Templates and records · ISO 17025 · Clause 4.1

ISO 17025 analysis of risks to impartiality

The evidence that the laboratory knows which relationships, pressures or interests could skew a result, and what it has done to stop that happening.

In one sentence

The analysis of risks to impartiality identifies, on an ongoing basis, the activities, relationships and circumstances of the laboratory and its staff that could compromise the objectivity of results, assesses each risk and records how it is eliminated or minimised, because clause 4.1 of ISO/IEC 17025 requires those risks to be identified on an ongoing basis and their treatment to be demonstrable, even though it imposes no specific format.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 17025 · Clause 4.1 Clauses are cited using the numbering of ISO/IEC 17025:2017, the current edition and the same one the Academy uses.
Type of information: Good practice The standard requires risks to be identified and their treatment demonstrated (4.1.4 and 4.1.5), without prescribing a record
Who fills it in: Laboratory management Supported by individual conflict of interest declarations from staff
When: On an ongoing basis With a formal review at least once a year and whenever ownership, key customers or activities change
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

Laboratory management must be committed to impartiality and must not allow commercial, financial or other pressures to compromise it. The standard requires risks to be identified on an ongoing basis, including those arising from the laboratory’s own relationships and from those of its staff.

If a risk is identified, the laboratory must be able to show how it eliminates or minimises it. ISO/IEC 17025 does not say this has to be a record in a given format, which is why it appears here as good practice. In practice, a documented and reviewed analysis is the simplest way to demonstrate it to the assessment team.

Belonging to a group that also manufactures, sells or advises on what the laboratory tests is the most common source of risk, along with pay linked to results and financial dependence on a single customer.

Read it in context: Impartiality and confidentiality, in the ISO 17025 Academy

Structure

Fields the template should include

Source of the risk: activity, relationship, person, customer
Description of how it could affect impartiality
Risk assessment
Measures to eliminate or minimise it
Residual risk and acceptance by management
Staff conflict of interest declarations
Review date and changes since the previous one

Example

Example: water laboratory within an industrial group

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

Field	Content
Laboratory	Northfield Analytical (fictitious) · wastewater testing
Risk 1	The owning group operates a treatment plant whose discharges the laboratory analyses
Measures	Technical management with no reporting line to the treatment plant · results locked once approved · dedicated annual internal audit
Risk 2	One customer accounts for 35 % of turnover
Measures	Independent review of that customer’s reports and complaints routed straight to management
Risk 3	A technician whose relative works for a customer
Measures	Signed declaration and exclusion from that customer’s tests
Review	12 January 2026 · 1 new risk · approved by management

At the audit

Mistakes auditors commonly flag

An analysis written once for accreditation and never reviewed.
It merely states that “there are no risks”.
It covers the laboratory’s relationships but not those of its staff.
Generic measures that cannot be verified.
Conflict of interest declarations that are never renewed.

In Kimobox

How this record is kept in Kimobox

1The analysis of risks to impartiality is held as a controlled document, with its versions.
2Staff confidentiality agreements are managed from the employee portal, linked to each person.
3The laboratory’s organisation chart and organisational relationships are documented in the same system.

Frequently asked questions

What people ask us before getting started

Is a written analysis of risks to impartiality mandatory?

The standard does not put it that way: it requires risks to be identified on an ongoing basis and you to show how they are eliminated or minimised. In practice, without a documented analysis that is very hard to demonstrate to the assessment team.

Is it enough for staff to sign an impartiality declaration?

No. The declaration helps detect individual conflicts, but the standard also requires the organisation’s own risks to be analysed: its ownership, its customers and its other activities.

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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
ISO/IEC 17000:2020 — Conformity assessment. Vocabulary and general principles ISO/IEC · 2020 edition
Entidad Nacional de Acreditación (Spain’s national accreditation body): laboratory accreditation criteria and documents ENAC · Official website, consulted in October 2026