Last Updated on September 24, 2025 by Melissa Lazaro

Setting Up Equipment, Calibration, and Maintenance Systems in ISO 15189 2022

Let’s be real—most labs focus so much on test accuracy and documentation that equipment management becomes an afterthought. But in my experience helping labs prep for ISO 15189:2022 audits, that’s exactly where problems start.

I’ve walked into labs where critical instruments hadn’t been calibrated in over a year. Maintenance logs were either missing or stuck in someone’s drawer. And when an auditor asks for calibration certificates? Panic mode.

Here’s what I’ve noticed: even the most competent lab teams get tripped up because they don’t have a simple, reliable system for managing equipment setup, calibration, and maintenance. Not because they don’t care—but because no one showed them how to build one that actually works day-to-day.

The good news? It doesn’t have to be complicated.

In this post, I’ll walk you through a practical, ISO 15189:2022-compliant approach to:

• Setting up and tracking your lab equipment,

• Planning and documenting calibrations the right way,

• And building a maintenance program that won’t get forgotten.

If you’ve ever scrambled for a calibration report or weren’t sure what to validate after installing a new analyzer—you’re not alone. This guide will help you get ahead of the chaos, pass audits with confidence, and keep your lab running smoothly.

Let’s dive in.

Understanding ISO 15189:2022 Requirements for Equipment and Calibration

Before we build the system, let’s get clear on what ISO 15189:2022 actually expects—because this is where a lot of labs go off track. They either overcomplicate things or completely miss key requirements.

Here’s what the standard is really saying:

ISO 15189:2022 wants you to do three things really well when it comes to equipment:

1. Control what’s being used

2. Prove it’s performing as intended

3. Document the entire lifecycle—from installation to retirement

Pretty straightforward, right? But applying that in a real lab takes a bit of structure.

Let’s break it down:

• Clause 6.4 is the core section on equipment. It says your lab must ensure that equipment:

  • Is suitable for its intended use

  • Is calibrated or verified at defined intervals

  • Is maintained and serviced regularly

  • Has records to prove all of the above

• Clause 6.3 ties in environmental conditions. Why does this matter? Because things like humidity, temperature, and vibration can affect how your equipment performs. You’ve got to control the surroundings and the tool.

• Traceability is key. Any equipment used to generate or verify results—especially measurements—needs traceable calibration. That means linking it back to a recognized national or international standard.

Quick example:

I worked with a regional lab that had a great setup—solid equipment, regular maintenance, everything running smoothly. But they hadn’t kept calibration certificates from the third-party vendor. When the auditor asked, no one could explain how the balances were traceable. It wasn’t a major nonconformity, but it was a confidence hit—and an easy one to avoid.

Bottom line?

If your equipment touches the test process or impacts result quality, ISO expects you to prove it’s reliable, calibrated, and under control. And if anything goes wrong with it, there should be a record of what happened—and what you did about it.

Setting Up a Lab Equipment Inventory System (The Right Way)

Let’s be honest—most labs think they have an equipment list… until an auditor asks for it. Then it’s either outdated, missing key info, or scattered across emails, spreadsheets, and binders.

If you want to stay ahead of ISO 15189:2022 (and save yourself a ton of stress), you need one centralized, up-to-date inventory system that tracks all essential details in one place.

Here’s what a proper equipment inventory should include:

• Unique ID or asset number

• Equipment name and model

• Manufacturer and serial number

• Date of purchase and installation

• Assigned location (room, bench, site)

• Assigned user or department

• Calibration status and due dates

• Maintenance schedule

• Validation or performance check status

• Status (in use, out of service, decommissioned)

Yes, it’s a long list—but once it’s set up, it becomes your single source of truth. And you won’t be scrambling the next time someone says, “When was that analyzer last calibrated?”

Pro Tip: Keep it searchable.

Whether you’re using Excel, Google Sheets, or a QMS software, make sure the list is filterable and sortable. That way you can instantly pull reports for:

• Equipment due for calibration this month

• All devices in hematology

• Everything that’s currently flagged “out of service”

A real-world example:

I helped a diagnostic lab in Malaysia migrate their handwritten logs to a cloud-based spreadsheet. We gave each piece of equipment a QR code that linked directly to its digital record—maintenance logs, calibration certs, everything. During audits, all they had to do was scan the QR code. The assessor was blown away.

You don’t need fancy software to make this work. You just need consistency, clarity, and control.

Planning and Scheduling Equipment Calibration (Without Missing a Due Date)

Now that you’ve got your equipment inventory in place, let’s talk calibration. This is one area where I see a lot of labs fall short—not because they aren’t doing it, but because the process isn’t planned, tracked, or documented properly.

Here’s the core idea:

If a piece of equipment affects patient results, it must be calibrated—and you need to prove it’s traceable and on schedule.

ISO 15189:2022 doesn’t leave much room for guesswork here. Clause 6.4 expects that calibration:

• Is performed at defined intervals (or before use if needed),

• Uses standards traceable to national or international references,

• And that you act if the equipment fails.

So, how do you stay on top of calibration?

