ISO 15189 Medical Laboratory Accreditation
Exsolution Consultancy provides ISO 15189, a Medical Laboratory Accreditation to demonstrate the quality and reliability of clinical or medical services. This Accreditation was developed for reliable participation in the medical, scientific and clinical fields through diagnostic labs.
What is ISO 15189 - Medical Laboratory Accreditation?
The ISO 15189 - Medical Laboratory Accreditation fulfills the requirements of clinical competency through diagnostic laboratories delivering timely results. It also focuses on providing accurate and reliable medical outputs meeting international standards.
How to implement the ISO 15189 - Medical Laboratory Accreditation?
Based on ISO IEC 17025 Accreditation, the competence and testing of laboratories meets the ISO 15189, a Medical Laboratory Accreditation criteria listed below:
- Providing advice on the type of sample and testing that may be required.
- Interacting with clinical staff with the laboratory responsible for the quality of service to clinicians referring patient samples for testing.
- Providing opinions on results of testing relative to diagnosis and patient care.
- Collecting samples or providing information on collection procedures, sample containers, and sample volumes.
- Ethical practice.
How the ISO 15189 - Medical Laboratory Accreditation works?
The ISO 15189 Medical Laboratory Accreditation involves independent assessments of medical labs with examination of personnel, competency, equipment’s, reagents and supplies. It’s accompanied with quality assurance, analytical, and pre-analytical factors as well.
Who performs the ISO 15189 - Medical Laboratory Accreditation?
The assessment is performed by qualified and trained assessors who conduct a thorough evaluation based on the above factors for data production. Periodic assessment on accredited medical labs ensures continued technical expertise. They also perform proficiency testing programs under proper guidance and approvals.
