Last Updated on September 24, 2025 by Melissa Lazaro

ISO 15189:2022 Accreditation – How to Get Accredited, Who Grants It, and What It Costs

Let’s be real—getting accredited to ISO 15189:2022 isn’t just a checkbox for medical labs anymore. It’s the gold standard that says, “We’re competent, consistent, and serious about quality.” But here’s what I’ve noticed after working with dozens of labs across the globe: most teams aren’t quite sure where to start.

Do we need to be certified or accredited?
Who do we talk to?
How much is this actually going to cost us?

If you’ve been asking those questions, you’re not alone—and you’re in the right place. In my experience helping labs go from zero to accredited, the confusion usually isn’t about the requirements. It’s about the process. That’s what we’re going to clear up today.

In this guide, I’ll walk you through exactly how ISO 15189:2022 accreditation works—from choosing the right accrediting body, to what the step-by-step process looks like, and yes, how to budget for it without guessing.

By the time you’re done reading, you’ll have a clear game plan—and way less stress about what lies ahead.

What Is ISO 15189:2022 Accreditation (and Why It’s Different from Certification)?

Here’s where a lot of labs get tripped up—so let’s clear this up right away.

ISO 15189:2022 accreditation is about proving that your medical laboratory is technically competent to deliver accurate and reliable results. It’s not just about having documents or ticking off clauses—it’s about how your lab performs under real-world conditions.

Now, here’s the part many teams confuse:
Accreditation is not the same as certification.

So what’s the difference?

• Certification, like ISO 9001, means your management system meets a standard. It’s typically issued by a certifying body and focuses on things like processes, documentation, and continual improvement.

• Accreditation, on the other hand, goes much deeper. It means a recognized authority has evaluated your lab’s technical ability to perform specific medical tests—and found you capable.

Think of it this way:

• Certification says, “Your system is organized.”

• Accreditation says, “You know how to run tests accurately, every time.”

Why that matters for medical labs

When patient care depends on your results, it’s not enough to say you’ve got good intentions or clean SOPs. ISO 15189:2022 wants proof—evidence that your lab staff are trained, your equipment is maintained, and your processes consistently deliver trustworthy results.

This is the accreditation that hospitals, governments, and diagnostic networks increasingly require. And if your lab wants to compete—or stay open—it’s becoming non-negotiable.

Who Provides ISO 15189 Accreditation? (And How to Choose the Right One)

One of the first questions I get from labs is:
“So who actually gives us this accreditation?”

And it’s a smart question—because not all accreditation bodies are created equal. Choosing the right one can save you time, confusion, and even money in the long run.

What Is an Accreditation Body?

An accreditation body is an independent, technically competent organization authorized to assess and accredit medical laboratories against ISO 15189:2022. They’re the ones who come in, review your system, check your records, watch your staff work, and ultimately decide whether your lab meets the mark.

These bodies are usually part of national or regional systems and are often recognized under international agreements like the ILAC MRA (International Laboratory Accreditation Cooperation – Mutual Recognition Arrangement). That matters, because ILAC-recognized accreditation is what makes your results globally trusted.

Examples of ISO 15189 Accreditation Bodies by Region

Here are some of the main players:

• United States: A2LA (American Association for Laboratory Accreditation), CAP (College of American Pathologists)

• United Kingdom: UKAS (United Kingdom Accreditation Service)

• Canada: SCC (Standards Council of Canada)

• India: NABL (National Accreditation Board for Testing and Calibration Laboratories)

• Australia: NATA (National Association of Testing Authorities)

• Germany: DAkkS

• International labs: May use multiple bodies depending on their scope, region, and client requirements

How to Choose the Right One for Your Lab

Here’s what to consider when selecting your accreditation body:

• Geographic relevance: Some labs must use their country’s official body due to regulations or contracts.

• Industry fit: Certain bodies specialize in medical, environmental, or forensic testing. Choose one with strong healthcare experience.

