ISO 15189 Medical Laboratories Quality Management System - Auditor Course "In-High Demand"

Course Duration: 16 Hrs. (Online)

• Class Room Link / Training Link will be shared through your registered email after the completion of the fee payment.
• Participants need to go through the Each chapter (Recorded Session) and complete the online assessment.
• Examination should be completed within One Month.
• After completion of the examination, participants gain the “Professional Skills Certification Aligned with International Standards”  
• Course materials can be downloaded from the classroom.

ISO 15189:2022 Internal Auditor Course – Online Self-Paced

Course Overview

This course provides in-depth knowledge of ISO 15189:2022 requirements for medical laboratories. Participants will gain practical understanding of general, structural, resource, process, and management system requirements, with real-world implementation and audit-focused guidance.

Course Objectives

By the end of this course, participants will be able to:

• Interpret ISO 15189:2022 clause-by-clause requirements
• Implement compliant laboratory quality management systems
• Manage risks, resources, and laboratory processes effectively
• Prepare laboratories for accreditation and internal audits
• Conduct internal audits and manage nonconformities

Course Content:

Module 1: General Requirements (Clause 4)

• Impartiality in medical laboratory operations
• Confidentiality principles and ethical responsibilities
• Management and release of laboratory information
• Personnel responsibility for data protection
• Requirements related to patients and users

Module 2: Structural and Governance Requirements (Clause 5)

• Legal entity and regulatory compliance
• Role, competence, and responsibilities of the laboratory director
• Delegation of duties and accountability
• Scope of laboratory activities and advisory services
• Organizational structure, authority, and quality governance
• Objectives, policies, and risk management

Module 3: Resource Requirements – Personnel & Infrastructure (Clause 6.1–6.3)

• Personnel qualification, competence, and authorization
• Continuing education and professional development
• Personnel records and competency assessment
• Facilities and environmental conditions
• Facility controls, storage, and personnel facilities
• Sample collection facilities and safety considerations

Module 4: Resource Requirements – Equipment & Reagents (Clause 6.4–6.6)

• Equipment selection, acceptance, and maintenance
• Equipment calibration and metrological traceability
• Equipment records and adverse incident reporting
• Reagents and consumables management
• Receipt, storage, acceptance testing, and inventory control
• Instructions for use and reagent-related incident handling

Module 5: External Services & Agreements (Clause 6.7–6.8)

• Service agreements with laboratory users
• POCT agreements and responsibilities
• Control of externally provided products and services
• Referral laboratories and consultant evaluation

Module 6: Pre-Examination Processes (Clause 7.1–7.2)

• Laboratory information for patients and users
• Examination requests and test selection
• Sample collection, identification, and handling
• Sample transportation and receipt
• Pre-examination sample preparation and storage

Module 7: Examination Processes (Clause 7.3)

• Verification and validation of examination methods
• Measurement uncertainty (MU)
• Biological reference intervals and decision limits
• Documentation of examination procedures
• Ensuring validity and reliability of results

Module 8: Post-Examination Processes (Clause 7.4)

• Reporting of examination results
• Critical results and communication
• Post-examination sample storage and disposal

Module 9: Control, Complaints & Continuity (Clause 7.5–7.8)

• Nonconforming work and corrective actions
• Data and information management systems
• Downtime and off-site data management
• Complaint handling process
• Business continuity and emergency preparedness

Module 10: Management System Requirements (Clause 8)

• Management system principles and documentation
• Document and record control
• Risk-based thinking and opportunities for improvement
• Continual improvement strategies
• Handling nonconformities and corrective actions

Module 11: Performance Evaluation & Auditing (Clause 8.8–8.9)

• Quality indicators and monitoring
• Internal audit planning and execution
• Management review inputs and outputs
• Accreditation readiness and continual compliance

Target Audience

• Medical Laboratory Professionals
• Quality Managers & Technical Managers
• ISO 15189 Implementation Teams
• Internal Auditors
• Accreditation & Compliance Officers

Final Assessment & Certification

• Online exam
• Practical case-based scenario
• Certificate issued upon successful completion

Key Learning Outcomes

After completing the course, participants will be able to:
✔ Understand all ISO 15189:2022 requirements
✔ Develop an effective internal audit programme
✔ Conduct independent, competent internal audits
✔ Identify nonconformities and improvement opportunities
✔ Prepare professional audit reports
✔ Support NABL/ISO 15189 accreditation readiness

Final Assessment & Certification

• Online final exam: 50 MCQs + scenario-based questions
• Certificate of Completion upon passing

Assessment: Participants may be evaluated through quizzes, and a final examination to ensure comprehension and application of the course material. 

Outcome: Participants completing the ISO 15189 Internal Auditor Training Program will gain the “Professional Skills Certification Aligned with International Standards” and expertise to plan, conduct, and report on internal audits of their organization's MLQMS. This program empowers professionals to contribute to the continual improvement of health and safety practices and ensures compliance with ISO 15189 standards.

Course Duration: 

• SELF-PLACED COURSE (Do not Wait ! Start Now !)

SELF-PLACED COURSE ( Do not Wait! Start Now !)

• After fee payment we will share the Self-Placed Course Link to your registered email address.
• After receiving mail join the class and start learn and complete the assignment and examinations.
• U-TECH INTERNATIONAL certificate of “Internal Auditor training program on ISO 15189 MLQMS" will be issued to participants only after successful completion based on written examination 

• Participants will be assessed through a 50 marks MCQ type online examination (open book) at the end of the course
• Minimum passing% criteria: 60%.( 30 Marks)

• U-TECH certificate of “Internal Auditor training program on ISO 15189  "Medical Laboratories Quality Management System” will be issued to participants only after successful completion based on performance during the course and in written examination 
• Others who have not successfully completed the course will be issued a certificate of attendance.

Training Link: This will be shared through your registered email after the completion of the fee payment.

Course materials will be provided for all participants

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