Last Updated on October 17, 2025 by Melissa Lazaro

Why Staff Training Is the Backbone of ISO 15189 Compliance

Here’s what I’ve noticed working with medical laboratories: most teams spend weeks perfecting their SOPs, updating policies, and preparing for audits—but forget one key factor that actually makes all those documents work: the people using them.

ISO 15189:2022 is built on competence. A lab can have beautifully written procedures, but if the staff performing the tests don’t fully understand them, compliance quickly falls apart. That’s why training isn’t just a requirement—it’s the backbone of your quality system.

In my experience, labs that treat training as an ongoing, structured process—not a one-off event—perform better in audits and produce more consistent, reliable results. Staff feel confident, assessors see competence, and management gets peace of mind.

In this guide, I’ll walk you through how to design an ISO 15189 training program that actually works—step-by-step, from identifying needs to proving competence.

Now, let’s look at what ISO 15189:2022 really expects when it comes to staff training and competence.

Understanding ISO 15189:2022 Training & Competence Requirements

ISO 15189:2022 makes one thing very clear—competence isn’t optional. Under Clause 6.2 (Personnel), every staff member performing tasks that affect the quality of examination results must be qualified, trained, and regularly evaluated.

That means your laboratory needs to go beyond simply keeping diplomas on file. You need to demonstrate that each person has the right knowledge, skills, and behavior to perform their duties consistently and correctly.

Here’s what that looks like in practice:

• Defining the competence requirements for every role.

• Providing structured training and supervision for new and existing staff.

• Maintaining up-to-date training records and competence evaluations.

• Reviewing staff performance regularly, especially after nonconformities or method updates.

Pro Tip: Certificates alone don’t prove competence. Auditors look for objective evidence—like observation checklists, test results, or internal audit feedback—to confirm that staff can actually do what they’ve been trained to do.

Common mistake: Labs often focus only on initial training. ISO 15189 expects continual competence monitoring, not a one-time sign-off.

Now that you know what the standard requires, let’s go over how to build a training program that meets those expectations and actually helps your team perform better.

Step-by-Step: How to Develop an ISO 15189 Training Program

Creating a training program doesn’t have to be complicated—it just needs to be consistent and tailored to your lab’s real workflow. The goal is to make sure every team member knows exactly what they’re responsible for, how to do it correctly, and how their role affects quality.

Here’s the process I recommend when setting up a training program for ISO 15189 compliance:

Step 1: Identify training needs.
Start by listing every position in your lab and outlining what knowledge or skills are essential for each. This becomes your baseline.

Step 2: Develop a training matrix.
Link each role to the required competencies—things like sample collection, equipment calibration, reporting, or safety. This matrix will guide all your future training efforts.

Step 3: Create or adopt training modules.
Use a mix of methods: SOP-based walkthroughs, mentorship programs, e-learning, or external workshops. The format doesn’t matter as much as consistency and documentation.

Step 4: Evaluate effectiveness.
After training, assess whether the staff member can perform the task independently and accurately. Observation, testing, or reviewing performance records all work.

Step 5: Keep detailed records.
Log every training session with the topic, date, trainer, and results. These records become evidence during accreditation.

Pro Tip: Blend theory and practice. A short talk on safety is good—but having staff demonstrate PPE use or waste disposal procedures is what truly shows competence.

Example: One small pathology lab I worked with paired new hires with experienced mentors for the first 30 days. Their error rates dropped by half, and their audit feedback praised their structured approach to training.

Once you’ve mapped your training needs, the next step is building a competency matrix to track progress and prove that training is effective.

Building a Competency Matrix (Template Included)

A competency matrix is one of the most practical tools for managing staff training under ISO 15189. It shows, at a glance, who’s qualified to do what, how they were trained, and when their next evaluation is due.

Think of it as your lab’s training dashboard—it keeps things organized, transparent, and audit-ready.

Here’s a simple example to get started:

When assessors see a well-maintained matrix like this, they know your lab takes competence seriously. It also helps you spot skill gaps early—before they become audit findings.

Pro Tip: Link your competency matrix with your document control system. When an SOP is revised, it should automatically trigger a review of affected staff competencies.

Common mistake: Letting the matrix sit untouched for months. Update it after every new hire, role change, or refresher training.

Once your matrix is in place, the next challenge is keeping those competencies current through ongoing assessment and refresher training.

Assessing and Maintaining Competence

Training isn’t a “one and done” activity—competence has to be demonstrated and maintained over time. ISO 15189 expects you to verify that your staff can consistently perform their assigned duties and that they stay current with updated methods, instruments, and procedures.

Here’s how I guide labs to manage this effectively:

1. Observe performance regularly.
Supervisors or section heads should directly observe staff performing key tasks—like calibrating equipment or reviewing test results—and document their findings.

2. Use objective assessments.
Written quizzes, blind sample tests, or participation in proficiency testing can all serve as proof of ongoing competence.

3. Review outcomes.
If an internal audit, complaint, or nonconformity points to a skill issue, it’s a sign that retraining might be needed.

4. Schedule refresher training.
Methods evolve, equipment changes, and even experienced staff forget steps over time. Plan periodic refreshers, especially in high-risk areas like sample handling or quality control.

