- Medical
- Quality
- Management System
ISO 15189 consultant in Malaysia for ISO 15189:2022 accreditation
ISO 15189:2022 accreditation support in Malaysia for medical laboratories to strengthen quality, competence, and patient-focused testing services.
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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).
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.
Who needs this?
Hospital laboratories, private diagnostic labs, pathology services, and healthcare organisations operating medical laboratory testing services.
Certification, training and compliance requirements vary by tender, buyer and regulator. We confirm what applies to you during the free consultation.
How we support you
A clear path from questions to readiness
Assess your starting point
Gap analysis against the requirements, scope confirmed and a realistic roadmap agreed.
Build the required system
Documentation, processes and records developed around how your organisation actually works.
Prepare your team
Role-based training, internal audits and corrective action so evidence is complete.
Prepare for assessment
Management review and support through the accreditation body’s assessment.
How we work with you
The right consultant for your ISO 15189 project
We match every project to an experienced consultant who knows your industry, and the same consultant stays with you until you’re accredited.
- Matched to your industryWe pair you with a consultant who understands your industry and the standard you’re working towards.
- Experienced with the standardYour consultant knows the requirements in detail and what auditors look for, and prepares your team for the accreditation assessment.
- One consultant, start to finishThe same person handles your gap analysis, documentation, internal audit and certification audit.
“DR ISO audit was a great experience. The audit team was professional, supportive, and highly skilled. Their structured approach, clear explanations, and constructive recommendations helped us validate our processes and identify meaningful opportunities for improvement”
Common questions
Before you enquire
How long does ISO 15189:2022 take?
It depends on your organisation’s size, scope and current readiness. After the gap analysis we give you a realistic timeline for your situation.
What support is included for ISO 15189:2022?
For ISO 15189:2022, the main 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. Support is tailored to where you are now and can include a gap analysis, documentation, implementation, staff training, internal audits and preparation for the accreditation assessment.
Is ISO 15189:2022 HRD Corp claimable?
DR ISO Malaysia is an HRD Corp registered training provider, so the training in your project can be claimable for eligible employers. We confirm the programme details and supporting documents during your consultation.
Does ISO 15189:2022 include a money-back guarantee?
Yes. The conditions are explained to you before you start and written into the agreement you sign, so you know exactly what is covered.
Explore further
Often combined with ISO 15189
Get clear guidance on your ISO 15189:2022 scope.
Book a free consultation or WhatsApp us. We reply within 24 hours.