The ISO 15189 Lead Auditor Training Course is designed to provide comprehensive training and certification to individuals aspiring to become ISO 15189 lead auditors for Medical Laboratory Management Systems. This e-learning course includes audio-visual presentations, handouts, videos, audit checklists, and exams, making it convenient for participants to learn from their office, home, or any location using their computer or mobile devices. Enrolling in this course allows you to learn everything required to become an ISO 15189:2022 lead auditor. Obtaining the ISO 15189:2022 lead auditor certificate through this course is easier compared to similar options in the global market. It is particularly beneficial for busy technical personnel, medical laboratory auditors, and accreditation bodies’ staff, offering flexibility in terms of learning timing and location.
Successful completion of this ISO 15189:2022 lead auditor training course will result in participants receiving a certificate as a trained ISO 15189:2022 Lead Auditor.
TOPICS COVERED UNDER ISO15189:2022 LEAD AUDITOR TRAINING
This ISO 15189:2022 lead auditor training online course is divided into three sections and comprises nine sessions:
- Session 1: Overview of ISO 15189:2022
- Session 2: Requirements of ISO 15189:2022
- Session 3: ISO 15189:2022 Management System Documentation
- Session 4: ISO 15189:2022 Accreditation Process
- Session 5: Risk Management
- Session 6: Audit Process
- Session 7: Audit Terms and Definitions & Roles and Responsibilities
- Session 8: Performing an Audit based on ISO 15189:2022
- Session 9: Nonconformity and Corrective Action
Each session includes audio-visual presentations, handouts, videos, and exams.
COURSE OBJECTIVES
Upon completing this ISO 15189 auditor training e-learning course, participants will be able to:
- Familiarize themselves with the new structure and clause-wise requirements of ISO 15189:2022
- Understand the requirements for pre-examination, examination, and post-examination processes
- Comprehend the structural, governance, and resource requirements for medical laboratories
- Understand the management system requirements for medical laboratories
- Grasp the new concepts of risk management and risk evaluation techniques
- Identify the documents and records that need to be maintained/retained by laboratories according to ISO 15189:2022 requirements
- Learn how to perform/lead audits of medical laboratories
- Utilize the ISO 15189:2022 clause-wise audit checklist
- Understand the processes involved in auditing, including opening and closing meetings as per ISO 19011 standards
- Acquire knowledge of various auditing types and questioning techniques
- Familiarize themselves with key terms, definitions, roles, and responsibilities for ISO 15189:2022 lead auditors
- Learn about the ISO 15189:2022 Laboratory Accreditation process
WHO SHOULD ATTEND THIS COURSE?
Individuals working with medical laboratories or those associated with ISO 15189:2022 accreditation bodies should consider attending this ISO 15189:2022 lead auditor training. This online training is beneficial for:
- Personnel of medical laboratories
- Quality managers of laboratories
- Laboratory managers
- Directors/management of laboratories and their representatives
- ISO 15189 consultants, compliance executives, and experts
- Anyone intending to perform audits conforming to the ISO 15189:2022 standard
PREREQUISITES
The following are considered advantageous for participants of this ISO 15189:2022 Lead Auditor Training course:
- Knowledge of Quality Management Systems
- Knowledge of medical laboratory activities
- Experience of working in a medical laboratory
- Ability to understand instructions in simple English
- Individuals with a Diploma or Bachelor’s degree may have an advantage
MORE INFORMATION
The fourth edition of ISO 15189 was published by ISO in December 2022. Accreditation of medical laboratories will now be granted by recognized accreditation bodies based on the requirements of the new ISO 15189:2022 edition. The revised edition is aligned with ISO/IEC 17025 and includes significant changes, such as increased emphasis on risk and the inclusion of point-of-care testing (POCT) requirements. Our ISO 15189:2022 lead auditor training addresses all aspects of the latest edition, offering a complete overview, covering features, benefits, and changes from the previous version. The course provides in-depth knowledge of requirements and the accreditation process for ISO 15189:2022. Additionally, participants will learn audit techniques, processes, and requirements, preparing them to qualify as ‘Lead Auditors’ for Laboratory Management Systems based on ISO 15189:2022.
AUTHORS & INSTRUCTORS
For details about the authors, trainers, and instructors, including their experience and background, please refer to our trainers’ page. They possess a wealth of expertise on the subject.
STUDY MATERIALS
This e-Learning course provides study materials that can be read after logging in or downloaded in PDF format. These materials reinforce key points and serve as reminders of the content learned. Access to study materials is removed after clearing the exam and generating the online certificate.
EXAMINATION AND COURSE CERTIFICATE
All paid E-learning courses include a Course Certificate issued upon completing the course and passing the session exams and the final exam with a minimum of 60% marks. Students who do not pass an exam have the option to retake it.
END OF COURSE INSTRUCTION
Upon completing the sessions and passing each session examination, students can take the final exam. Successfully clearing the final exam marks the end of the course. The training certificate is available on our LMS for printing or saving, and its authenticity can be verified by entering the name and certificate number.…
