Last Updated on September 24, 2025 by Melissa Lazaro

ISO 15189 2022 Accreditation Timeline: How Long It Takes and Why

Let’s be honest—most labs aren’t totally sure how long ISO 15189:2022 accreditation is supposed to take. I hear this all the time from clients: “Can we get accredited in three months?” or “What’s a realistic timeline?” And my answer is always the same: It depends—but you need to plan smarter, not just faster.

In my experience helping dozens of labs through this process—some starting from scratch, others transitioning from older versions—the timeline can stretch out quickly if you’re not prepared. Not because the standard is impossible, but because most teams underestimate the real scope of work involved.

So in this article, I’m going to break it down for you:

• How long ISO 15189:2022 accreditation really takes

• What steps are involved

• What causes delays

• And how to shave weeks (or even months) off your timeline without cutting corners

If you’re looking for a polished sales pitch, this isn’t it. But if you want a clear, honest roadmap based on real lab experience? You’re in the right place. Let’s dive in.

What Actually Drives the ISO 15189:2022 Accreditation Process?

Before we start throwing timelines around, let’s get clear on what this process is really about. Because here’s something I’ve noticed—many labs think ISO 15189 is just a paperwork exercise. Fill in a few templates, write a quality manual, schedule an audit… done. Right?

Not quite.

It’s About Proving You’re Competent—Not Just Compliant

ISO 15189:2022 isn’t just a checklist. It’s a deep dive into how your lab actually works—how you manage quality, train your staff, validate methods, control documents, and deal with risks. Accreditation bodies aren’t just ticking boxes. They want to see that your lab produces reliable, consistent, and accurate results every single day—not just when the auditors show up.

So when we talk about timelines, we’re really talking about:

• How long it takes to build a functioning, sustainable quality management system

• How quickly your team can implement and live those systems

• How ready you are to be assessed by an external accreditation body

In other words, the process is driven by your lab’s reality—not just a standard on paper.

From Experience: Two Labs, Two Very Different Journeys

I once worked with two labs starting around the same time. One was a new diagnostics startup with no prior systems in place. They needed everything—from SOPs to equipment maintenance plans. Their timeline? Just under 12 months.

The other was a national referral lab already certified to ISO 9001. They had robust processes but needed to adjust them for ISO 15189:2022. With solid leadership and a focused quality team, they were audit-ready in 5 months.

The key difference? One had to build everything from scratch. The other just had to adapt and align.

So, How Long Does ISO 15189:2022 Accreditation Actually Take? A Phase-by-Phase Breakdown

Let’s get into what you really came here for: the timeline.

Now, I’m not going to give you some generic answer like “it takes 6 to 12 months” and leave it at that. Instead, let’s walk through each phase and what actually happens—because that’s where the real variation comes in.

Phase 1: Gap Assessment and Planning (2–4 weeks)

This is where you find out how far your current system is from ISO 15189:2022.
In my experience, this is one of the most important—but most overlooked—phases. Skipping it usually leads to more delays down the line.

What’s involved:

• Reviewing your current quality system

• Identifying missing or non-compliant elements

• Creating an action plan and realistic timeline

Pro tip: Get outside help here if your team isn’t familiar with the new 2022 revision. A good consultant can save you weeks of guessing.

Phase 2: Document Development and System Setup (1–3 months)

This is the real “building” phase. You’ll need to create or update:

• Quality manual

• SOPs

• Method validations

• Training records

• Equipment maintenance protocols

Reality check: If your lab has nothing documented, expect this to take 3+ months. If you’re transitioning from 2012, you may get it done in 4–6 weeks with the right support.

Phase 3: Implementation and Staff Training (1–2 months)

Here’s where theory meets practice. Your documents don’t mean anything unless your staff actually follow them. This phase includes:

• Rolling out new procedures

• Conducting internal training

• Assigning responsibilities

• Starting to generate records as evidence

This phase usually overlaps with document development, but don’t rush it. Auditors will ask staff questions—and they can tell when people are just reading from a script.

Phase 4: Internal Audit and Management Review (3–4 weeks)

Before you invite the accreditation body in, you need to:

• Run at least one full internal audit cycle

• Hold a documented management review

• Address any internal nonconformities

This is where a lot of labs stall—especially if they didn’t build internal audit capacity early on.

Phase 5: External Audit Scheduling and Final Assessment (2–4 months depending on the body)

Once you’re confident your system is in place, you’ll apply to the accrediting body. They’ll review your documents, then schedule:

• A pre-assessment (optional but helpful)

• A formal assessment audit

Depending on the body’s availability, it may take weeks or even months to get on their calendar. Then, you’ll need to close out any audit findings (usually within 30–90 days).

