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 INTERNATIONAL CERTIFICATE / AWARD.
- Course materials can be downloaded from the classroom.
ISO 15189:2022 Internal Auditor Course – Online Self-Paced
Master Medical Laboratory Quality & Competence Auditing at Your Own Pace
This comprehensive self-paced online course is designed for laboratory professionals, quality managers, and auditors who want to develop the skills required to plan, conduct, report, and follow up on internal audits in accordance with ISO 15189:2022 – Medical Laboratories: Requirements for Quality and Competence.
Participants gain a strong understanding of ISO 15189 clauses, auditing techniques, evidence collection, non-conformity identification, and improvement strategies—essential for maintaining accreditation and ensuring quality patient care.
Who Should Enroll?
- Medical laboratory technicians / technologists
- Quality managers & quality officers
- Laboratory supervisors
- Internal auditors & compliance staff
- Hospital and diagnostic center staff
- Anyone preparing for NABL/ISO 15189 accreditation
Course Format (Self-Paced)
✔ 100% Online – learn anytime, anywhere
✔ Lifetime access to modules
✔ Practical examples & downloadable templates
✔ Final assessment + Certificate of Completion
Course Modules & ISO 15189 Clauses Covered
Module 1: Introduction to ISO 15189:2022
- Purpose, scope & structure
- Relationship with ISO/IEC 17025 & ISO 9001
- Key changes in ISO 15189:2022
- Understanding risk-based thinking
Module 2: Laboratory Management System Requirements
Clauses Covered: 4.1 – 4.15
- 4.1 Organization & Leadership
- 4.2 Quality Management System (QMS)
- 4.3 Documented Information
- 4.4 Service Agreements
- 4.5 Examination by Referral Labs
- 4.6 External Services & Supplies
- 4.7 Advisory Services
- 4.8 Complaint Management
- 4.9 Nonconformity & Corrective Action
- 4.10 Continual Improvement
- 4.11 Control of Records
- 4.12 Personnel Competence & Training
- 4.13 Facilities & Environmental Conditions
- 4.14 Equipment Management
- 4.15 Laboratory Information Management
Module 3: Technical Requirements for Medical Laboratories
Clauses Covered: 5.1 – 5.10
- 5.1 Personnel
- 5.2 Accommodation & Environmental Conditions
- 5.3 Laboratory Equipment, Reagents & Consumables
- 5.4 Pre-Examination Processes
- 5.5 Examination Procedures
- 5.6 Post-Examination Processes
- 5.7 Ensuring Quality of Examination Results
- 5.8 Reporting of Results
- 5.9 Release of Results & Amendments
- 5.10 Metrological Traceability, Uncertainty & Validation
Module 4: Internal Auditing Principles
- ISO 19011 auditing guidelines
- Types of audits – process, system, compliance
- Auditor responsibilities & ethics
- Risk-based internal auditing
Module 5: Audit Planning & Preparation
- Annual audit planning
- Audit scope, criteria & objectives
- Checklist development (with templates)
- Defining process interactions
Module 6: Conducting the Audit
- Opening meeting
- Interview techniques
- Document & record review
- Identifying nonconformities
- Objective evidence collection
Module 7: Reporting & Follow-Up
- Writing clear audit reports
- Nonconformity classification: Major/Minor/Observations
- Root cause analysis (5 Why, Fishbone)
- Corrective action verification
- Closing meeting best practices
Module 8: 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 INTERNATION CERTIFICATE 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
EXAM DETAILS (DURATION, PATTERN)
• 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)
CERTIFICATION
• 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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