Clause	What It Covers	Why It Matters
7.3 – Validation and Verification of Examination Procedures	You must confirm that methods meet intended performance before use.	Ensures test results are accurate and defensible.
7.4.1 – Selection and Evaluation of Examination Procedures	You must choose methods suitable for their clinical or analytical purpose.	Prevents inappropriate or unverified tests from being used.
7.5.1 – Performance Verification	You must verify performance claims when using established or standardized methods.	Confirms that manufacturer or reference data hold true in your lab.

Document	Purpose	Reviewed By
Validation Plan	Defines scope and acceptance criteria	Technical Manager
Validation Data Sheets	Captures raw results and statistics	Analyst / Supervisor
Validation Report	Summarizes outcomes and decisions	Quality Manager
Approval Form	Formal authorization for routine use	Laboratory Director

Step-by-Step Process for Method Verification

Verification is simpler than validation, but it’s equally important. It confirms that a standardized or manufacturer-validated method performs as expected in your laboratory’s specific conditions.

Think of it as a localized quality check. You’re not reinventing the science — you’re confirming that your staff, equipment, and environment can deliver the same level of performance the method promises.

Here’s a structured way to do it right under ISO 15189:2022.

Step 1: Identify What Needs Verification

You only verify established methods — those already validated by an external authority (for example, ISO, CLSI, or the manufacturer).
Examples include:

• A CE-marked diagnostic kit used for the first time in your lab.

• A published WHO or CLSI method newly adopted for a test.

• A previously validated method implemented on new equipment.

Pro Tip:
Make a list of all examination methods and note whether each requires validation or verification. It’s a simple spreadsheet, but it saves hours of confusion later.

Step 2: Define Verification Parameters

Select which characteristics you’ll confirm locally. For most labs, these include:

• Accuracy – Compare your results with a reference method or control sample.

• Precision – Test repeatability over several runs.

• Linearity / Range – Confirm the method works across the expected concentration range.

• Detection Limit – Verify sensitivity using your own reagents and instruments.

You don’t need to redo every study from the manufacturer, only those that could be affected by your environment.

Step 3: Perform Verification Testing

Run side-by-side tests or replicate measurements using control materials.
Collect enough data to be statistically meaningful — usually at least five replicates per concentration level for quantitative methods.

Record:

• Lot numbers of reagents and controls.

• Environmental conditions.

• Equipment and operator details.

Pro Tip:
Use a simple Verification Data Sheet with checkboxes for each parameter tested and space for raw results. Auditors like seeing consistent formats across methods.

Step 4: Compare Results with Acceptance Criteria

Assess your data against either:

• The manufacturer’s claimed performance, or

• Reference method results.

If everything falls within the defined range, document that the method is verified for use.
If not, investigate — it could be an environmental issue, operator error, or instrument calibration problem.

Step 5: Document and Approve the Verification Report

Prepare a short Verification Report summarizing what was tested, how it was tested, and whether the method met requirements.

Include:

• Method title and source.

• Verification parameters and outcomes.

• Deviations, corrective actions, and final decision.

• Approval signatures (usually Technical Manager and Quality Manager).

Common Mistake:
Labs often perform verification but fail to record it formally. Remember: if it isn’t documented, it didn’t happen — at least in the eyes of an auditor.

Step 6: Maintain Traceability and Review

Keep all verification data with your quality records. Review the method whenever there’s a change in reagent, software, or instrument model.

In my experience:
One biochemistry lab avoided a major nonconformity by doing this consistently — every time they changed a reagent lot, they verified precision with just five samples. The assessor called it “a textbook example of good verification practice.”

ISO 15189 Method-Validation and Verification Templates

Every lab knows validation and verification are required — but where most teams struggle is in documenting them clearly and consistently. Assessors don’t just want data; they want structure, traceability, and proof that the process was followed from start to finish. That’s where standardized templates become essential.

Well-designed templates make sure nothing gets missed. They also keep your QMS organized, reduce audit stress, and let any trained staff member pick up where another left off.

