Internal Audit for ISO 17025

What to Include in an Internal Audit for ISO/IEC 17025

So, what exactly should you look at during an Internal Audit for ISO/IEC 17025? The answer is both broad and specific. Broad, because you need to cover your entire management system and technical operations. Specific, because you’ll need to dig into particular processes, documents, and actions to see how well they align with the standard.

Let’s break it down.

Start with the Management System

This is the part that covers your policies, procedures, records, and how your lab is organized to meet ISO/IEC 17025 requirements. A thorough Internal Audit for ISO/IEC 17025 should include reviews of:

• Document and record control

• Quality objectives and policies

• Risk management activities

• Internal communication and responsibilities

• Previous audit findings and corrective actions

You’re basically checking: Are we doing what we say we do? And is it working?

Don’t Skip the Technical Side

Here’s where ISO/IEC 17025 gets serious. Your internal audit should go beyond the office and into the lab. That means reviewing technical operations to confirm they meet both the standard and your lab’s own procedures.

During your Internal Audit for ISO/IEC 17025, include:

• Staff competence and training records

• Method validation or verification

• Equipment calibration, maintenance, and traceability

• Sampling procedures and handling

• Reporting and review of test or calibration results

Use a mix of methods—document review, observation, and interviews—to gather objective evidence. And always be sure to audit against your own procedures as well as the ISO/IEC 17025 clauses.

Audit What Matters Most

One of the smartest ways to structure your Internal Audit for ISO/IEC 17025 is to focus on high-impact areas first. If a certain process is new, has caused issues before, or directly affects results—put it at the top of your audit scope.

By covering both the management and technical components, you’ll ensure your audit doesn’t just meet the minimum—it actually gives you useful insights you can act on.

Next up, we’ll walk through how to conduct the audit itself—step by step—so you feel confident and in control on audit day. Let’s dive in!

How to Conduct the Internal Audit

Now that you’ve got your plan and scope in place, it’s time to actually conduct the audit. This is where everything comes together. A well-executed Internal Audit for ISO/IEC 17025 helps you uncover not just nonconformities, but opportunities to improve how your lab operates every day.

Let’s walk through it step by step—no stress, no guesswork.

Start with Preparation

Before stepping into the lab or opening a file, take a little time to prepare. Review the relevant procedures, previous audit findings, and any updates in your management system. If you’re auditing a technical activity, make sure you understand the method and the related ISO/IEC 17025 requirements.

A good Internal Audit for ISO/IEC 17025 starts with a checklist—customized to your lab. This helps guide your questions and keeps your audit focused on what really matters.

Observe, Ask, and Record

During the audit, your job is to gather objective evidence. That means:

• Watching how procedures are actually performed

• Asking staff how they follow processes

• Reviewing records and documents

• Comparing what’s happening in real time to what your procedures say

This is where things get interesting. A strong Internal Audit for ISO/IEC 17025 doesn’t just check boxes—it explores whether the system is actually working. You might notice, for example, that calibration records are present—but not signed. Or that a test method is being performed slightly differently than written.

When you spot something, take note. But don’t jump to conclusions. Ask open-ended questions like:

• “Can you walk me through how you do this step?”

• “Where is that recorded?”

• “Has this process changed recently?”

These questions help uncover not just nonconformities, but root causes.

Keep It Respectful and Supportive

One of the most important parts of conducting an Internal Audit for ISO/IEC 17025 is your tone. You’re not there to catch people doing something wrong—you’re there to help the lab stay accurate and consistent. Approach the audit like a peer review, not an interrogation.

Staff should feel comfortable sharing concerns or inconsistencies. Sometimes, they’ll even highlight issues you might’ve missed.

Once you’ve gathered your evidence, it’s time to wrap up with clear notes and findings. Next, we’ll look at how to report what you found and manage follow-up actions to keep your system strong and responsive. Let’s keep going!

Managing Audit Findings and Driving Improvement

Once your audit is complete and the observations are documented, it’s time to shift gears—because how you handle findings is just as important as finding them in the first place. One of the core goals of an Internal Audit for ISO/IEC 17025 is not just to identify gaps, but to use them as a springboard for improvement.

So, let’s walk through how to report findings clearly and turn them into meaningful action.

