ISO 15189: Mastering Laboratory Quality Management for Total Risk Assurance Curriculum
This comprehensive course is designed to provide participants with a thorough understanding of laboratory quality management and total risk assurance, as outlined in the ISO 15189 standard. Upon completion of this course, participants will receive a certificate issued by The Art of Service.Course Overview This course is designed to be: - Interactive and engaging, with hands-on projects and real-world applications
- Comprehensive, covering all aspects of laboratory quality management and total risk assurance
- Personalized, with flexible learning options and lifetime access to course materials
- Up-to-date, with the latest developments and best practices in laboratory quality management
- Practical, with actionable insights and takeaways that can be applied in the workplace
- High-quality, with expert instructors and high-quality content
- Certified, with a certificate issued by The Art of Service upon completion
- Flexible, with user-friendly and mobile-accessible course materials
- Community-driven, with opportunities for discussion and collaboration with peers
- Gamified, with progress tracking and rewards for completion
Course Outline This course is divided into the following modules: Module 1: Introduction to Laboratory Quality Management
- Overview of laboratory quality management and its importance
- History and development of laboratory quality management standards
- Key principles and concepts of laboratory quality management
- Introduction to the ISO 15189 standard
Module 2: Laboratory Quality Management System (LQMS)
- Definition and scope of the LQMS
- Key components of the LQMS, including policies, procedures, and records
- Establishing and maintaining the LQMS
- Role of top management in the LQMS
Module 3: Risk Management in the Laboratory
- Introduction to risk management and its importance in the laboratory
- Identifying and assessing risks in the laboratory
- Developing and implementing risk mitigation strategies
- Monitoring and reviewing risk management effectiveness
Module 4: Quality Control and Quality Assurance
- Definition and scope of quality control and quality assurance
- Key components of quality control and quality assurance, including testing, calibration, and validation
- Establishing and maintaining quality control and quality assurance programs
- Role of quality control and quality assurance in the LQMS
Module 5: Laboratory Information Management Systems (LIMS)
- Definition and scope of LIMS
- Key components of LIMS, including hardware, software, and data management
- Establishing and maintaining LIMS
- Role of LIMS in the LQMS
Module 6: Auditing and Continuous Improvement
- Introduction to auditing and its importance in the laboratory
- Types of audits, including internal, external, and third-party audits
- Conducting and responding to audits
- Continuous improvement and the role of auditing in the LQMS
Module 7: Management Review and Continual Improvement
- Introduction to management review and its importance in the laboratory
- Key components of management review, including review of policies, procedures, and records
- Establishing and maintaining a management review program
- Role of management review in the LQMS
Module 8: Laboratory Quality Management and Regulatory Compliance
- Introduction to regulatory compliance and its importance in the laboratory
- Key regulations and standards affecting laboratory quality management, including ISO 15189 and CLIA
- Establishing and maintaining regulatory compliance programs
- Role of regulatory compliance in the LQMS
Module 9: Ethics and Professionalism in the Laboratory
- Introduction to ethics and professionalism in the laboratory
- Key principles and concepts of ethics and professionalism, including confidentiality, integrity, and respect
- Establishing and maintaining a culture of ethics and professionalism in the laboratory
- Role of ethics and professionalism in the LQMS
Module 10: Conclusion and Final Assessment
- Review of key concepts and takeaways from the course
- Final assessment and evaluation of participant understanding
- Issuance of certificate upon completion
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Module 1: Introduction to Laboratory Quality Management
- Overview of laboratory quality management and its importance
- History and development of laboratory quality management standards
- Key principles and concepts of laboratory quality management
- Introduction to the ISO 15189 standard
Module 2: Laboratory Quality Management System (LQMS)
- Definition and scope of the LQMS
- Key components of the LQMS, including policies, procedures, and records
- Establishing and maintaining the LQMS
- Role of top management in the LQMS
Module 3: Risk Management in the Laboratory
- Introduction to risk management and its importance in the laboratory
- Identifying and assessing risks in the laboratory
- Developing and implementing risk mitigation strategies
- Monitoring and reviewing risk management effectiveness
Module 4: Quality Control and Quality Assurance
- Definition and scope of quality control and quality assurance
- Key components of quality control and quality assurance, including testing, calibration, and validation
- Establishing and maintaining quality control and quality assurance programs
- Role of quality control and quality assurance in the LQMS
Module 5: Laboratory Information Management Systems (LIMS)
- Definition and scope of LIMS
- Key components of LIMS, including hardware, software, and data management
- Establishing and maintaining LIMS
- Role of LIMS in the LQMS
Module 6: Auditing and Continuous Improvement
- Introduction to auditing and its importance in the laboratory
- Types of audits, including internal, external, and third-party audits
- Conducting and responding to audits
- Continuous improvement and the role of auditing in the LQMS
Module 7: Management Review and Continual Improvement
- Introduction to management review and its importance in the laboratory
- Key components of management review, including review of policies, procedures, and records
- Establishing and maintaining a management review program
- Role of management review in the LQMS
Module 8: Laboratory Quality Management and Regulatory Compliance
- Introduction to regulatory compliance and its importance in the laboratory
- Key regulations and standards affecting laboratory quality management, including ISO 15189 and CLIA
- Establishing and maintaining regulatory compliance programs
- Role of regulatory compliance in the LQMS
Module 9: Ethics and Professionalism in the Laboratory
- Introduction to ethics and professionalism in the laboratory
- Key principles and concepts of ethics and professionalism, including confidentiality, integrity, and respect
- Establishing and maintaining a culture of ethics and professionalism in the laboratory
- Role of ethics and professionalism in the LQMS
Module 10: Conclusion and Final Assessment
- Review of key concepts and takeaways from the course
- Final assessment and evaluation of participant understanding
- Issuance of certificate upon completion