Topic outline
Basic knowledge of ISO 15189 - Quality Management System -
1. What are ISO standards?
2. Essence of ISO 15189
3. Quality Management System of laboratory services
4. Implementation of ISO 151890:19:53
ISO 15189 accreditation program for molecular-genetic laboratories
1. Efforts for quality assurance in molecular-genetic testing
2. Implementation guidance of ISO 15189 for NGS-based tests
3. Regional and international efforts to standardize the pre-examination process
4. International efforts to standardize multiplex molecular-genetic tests
5. Challenges to the EQA/PT program0:34:37
Management system specific to molecular-genetic tests
1. Operation of ISO 15189 and molecular-genetic tests
2. Current status of ISO 15189 certification audits
3. Management requirements in ISO 15189
4. Process-based QMS model and management principles0:30:32
Technical requirements specific to molecular-genetic tests (Part-1)
1. Overview of technical requirements in ISO 15189
2. 5.2 Laboratory design and facility; how to prevent contamination
3. 5.3 Equipment and reagent management
4. 5.5 Verification and validation of examination procedures
5. 5.4 Pre-examination handling, preparation and storage, collection
6. 5.4 Pre-examination process standards
7. Biobank considerations
8. Personnel requirements for biobank0:57:38
Technical requirements specific to molecular-genetic tests (Part-2)
1. Information management
2. Documentation of examination procedures
3. General personnel requirements
4. Performance monitoring
5. External quality assessment and alternative method
6. Post-examination0:40:54
Educational Curriculum, Qualification, and Career Development of Laboratory Professionals in Molecular Biology
1. Laboratory Personnel in Quality Assurance of Molecular-Genetic Testing
2. Qualification Examination of Laboratory Technologists in Molecular-Genetic Testing
3. Qualification of the Laboratory Director in Molecular-Genetic Testing
4. Education and Training of Auditors in ISO 15189 for NGS-based Tests0:35:16
ISO 15189 Clinical Laboratory Accreditation - Accreditation of gene-related testing -
1. Comparison between ISO 15189 and CAP accreditations
2. Key points of ISO 15189 accreditation
3. Key points of gene-related testing
4. Key points of next-generation sequencing accreditation
5. Summary
0:59:39