Basic knowledge of ISO 15189 - Quality Management System -

1. What are ISO standards?2. Essence of ISO 151893. Quality Management System of laboratory services4. Implementation of ISO 15189

ISO 15189 accreditation program for molecular-genetic laboratories

1. Efforts for quality assurance in molecular-genetic testing2. Implementation guidance of ISO 15189 for NGS-based tests3. Regional and international efforts to standardize the pre-examination process4. International efforts to standardize multiplex molecular-genetic tests5. Challenges to the EQA/PT program

Management system specific to molecular-genetic tests

1. Operation of ISO 15189 and molecular-genetic tests2. Current status of ISO 15189 certification audits3. Management requirements in ISO 151894. Process-based QMS model and management principles

Technical requirements specific to molecular-genetic tests (Part-1)

1. Overview of technical requirements in ISO 151892. 5.2 Laboratory design and facility; how to prevent contamination3. 5.3 Equipment and reagent management4. 5.5 Verification and validation of examination procedures5. 5.4 Pre-examination handling, preparation and storage, collection6. 5.4 Pre-examination process standards7. Biobank considerations8. Personnel requirements for biobank

Technical requirements specific to molecular-genetic tests (Part-2)

1. Information management2. Documentation of examination procedures3. General personnel requirements4. Performance monitoring5. External quality assessment and alternative method6. Post-examination

Educational Curriculum, Qualification, and Career Development of Laboratory Professionals in Molecular Biology

1. Laboratory Personnel in Quality Assurance of Molecular-Genetic Testing2. Qualification Examination of Laboratory Technologists in Molecular-Genetic Testing3. Qualification of the Laboratory Director in Molecular-Genetic Testing4. Education and Training of Auditors in ISO 15189 for NGS-based Tests

ISO 15189 Clinical Laboratory Accreditation - Accreditation of gene-related testing -

1. Comparison between ISO 15189 and CAP accreditations2. Key points of ISO 15189 accreditation3. Key points of gene-related testing4. Key points of next-generation sequencing accreditation5. Summary