Here’s how to structure the key templates your lab should be using.

Validation Plan Template

Purpose: Defines the objective, scope, and acceptance criteria of your validation project before any testing begins.

Key Fields:

• Method name and unique ID
• Purpose (e.g., new in-house test, modified commercial kit)
• Performance characteristics to be evaluated
• Sample types and number of replicates
• Acceptance criteria for each parameter
• Assigned responsibilities
• Approval signatures

Pro Tip:
Keep the plan one page long. The goal is clarity, not complexity.

Validation Data Sheet

Purpose: Captures raw data, calculations, and summary results for each parameter tested.

Key Fields:

• Parameter (accuracy, precision, linearity, etc.)
• Instrument and reagent details
• Results table and statistical summary
• Graphs or control charts
• Comments or anomalies

Common Pitfall:
Labs often scatter results across multiple notebooks or files. Centralize everything on one sheet for easy review.

Verification Report Template

Purpose: Summarizes evidence confirming an existing method performs correctly under your lab’s conditions.

Key Fields:

• Method title and reference (e.g., ISO, CLSI, or manufacturer method)
• Verification parameters and data summary
• Comparison with manufacturer or reference performance claims
• Deviations and corrective actions
• Final decision (verified / conditional / not verified)
• Sign-off section for reviewers and approvers

Pro Tip:
Use checkboxes for each parameter (accuracy, precision, detection limit). This makes verification quick and standardized across all methods.

Approval Form Template

Purpose: Provides formal authorization to use the validated or verified method for routine testing.

Key Fields:

• Method ID and title
• Validation/verification reference number
• Final decision
• Reviewer and approver signatures
• Date of approval and next review date

In my experience:
Labs that include a short approval form at the end of every report rarely face documentation findings. It shows closure — that each method went through a controlled review before implementation.

Summary Table

Template	Purpose	Key Benefit
Validation Plan	Define scope and criteria	Sets expectations upfront
Validation Data Sheet	Record test data	Keeps results organized
Verification Report	Summarize findings	Ensures traceability
Approval Form	Authorize use	Proves management control

Documentation and Record-Keeping Tips

Here’s something most labs underestimate — you can do excellent validation and verification work, but if the documentation is disorganized, it’s as good as not done. ISO 15189:2022 expects traceability, not just data. Every record should tell the story of what was done, when, how, and by whom.

Keep a Clear Document Trail

For every method you validate or verify, make sure you can trace each stage:

1. Plan created and approved.

2. Testing completed with raw data recorded.

3. Results analyzed and summarized.

4. Review and authorization documented.

If any of these steps are missing or stored in different folders, you’re setting yourself up for findings during an audit.

Pro Tip:
Name your files consistently:
[MethodID]_[Type]_[Date]_v1
For example: PCR_COVID19_ValidationReport_2025-03_v1
That single habit saves hours when auditors ask for evidence.

Centralize Data and Reports

Don’t scatter validation records across multiple drives or personal folders. Create a single, controlled repository — digital or physical — where all related forms, data sheets, and approvals are stored together.

In my experience:
One mid-size clinical lab used an “All Validations” folder with sub-folders by instrument type (Hematology, Chemistry, Microbiology). Each had its own tracking sheet showing validation status and next review date. Their audit turnaround time dropped by half.

Ensure Version Control

Every validation or verification record must be traceable to the correct version of the method and instrument used.
If you update a test procedure or change equipment, cross-reference the new validation or verification data in your change-control log.

Common Pitfall:
Labs often forget to link updated SOPs to their previous validation files, leaving auditors unsure which version of the method was tested. Always include a short note like “Supersedes validation report VR-2024-03 due to reagent change.”

Digitize When Possible

Electronic systems or spreadsheets with locked fields help maintain consistency. They also make it easier to search by method ID, parameter, or approval date.

Pro Tip:
Use PDF versions for final approved reports with digital signatures — editable drafts should stay in a working folder until formally approved.

