Last Updated on September 24, 2025 by Melissa Lazaro

How to Implement ISO 15189:2022 – Full Lab Compliance

Let’s be honest—when most lab teams hear “ISO 15189:2022,” their first reaction is stress. And I get it. I’ve worked with enough clinical and diagnostic labs to know that the idea of rebuilding your quality system, retraining your staff, and passing an external audit feels… heavy.

But here’s what I’ve noticed:
The labs that succeed aren’t the ones that have it all figured out from day one. They’re the ones who take a practical, step-by-step approach, involve their team early, and focus on building systems that work in real life, not just on paper.

In this guide, I’m going to walk you through exactly how to implement ISO 15189:2022 in your lab—from initial planning to full compliance. Whether you’re upgrading from the 2012 version or starting fresh, I’ll show you what matters most, what to avoid, and how to make your implementation as smooth (and stress-free) as possible.

No fluff. No jargon overload. Just real talk, practical steps, and some insights from the field that could save you months of guesswork.

Let’s get started.

Step 1: Understand the ISO 15189:2022 Requirements in Full Context

Before you start editing documents or launching training programs, let’s slow down and get clear on what this standard is actually asking for.

ISO 15189:2022 isn’t just a reworded version of the 2012 standard. It’s a complete shift in mindset. You’re no longer just proving your lab has a quality system—you’re showing that your lab uses it to produce reliable, timely, and accurate results, every single day.

So what changed?

Here’s what I’ve seen catch most labs off guard:

• The structure is completely new.
  It now follows something called the High-Level Structure (same as ISO 9001 and 17025), which means more consistency across standards—but also, a full reorganization of your documentation.

• Risk-based thinking is no longer optional.
  This version expects you to anticipate issues before they happen. It’s about being proactive, not just reacting when something goes wrong.

• Competence and impartiality get way more attention.
  ISO wants to know your people are qualified—and that their work isn’t being influenced by pressure, bias, or unclear authority.

Real example from the field:

One lab I worked with thought they were ready because they had passed their 2012 audit just a year earlier. But when we reviewed their system against the 2022 version, they had gaps in risk planning, no documented impartiality assessments, and their quality manual didn’t match the new clause structure. They weren’t far off—but without rethinking how the system actually worked day to day, they wouldn’t have made the cut.

Key takeaway:

Don’t jump straight into “fixing” documents. Start by reading the standard with your leadership team, talking through what each section means in your lab’s context, and identifying where your current processes support (or don’t support) the new expectations.

Step 2: Conduct a Practical Gap Analysis

Now that you’ve got a clear understanding of what ISO 15189:2022 actually expects, it’s time to figure out where your lab stands today. And for that, you need one thing: a solid, honest gap analysis.

This step is like turning the lights on in a dark room. You can’t fix what you don’t see—and you definitely don’t want to start rewriting procedures blindly or guessing what the auditors might want.

What is a gap analysis (and what it’s not)?

A proper gap analysis compares your current system to the new ISO 15189:2022 requirements—clause by clause. It’s not just about checking boxes. It’s about asking:

• Do we meet this requirement?

• If not, what’s missing?

• Do we have evidence to prove it?

• Is this process working, or are we just going through the motions?

Here’s how I help clients run one:

We sit down with a simple spreadsheet or checklist that lists every clause of the new standard. For each one, we walk through:

• What the clause means in plain English

• What the lab currently does

• What’s missing or needs improvement

• Who’s responsible for fixing it

No fancy software needed—just clarity, teamwork, and honesty.

Real story from the trenches:

I worked with a diagnostics lab that thought they were mostly compliant. But during our gap analysis, we found out they had zero documentation around impartiality, and their internal audits were happening once every two years. Not only were they noncompliant—they were exposed to major risk. By spotting these issues early, they had time to correct them long before the external audit.

Quick reminder:

You don’t have to fix everything at once. The goal of a gap analysis is to create a roadmap. Once you know your weak spots, you can prioritize what matters most—and avoid wasting time on things that are already working well.

Step 3: Build or Update Your Quality Management System (QMS)

Alright, this is where things start getting real. Once you’ve identified the gaps, it’s time to build—or rebuild—a quality management system that actually works for your lab and aligns with the new ISO 15189:2022 requirements.

Let me say this upfront: your QMS isn’t just a pile of documents.
It’s the system that connects your people, your processes, and your purpose. If it’s clunky, outdated, or disconnected from your day-to-day work, it’s going to hold you back—fast.

What does ISO 15189:2022 expect from your QMS?

