ISO 17025 Nonconformity Examples (Common Audit Findings Explained)

ISO/IEC 17025 audits can expose gaps fast—especially when a lab can’t show clear, traceable evidence for how work is performed and controlled. This guide provides practical ISO 17025 nonconformity examples and keeps common audit findings explained in plain English, so you can recognize what’s being cited, why it matters, and what objective evidence typically closes the gap. From an auditor/assessor perspective, findings are usually written when I can’t trace a result end-to-end—from the request to the method and equipment used, to raw data, review, and the final report.

A nonconformity simply means your lab did not meet a requirement in ISO/IEC 17025:2017 (or you didn’t follow your own documented process). That can delay accreditation, trigger additional corrective actions, or create repeat findings if the underlying cause isn’t addressed. Typical examples include:

• missing method verification/validation records,
• incomplete competence and authorization evidence,
• equipment used past calibration due dates,
• uncontrolled document changes,
• technical records that can’t be traced end-to-end,
• report elements missing from controlled templates,
• weak internal audits,
• and corrective actions without effectiveness checks.

These findings commonly map back to core clauses on competence, equipment and traceability, methods, technical records, reporting, document control, and corrective action.
Once you see the pattern behind a finding, you can correct the process—not just patch the symptom—so it doesn’t return in the next assessment.

Key Takeaways

• Nonconformities pop up when you don’t meet ISO/IEC 17025 or your own procedures.
• Typical examples involve training, calibration, document control, and corrective action.
• Solid internal audits and real root cause analysis help you avoid repeat findings.

ISO 17025 Audit Findings Explained (Plain English)

ISO 17025 findings aren’t personal—they’re just documentation showing where your lab didn’t meet a specific requirement for accreditation.

If you want a quick overview of how findings are issued and reviewed during lab assessments, this is a solid reference: The Anatomy of a Laboratory Assessment (ANAB).

What Is An ISO 17025 Nonconformity?

An ISO 17025 nonconformity means your lab didn’t meet a stated requirement in the standard or in your own system.

It might relate to technical work or your management system. Maybe someone used equipment past the calibration due date, skipped a method step, or missed a required review in a management meeting.

Nonconformities always link to a specific ISO 17025 clause. Auditors will cite the clause number and describe what they saw.

Common examples:

• Missing training or competence records
• Incomplete environmental monitoring logs
• Reports issued without proper authorization
• Uncontrolled or outdated procedures in use

The accreditation body (A2LA or whoever you’re working with) expects you to correct the issue and address the root cause. Closing out the finding properly keeps your accreditation safe and your results credible.

How Auditors Write Findings

Auditors don’t leave things vague. They always document three things: requirement, evidence, and gap.

Most findings look like this:

Element	What It Means
Requirement	The ISO 17025 clause or your procedure
Evidence	What the auditor saw or reviewed
Gap	How the evidence failed to meet the requirement

For example, an auditor might write:
Clause 6.4 requires equipment to be calibrated at specified intervals. The micrometer ID 123 was past due by three months at the time of use.

This keeps findings factual and to the point.

If you get used to this structure, you’ll start to predict how your accreditation body will evaluate your lab. It’s a good idea to train staff to use the same format for the ISO 17025 internal audit.

Major Vs Minor Nonconformities (Practical Explanation)

Not all nonconformities are created equal.

A major nonconformance can impact result reliability or show your system’s broken somewhere. If you don’t fix it fast, you could face delayed or suspended accreditation.

Major issues might include:

• Using uncalibrated or non-traceable equipment
• No proof of method validation for in-house methods
• Repeatedly skipping internal audits

A minor nonconformance is usually isolated and doesn’t directly mess with result validity.

Minor examples:

• A missing date on a training record
• A typo in a controlled document
• One incomplete calibration entry

Accreditation bodies like A2LA or similar decide which is which. Majors demand tougher corrective action and sometimes a formal review before you get approval.

The Fastest Way To Self-Check

You can cut down audit findings by checking four areas before your assessment.

1. Equipment control
Make sure all equipment is calibrated and traceable to national or SI standards.

2. Personnel competence
Match every technician to their training and authorization. Keep those records up to date.

3. Method and report control
Check that methods are validated and current. Look at recent reports—are the units, uncertainty, and signatures right?