• Turnaround time: Some bodies are faster to respond and schedule audits than others. Ask upfront.

• Support and clarity: How well do they explain their process? Are they responsive during the prep phase?

• Recognition: Make sure they’re ILAC MRA signatories—that’s the gold standard for global recognition.

One story from the field:

A diagnostics startup I worked with in Southeast Asia initially chose a lesser-known accreditor based on price alone. But six months in, they found that their accreditation wasn’t accepted by local regulators. They had to start the process over—with a recognized body—and it set them back nearly a year.

Lesson learned: go with a body that’s both credible and well-aligned with your region and scope.

The ISO 15189:2022 Accreditation Process – Step by Step

Getting accredited to ISO 15189:2022 might seem like a mountain at first. But once you see the full path laid out, it becomes a series of manageable steps—and that’s where most labs breathe a little easier.

Here’s how the process really works, based on what I’ve seen with labs of all sizes:

1. Initial Inquiry and Application

This is where it starts. You contact your chosen accreditation body and request their application pack. This usually includes:

• Scope of accreditation form (you define what tests you want covered)

• Checklist of required documentation

• Fee schedule

• Timeline expectations

Tip: Don’t rush this part. It sets the tone for everything that follows.

2. Optional Pre-Assessment (But Highly Recommended)

Many labs skip this to save time or money—but in my experience, a pre-assessment is one of the smartest moves you can make.

An assessor will review your readiness without formally grading you. They’ll spot gaps, flag risky areas, and give you a feel for how the real audit will go.

One lab I worked with caught three critical documentation gaps during pre-assessment—fixing them early saved them a major finding later.

3. Document Review (Stage 1 Audit)

Here, the accreditation team reviews your documented quality system:

• Quality manual

• SOPs

• Risk assessments

• Internal audit reports

• Training records

If they find anything missing or unclear, you’ll get a chance to update it before the on-site assessment.

4. On-Site Assessment (Stage 2 Audit)

This is the main event. Assessors will:

• Interview your staff

• Observe test procedures in real-time

• Review records and traceability

• Evaluate risk controls, equipment logs, and nonconformity handling

• Follow test samples from receipt to result

Expect this to last 1 to 5 days, depending on your lab size and scope.

5. Corrective Action Phase

If assessors find nonconformities—don’t panic. You’ll get a formal report outlining what needs to be fixed.

You’ll then need to:

• Analyze the root cause

• Implement corrective actions

• Submit documented evidence

The faster and clearer your response, the faster the approval.

6. Accreditation Decision

Once your corrective actions are accepted, the body’s decision committee will review the full package and issue your ISO 15189:2022 accreditation certificate.

You’re now officially accredited—congrats.

7. Surveillance and Reaccreditation

It doesn’t end there. Most accreditation bodies require:

• Annual surveillance audits (shorter than the initial one)

• Full reaccreditation every 3 to 5 years

This ensures your lab stays compliant and improves continuously.

How Much Does ISO 15189 Accreditation Cost? (And What Affects the Price)

Let’s be honest—accreditation isn’t cheap. But it’s also not a black box. Once you know the cost drivers, you can budget with confidence and avoid surprises.

What You’re Really Paying For

Here’s what typically makes up the total cost:

• Application fee: A fixed, upfront fee just to open your file. Usually a few hundred to a few thousand dollars.

• Document review: Time spent by assessors reviewing your quality manual, SOPs, and internal audits.

• On-site audit days: The biggest cost. The more complex or widespread your lab operations, the more days required.

• Assessor travel and lodging: If assessors need to fly or stay overnight, you’re covering the bill.

• Corrective action review: If there are nonconformities, time spent reviewing your responses is billable.

• Annual surveillance fees: Ongoing checks to make sure your system remains compliant.

• Reaccreditation fees: Every three to five years, you’ll go through another full cycle.