Here’s the short list:

• A documented quality policy and objectives that align with your lab’s purpose

• Processes and procedures that reflect how work is actually done—not how someone thinks it should be done

• A structure that follows the new clause layout: Context, Leadership, Planning, Support, Operation, Performance Evaluation, and Improvement

• Evidence that your system supports impartiality, competence, and continual improvement

What I’ve seen work well:

One of my clients—a medium-sized clinical lab—decided to throw out their old “ISO binder” and start fresh. They used the ISO 15189:2022 clause structure as their framework, rewrote procedures in plain English, and even included QR codes that linked to videos for staff training. Not only did it impress the auditor, but the staff actually used the system.

Here’s how to approach it:

1. Start with a document map
   Match each clause to existing documents, and highlight what’s missing. This makes updating your system more organized and less overwhelming.

2. Prioritize usability over formality
   You don’t need a 100-page quality manual. You need one that people read, understand, and follow.

3. Standardize formatting
   This sounds minor, but consistent formatting helps staff spot changes, follow procedures, and stay compliant.

4. Make version control effortless
   Whether you’re using a digital system or a shared folder, make sure everyone knows which version of each document is the current one—and how to request updates.

Quick Insight:

I often tell labs: if your QMS only comes out during audits, you’ve already lost. The best systems are the ones your staff relies on daily—not the ones that gather dust in a file cabinet or hide on a forgotten drive.

Step 4: Train and Engage Your Team

Let me be blunt: even the best-documented quality system will fall flat if your team isn’t on board. ISO 15189:2022 makes it very clear—competence, awareness, and active participation aren’t just nice-to-haves. They’re required.

And here’s what I’ve noticed time and again:
The labs that train early, train clearly, and train often are the ones that pass audits with fewer issues—and less stress.

So how do you get your people aligned?

• Start with role-specific awareness
  Don’t run one big generic training session. Break it down. What does ISO 15189 mean for your technicians? Your admin team? Your section heads? Each group needs different information—and they’ll engage better when the training feels relevant.

• Create a competence matrix
  This is one of the most underrated tools. List every job role, every critical task, and who is trained, competent, or still in progress. Keep it up to date and use it as your go-to document for audits, staffing decisions, and training plans.

• Make training continuous, not one-time
  A common mistake is running a few kickoff workshops and calling it done. Instead, try short, monthly refreshers—five to ten minutes is enough. Highlight one clause, one change, or one quality issue that came up. Keep it fresh.

Real-world example:

A client of mine had a tough time getting staff to take ISO seriously—until they started “quality huddles.” Just ten minutes, once a week, covering one real-life issue tied to the standard. It worked. Staff started asking questions, spotting risks early, and even suggesting changes to procedures. That’s the kind of engagement ISO wants to see—and auditors notice it, too.

Quick Tip:

Track not just who attended training, but what they understood. Use short quizzes, verbal feedback, or simple checklists to confirm that training landed.

Step 5: Embed Risk Management and Continual Improvement

Here’s where ISO 15189:2022 really steps things up.

This version of the standard doesn’t just want you to react to mistakes. It expects your lab to think ahead—to build systems that anticipate problems, prevent them, and improve as you go.

In short, you’re not just managing quality—you’re managing risk and driving improvement.

What does that look like in a real lab?

• You spot risks before they become failures
  That doesn’t mean launching a massive risk management program. It means building a habit across the team of asking, “What could go wrong here?” Whether it’s a test method, a staffing decision, or a new supplier—you’re looking at it through a proactive lens.

• You fix problems at the root
  If you’re only correcting errors, you’re stuck in a loop. ISO wants to see that you’re investigating why problems happen and changing processes so they don’t repeat. This is where tools like root cause analysis or the “5 Whys” method really help.

• You use feedback and data to improve
  Customer complaints, staff suggestions, audit findings—they’re all gold. The standard expects you to track them, analyze them, and use them to refine how your lab works.

Example from the field:

One lab I worked with kept having delays in result reporting. Every time, they would explain it away—”short-staffed,” “equipment issue,” “rush sample.” But once we dug into the root cause, we realized their workload wasn’t being distributed evenly, and urgent samples weren’t flagged clearly. They made a few simple workflow changes, and the delays dropped by over 40%. That’s what continual improvement looks like in practice.

A few ways to make it stick:

• Keep a simple risk log. One tab for identified risks, one for mitigation steps. Review it monthly with your team.

• Use internal audits and nonconformity reports as a trigger for real change—not just closing the issue, but improving the process.

• Celebrate improvements, even small ones. It keeps people motivated and engaged.

Quick Tip:

If you’re not tracking any risks right now, start with three: one operational, one equipment-related, and one related to staff or training. That alone shows auditors you’re thinking critically—and gives you a place to grow from.

Step 6: Perform a Trial Run with Internal Audit and Management Review

By now, you’ve built or updated your system, trained your people, and started thinking in terms of risks and improvement. So before you bring in the external auditors, it’s time to take your system for a test drive—and that means running a solid internal audit and a real management review.

