  This consistency helps your team stay on track and shows auditors that you’ve built a mature system.

Pro Tip 4: Do a “Post-Correction” Debrief

After you’ve closed out a corrective action, take five minutes to ask:

• Did the solution work?

• Did it introduce any new risks?

• Is this something we should prevent elsewhere in the lab?

Those little debriefs lead to big improvements over time.

Pro Tip 5: Keep a “Lessons Learned” Log

This is one of my favorites. Start a running list of audit takeaways—both things that went wrong and what went right. It’s a goldmine for prepping future audits, training new team members, and keeping your QMS growing.

Common Mistakes and FAQs (And How to Avoid Them)

Even well-prepared labs can stumble after an audit—not because they’re ignoring issues, but because they don’t fully understand how to close the loop. These mistakes are easy to make, but even easier to fix when you know what to watch for.

Common Mistakes to Avoid

Mistake 1: Skipping the Root Cause Analysis

Jumping straight to “we’ll fix it” without asking why it happened leads to repeat findings. Always start with root cause—even if the issue seems obvious.

Mistake 2: Using “Staff Retraining” as a Default Fix

This is the most overused (and least effective) corrective action. If the root cause is a flawed process or unclear SOP, retraining won’t change the outcome. Fix the system, not just the behavior.

Mistake 3: Vague or Incomplete Action Plans

“Reviewed and corrected” or “Team reminded” won’t cut it. Auditors want specifics: what changed, who’s responsible, and how you’ll know it worked.

Mistake 4: Not Verifying the Fix

Many labs close the action as soon as a change is made—but they don’t check if the problem actually stopped. Always follow up to confirm effectiveness.

Mistake 5: Ignoring Opportunities for Improvement

OFIs are optional, yes—but they’re still valuable. Addressing them shows maturity and commitment to continuous improvement.

Frequently Asked Questions

Q1: How soon should we respond to audit findings?

Typically, your corrective action plan is due within 30 days of receiving the report. But start working on it right after the audit—especially for anything marked as major.

Q2: What if we disagree with the finding?

You can respectfully request clarification or submit a formal response—but focus on understanding the auditor’s perspective first. In many cases, you can still use the feedback to improve.

Q3: Can we close multiple findings with one corrective action?

Only if they stem from the same root cause. Otherwise, treat them separately to show that you’ve investigated each issue thoroughly.

Don’t Just Correct—Improve

Here’s the truth I’ve seen play out again and again: corrective actions aren’t just about satisfying auditors—they’re your lab’s biggest opportunity for growth.

When you take the time to dig into the root cause, build a clear plan, and follow through with intention, you’re doing more than closing a finding—you’re strengthening your entire quality system.

Let’s recap what matters most:

• Understand your findings—and don’t over- or underreact

• Always start with why before deciding what to fix

• Make sure your action plans are specific, trackable, and owned

• Document everything clearly and consistently

• Use your corrective actions to feed bigger improvements—not just tick boxes

In my 10+ years supporting labs through ISO 15189 audits, I’ve seen how small, thoughtful changes made after the audit often lead to the biggest leaps in quality, confidence, and consistency.

Ready to turn your audit findings into a strength?

If you want help writing corrective action plans, guiding your team through root cause analysis, or creating a post-audit improvement strategy that actually sticks, we’ve got your back.

Get in touch with QSE Academy for personalized guidance, tools, and expert support that turns post-audit stress into smart, sustainable progress.