Writing Clear, Useful Findings

Your findings should be easy to understand and focused on facts. Avoid vague statements like “procedure not followed.” Instead, be specific:

• “Calibration certificate for Balance B-102 was missing from the equipment file.”

• “Staff member performed pH testing but was not listed on the competency matrix.”

During an Internal Audit for ISO/IEC 17025, it’s important to tie each finding to the relevant clause of the standard or your internal procedure. This shows that you’re auditing both compliance and consistency—and that you understand the link between the system and real-life lab activities.

Assigning Corrective Actions

Once findings are documented, the next step is assigning responsibility. Who will investigate the root cause? Who will implement the fix? What’s the timeline?

A good Internal Audit for ISO/IEC 17025 doesn’t leave issues hanging. It includes:

• A clear deadline for the corrective action

• Evidence that the root cause was analyzed (not just the symptom)

• Documentation of what was changed—procedure, training, process, etc.

You’re not just correcting errors. You’re making your system stronger and more reliable.

Follow-Up and Verification

Before you close out an audit, take one last step: verify that the action was effective. This might mean checking that a new form is being used, confirming that training has occurred, or reviewing updated records.

In any Internal Audit for ISO/IEC 17025, follow-up shows your commitment to continuous improvement. It also ensures that problems don’t repeat—and that your fixes are actually working in real conditions.

By treating audit findings as opportunities, not failures, you build a quality culture where everyone contributes to improving the system.

Up next, we’ll look at how to connect all of this back to your lab’s bigger picture—using audit results to inform decisions, reviews, and overall system health. Let’s bring it full circle

Tying Everything Back to the Management System

At this point, you’ve completed your audit, documented the findings, and followed up with corrective actions. But there’s one more step that really ties everything together—making sure your Internal Audit for ISO/IEC 17025 feeds directly into your lab’s broader management system.

ISO/IEC 17025 isn’t just about fixing problems as they come up—it’s about running a system that’s continually learning and improving. And your internal audit is one of the strongest tools to make that happen.

Feed Results into Management Review

Clause 8.9 of the ISO/IEC 17025 standard requires your lab to perform a management review. That review should include, among other things, the results of your internal audits. So instead of treating the Internal Audit for ISO/IEC 17025 as a stand-alone activity, it should directly inform your leadership team.

During the review, ask:

• What trends did we see in our audit findings?

• Were any issues recurring or systemic?

• Have previous corrective actions actually worked?

• What opportunities did the audit uncover?

When your internal audits help guide strategic decisions, they go from being a checkbox activity to a real driver of quality.

Use Audit Data to Spot Patterns

Over time, the findings from your Internal Audit for ISO/IEC 17025 will tell a story. Maybe certain processes need more attention. Maybe training gaps are more common in a specific area. Or maybe your documentation system needs a refresh.

This is where the real value of internal auditing shows up—not just in individual corrections, but in the patterns you can identify and act on.

Keep the System Aligned

One of the best things you can do after each Internal Audit for ISO/IEC 17025 is check that your quality documentation still reflects what’s happening in practice. If procedures were updated as a result of findings, make sure those updates are rolled out, communicated, and implemented.

This ongoing alignment is what makes your system truly “alive.” It means your policies, procedures, and day-to-day practices are in sync—which is exactly what ISO/IEC 17025 is all about.

So don’t stop at the checklist. Let your internal audits shape how your lab operates, improves, and succeeds. When done right, an Internal Audit for ISO/IEC 17025 becomes more than a requirement—it becomes a built-in quality compass for your entire organization.

Levy M.

I hold a Master’s degree in Quality Management, and I’ve built my career specializing in the ISO/IEC 17000 series standards, including ISO/IEC 17025, ISO 15189, ISO/IEC 17020, and ISO/IEC 17065.

My background includes hands-on experience in accreditation preparation, documentation development, and internal auditing for laboratories and certification bodies.

I’ve worked closely with teams in testing, calibration, inspection, and medical laboratories, helping them achieve and maintain compliance with international accreditation requirements.

I’ve also received professional training in internal audits for ISO/IEC 17025 and ISO 15189, with practical involvement in managing nonconformities, improving quality systems, and aligning operations with standard requirements.

At QSE Academy, I contribute technical content that turns complex accreditation standards into practical, step-by-step guidance for labs and assessors around the world.

I’m passionate about supporting quality-driven organizations and making the path to accreditation clear, structured, and achievable.