Prepare for ISO 15189:2022 accreditation with structured, assessment-ready support.
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Standard overview
About ISO 15189:2022
ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. It supports laboratories in demonstrating reliable, patient-focused testing services to users, regulators, and accreditation bodies, and also applies to point-of-care testing (POCT).
Important Note
ISO 15189:2012 has been withdrawn. Following ISO 15189:2022 publication in December 2022, ILAC’s transition period ended in December 2025.
Business value
Key Benefits
Demonstrate technical competence in medical laboratory testing.
Improve reliability, traceability, and consistency of test results.
Strengthen patient safety and clinical confidence in laboratory outputs.
Support accreditation readiness and regulatory recognition.
How we support you
A clear path from questions to readiness
The exact scope is tailored to your organisation. The working approach remains practical, structured, and focused on helping your team understand what happens next.
Assess your starting point
We clarify your scope and identify the practical gaps between current operations and the requirements.
Build the required system
Documentation and processes are developed around how your organisation actually works.
Prepare your team
Training and implementation support help relevant teams understand their responsibilities.
Prepare for assessment
Internal checks and readiness support help you approach the external review with clearer evidence.
Common questions
Before you enquire
How long does ISO 15189:2022 take?
The timeline depends on your organisation's size, scope, current documentation, operational readiness, and the availability of key personnel. After the initial consultation, we can outline the likely stages and a realistic working timeline.
What support is included for ISO 15189:2022?
For ISO 15189:2022, the main implementation focus areas are pre-examination, examination, and post-examination processes, method verification and validation, measurement traceability and equipment controls, quality assurance of results, and patient safety and point-of-care testing controls where applicable. We tailor support to your current position and may help with gap assessment, documentation, implementation, staff training, internal checks, and preparation for the relevant external review.
Is ISO 15189:2022 HRD Corp Claimable?
Yes. This service is HRD Corp Claimable. Our team can confirm the programme details and supporting documentation during your consultation.
Does ISO 15189:2022 include a money-back guarantee?
Yes. DR ISO Malaysia includes a money-back guarantee for this service. The applicable terms, eligibility conditions, and client responsibilities will be stated in your written proposal so you can review them before confirming the engagement.
Talk through your requirements
Get clear guidance on your ISO 15189:2022 scope.
Tell us about your organisation and target timeline. We'll respond within 24 hours.