ISO 15189 Training – Lead Auditor

About ISO 15189 Lead Auditor Training

ISO 15189 outlines the requirements for medical laboratories’ competence and quality management systems. Achieving compliance with ISO 15189 is crucial for laboratories to demonstrate their ability to consistently deliver accurate and reliable testing services. Empowering Assurance Systems is proud to offer the ISO 15189 Lead Auditor Course, a comprehensive training program designed to equip professionals with the skills and knowledge to lead effective audits in medical laboratories.

Course Curriculum for ISO 15189 Training

The ISO 15189 Lead Auditor Training Course curriculum is designed to provide participants with a thorough understanding of the ISO 15189 standard and equip them with the necessary skills to lead successful audits in medical laboratories. The curriculum covers topics such as quality management principles, risk-based thinking, audit planning and preparation, audit techniques, and reporting.

Through a combination of lectures, interactive discussions, case studies, and practical audit simulations, participants gain practical knowledge and hands-on experience in conducting audits according to the ISO 15189 requirements. The curriculum is carefully crafted to ensure participants develop the competence and confidence to excel as ISO 15189 Lead Auditors.

Flexible Delivery Methods for ISO 15189 Training

We understand the importance of flexibility and convenience in ISO 15189 training programs. To cater to diverse learning preferences and organizational requirements, we offer various methods of delivery for our ISO 15189 Lead Auditor Training:

• Open Classroom ISO 15189 Training: Our open training sessions are conducted at designated locations and are open to professionals from various organizations. These sessions provide an excellent opportunity to network, collaborate, and exchange knowledge with peers from diverse industries.
• In-House ISO 15189 Training: We provide the option for in-house training that can be customized to meet your organization’s specific needs. Our expert trainers will deliver the ISO 15189 Lead Auditor course at your premises, ensuring that the content aligns with your organizational goals and processes.
• Virtual ISO 15189 Training via Zoom: Our virtual training option allows participants to attend interactive sessions from the comfort of their own location. Through the use of Zoom, a leading video conferencing platform, participants can actively engage with trainers and fellow learners, participate in discussions, and receive real-time guidance.

We believe in providing flexible training solutions that cater to the unique requirements of our clients, ensuring access to high-quality ISO 15189 training in a manner that suits their preferences and logistical considerations.

ISO 15189 Lead Auditor Course Duration

The ISO 15189 Lead Auditor Training offered by Empowering Assurance Systems is designed to provide participants with in-depth knowledge and practical skills in auditing quality management systems for medical laboratories. The course duration is set at 5 days, consisting of a total of 40 hours of instruction and interactive learning. During these 5 days, participants will explore key topics such as audit planning, conducting audits, evaluating nonconformities, reporting findings, and effective communication in the auditing process.

Our ISO 15189 training sessions are thoughtfully structured to strike a balance between theoretical concepts and hands-on application, ensuring that participants gain a thorough understanding of ISO 15189 requirements and develop the necessary skills to conduct audits effectively. For the latest course dates and schedule, please refer to our ISO 15189 Training Schedule.

Why Choose EAS for ISO 15189 Training?

When it comes to ISO 15189 Training, selecting Empowering Assurance Systems (EAS) offers several distinct advantages:

• Expert Trainers: Our trainers are industry experts with extensive knowledge and practical experience in ISO standards and auditing practices. Their expertise brings real-world insights and valuable examples to the ISO 15189 training sessions, enriching the learning experience.
• Comprehensive Curriculum: Our ISO 15189 training course is designed to cover all essential aspects of ISO 15189 auditing. The curriculum ensures participants develop a comprehensive understanding of the standard and its practical application in medical laboratories.
• Flexible Training Options: We understand that professionals have varying schedules and training requirements. That’s why we offer flexible training options, including open training sessions, in-house ISO 15189 training customized to your organization’s needs, and virtual training through Zoom. This flexibility allows you to choose the format that best suits your availability and preferences.
• Industry Recognition: Our ISO 15189 training program is widely respected within the industry. The certification obtained upon successful completion of the training holds significant value and is regarded by employers. It serves as a testament to your expertise and commitment to quality management systems in medical laboratories.
• Practical Focus: At EAS, we believe in practical learning that goes beyond theoretical knowledge. Our ISO 15189 training places a strong emphasis on practical application. Through interactive exercises, case studies, and real-world examples, participants develop the necessary skills to effectively apply auditing principles in their work environment. This hands-on approach ensures that you not only understand the concepts but also gain the confidence to implement them successfully.

Assessments and Certification

Continuous Assessment: Candidates are evaluated throughout the course on attendance, active participation, completion of individual and group exercises, and professional engagement during class discussions.

IRCA Examination: At the end of the ISO 15189 Lead Auditor Course, whether delivered in a classroom, virtual, or in-house setting, participants must complete the IRCA examination conducted online. The examination specifications are as follows:

• Duration: 1 hour and 45 minutes
• Questions: 40, without options or negative marking
• Content: Covers five domains—concepts and principles, audit methodologies, audit planning, audit conducting, and reporting/closing
• Total Marks: 80, with a required minimum pass mark in each domain and an overall score of at least 50% (40 marks)
• Format: Open book, but internet searches are restricted; access to the relevant ISO standard (electronic or paper copy) is recommended
• Marking: All questions are computer-graded
• Security: Responses cannot be changed after submission
• Preparation: Sample questions are discussed to familiarize candidates with the format
• Proctoring: IRCA’s exams are proctored live to ensure integrity. Candidates verify their ID through a secure portal and are monitored via webcam by a proctor who ensures compliance with exam rules. Unauthorized resources or leaving the exam screen are prohibited. Sessions may be recorded for further review.

Candidates taking the exam in languages other than English, Spanish, Japanese, Arabic, or Traditional Mandarin will complete a paper-based version.

Certification: Participants achieving 70% or higher in continuous assessment, plus 50% or above in the final examination, will receive a CQI/IRCA-accredited certificate of successful course completion, recognized globally within certification standards. Candidates who do not meet this threshold will be issued a certificate of attendance.