Here’s a system that works:

1. Assign calibration frequencies based on risk and usage
   Daily-use pipettes? Calibrate more frequently. Backup centrifuge that runs twice a month? Less often, but still regularly.

2. Use a master calibration schedule
   Create a centralized calendar (physical or digital) with reminders. Color-code status:

   • Green = up to date

   • Yellow = due soon

   • Red = overdue

3. Document everything
   Keep all calibration certificates organized and review them before filing. Don’t just scan and save—make sure they:

   • Show traceability (to national/international standards)

   • Include acceptable ranges and actual results

   • Note any out-of-tolerance conditions and corrective actions

4. Have a plan for failed calibrations
   If something’s out of tolerance, stop using it. Identify impacted results, notify affected parties if necessary, and document your investigation and follow-up.

Real story:

One hematology lab I worked with missed a pipette calibration because the technician who handled it had left. A routine internal audit caught the gap—but by then, 200+ blood counts had been reported using potentially off-target volumes. It was a tough call, but the lab chose to recheck high-risk results and notify clients. It was messy, but they owned it—and updated their system to flag upcoming calibrations at least 30 days out. No repeats since.

Bottom line:
If it gets measured, it gets calibrated. And if calibration lapses, it needs to be addressed—not ignored.

Establishing an Equipment Maintenance Program (That Actually Gets Followed)

Let’s face it—maintenance is often the first thing to get skipped when labs get busy. I’ve walked into labs where analyzers hadn’t been serviced in over a year and the only “maintenance log” was a sticky note on the side of the machine. Not great.

The truth is, an unmaintained piece of equipment is a ticking time bomb, especially in a regulated environment like ISO 15189:2022. And the standard agrees—it expects a defined, documented maintenance system that supports reliable performance.

So how do you build a maintenance program that people actually stick to?

Here’s what works in real labs:

1. Start with the Manufacturer’s Recommendations

This is your baseline. If the user manual says service every 6 months, that’s your starting point. Then adjust based on your actual workload and environment.

2. Create Simple, Role-Specific Checklists

Break it down into:

• Daily checks (e.g., visual inspections, cleaning)

• Weekly or monthly tasks (e.g., filter replacements, system flushes)

• Annual preventive maintenance (vendor or in-house service)

Print them. Post them. Include them in training. And make them part of routine responsibilities—not an extra task “if there’s time.”

3. Track All Maintenance Activity

For each action, you need:

• Date performed

• Who did it

• What was done

• Any issues found and actions taken

Use a binder, spreadsheet, or digital log—just make sure it’s up to date and easy to access.

4. Assign Ownership

If “everyone” is responsible, no one is. Assign specific staff to monitor maintenance status for each department or instrument type. Include oversight in your internal audits or monthly QMS reviews.

A real-world win:

One microbiology lab I worked with had issues with recurring temperature fluctuations in their incubators. After some digging, we found the filters hadn’t been cleaned in months. We set up laminated weekly checklists with initials and visual reminders right on the units. Within a month, temperature stability was back on track—and guess what? Their error rates dropped, too.

Pro tip:

Schedule your preventive maintenance during low-volume times or after hours. That way, it doesn’t disrupt daily operations—and it actually gets done.

What Documentation You Need (And How to Keep It Audit-Proof)

Here’s the truth: doing the work isn’t enough if you can’t prove it. I’ve seen labs do everything right—calibration on time, maintenance done like clockwork—but still struggle during audits because the documentation was disorganized, incomplete, or just plain hard to find.

So what do you actually need to keep?

Let’s break it down. For each piece of equipment, you should have:

• Equipment Inventory Record
  That includes make, model, serial number, location, assigned user, and status.

• Calibration Certificates
  Must include:

  • Traceability to national or international standards

  • Measurement results

  • Pass/fail status

  • Any corrective actions if values were out of range

• Maintenance Records
  Include:

  • Date, person responsible, type of service performed

  • Whether it was preventive or corrective

  • Any issues found, fixed, or flagged for follow-up

• Installation and Validation Reports
  For new or relocated equipment. Show how you confirmed it was set up correctly and performs as expected in your lab.

• Service Contracts and Vendor Logs
  Keep a copy of external service agreements, vendor-supplied checklists, and engineer visit reports. These count toward your compliance.

• Out-of-Service or Decommission Logs
  When you take something offline, document it—why, when, who approved it, and how it was removed from your active list.

Make it easy to access, not easy to lose

You don’t need fancy software. But you do need structure:

• Digital folders organized by equipment ID or department

• Clear file names (e.g., “Pipette_X123_Calibration_2024-03-10.pdf”)

• Backups—always. Cloud or external hard drive, preferably both.

• Quick reference list—for internal audits or when the assessor asks, “Can I see your last three service records for this unit?”

Client example:

One genetics lab I worked with had everything saved—just not in one place. During a mock audit, it took them 45 minutes to locate a centrifuge’s calibration history. We helped them move to a shared drive with a simple folder template and a linked index. Next audit? They pulled everything up in two minutes flat.

Pro tip: Keep a printed or bookmarked audit checklist that tells you exactly which documents you’ll need to show for each type of equipment. Saves time. Saves stress.

