Accreditation of molecular diagnostic labs is a critical process that ensures these facilities meet specific quality and competency standards in conducting molecular testing. At ClueGenix we can help our clients acheive the following -
Quality Assurance: Accreditation verifies that a molecular diagnostic lab operates according to international standards of quality management, technical competence, and procedural reliability. This ensures the accuracy and reliability of test results, crucial for patient diagnosis and treatment.
Credibility and Trust: Accredited labs are recognized for their commitment to high standards, enhancing trust among patients, healthcare providers, and regulatory bodies.
Regulatory Compliance: Many countries require labs to be accredited to comply with national regulations and to participate in healthcare systems, clinical trials, and research studies.
Accreditation Bodies:
International Standards: Labs typically seek accreditation based on international standards such as ISO 15189 (Medical laboratories - Requirements for quality and competence) or ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).
National Accreditation Bodies: Each country often has a national accreditation body responsible for assessing and accrediting labs. For example, in India, the National Accreditation Board for Testing and Calibration Laboratories (NABL) is the primary body accrediting testing and medical laboratories.