ISO 15189:2022
Medical Laboratories Accreditation
Demonstrate technical competence and confidence in your medical laboratory through ISO 15189 accreditation. AAA recognizes laboratories that consistently deliver accurate, reliable, and patient-focused diagnostic services while meeting international best practices.
- 59+Countries Served
- 287Assessors & Experts
- 3 YearsAccreditation Validity
- GlobalRecognition
Who Should Apply?
Is ISO 15189 Accreditation Right for Your Medical Laboratory?
ISO 15189 is the internationally recognized standard specifying requirements for quality and competence in medical laboratories. It is designed for laboratories that provide examination services used in the diagnosis, prevention, monitoring, and treatment of disease.
Accreditation demonstrates that your laboratory has competent personnel, appropriate examination procedures, suitable equipment, effective quality controls, reliable reporting processes, and management systems necessary to provide consistent and clinically reliable results. ISO 15189:2022 also applies to point-of-care testing.
Suitable for laboratories performing
Hematology
Microbiology
Immunology & Serology
Molecular Diagnostics
Histopathology & Cytology
Blood Transfusion / Immunohematology
Point-of-Care Testing
Benefits
Why ISO 15189 Accreditation Matters
01
Demonstrate Medical Laboratory Competence
Provide independent evidence that your laboratory has competent personnel, appropriate procedures, equipment, quality controls, and management systems necessary to produce reliable examination results.
02
Strengthen Confidence in Patient Results
Increase confidence among clinicians, patients, hospitals, regulators, and healthcare organizations that laboratory results are accurate, reliable, and suitable for clinical decision-making.
03
Support Patient Safety
Strengthen controls throughout the examination process—from patient preparation and sample collection through examination, reporting, and interpretation—to reduce errors that may affect patient care.
04
Support Regulatory & Healthcare Requirements
Meet accreditation expectations established by healthcare systems, hospitals, regulators, procurement authorities, insurers, and other organizations that depend on reliable medical laboratory services.
Assessment Areas
Key Areas Assessed During Accreditation
AAA evaluates the management, technical, quality, and patient-related controls needed to produce reliable medical laboratory results.
01
Governance & Management System
Organizational responsibilities, leadership, documented systems, quality objectives, risk management, records, and continual improvement.
02
Personnel Competence
Qualifications, training, experience, authorization, competency evaluation, and continued professional development.
03
Pre-Examination Processes
Patient preparation, requests, specimen collection, identification, transportation, reception, handling, and acceptance criteria.
04
Examination Methods & Validation
Method selection, verification or validation, reference intervals, biological reference values, and technical implementation.
05
Equipment, Reagents & Consumables
Equipment selection, calibration, maintenance, verification, reagents, consumables, inventory controls, and technical suitability.
06
Quality Assurance of Results
Internal quality control, external quality assessment, proficiency testing, comparisons, and monitoring of examination performance.
07
Post-Examination & Reporting
Result review, authorization, reporting, critical-result communication, amended reports, interpretation, and retention of information.
08
Patient Safety, Risk & Improvement
Nonconforming work, risk management, complaints, corrective actions, internal audits, quality indicators, and continual improvement.
How It Works
Accreditation Process & Application
Accreditation Process
- Step 1
Submit Your Application
Define the requested medical laboratory scope, including examination disciplines, methods, locations, and services.
- Step 2
Document Review
AAA reviews management-system documentation, procedures, personnel information, quality controls, examination methods, equipment arrangements, and the requested scope.
- Step 3
Accreditation Assessment
Qualified technical assessors evaluate the laboratory against ISO 15189 requirements and the requested medical laboratory scope.
- Step 4
Corrective Actions
Where findings are identified, the laboratory submits corrective actions together with supporting evidence for review.
- Step 5
Independent Accreditation Decision
Assessment findings and supporting evidence are independently reviewed before an accreditation decision is made.
- Step 6
Accreditation Granted
Successful medical laboratories receive an accreditation certificate and approved scope, valid for three years.
Client Experience
Hear From an AAA-Accredited Medical Laboratory
Discover how AAA accreditation has supported medical laboratories in strengthening technical competence, improving confidence in examination results, and reinforcing quality across patient-care services.
Global Medical City · Egypt
Learn how Global Medical City strengthened confidence in its laboratory services through ISO 15189 accreditation and why the team chose AAA as its accreditation partner.
Improved Laboratory Quality
International accreditation strengthens confidence in laboratory quality management and technical competence.
Greater Patient Confidence
Reliable laboratory services support clinicians and improve confidence in patient care.
International Recognition
ISO 15189 accreditation demonstrates compliance with internationally recognized requirements for medical laboratories.
FAQ
Frequently Asked Questions
Common questions about ISO 15189 medical laboratory accreditation.
What is ISO 15189?
ISO 15189 specifies requirements for quality and competence in medical laboratories and is used to assess or recognize laboratory competence.
What types of medical laboratories can apply?
Medical laboratories operating in clinical chemistry, hematology, microbiology, immunology, molecular diagnostics, pathology, cytology, blood transfusion, and other diagnostic areas may apply.
Does ISO 15189 apply to point-of-care testing?
Yes. ISO 15189:2022 is also applicable to point-of-care testing.
Can a newly established medical laboratory apply?
Yes. A newly established laboratory may apply once it has implemented its management system and can demonstrate operational capability, competent personnel, effective examination procedures, equipment controls, and quality-assurance activities.
Is proficiency testing required?
Participation in proficiency testing, external quality assessment, or other suitable comparison activities may be required where relevant and available for the examinations included within the requested scope.
Can multiple disciplines and locations be included?
Yes. Multiple examination disciplines and laboratory locations may be included, subject to assessment of the activities, personnel, equipment, management controls, and services performed.
How long is accreditation valid?
AAA accreditation is valid for three years, subject to continued compliance with accreditation requirements and completion of applicable surveillance or reassessment activities.
How do I begin?
Complete the accreditation application form or contact the AAA team to discuss your laboratory disciplines, examination services, locations, and proposed accreditation scope.
Take the Next Step
Ready to Apply for ISO 15189 Accreditation?
Take the next step toward independent recognition of your medical laboratory’s quality and technical competence. Our team is ready to guide you through the accreditation process and help define the appropriate scope for your laboratory.