Let’s be real—if you wait until the formal assessment to discover what’s broken, it’s already too late.

Start with an internal audit that actually matters

This isn’t just a checkbox exercise. A good internal audit is where you stress-test your system, challenge your processes, and uncover things that look good on paper but fall apart in practice.

Here’s how to do it right:

• Use your gap analysis to guide your audit plan. Focus on the clauses and processes where you had the biggest changes or known issues.

• Involve multiple auditors, if you can. Fresh eyes catch more. If you’re a smaller lab, bring in a consultant or a peer from another department.

• Document nonconformities and opportunities for improvement. Don’t hide findings. Use them as fuel to strengthen your system before your real audit.

Then, hold a management review that’s more than a formality

The standard wants to see that your leadership team is actively involved—not just approving documents, but reviewing performance, understanding risks, and driving improvement.

A strong management review should include:

• Quality objectives and progress toward them

• Internal audit findings

• Feedback and complaints

• Nonconformities and corrective actions

• Risk reviews and improvement opportunities

• Resource needs

• Plans going forward

Make sure you record decisions and action items. This isn’t just for the auditor—it keeps your team aligned and focused.

Real-world insight:

I once helped a lab run their first ISO 15189:2022-style management review. They expected it to last 30 minutes. It went nearly two hours—but by the end, they’d identified three under-the-radar risks, clarified their top two quality goals, and agreed to streamline a process that had been slowing down reporting times for months. That meeting alone shifted their whole implementation forward.

Quick Tip:

Schedule your internal audit and management review at least two months before your formal assessment. That gives you time to fix issues, re-audit if needed, and go into your external audit with confidence.

Step 7: Book Your Assessment and Maintain Momentum

You’ve done the work—closed your gaps, trained your team, tested your system—and now it’s time to bring in the external assessors. But here’s the truth most labs don’t talk about: implementation doesn’t end when you get the certificate.

This final step is about crossing the finish line—and keeping your quality system alive afterward.

First, getting ready for the formal assessment

Once you feel confident, reach out to your chosen accreditation body and schedule the audit. They’ll walk you through timelines, document submissions, and what to expect on the assessment day(s).

Here’s how to prepare:

• Make sure all your documentation is organized and accessible
  Use a shared drive, binder, or system where everything from your quality manual to internal audits and risk logs is easy to find.

• Brief your team on what to expect
  Walk through how the audit works, who might be interviewed, and how to answer questions honestly and clearly. A calm, prepared team makes a huge difference.

• Double-check that previous nonconformities have been resolved
  If this is a transition audit or re-accreditation, be ready to show evidence of corrective actions and improvements made.

Then, keep the momentum going after accreditation

This part matters more than most people realize.

Some labs relax once they get their certificate. But ISO 15189:2022 is designed to help labs improve continuously—not just pass audits every few years.

Here’s how to keep it alive:

• Keep training and internal audits on a recurring schedule
  Don’t treat them like once-a-year events. Build them into your regular operations.

• Set quarterly quality review meetings
  Revisit your objectives, review performance data, and adjust plans as needed. You’ll stay compliant—and more importantly, stay ahead.

• Keep collecting feedback—from staff, clients, and auditors
  Use it to improve your processes and show your team that quality is everyone’s job, not just the QA manager’s.

Real talk:

One lab I worked with celebrated hard after they passed their audit—and rightly so. But what impressed me even more was how they followed up: they sent out a short survey to staff asking, “What part of the system felt useful—and what felt like busywork?” They used that input to streamline procedures even further. That mindset is why they’re still thriving two years later.

Quick Tip:

Treat the assessment like a milestone—not a finish line. The real win isn’t the certificate—it’s a quality system your team can trust and build on.

Pro Tips & Insider Insights: What Actually Works in Real Labs

These aren’t theories from a textbook—they’re lessons from the trenches. After helping labs implement ISO 15189:2022 across different sizes, scopes, and specialties, here’s what I know for sure moves the needle.

Pro Tip 1: Don’t Try to Do Everything at Once

ISO 15189 implementation can feel like a mountain. So break it into manageable chunks. Focus on one section of the standard each week, and give yourself permission to tackle it piece by piece. Progress beats perfection every time.

From experience:
One small lab I supported worked ISO into their weekly ops meetings—one clause per session. In three months, they had a stronger system than larger labs trying to rush it all in a month.

Pro Tip 2: Use the New Clause Structure to Rebuild Smarter

Trying to cram the new requirements into your old document layout? Stop. You’ll save time and confusion by mapping your entire QMS to the new clause structure from the start.

Why it works:
Auditors instantly see alignment. Staff can follow procedures easier. Updates become more organized.