So What’s the Total Time?

Here’s a rough guide based on real projects:

Every lab is different, but this framework gives you something solid to plan around.

What Speeds You Up—or Slows You Down? Key Factors That Affect Your Timeline

Now that we’ve walked through the phases, let’s talk about the reality check: your timeline will depend heavily on your lab’s specific situation. Over the years, I’ve seen labs fly through accreditation—and others stall for months—because of the same handful of issues.

1. How Committed Is Your Leadership Team?

Here’s what I’ve noticed: when lab managers and leadership are fully on board, the process moves faster—period. If upper management is hesitant to allocate time, resources, or decision-making authority, everything slows to a crawl.

Pro tip: Make sure someone on your leadership team owns the process. Not just in name—but in practice.

2. Do You Have the Right People in the Right Roles?

A well-defined quality team with clear responsibilities can shave weeks off your implementation time. But if tasks are spread thinly across already-busy staff—or worse, no one’s really driving things—expect delays.

Real story: I worked with a diagnostic lab that had a brilliant pathologist in charge—but no one else trained in quality. We lost two months just getting people up to speed. Once they hired a dedicated QA officer, the timeline improved immediately.

3. Are You Starting from Scratch or Just Upgrading?

Let’s be real—if your lab doesn’t have any kind of QMS in place, you’re building from the ground up. That takes time. But if you’ve already got ISO 9001 or even an older version of ISO 15189, you’ve got a head start. You’ll still need to close the gaps, but your foundation is stronger.

4. How Complex Is Your Operation?

Single-location labs with a narrow testing scope can move quickly. But if you’ve got multiple departments, high test volumes, or specialized services like molecular diagnostics or pathology, implementation takes longer. More people to train, more records to gather, more risk points to control.

5. Which Accrediting Body Are You Working With?

This is a big one—and one most labs forget. Some accreditation bodies are fully booked months in advance. Others require a pre-application review, and some have longer turnaround times for audit reports. That alone can stretch your timeline by three months or more.

Tip: Reach out early and ask about availability before you finalize your internal schedule.

Bottom line? The more prepared, resourced, and focused your team is, the faster you can move. Up next, we’ll look at how transitioning from the 2012 version of ISO 15189 affects your timeline—and what’s changed in the 2022 revision that might catch you off guard.

Transitioning from ISO 15189:2012 to 2022: What’s New—and How It Affects Your Timeline

If your lab is already accredited under ISO 15189:2012, you might be thinking, “How hard can this transition be?” And while you’re not starting from zero, make no mistake—the 2022 revision introduces some big shifts that do require time and planning.

So, What’s Actually Changed?

Here’s the short version: ISO 15189:2022 leans more heavily into risk-based thinking, process-based management, and integration with ISO/IEC 17025 principles. It also updates language to reflect more modern lab practices, especially in areas like digital records, remote sample collection, and patient confidentiality.

Key changes include:

• More emphasis on risk and opportunities

• Defined leadership responsibilities

• Stronger focus on competence and impartiality

• Reorganized clause structure to align with other ISO standards

These aren’t just cosmetic updates. They affect how you document, train, and audit your system.

How the Transition Impacts Your Timeline

Even if your lab is already accredited, you’ll still need to:

• Conduct a full gap assessment against the 2022 standard

• Update procedures, manuals, and training materials

• Retrain staff on any process or documentation changes

• Demonstrate compliance during a reassessment audit or surveillance visit

In my experience, most labs need 3 to 6 months to fully transition—assuming they already had a well-maintained QMS under the 2012 version. If things have slipped since your last audit? Expect closer to 6+ months.

Quick Example from the Field

One hospital lab I worked with had held ISO 15189:2012 accreditation for years—but hadn’t updated their internal audit process in almost 18 months. When we did a gap check, we found they weren’t even tracking risks in a structured way. It took them four months just to realign their documentation and train staff properly.

Working with Accreditation Bodies: What to Expect and Why It Affects Your Timeline

Now that you’ve got your internal system ready—or at least in motion—there’s another major factor that can influence how long the whole accreditation process takes: the accreditation body itself.

And let’s be real—this part can get frustrating if you don’t plan ahead.

Why Accreditation Body Timelines Matter

Even if your lab is 100 percent ready, you can’t move forward without the accreditor. And depending on where you’re located and who you choose, you might wait weeks or even months just to get your audit on the calendar.