Ballpark Numbers (Based on Lab Size and Scope)

Let’s break it down by real-world lab scenarios:

• Small lab (limited tests, under 10 staff):
  Budget around $10,000 to $20,000 USD for initial accreditation.

• Medium-sized lab (multi-discipline, 10–30 staff):
  Expect $20,000 to $35,000 USD, including surveillance.

• Large or reference lab (wide scope, 30+ staff):
  You’re likely looking at $40,000 to $60,000 USD, especially if international assessors are involved.

These numbers vary based on location, accreditation body, and whether you require significant corrective actions.

Hidden or Overlooked Costs

This is where many labs get blindsided:

• Internal staff time: Preparing documents, training, and being pulled into audits adds up fast.

• System upgrades: You may need to invest in LIMS, calibration tools, or data integrity improvements.

• Consulting or coaching: Not required, but often essential for labs new to ISO 15189.

• Translation and localization: If your SOPs aren’t in the assessor’s language, you’ll need accurate versions.

A quick tip from experience:

A lab I supported in Europe underestimated their total cost by nearly 30 percent—because they didn’t budget for surveillance fees and forgot to factor in international assessor travel. Once they corrected that, they got executive buy-in a lot faster. Transparency matters.

How to Choose the Right Accrediting Body for Your Lab

Not all accreditation bodies are the same—and choosing the right one isn’t just about location or price. It’s about fit. The right accreditor understands your type of testing, supports your lab’s growth, and provides clarity throughout the process. The wrong one? That can cost you time, money, and even credibility.

Start with These Key Questions

Here’s what I recommend asking every accrediting body before signing anything:

• Are you an ILAC-MRA signatory?
  If they aren’t, your accreditation might not be recognized internationally—or even nationally in some cases.

• What types of labs do you specialize in?
  You want assessors who understand your testing environment, not generalists.

• What’s your average turnaround time from application to decision?
  Some bodies move quickly; others have long backlogs. Ask for transparency.

• Do you offer pre-assessment services or technical guidance before the audit?
  Bodies that help you prepare (without compromising impartiality) often make the process smoother.

• What kind of post-accreditation support do you provide?
  Some bodies check in, provide updates on standard changes, and offer continuing education. Others disappear until it’s time to re-audit.

Compare Based on Fit, Not Just Fees

While budget matters, don’t let price drive the entire decision. Look at:

• Reputation and relationships in your region and industry

• Communication style—Are they responsive? Clear? Flexible?

• Access to local assessors—This affects both cost and context

• Client experience—What do other labs say about working with them?

In my experience, the labs that choose based on relationship and responsiveness—not just cost—get through accreditation faster and with less friction.

One story that stuck with me:

I once worked with a diagnostic startup that chose an accreditation body based purely on a low quote. Six months in, they hadn’t heard back after document submission. Emails were going unanswered. Eventually, they switched to a better-aligned body—and had their certificate in hand within 90 days. They later told me, “We would’ve gladly paid more to not lose six months.”

Pro Tips and Insider Insights from the Field

Over the years, I’ve seen labs struggle, pivot, and succeed through the ISO 15189 process. The difference-maker? Not always budget or size—it’s mindset and planning. Here are some lessons learned from the field that can save you time, money, and frustration.

Pro Tip #1: Start with a Gap Assessment—Before You Touch an Application

This one’s huge. Whether you bring in a consultant or use an internal quality lead, perform a structured gap analysis before reaching out to an accreditation body. It helps you:

• Spot major system weaknesses

• Set realistic timelines

• Prioritize documentation and training

Labs that skip this often end up scrambling during audits, or worse—facing preventable nonconformities.

Pro Tip #2: Choose Assessors Who Understand Your Lab’s Work

Ask the accreditation body to assign assessors familiar with your discipline (molecular, microbiology, hematology, etc.). A mismatch can lead to unrealistic expectations or misinterpretations.