Pro Tip: Keep competence assessments simple but structured—use short forms or digital checklists that include task name, evaluator, date, and result.

Common mistake: Assuming that long tenure equals competence. ISO 15189 wants proof, not assumptions. Even seasoned technologists need documented evidence of competence to meet the standard.

Once your team’s competence is regularly monitored, the next step is connecting all that training activity to your quality management system.

Integrating Training into Your Quality Management System

Here’s something I tell every lab team I work with: training shouldn’t live in isolation. It’s not a side activity—it’s a core part of your Quality Management System (QMS).

ISO 15189 connects training to almost every major clause. When done right, it feeds directly into document control, internal audits, management review, and continual improvement.

Here’s how to make that connection work in practice:

• Document Control: Every time you issue or revise an SOP, trigger a quick review to identify who needs retraining. This keeps your team aligned with the latest procedures.

• Internal Audits: Use audit results to uncover training gaps. If errors or nonconformities appear repeatedly, they often trace back to missing or ineffective training.

• Management Review: Include training summaries in your review agenda—completed sessions, overdue evaluations, and upcoming refresher needs.

• Risk Management: When you assess risks (like human error), integrate preventive training measures into your risk treatment plan.

Pro Tip: Create a direct link between CAPA and training. Every corrective action should include a question: “Does this require retraining?” If the answer is yes, schedule it immediately and document completion.

Example: A clinical chemistry lab I worked with found recurring transcription errors. Instead of updating just the SOP, they added a quick refresher training and verification test. The issue disappeared in less than a month.

Once training becomes part of your QMS flow, it naturally builds consistency. The next step is preparing your staff to shine during accreditation audits—because their confidence is your best evidence.

Preparing Staff for Accreditation Audits

Here’s something every lab learns eventually—assessors don’t just audit your documents, they audit your people. Staff confidence, understanding, and consistency often make or break an ISO 15189 assessment.

That’s why preparing your team for audit interviews is just as important as organizing your paperwork. Assessors will often approach bench staff directly to ask questions like:

• “Can you explain this procedure?”

• “Show me where you record calibration results.”

• “What do you do if a test result seems questionable?”

If your team hesitates or gives inconsistent answers, it signals weak training—even if your documentation looks perfect.

Here’s how to get everyone ready:

• Hold mock interviews and practice common assessor questions.

• Encourage staff to explain procedures in their own words—it’s better than memorized responses.

• Review how to locate records quickly; fumbling through folders creates unnecessary pressure.

• Remind staff that assessors aren’t there to trap them—they’re verifying system effectiveness.

Pro Tip: Keep pre-audit preparation light and positive. Stress-free staff perform better and project confidence.

Common mistake: Only training managers for audits. Assessors often talk to technicians, receptionists, or support staff—anyone involved in the workflow. Everyone should be ready to explain their role clearly.

Once your team is confident and audit-ready, let’s look at some of the most common questions labs ask about training and competence.

FAQs – ISO 15189 Training & Competence

Q1. How often should we retrain staff?
That depends on your processes and risk level. For critical areas like sample handling, testing, and data integrity, annual refreshers are ideal. For other processes, retraining should be scheduled whenever procedures change, new equipment is introduced, or audits reveal performance gaps.

Q2. Do online trainings count as valid ISO 15189 evidence?
Yes—if they’re properly documented. Record the training topic, date, trainer or platform, and include proof of participation (like a quiz result or certificate). The key is showing that staff not only attended but understood and applied the content.

Q3. What’s the best way to train new hires?
Start with a structured onboarding plan. Introduce them to the Quality Manual, relevant SOPs, and safety procedures. Then, assign a mentor to supervise their first few weeks of work. Only allow independent work once their competence is verified and documented.

Q4. Who should oversee staff training in the lab?
The Quality Manager typically coordinates the program, but section heads and technical supervisors should handle day-to-day training and competence assessments. Collaboration ensures that training reflects both quality requirements and practical realities.

Turn Training into a Competitive Advantage

Training isn’t just about ticking the ISO 15189 box—it’s what keeps your lab reliable, resilient, and respected. Well-trained staff catch errors early, handle audits with confidence, and deliver results your clients can trust.

In my experience, the labs that invest in consistent, well-documented training don’t just pass audits—they build cultures of excellence. Staff feel valued, processes run smoothly, and quality becomes second nature instead of a checklist.

If you’re ready to strengthen your team, start with a clear plan. Download QSE Academy’s ISO 15189:2022 Training Matrix Template to map out competencies, track progress, and stay audit-ready year-round.

Because in the end, your people aren’t just part of your quality system—they are your quality system.

Melissa Lazaro

Melissa Lavaro is a seasoned ISO consultant and an enthusiastic advocate for quality management standards. With a rich experience in conducting audits and providing consultancy services, Melissa specializes in helping organizations implement and adapt to ISO standards. Her passion for quality management is evident in her hands-on approach and deep understanding of the regulatory frameworks. Melissa’s expertise and energetic commitment make her a sought-after consultant, dedicated to elevating organizational compliance and performance through practical, insightful guidance.