Here’s what usually happens:

1. You submit an application

2. The body reviews your documents (which can take 2–4 weeks)

3. They schedule a pre-assessment (optional, but highly recommended if this is your first time)

4. Then comes the full assessment audit

5. If there are findings, you’ll need to submit evidence of corrective actions

6. Only after that will you receive your accreditation decision

Each of those steps has its own internal timeline—and none of them are instant.

What You Can Do to Stay Ahead

1. Reach Out Early
Even before your QMS is fully implemented, start conversations with your preferred accrediting body. Ask:

• What’s the current wait time for audits?

• Do they offer virtual pre-assessments?

• What’s their average lead time from application to final report?

2. Don’t Skip the Pre-Assessment
I’ve seen labs try to skip this to save time—and end up failing the full audit. A pre-assessment helps identify weak points while there’s still time to fix them.

3. Have Your Corrective Action Process Ready
The clock doesn’t stop after your audit. Most labs get at least a few minor nonconformities, which must be addressed—quickly and thoroughly. If you wait weeks to respond, your timeline stretches again.

A Quick Real-World Example

One lab we supported was fully audit-ready by July. But their accrediting body couldn’t schedule the audit until October. Add three more weeks for the report, and another month to close two nonconformities. End result? Accreditation wasn’t finalized until December—five months after internal readiness.

How to Reduce Your ISO 15189:2022 Timeline Without Cutting Corners

Let’s be honest—every lab wants to get accredited faster. But here’s the catch: speeding up the process doesn’t mean skipping steps. It means working smarter, being proactive, and leaning into proven tools and strategies.

In my experience, labs that finish in six to eight months don’t move faster because they work harder. They move faster because they start right, stay focused, and avoid unnecessary detours.

1. Start with a Proper Gap Assessment

Before you write a single SOP or schedule an audit, do a deep, honest assessment of where your lab stands against the 2022 version of the standard.

Why it matters: It gives you a roadmap. You’ll know exactly what’s missing, what needs updating, and what’s already working. This helps you avoid rework, which eats up time like nothing else.

Insider tip: If you’ve never done this before, bring in someone who has. A focused 2-week gap review can save you 2 months of trial and error.

2. Use Pre-Built Documentation (But Customize It)

Templates and toolkits are a lifesaver—as long as you don’t treat them like plug-and-play systems. Start with a solid framework, but make sure the documents reflect how your lab actually operates.

Why it matters: Auditors can spot a generic quality manual a mile away. Plus, if your staff can’t explain or follow what’s written, nonconformities are guaranteed.

3. Assign an Internal Lead—and Give Them Time

Labs that move quickly always have a dedicated person managing the process. Someone who’s empowered to make decisions, coordinate departments, track progress, and respond to questions from the accreditation body.

What works best: Block time in their schedule. Don’t treat this as a side project. Accreditation is a big deal—it deserves real attention.

4. Build in Real-Time Training

Don’t wait until a week before the audit to train staff. Start early and do it in small, manageable pieces:

• 15-minute weekly refreshers

• Short quizzes or huddles

• One-on-one coaching for key technical leads

Bonus: Keep a training tracker. Auditors love to see evidence of ongoing learning—it shows maturity in your QMS.

5. Stick to a Weekly Implementation Plan

Instead of saying “We’ll finish implementation in 3 months,” break it down:

• Week 1–2: Finalize SOP drafts

• Week 3–4: Begin document control training

• Week 5–6: Launch internal audit schedule

• Week 7–8: Complete full-cycle dry run

This kind of micro-planning keeps teams engaged and helps you catch delays early—when they’re still easy to fix.

Real Example:
One regional lab we worked with set up a 10-week plan with milestone check-ins every Friday. By week 11, they were ready for their pre-assessment—and passed with only two minor findings. No scramble, no burnout, and a clear timeline they could actually follow.

Pro Tips and Insider Insights to Help You Stay on Track

After guiding dozens of labs through the ISO 15189 process, I’ve seen what works—and what derails even the best intentions. If you want to stay on schedule without sacrificing quality, these are the tips worth bookmarking.

PRO TIP 1: Don’t Wait for Perfection—Start with What You Have

Labs often delay progress waiting for the “perfect” document format, training session, or QMS software. In reality, progress beats perfection. Get your first drafts done, get feedback, and refine from there.

“One of our clients spent six weeks debating between two document templates. Once they picked one and moved forward, they completed their quality manual in a week.”

