Templates and records · ISO 17025 · Clause 7.2

ISO 17025 test method validation report

The evidence that a method gives results fit for their intended use: verification when the method is standard, full validation when it is in-house, modified or used outside its scope.

In one sentence

The method validation report records the validation procedure used, the requirements the method must meet, the performance characteristics determined —trueness, precision, limit of quantification, range, selectivity, robustness—, the results and a statement on the validity of the method, because clause 7.2.2.4 of ISO/IEC 17025 requires those records to be kept for non-standard, laboratory-developed and modified methods and for standard methods used outside their scope, and 7.2.1.5 requires standard methods to be verified before use.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 17025 · Clause 7.2 Clauses are cited using the numbering of ISO/IEC 17025:2017, the current edition and the same one the Academy uses.
Type of information: Mandatory record Verification records (7.2.1.5) and validation records (7.2.2.4)
Who fills it in: Staff authorised to validate methods Authorisation to develop, modify, verify and validate methods is one of those required by 6.2.6
When: Before the method is used for customers And again when the method, critical equipment or the reference standard changes
How long it is kept: Set by the laboratory The standard requires a retention time to be defined for each record, consistent with contractual and legal obligations (8.4.2). Covering at least the accreditation cycle lets you show the history at every reassessment.

What the standard requires

What ISO 17025 demands and what it leaves to your judgement

Before introducing a standard method, the laboratory verifies that it can perform it properly and achieve the required performance, and keeps a record of that verification. If the issuing body revises the method, the verification is repeated to the extent necessary.

Validation is mandatory for non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. It must be as extensive as the application demands, and the record includes the procedure, the specification of requirements, the performance characteristics, the results and the statement of validity.

The characteristics studied depend on the method; the standard lists, among others, measurement range, accuracy, uncertainty, limit of detection and limit of quantification, selectivity, linearity, repeatability or reproducibility, robustness and bias.

Read it in context: Process requirements, in the ISO 17025 Academy

Structure

Fields the template should include

Method, version and type: standard, modified, in-house
Scope: matrices, range and intended use
Performance requirements and their origin (customer, regulation, standard)
Experimental design: levels, replicates, reference materials
Characteristics determined and their values
Comparison against requirements
Associated uncertainty
Statement of validity and limitations
Approval and date

Example

Example: validating zinc in water by ICP-MS

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Method	PE-ICP-07 · in-house method · wastewater and surface water
Requirements	Limit of quantification ≤ 10 µg/L · accuracy ±10 % · precision ≤ 5 % CV
Design	3 levels × 10 replicates over 5 days · certified wastewater reference material
Results	LOQ 5 µg/L · recovery 97-103 % · intermediate reproducibility CV 3.8 %
Linearity	5-500 µg/L, coefficient of determination 0.9995
Selectivity	No significant interference from saline matrices up to 2 g/L chloride
Uncertainty	±8 % (k = 2) at 50 µg/L
Statement	Fit for intended use · approved by technical management on 20 January 2026

At the audit

Mistakes auditors commonly flag

Standard methods in use with no recorded verification.
Performance requirements set after the results were seen.
Changes to a standard method that nobody recognises as modifications.
Validation carried out on a matrix different from those tested.
Verification not repeated when the method’s standard is updated.

In Kimobox

How this record is kept in Kimobox

1Method validation is managed as a controlled document linked to the process.
2Each current method keeps its version, and any change leaves a trace in the history.
3Each technician’s competence and authorisation to validate methods is shown on the employee portal.

Frequently asked questions

What people ask us before getting started

Are verifying and validating a method the same thing?

No. Verifying means checking that the laboratory achieves the performance already established for a standard method; validating means establishing that performance for an in-house, modified or out-of-scope method. Validation is broader.

What changes in a clinical laboratory?

ISO 15189 follows the same logic, but most clinical methods are CE-marked commercial ones, so the usual record is verification of the performance claimed by the manufacturer. This is covered in the ISO 15189 method verification template.

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Sources

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories ISO/IEC · November 2017
Entidad Nacional de Acreditación (Spain’s national accreditation body): laboratory accreditation criteria and documents ENAC · Official website, consulted in October 2026