Format: E-course
Duration: 270 minutes
Instructors: Coral MED
Learning Credits: 0.5 ANSI/IACET CEUs
Accrediting Body: Coral MED
*This course was updated on Jan 01, 1970.
Laboratory Regulatory Compliance and ISO 15189 develops the practical competence required to interpret, apply, monitor, and sustain laboratory compliance within a structured quality and accreditation environment. Learners examine legal, regulatory, accreditation, professional, and organizational obligations; ISO 15189 management and technical requirements; roles of regulators and accreditation bodies; and the translation of requirements into laboratory processes, responsibilities, controls, and objective evidence. The course also develops skills in compliance gap assessment, risk-based prioritization, regulatory change monitoring, and implementation verification. Emphasis is placed on patient safety, result reliability, accountability, traceability, and maintaining evidence of sustained conformity.
By the end of this unit, learners will be able to: 7.1.1 Explain the purpose and scope of laboratory regulatory compliance. 7.1.2 Interpret the management and technical requirements of ISO 15189. 7.1.3 Differentiate the roles of regulators, accreditation bodies, professional councils, and laboratory leadership. 7.1.4 Map regulatory and standards requirements to laboratory processes and responsibilities. 7.1.5 Assess gaps between documented requirements and operational practice 7.1.6 Develop a structured approach for monitoring and implementing regulatory change.
Upon successful completion, learners will be able to: After completing this course, the learner can: Interpret legal, regulatory, accreditation, professional, and organizational compliance obligations affecting laboratory services. Apply ISO 15189 management and technical requirements to laboratory processes, responsibilities, controls, and records. Map regulatory and standards requirements to accountable roles, procedures, workflow activities, and objective conformity evidence. Conduct compliance gap assessments and prioritize corrective actions using patient-safety, compliance-risk, and feasibility criteria. Translate new or revised requirements into controlled policy, process, training, documentation, and implementation changes.
Basic understanding of laboratory operations and quality management principles.
All learning events delivered through the Coral Plus Learning Management System (LMS) are governed by the following Course Policies and Expectations. Participation in a Coral MED learning event constitutes the learner's agreement to comply with these policies. These expectations are designed to ensure a professional, respectful, secure, and effective learning environment consistent with the IACET 2018 Standard.
Participation and Engagement
Learners are expected to actively participate in all required learning activities, including modules, webinars, discussions, and assessments. For asynchronous courses, participation is verified through LMS activity logs, module completion, and assessment submission. For synchronous sessions, learners are encouraged to join several minutes early to address any technical issues and ensure full participation.
Registration and Access
Participants must register in advance to receive access to the learning event. Access links, passwords, and login credentials-when applicable-are provided securely to registered participants only and must not be shared. Unauthorized access or distribution of access credentials is prohibited.
Technology and Technical Readiness
Learners are responsible for ensuring they have a stable internet connection, compatible devices (computer, tablet, or smartphone), and recommend web browsers to support the learning experience. A microphone and webcam may be required for interactive sessions. Learners should test audio and video settings prior to the start of the session to minimize disruptions.
Webinar Delivery and Recording
Live webinars may be recorded for educational and quality assurance purposes. Recorded sessions may be made available to registered participants following the learning event. Recordings are intended solely for educational use and remain the intellectual property of Coral MED Management Institute.
Assessment and Timely Completion
Learners must complete all required instructional modules, achieve the minimum passing score on all required knowledge checks and graded assessments, and submit all course evaluations within the designated course timeframe to qualify for CEU credit or a certificate of completion. Failure to complete required components or meet the minimum passing standard by the stated deadline may result in ineligibility for credit, unless prior written approval for an extension has been granted.
Academic Integrity and Professional Conduct
Learners are expected to demonstrate honesty, integrity, and professionalism throughout the learning event. Plagiarism, misrepresentation of work, unauthorized collaboration, or falsification of records is prohibited. Respectful conduct is required in all learning environments, including virtual discussions and live sessions.
Privacy, Confidentiality, and Data Protection Policy
Learners must adhere to all privacy and confidentiality requirements, and applicable data protection regulations. Participants should not share personal, patient, or confidential information during learning activities, discussions, or webinars. Any proprietary or sensitive information encountered during the course must be handled in accordance with Coral MED's confidentiality and data protection policies. All learner information including enrollment data, grades, and records-is maintained in secure systems compliant with IACET 8.6 and federal privacy standards (FERPA and HIPAA, as applicable). Information is used solely for educational administration and reporting. No personal data will be released without written consent.
Learning Environment and Schedule
A detailed agenda will be provided in advance of the learning event. Sessions will adhere to the published schedule to ensure all planned topics are covered. Time will be allocated for questions, discussion, and learner interaction as appropriate to the course format.
Support and Technical Assistance
Technical support contact information or helpdesk access will be provided during live sessions and within the LMS. Common technical issues and troubleshooting guidance may be addressed at the beginning of the session. Learners are encouraged to seek assistance promptly if issues arise.
Learning Resources
Relevant learning materials, such as presentation slides, recordings, reference documents, or additional reading resources, may be shared with registered participants following the learning event. These materials are provided for personal educational use only.
Proprietary and Confidential Information Policy
Certain learning modules, case studies, or demonstrations may contain proprietary or confidential information belonging to Coral MED or its partners. Learners and instructors are required to maintain the confidentiality of such information and may not share, disclose, or reproduce any proprietary content outside the course environment. All participants must adhere to nondisclosure and confidentiality obligations outlined in enrollment agreements and faculty contracts. Violation of this policy may result in disciplinary action, loss of CEU credit, or legal remedies where applicable.
Intellectual Property Rights Policy
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Non-Discrimination and Equal Opportunity Policy
Coral MED Management Institute is committed to providing an inclusive learning environment that is free from discrimination, harassment, and retaliation. Admission, participation, assessment, and certification decisions are made without regard to race, color, national origin, ancestry, gender, gender identity or expression, sexual orientation, disability, age, religion, marital status, veteran status, or any other legally protected status. Any learner or staff member who believes they have been subject to discrimination or harassment should report the concern in writing to the Compliance & Equity Officer for prompt review and resolution.
Code of Conduct and Equity Policy
Coral MED is committed to creating a learning environment that promotes respect, inclusion, and cultural sensitivity. Harassment, discrimination, or disruptive behavior of any kind will not be tolerated. Violations may lead to removal from the course and reporting to appropriate authorities if warranted.
Laboratory compliance and regulatory-affairs professionals Quality management and accreditation practitioners Laboratory service and operational leaders Technical supervisors and process owners Internal audit and compliance-assurance practitioners Risk and governance professionals supporting laboratory services Quality-system and document-control coordinators Laboratory professionals preparing for accreditation responsibilities Healthcare quality professionals with diagnostic-service oversight