PRO TIP 2: Build Accreditation Tasks into Your Weekly Workflow

If ISO prep is treated as an extra project, it gets pushed aside when daily lab work piles up. The labs that succeed? They embed tasks like training, documentation reviews, and audits into their normal weekly rhythm.

“We helped one lab implement a 30-minute ‘quality block’ three times a week. That small habit saved them hours of rushed catch-up before their audit.”

INSIDER INSIGHT: Your Staff’s Confidence Can Make or Break the Audit

Auditors don’t just review documents—they talk to your people. If your team understands the system and speaks confidently about it, that builds trust fast. Invest early in training, not just templates.

PRO TIP 3: Clarify Your Audit Timeline with the Accreditor—Early

Many labs assume they can apply one month and get audited the next. Not true. Some accreditation bodies have a 2- to 4-month lead time. Locking in your assessment date early helps you reverse-engineer your timeline with clarity.

Common Mistakes to Avoid—and Your Top Questions Answered

Let’s be real—most delays in ISO 15189:2022 accreditation don’t come from the standard itself. They come from the way teams approach it. Here’s a short list of pitfalls I’ve seen even experienced labs fall into—and some answers to the questions I get asked all the time.

Common Mistakes That Slow Labs Down

1. Treating Accreditation Like a Documentation Exercise
A stack of SOPs doesn’t mean much if your staff don’t understand them. ISO 15189 is about competence and consistency, not just paperwork.

Tip: Build in time for internal practice and simulations—especially for interviews with auditors.

2. Waiting Too Long to Start Internal Audits
This one’s huge. Internal audits take time to plan, conduct, document, and follow up. If you delay them until the end, you risk missing critical issues before the real assessment.

3. Skipping Staff Training or “Saving It for Later”
Your documents won’t pass the audit—your team will. Train early, check understanding often, and make sure people are comfortable answering basic audit questions.

4. Relying on Templates Without Adapting Them
Pre-built documents are helpful—but only if they reflect your actual process. Auditors will ask: “Do you follow this?” And your staff needs to say yes—and prove it.

5. Underestimating the Accreditation Body’s Timeline
If you think you’ll apply this month and get audited next month… think again. Booking delays, holiday schedules, and review cycles can easily add 2–3 months.

Frequently Asked Questions

Q1: How long does ISO 15189:2022 accreditation really take from start to finish?
A: For most labs, between 6 and 12 months—depending on your starting point, resources, and complexity. If you’re starting from scratch, plan for the higher end. If you’re transitioning from ISO 15189:2012 with a strong QMS already in place, you might get it done in 4 to 6 months.

Q2: Can we fast-track the process?
A: You can speed things up with expert help, solid planning, and by using templates—but you still need to generate records, train your team, and implement processes. Shortcuts usually come back to bite you during the audit.

Q3: What’s the biggest cause of delay once the audit is scheduled?
A: Failing to respond to nonconformities on time—or submitting weak evidence. You typically have 30 to 90 days to close findings after the assessment. If your responses are incomplete, that clock resets.

Plan Smart, Move Steady, and Get Accredited with Confidence

If there’s one thing I’ve learned from helping labs all over the world with ISO 15189, it’s this: the labs that succeed aren’t the ones that rush—it’s the ones that plan smart, stay consistent, and keep their people engaged.

We’ve covered a lot here—from what drives the accreditation process, to how long each phase typically takes, what speeds you up, and what slows you down. You now know that ISO 15189:2022 accreditation isn’t just about ticking boxes—it’s about building a system your lab can stand behind. A system your staff understands. And a system that earns trust, internally and externally.

Let’s quickly recap what you should take away:

• Most labs need 6 to 12 months, depending on complexity and readiness.

• The timeline is flexible, but only if you stay focused and clear on each phase.

• Delays usually come from internal audits, training gaps, or audit scheduling—not the standard itself.

• You can shorten the timeline with the right tools, guidance, and team structure—without sacrificing quality.

In my experience, the labs that get through this process smoothly are the ones that don’t try to do it alone. They ask questions, they get help when needed, and they treat accreditation as a real opportunity—not just a box to check.

Need help mapping out your timeline or getting your QMS off the ground?
That’s exactly what we do at QSE Academy. Whether you’re starting from scratch or transitioning from ISO 15189:2012, we’ve got the tools, templates, and hands-on support to help you move forward—confidently and on schedule.

Ready to get started? Visit www.qseacademy.com or reach out for a free consultation. Let’s take the guesswork out of your accreditation journey.