One lab I supported had an assessor with zero background in clinical virology. It made the audit rougher than it needed to be. They switched assessors the next cycle—and had a much smoother ride.

Pro Tip #3: Build Accreditation Costs into Your Annual Budget—Not Just Once

It’s easy to treat accreditation like a one-time project. But costs are recurring:

• Surveillance fees

• Staff training

• System maintenance

• Reassessments every few years

Spread those out in your operating budget and plan for them long-term. It builds leadership buy-in and prevents last-minute spending stress.

Pro Tip #4: Use Internal Audits as Real Practice—Not Just a Requirement

Don’t treat internal audits like a formality. Make them challenging. Involve cross-functional teams. Track root causes like your accreditation depends on it—because it does.

One client said, “Our internal audit felt harder than the real one.” That’s a good sign.

These aren’t just checklist items—they’re mindset shifts. They turn accreditation from a painful project into a quality culture that sustains itself.

Common Mistakes to Avoid (and FAQs That Deserve Straight Answers)

Getting accredited isn’t easy—but a lot of the stress and rework comes from avoidable missteps. If you know what to watch out for early, you can save your team time, frustration, and budget.

Top Mistakes Labs Make

1. Confusing Certification with Accreditation

This one happens more often than you’d think. Labs prepare for ISO 9001, thinking it covers them for ISO 15189. It doesn’t. Certification covers your management system. Accreditation covers technical competence—and it’s way more rigorous.

2. Starting Without a Roadmap

Jumping straight into documentation or training without a gap analysis leads to wasted effort. Start with a plan, prioritize based on risk, and pace your efforts.

3. Underestimating Staff Readiness

Your SOPs might be solid, but if your team isn’t trained to explain and apply them in daily practice, assessors will catch that. Real competence matters—not just paperwork.

4. Ignoring Nonconformities After the Audit

A late or weak corrective action response can delay your accreditation by months. Treat the response phase as seriously as the audit itself.

5. Budgeting Only for the First Year

Surveillance audits, re-training, ongoing system upgrades—they all cost time and money. Build a multi-year budget early.

Frequently Asked Questions (FAQs)

Q1: Can we get accredited without hiring a consultant?

Yes—if you have a strong internal quality lead with ISO 15189 experience. But for first-timers or startups, bringing in expert support early often saves money and stress later on.

Q2: How long does it usually take to get accredited?

On average, six to eighteen months, depending on your lab’s starting point, documentation quality, and how quickly you respond to audit findings.

Q3: Is ISO 15189 accreditation legally required?

It depends on your country and sector. In some places (like France, India, and South Africa), it’s mandatory for medical labs. In others, it’s voluntary—but increasingly expected for contracts, partnerships, or reimbursement.

These are the kinds of truths that don’t always show up in official guides—but they absolutely show up in real labs.

Your Road to ISO 15189:2022 Accreditation Starts Here

Let’s step back for a second. If you’ve made it this far, you’re clearly serious about getting your lab ISO 15189:2022 accredited—and that already puts you ahead of the curve.

Here’s what I want you to take away:

• Accreditation isn’t just about having a system on paper. It’s about proving, day in and day out, that your lab delivers consistent, accurate, and reliable results. That’s what ISO 15189 is built to verify.

• Choosing the right accreditation body matters. The wrong one can cost you time and credibility. The right one becomes a long-term partner in your lab’s growth.

• Cost isn’t just a number—it’s a commitment. Think of accreditation as an investment in trust, quality, and market access.

In my experience helping labs across five continents, the ones that succeed are the ones that start with clarity, build the right team, and treat accreditation as more than a compliance checkbox.

If you’re ready to take that next step, don’t guess your way through it. Download our free ISO 15189 Accreditation Starter Kit, or book a quick consult—we’ll walk through your current state, goals, and what a realistic roadmap looks like for your lab.

Your lab’s excellence deserves recognition. Let’s make sure you get it.