Templates and records · ISO 15189
ISO 15189 templates and records
Eight records specific to the medical laboratory, from sample receipt to notifying a critical result, each with the ISO 15189:2022 clause that calls for it, its fields and a completed example.
In one sentence
ISO 15189 shares its structure with ISO/IEC 17025, but its records revolve around the patient: verification of the performance of commercial methods, reference intervals and clinical decision limits, sample rejection and pre-examination incidents, communication of critical results, internal quality control at clinical decision levels, external quality assessment, quality indicators for every phase and agreements with those performing point-of-care testing.
- Current edition
- ISO 15189:2022 The transition from the 2012 edition ended on 6 December 2025
- Point-of-care testing
- Included in the standard The requirements of ISO 22870 were integrated into the 2022 edition
- Structure
- Aligned with ISO/IEC 17025:2017 General, structural, resource, process and management system requirements
- Commercial methods in the EU
- Regulation (EU) 2017/746 CE-marked reagents used unmodified are verified, not validated
Contents
ISO 15189 templates and records
Clauses are cited using the numbering of ISO 15189:2022, the edition in force since the transition ended in December 2025 and the same one the Academy uses.
Method verification
How to verify a CE-marked method under ISO 15189:2022: performance characteristics, specifications, results…
Reference intervals
How to document reference intervals and clinical decision limits under ISO 15189:2022: source, population…
Pre-examination incidents
How to record sample acceptance and rejection under ISO 15189 (7.2): cause, decision, notice to the…
Critical results
What to record when communicating a critical result under ISO 15189:2022: time, who called, who received…
Internal quality control
How to record internal quality control in a medical laboratory: clinical decision levels, control rules…
External quality assessment
How to record participation in external quality assessment schemes (ISO 15189): coverage, samples, results…
Quality indicators
How to define and monitor medical laboratory quality indicators: pre-examination, examination and…
POCT agreement
What the agreement between the laboratory and the services performing point-of-care testing (POCT) covers…
Frequently asked questions
What people ask us before getting started
Which records are specific to ISO 15189 rather than ISO/IEC 17025?
Those tied to patient care: reference intervals and clinical decision limits (7.3.5), sample acceptance and rejection criteria (7.2), communication of critical results (7.4.1), quality indicators for the pre-examination, examination and post-examination phases (8.8.2) and agreements with users of point-of-care testing (6.7.2).
Are ISO/IEC 17025 templates any use for a medical laboratory?
Partly. Impartiality, complaints, nonconforming work and equipment records work almost the same. But method validation, quality control and interlaboratory comparison take a different approach, which is why they have their own template here, linked to the ISO/IEC 17025 one.
Must laboratory records be kept with the medical record?
Result reports form part of the patient's clinical information and follow health regulations; quality records — controls, verifications, indicators — are kept by the laboratory for as long as its procedure specifies.
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