Linking Equipment to Process Validation and Risk Management

Let’s be honest—this is the part a lot of labs overlook. You’ve got your equipment set up, calibrated, and maintained… but how does it tie into the actual tests you’re running? ISO 15189:2022 expects your quality system to be integrated—not a bunch of checklists in silos.

And that means your equipment management has to connect directly to process validation and risk control.

Why this matters:

If a key piece of equipment fails or drifts outside tolerance, it’s not just a maintenance issue—it could compromise patient results. That’s why ISO wants you to think beyond the tool and look at the bigger picture.

Here’s how to make the connection:

1. Flag equipment used in validated processes
   When you validate a method or process, document which equipment was involved. That way, if anything changes—like replacing a machine or updating software—you’ll know if the process needs to be revalidated.

2. Include equipment in your risk register
   Identify high-risk equipment. Ask:

   • What happens if this equipment fails or drifts?

   • Are there safeguards in place (like duplicate machines, QC checks, backups)?

   • How quickly would we catch the issue?

   The higher the risk, the tighter your controls should be—more frequent calibrations, extra QC, redundancy, etc.

3. Revalidate when something changes
   This includes:

   • Equipment relocation

   • Software or firmware upgrades

   • Major repairs or component replacements

   • Switching reagent types or detection kits that affect output

4. Document equipment dependencies in SOPs
   If a procedure relies on specific equipment—note it. That way, staff won’t just swap in a “similar” tool without realizing it might compromise results.

A real-world scenario:

I supported a virology lab that switched out a thermal cycler without notifying QA. Same brand, newer model. Everything looked fine… until internal QC started drifting. Turns out the ramp speed was slightly different, affecting amplification. Because they hadn’t linked their PCR method to that specific model in the validation, no one caught the risk until it hit the data. Now, their validation reports include serial numbers and dependencies for every critical method.

Bottom line:
Your equipment isn’t just hardware—it’s part of the quality chain. And ISO 15189:2022 wants that chain documented, monitored, and protected from risk.

Common Mistakes and FAQs About Equipment, Calibration, and Maintenance

Even well-run labs slip up when it comes to equipment systems. And honestly, it’s not because they’re careless—it’s because the day-to-day workload is heavy, and without a clear system, things fall through the cracks.

Here’s what I see most often (and how to avoid it):

Common Mistakes Labs Make

Mistake 1: Treating calibration as optional
If your equipment produces or verifies patient results, calibration isn’t a suggestion—it’s a must. Skipping it (or delaying it) is one of the fastest ways to get a nonconformity.

Mistake 2: Filing calibration certificates without checking them
I’ve seen labs file “compliant” certs only to realize later that the results were actually out of tolerance. Always review before you store.

Mistake 3: No system for tracking due dates
If you’re relying on memory or sticky notes, something will get missed. You need a tracker—spreadsheet, calendar alert, whatever works for your team.

Mistake 4: Maintenance logs are inconsistent or incomplete
If it’s not documented, it didn’t happen. That’s the rule in ISO. Maintenance needs to be logged every single time—no matter how routine.

Mistake 5: Overlooking the connection between equipment and test validation
Swapping out a piece of equipment might require revalidation. If you’re not tracking that connection, you’re putting test quality at risk without realizing it.

Frequently Asked Questions

Q1: Do we have to calibrate every piece of lab equipment?
Not necessarily. Only equipment that performs or influences a measurement used in patient testing needs traceable calibration. Non-critical tools might just need functional checks or verification.

Q2: What happens if we miss a calibration date?
You need to immediately stop using the equipment, assess whether results could be affected, investigate the impact, and document the corrective action. Don’t try to backdate or skip reporting—it’ll come back to bite you.

Q3: Can we do in-house calibration and maintenance?
Yes, but only if your staff are trained and you can show traceability. If you’re missing certified reference standards or documentation, it’s safer to go with an accredited provider.

Build Equipment Systems That Make Your Lab Stronger—Not Just Compliant

Let’s wrap this up.

Setting up proper systems for equipment, calibration, and maintenance isn’t just about passing your ISO 15189:2022 audit. It’s about running a lab that’s reliable, efficient, and trusted—by your team, your clients, and the clinicians who depend on your results.

In my experience, the labs that thrive don’t wait until an assessor is scheduled to get their systems in shape. They build routines that work in real life:

• A clean, accessible equipment inventory

• Calibration that’s traceable, reviewed, and on time

• Maintenance that’s consistent and well-documented

• And everything tied back to test performance and risk control

You don’t need to be perfect—you just need to be organized, transparent, and proactive.

So what’s your next step?

If you don’t already have:

• A master equipment tracker

• A monthly calibration/maintenance calendar

• Clear SOPs and ownership for documentation

Start there. Small moves can make a big difference.

And if you want help building it right the first time?
That’s exactly what we do at QSE Academy. We’ve helped labs around the world set up ISO 15189 equipment systems that are simple to manage and fully audit-ready.

Grab our free ISO 15189 Equipment Compliance Toolkit, or reach out if you’d like support reviewing or upgrading your current setup. Either way, don’t wait until you’re in the middle of an audit to realize what’s missing.

Build it now—and build it strong.