Pro Tip 3: Turn Risks into Conversations, Not Just Paperwork

Don’t let your risk register become a static spreadsheet. Use it to spark discussions in team huddles or review meetings. Ask, “Has anything changed that we need to flag?” It keeps the idea of risk fresh and relevant.

Client insight:
One lab added a 5-minute “risk pulse check” at the end of every team meeting. It led to early warnings on issues before they became real problems.

Pro Tip 4: Internal Audits Aren’t About Playing Gotcha

Train your internal auditors to look for process breakdowns, not people to blame. When staff feel safe pointing out issues, you uncover the stuff that really matters—and fix it before the assessors do.

What happened in real life:
A lab technician admitted during an internal audit that a calibration step was routinely skipped “to save time.” That single conversation led to a procedural redesign and avoided a nonconformity during their external audit.

Pro Tip 5: Celebrate the Small Wins

Implementation takes time and energy. When you hit a milestone—like finishing your gap analysis, passing your internal audit, or completing staff training—celebrate it. Recognition fuels motivation and builds a quality culture.

What I saw work:
One lab created a “compliance wall” where team members posted achievements—big and small. It made the process feel real and human.

Common Mistakes and FAQs: What Trips Labs Up (and How to Avoid It)

You’ve probably already guessed—most labs don’t fail implementation because they’re lazy. They fail because they don’t fully understand the standard, rush the process, or overlook the little details that matter.

Let’s break down the most common mistakes I’ve seen—and then I’ll tackle the questions you’re probably wondering about.

Top Mistakes to Avoid

Mistake 1: Treating ISO 15189 Like a Paperwork Exercise
If you’re just updating documents to “tick boxes” for the auditor, you’re missing the point. ISO 15189:2022 is about how your lab functions, not how it looks on paper. Your procedures need to reflect your actual workflows—warts and all.

Mistake 2: Keeping Implementation in a Quality “Silo”
This happens a lot. The quality manager tries to do it all alone. But compliance only sticks when the whole team is involved. Get department heads, technicians, and even admin staff into the loop early. You’ll get better buy-in and fewer surprises.

Mistake 3: Skipping the Dry Run
Going straight into your formal assessment without doing a real internal audit and management review? That’s like taking a final exam without studying. You will miss things—and it could cost you accreditation or delay your approval.

Mistake 4: Forgetting About Evidence
Verbal answers don’t pass audits. You need clear, dated records to back up everything—training, maintenance, decisions, risk assessments, you name it. If you can’t show it, it didn’t happen (as far as ISO’s concerned).

Frequently Asked Questions

Q1: How long does ISO 15189:2022 implementation usually take?
It depends on your starting point. Most labs need between six to twelve months. If you’re transitioning from 2012 and already have a strong QMS, it might take less. But if you’re starting from scratch, give yourself time—and build in room for retraining and internal audits.

Q2: Can we just update our documents and pass?
Not really. The 2022 version is about behaviors, not just documents. If your lab isn’t actively managing risk, training staff, and reviewing performance regularly, updated SOPs won’t save you during an audit.

Q3: Do we need special software to be compliant?
Nope. Many labs still manage ISO 15189 using shared folders and spreadsheets. But digital tools can help—especially for version control, training records, and audit tracking. It’s more about consistency and clarity than technology.

Q4: Will we get nonconformities during our audit?
Most labs do—and that’s okay. What matters is how you respond. Show that you understand the issue, take action quickly, and document your corrections. That builds trust with assessors and strengthens your system long-term.

ISO 15189:2022 Doesn’t Have to Be Complicated—Just Clear and Consistent

If there’s one thing I’ve learned from helping labs implement ISO 15189:2022, it’s this: compliance isn’t about getting it perfect—it’s about getting it real.

Real systems.
Real habits.
Real accountability.

You don’t need the biggest budget, the most high-tech tools, or a hundred-page manual. What you do need is a system that reflects how your lab actually works—and a team that understands why quality matters beyond just passing an audit.

Let’s recap the path:

• You start by understanding the standard—no guessing, no assumptions.

• Then, you run a gap analysis to find what’s missing.

• You build a quality management system that works for your lab, not against it.

• You train your team, engage them, and make quality everyone’s responsibility.

• You embed risk thinking, fix issues at the root, and improve continuously.

• You test your system internally, learn from it, and walk into your assessment ready.

• And after you pass? You keep going. Because quality isn’t a finish line—it’s your foundation.

What’s next?

If you’re ready to get started but still unsure how to organize everything, grab our ISO 15189:2022 Implementation Checklist—it lays out the key steps and keeps you focused on what matters most.

Or if you’d rather not do this alone, book a free consult and we’ll map out your lab’s implementation game plan together.

Whatever you choose—just start. The sooner you do, the more confident (and audit-ready) your lab will be.