4. Internal audits and management review
Confirm you’ve done them on time and covered every ISO 17025 clause.

Think like an auditor. Ask yourself: What clause requires this? Where’s the evidence?

If you can’t answer both, you probably have a non-conformance to fix before your accreditation assessment.

ISO 17025 Nonconformity Examples

Feel free to use these examples to document a nonconformity during internal or external audits. Each one pinpoints a clear issue and ties it to ISO/IEC 17025 requirements.

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• Internal Audit Not Conducted as Planned
  The laboratory didn’t complete internal audits for all activities within the scheduled cycle. This doesn’t meet ISO/IEC 17025 requirements for internal audits under Section 8.8.
• Management Review Incomplete (Section 8.9)
  The latest management review record left out results of internal audits, customer feedback, or risk actions. That fails to meet the input requirements of Section 8.9 – Management Review.
• Measurement Uncertainty Not Reported
  Measurement uncertainty wasn’t calculated or reported for quantitative test results where required. That’s not compliant with ISO 17025’s requirements for valid reporting.
• Outdated Test Method Used in Chemical Testing
  The chemical testing lab used a superseded test method for water analysis. The method review process didn’t catch the update.
• Equipment Calibration Record Missing
  Calibration records for a balance used in testing and calibration were incomplete. No evidence showed traceability to national standards.
• Uncontrolled Document in Use
  Staff used a printed procedure that wasn’t the current approved version. The document control process didn’t prevent unintended use.
  
  Each statement spells out what happened, where it failed, and which requirements affected.

Common ISO 17025 Nonconformities (Top 10–15 By Theme)

Most ISO 17025 nonconformities cluster around a few familiar themes. You’ll often see gaps in resources, process control, and management oversight inside the quality management system (QMS).

Here’s what usually comes up, grouped by theme:

1. Management System and Documentation

• Outdated or uncontrolled procedures
• Poor document control in the quality system
• Incomplete management review records
• Weak control of QMS changes

2. Internal Audits and Corrective Action

• Internal audits not done as planned
• Audits that skip technical activities
• Shallow root cause analysis
• Corrective actions not checked for effectiveness

Quality managers really need to make sure audits cover the full scope—not just the paperwork.

3. Personnel and Competence

• Missing competence records
• Lack of training or authorization
• Unclear role definitions

You’ve got to define who can do each test or calibration and keep proof.

4. Equipment and Metrological Traceability

• Incomplete calibration records
• No traceability to national or international standards
• Poor control of equipment maintenance

Traceability and evaluating uncertainty still trip up a lot of labs.

5. Technical Process Control

• Incomplete method validation or verification
• Missing measurement uncertainty evaluations
• Weak control of test items or environmental conditions
• Improper use of accreditation symbols

If your quality management system isn’t controlling daily lab work, nonconformities show up fast. Quality managers who stay engaged and monitor things closely catch repeat findings before they become a pattern.

How To Prevent ISO 17025 Nonconformities

You prevent ISO 17025 nonconformities by building control into your everyday work—not just scrambling before an audit. The trick is setting up systems that catch issues early and making sure someone actually owns the responsibility.

Kick things off with real cause analysis.
When you spot a finding, use the 5 Whys to dig past the obvious and find the actual breakdown.

• What failed?inter
• Why did that situation exist?
• What control was missing?
• Why wasn’t it there?

Link every corrective action in ISO 17025 to the root cause—not just the symptom. Then check if it actually worked. Set a review date 30–60 days later and see if the issue pops back up.

Some simple controls help avoid the most common gaps:

Risk Area	Preventive Action
Expired calibration	Automated reminders and monthly log checks
Training gaps	Annual competence reviews and sign-offs
Outdated documents	Central document control with version tracking
Weak internal audits	Process-based checklists, not generic templates

Treat preventive actions like a normal part of operations. Track near misses and small errors before they turn into formal nonconformities.

Make sure someone owns each key process—they should monitor updates and report risks during management review.

If your team isn’t comfortable with root cause analysis or building systems, it’s worth bringing in qualified consultants for targeted help. Just don’t let them replace your responsibility.

