A medical laboratory result is acted on. A clinician changes a diagnosis, starts a treatment, or sends a patient home on the strength of it. ISO 15189:2022 exists because a laboratory needs to be able to show, not assert, that the result it issued can carry that weight.
This course offers in-depth training on developing and executing an ISO 15189:2022 management system, and is designed to extend the skills of quality and technical managers and other staff in medical testing laboratories. Through a step-by-step method it equips you to establish a Laboratory Management System aligned with the standard, whether you are preparing your organisation for assessment and accreditation or already hold a quality or technical role in an accredited laboratory.
Key Learning Outcomes
The Method
You leave with a toolkit, not just notes: the course includes a customisable toolkit to accelerate your programme and give your implementation team something to work from on the first day back.
Why It Matters
Technical competence evidenced rather than claimed.
Test results that hold up, consistently, across shifts and analysts.
The reason the rest of it exists: a result a clinician can safely act on.
A stronger position against regulatory and contractual requirements.
Confidence among referring healthcare providers and their patients.
Walking into an assessment knowing where the evidence sits.
A Common Question
Written specifically for medical laboratories, focused on patient care, the quality of medical testing and laboratory competence.
Applies to general testing and calibration laboratories across many industries, without the patient-care focus.
If your laboratory does both: some organisations hold both, for example a diagnostics group with an environmental or calibration arm. We run a separate ISO/IEC 17025 programme, so talk to us about sequencing them rather than booking both at once.
Who Should Attend
Already accredited? The course is written both for laboratories preparing for assessment for the first time and for quality or technical managers in an accredited laboratory who want to sharpen what they already run.
Why Choose Us
Internationally trained experts with long experience in an accredited medical testing laboratory and in assessments with the national accreditation body.
A practical course built on real laboratory situations rather than clause recital.
Accelerated learning techniques used throughout to aid understanding and retention.
A toolkit you can adapt, so implementation starts from a template rather than a blank page.
Part of the Quality Austria group network with international reach.
Course Details
A three-day programme available as a virtual session, a public classroom batch or an in-house delivery at your own laboratory, which suits bringing a quality and technical team through together.
The programme is structured as an implementation project, from baseline review through documentation and risk management to accreditation readiness.
FAQ
The ISO 15189:2022 Medical Laboratory Management System Training Course is designed to help professionals understand, implement and manage laboratory quality systems in accordance with ISO 15189:2022 requirements for medical testing laboratories.
This course is suitable for quality managers, technical managers, laboratory technicians, pathologists, healthcare professionals and individuals responsible for implementing, maintaining or improving quality systems in medical laboratories.
ISO 15189 accreditation helps laboratories demonstrate technical competence, improve the accuracy and reliability of test results, enhance patient safety, strengthen regulatory compliance and build confidence among healthcare providers and patients.
The training covers ISO 15189:2022 requirements, laboratory quality management systems, risk management, documentation development, operational controls, internal audits, continual improvement and accreditation preparation processes.
ISO 15189 is specifically designed for medical laboratories and focuses on patient care, medical testing quality and laboratory competence, while ISO/IEC 17025 applies to general testing and calibration laboratories across multiple industries.
Yes, the course includes practical implementation approaches, real-life laboratory examples, documentation support, gap analysis concepts and step-by-step guidance for establishing an effective laboratory management system.
ISO 15189 training helps professionals strengthen expertise in laboratory quality management, accreditation requirements, risk-based thinking and compliance practices, improving career opportunities in healthcare diagnostics, laboratory management and quality assurance roles.
Talk to our team about the next available batch or in-house delivery at your laboratory.