Retention and Review

Keep all validation and verification records for the full retention period required by your national authority or accreditation body. Schedule reviews annually or whenever the method, reagent, or equipment changes.

Remember — strong documentation isn’t about paperwork, it’s about evidence of control. If your files tell a complete and logical story, your audit will run smoothly.

Real-World Example – Validation Done Right

A few years ago, I worked with a molecular diagnostics lab that was rolling out a new PCR assay. They had solid technical skills, but their validation documentation was a mess—data stored in different folders, missing signatures, and no summary linking the results to acceptance criteria.

We started fresh. The lab created a Validation Plan outlining exactly what they would test: accuracy, precision, detection limit, and linearity. Each experiment had its own Data Sheet, and all results were compiled into one Validation Report. They ended with an Approval Form signed by both the Technical and Quality Managers.

During the audit, the assessor flipped through their binder and said, “This is the cleanest validation I’ve seen all quarter.”
The lab passed without a single nonconformity.

Here’s what made the difference:

• Every document told a complete story—from planning to approval.

• Results were summarized in plain language with clear acceptance criteria.

• All files were named consistently and easy to trace.

Lesson:
Validation isn’t just about running the numbers. It’s about showing, step by step, that your method produces reliable results every time. A structured approach and well-designed templates make that story simple to tell—and even easier to defend in an audit.

FAQs – Method Validation & Verification in ISO 15189:2022

Q1: Can we rely entirely on manufacturer validation data?

Not entirely. Manufacturer data demonstrates that the method works under their conditions. ISO 15189 requires your lab to confirm that the same performance can be achieved under your conditions — equipment, staff, environment, and sample types. That’s what verification is for.
In short: you can use manufacturer data as supporting evidence, but you still need to verify it locally.

Q2: When should we perform full validation instead of verification?

You must perform full validation when you:

• Develop an in-house method.
• Modify a published or manufacturer method.
• Change critical parameters such as instrument type, detection chemistry, or matrix.
  If you’re using a recognized standard or unmodified commercial method, verification is enough.

Pro Tip:
If you’re unsure, ask whether your lab’s actions could alter the method’s performance characteristics. If yes, validate. If not, verify.

Q3: Do we need templates for every method and instrument?

Yes. Every examination procedure should have its own validation or verification record, even if two instruments use the same method. This shows traceability and consistency between equipment.

Example:
If two analyzers run the same glucose test, verify both separately — small performance variations can occur due to calibration or maintenance differences.

Q4: How long should we keep validation and verification records?

Keep them for at least the same period as your test records, or as specified by your accrediting body. Typically, that means at least five years or until the method is replaced or withdrawn. Always confirm with local requirements.

Simplify Validation with Ready-to-Use Templates

At its core, ISO 15189:2022 isn’t just about meeting documentation requirements — it’s about building confidence in your laboratory’s results. Method validation and verification are how you prove that confidence. When done properly, they show your lab is competent, consistent, and scientifically in control.

But here’s what I’ve seen over and over again: the science is solid, yet the paperwork tells a different story. Missing data sheets, scattered files, and unsigned reports can undo months of good work. That’s why structured templates make all the difference — they guide the process, keep evidence consistent, and make audits straightforward.

A good set of templates helps you:

• Plan, execute, and review validations and verifications with clarity.

• Maintain full traceability from raw data to approval.

• Present your methods confidently to auditors and clients alike.

In my experience, once a lab implements standardized validation templates, the entire process becomes faster and less stressful. Staff know exactly what to document, managers know what to review, and auditors see a system that’s transparent and trustworthy.

If your lab is preparing for ISO 15189:2022 accreditation or upgrading your documentation, start with the right structure.

Next Step:
Download QSE Academy’s ISO 15189:2022 Method Validation & Verification Template Pack — complete with editable forms, acceptance criteria examples, and built-in review sections. It’s designed to save you time, strengthen your evidence, and keep your lab audit-ready year-round.