PLANREFERENCE OUTLINE

ISO 15189 Implementation Plan

Implementation plan for a medical laboratory system scoped across all three examination phases, since most diagnostic error happens outside the analysis. Risk assessed as harm to the patient rather than as a defect in the result, point-of-care testing brought inside the system as the current edition requires, competence per examination, commercial methods verified in your own population, and turnaround set from the clinical requirement. Maps to ISO 15189:2022.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ISO 15189:2022
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

The medical laboratory standard governs examinations performed on human specimens for the care of an individual patient, and its requirements extend well beyond the bench. The characteristic implementation failure is starting the system at the analytical phase: the mislabelled tube and the report nobody acted on are both in scope, and both are where diagnostic error actually concentrates.

What's Inside

✓Scope statement covering pre-examination, examination and post-examination, with the boundaries of each phase named
✓Risk assessment framed as harm to the patient rather than as a defect in the reported result
✓Point-of-care testing inventory and governance, bringing ward and clinic devices inside the laboratory system
✓Competence assessment per examination, with initial assessment, reassessment dates and the evidence actually held
✓Method verification in your own population, on your instruments, with measurement uncertainty estimated and recorded
✓Internal quality control and external quality assessment, including the defined response to a failed round
✓Turnaround time set from the clinical requirement, with the escalation route used when it is missed

How to Use It

1Start the scope at the specimen request and end it at the acted-upon report, rather than at the analyser
2Frame every risk as harm to the patient — that separates a defect changing no decision from a missed diagnosis
3Inventory point-of-care devices on wards before writing procedures, because devices bought outside the laboratory budget are routinely missed
4Verify each commercial method in your own population, on your instrument, by your staff, and record the uncertainty
5Assess competence per examination rather than per person; a competent haematologist is not thereby competent on every analyser
6Set turnaround from what the clinician needs, then measure against it, or the target records only what you already achieve
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Scope Across All Three Phases
2Risk Assessed as Harm to the Patient
3Point-of-Care Testing Inside the System
4Competence Per Examination
5Method Verification and Validation
6Quality Control, External Assessment and Turnaround
REGULATORY CONTEXT

ISO 15189:2022 sets the requirements for quality and competence in medical laboratories, covering all three examination phases, risk management expressed as harm to the patient, competence, method verification and point-of-care testing. It does not decide which examinations your laboratory offers, what turnaround the clinical service requires, or how much verification a given method needs in your population — those determinations are the laboratory’s. The implementation sequence here is SPEQ practitioner synthesis.

MAPPED STANDARDS
ISO 15189:2022
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