ISO 15189 MEDICAL LABORATORY ACCREDITATION
ISO 15189 Documents
AR 2253, Accreditation Requirements: ISO 15189 Accreditation Medical Test Laboratories - Establishes policies for and describes the accreditation process for ISO 15189 medical test laboratories
FA 2061, Application for ISO 15189 Accreditation
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Medical laboratories can be accredited to ISO 15189, Medical laboratories - Particular requirements for quality and competence, to demonstrate the quality and reliability of their services. ISO 15189 was developed with the participation of the medical, scientific, and clinical community, and it contains requirements for diagnostic labs to demonstrate competence to deliver reliable timely, accurate, and reliable results.
Based on ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, and ISO 9001, Quality management systems - Requirements, ISO 15189 includes five additional criteria for medical laboratories
- 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.
ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. Qualified assessors conduct a thorough evaluation of all factors affecting the production of test data.
To ensure continued compliance, accredited medical laboratories are regularly re-assessed to ensure they maintain their technical expertise. They are also required to participate in proficiency testing programs (EQAs).
This diagram outlines the SCB process:
