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Templates and records · ISO 17025

ISO/IEC 17025 templates and records

Ten records the accreditation assessment team asks to see in a testing or calibration laboratory, each with the clause that requires it, its fields and a completed example.

In one sentence

ISO/IEC 17025 asks the laboratory for records that prove its technical competence, not just its organisation: the review of each request with the agreed decision rule, method verification and validation, the evaluation of measurement uncertainty, the file and calibration of each piece of equipment, staff authorisation by activity, monitoring of the validity of results, proficiency testing, complaints and nonconforming work; the analysis of risks to impartiality has no prescribed format, but it must be demonstrable.

Content reviewed on

Current edition
ISO/IEC 17025:2017 Third edition, published November 2017
Technical records
Clause 7.5 They must allow the activity to be repeated under conditions as close as possible to the original
Format
Free choice The standard sets the content; the laboratory decides whether it is paper, a spreadsheet or an application
Accreditation in Spain
ENAC Entidad Nacional de Acreditación, the national accreditation body

Contents


ISO 17025 templates and records

Clauses are cited using the numbering of ISO/IEC 17025:2017, the current edition and the same one the Academy uses.

Clause 4.1 · Good practice

Risks to impartiality

How to identify and address risks to a laboratory’s impartiality under ISO/IEC 17025 (4.1): sources…

Clause 7.1 · Mandatory record

Review of requests and contracts

What to record when reviewing a test request under ISO/IEC 17025: methods, capability, subcontracting, the…

Clause 7.2 · Mandatory record

Method validation

How to verify a standard method and validate an in-house one under ISO/IEC 17025: performance…

Clause 7.6 · Mandatory record

Measurement uncertainty

How to document the evaluation of measurement uncertainty ISO/IEC 17025 requires: contributions, the budget…

Clause 6.4 y 6.5 · Mandatory record

Equipment file and calibration

What the file for each piece of laboratory equipment holds under ISO/IEC 17025: identity, software…

Clause 6.2 · Mandatory record

Staff qualification and authorisation

How to record each technician’s competence and authorisation under ISO/IEC 17025: requirements, training…

Clause 7.7.1 · Mandatory record

Internal quality control

How to record the monitoring of the validity of results under ISO/IEC 17025: control materials, control…

Clause 7.7.2 · Mandatory record

Proficiency testing

How to plan and record proficiency testing and interlaboratory comparisons under ISO/IEC 17025: scope…

Clause 7.9 · Mandatory record

Complaints log

How to handle and record a complaint in an accredited laboratory under ISO/IEC 17025: receipt, validation…

Clause 7.10 · Mandatory record

Nonconforming work

What a laboratory’s nonconforming work record must cover: impact on earlier results, recall of reports…

Frequently asked questions


What people ask us before getting started

Which records does ISO/IEC 17025 require?

Among others: the review of requests and contracts (7.1.8), method verification and validation (7.2), the technical records of each test or calibration (7.5), the file for each piece of equipment (6.4.13), staff competence and authorisation (6.2.5), monitoring of the validity of results (7.7), complaints (7.9), nonconforming work (7.10), and corrective actions, audits and management reviews (8.7 to 8.9).

How do these records differ from ISO 9001 records?

ISO 9001 shows that the management system works; ISO/IEC 17025 also requires you to show that each result is technically valid. That is why records appear that ISO 9001 does not ask for: method validation, uncertainty, intermediate checks on equipment, proficiency testing or staff authorisation by method.

What if the laboratory is a clinical one?

Clinical laboratories are accredited against ISO 15189, which follows the same structure as ISO/IEC 17025 but adapts the requirements to the patient: verification of commercial methods, reference intervals, critical results and external quality assessment. Its templates sit in the ISO 15189 section.

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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.

  1. ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories ISO/IEC · November 2017
  2. Entidad Nacional de Acreditación (Spain’s national accreditation body): laboratory accreditation criteria and documents ENAC · Official website, consulted in October 2026
  3. ILAC Policy Series (P9 on proficiency testing, P10 on metrological traceability) ILAC · Current editions