Consistency is what stops repeat findings.

Frequently Asked Questions

ISO 17025 nonconformities can mean anything from a serious system breakdown to just a small documentation slip-up. It really comes down to judging each situation—what’s the risk, how does it affect results, and does it break a specific clause in the standard?

What constitutes a major nonconformance within an ISO 17025 accredited laboratory?

A major nonconformance happens when you directly fail to meet an ISO/IEC 17025 requirement or even your own documented procedure. This kind of problem puts the validity of your test or calibration results at risk.

If you release results without doing proper method validation, you’re looking at a major nonconformance. It’s the same story if you can’t show evidence that your staff is competent for the work they’re doing.

When you can’t demonstrate traceability to national or international standards, that’s a big red flag too. If there’s any doubt about your technical competence or data accuracy, auditors usually call it major.

How can you identify minor nonconformities in an ISO 17025 certified testing process?

You’ll spot minor nonconformities when you notice small gaps that don’t mess with test results directly. Usually, these are about incomplete records or tiny procedural missteps.

For instance, maybe a calibration record is missing a signature, but the calibration itself checks out. Or you find a form using an old template, even though the data’s still accurate.

These issues show you’ve got some weak spots in control, but they don’t ruin your results. Still, it’s smart to fix them before they snowball into something bigger.

Which examples illustrate a lack of metrological traceability as per ISO 17025 standards?

Metrological traceability means you can link your measurement results to recognized reference standards through a solid, unbroken chain of calibrations.

If you use equipment calibrated by a provider who can’t prove traceability to national standards, you’re missing the mark. It’s also a problem if your calibration certificates leave out measurement uncertainty.

Reference materials without valid certificates? That breaks the traceability chain. If you can’t back up the chain of comparison, you’re not meeting ISO 17025.

What are common nonconformities found in laboratory documentations under ISO 17025?

Documentation issues usually show up as outdated procedures, missing version control, or unsigned approvals—classic signs of weak document control.

Sometimes test reports leave out required details like measurement uncertainty or decision rules. Incomplete training records pop up a lot too.

When your documents don’t line up with what’s actually happening in the lab, auditors notice. Your written system really should match your day-to-day work.

Can you provide typical instances of nonconforming test equipment calibration in ISO 17025?

You run into nonconforming calibration when you use equipment past its calibration due date. Auditors see this one all the time.

If you don’t check the impact of out-of-tolerance results after calibration, that’s another problem. Skipping the assessment of previous test results just adds risk for your clients.

Equipment without calibration labels or with unclear status markings is a classic issue too. People need to know at a glance if equipment is good to go or not.

What are the key elements to consider when reporting a nonconformity in an ISO 17025 context?

When you report a nonconformity, spell out the exact requirement you didn’t meet. Point to the relevant ISO 17025 clause or your internal procedure.

List the objective evidence—record numbers, observed actions, that kind of thing. Stay away from vague language; stick to what you saw or found.

Include what you did right away to fix it, your root cause analysis, and your corrective action plan. Good reporting makes follow-up easier and helps stop the same problem from popping up again.

Conclusion

If your lab doesn’t meet a clause requirement or your own procedure, you’ll run into ISO 17025 nonconformities. These issues usually pop up around competence, calibration, document control, data integrity, and internal audits.

Jumping on problems early and staying consistent really helps lower your risk. Keep your records complete and up to date—plus, make them easy to track down when you need them. Your team should know exactly what they’re supposed to do, and you ought to be able to show proof they’ve got the right training and skills.

Auditors tend to zero in on a few areas:

• Staff competence and training records
• Valid equipment calibration and traceability
• Controlled documents and updated SOPs
• Secure data handling and result validation
• Effective corrective action and follow‑up

Every nonconformity is more of a warning than a disaster. Figure out the real cause, fix it, and double-check to make sure it doesn’t sneak back in.

ISO/IEC 17025 goes way beyond just filling out forms. The system has to actually work in your day-to-day—not just look good for an audit.

When you keep your controls solid and review them regularly, you help protect your results. And honestly, that builds a lot of trust with clients, regulators, and accreditation folks.