Course description
Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirements (CQI/IRCA Certified)
This course provides you with the skills and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based on case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements. You will participate in simulated auditing exercises that include planning, preparing and evaluating audit evidence. You will also practice the application of ISO 13485:2016 and the MDSAP requirements.
The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Students will have two hours to complete the exam, which is provided and proctored in a virtual format (2.5 hours for non-native English-speaking students). Our course requires highly interactive work and ongoing instructor assessment throughout the week.
Students should be entering the QMS Lead Auditor course with a basic understanding of the ISO 13485 quality system requirements, so mandatory prerequisite reading and a competency assessment will be provided on enrollment.These prerequisites must be completed in advance of the course start date.
Upcoming start dates
Suitability - Who should attend?
This class is helpful for all management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems or involvement with product design and development.
Training Course Content
By the end of this training, students will:
- Understand how to plan, conduct, report and follow up on a QMS audit in accordance with ISO 19011, ISO 13485:2016 and MDSAP
- Apply the MDSAP audit strategies adopted by Auditing Organizations in the MDSAP program
- Identify nonconformities, apply accurate grades to nonconformities (in accordance with the MDSAP grading system) and prepare an audit report in accordance with the MDSAP criteria
Course delivery details
The 5-day event consists of 4 days of different interactive sessions about auditing followed by a 2-hour written virtual examination on the 5th day. Our course requires that you work together with your tutors for 40 hours before the examination. That means you will have four long 10-hour days together.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 5
The instructor’s ability to make what could be a dry topic, an engaging and enlightening discussion that has certainly made me reassess my skills as an auditor
The instructors were amazing, I feel priviledged to have been trained by such experienced instructors.
Excellent skilled, experienced trainers who knew what to deliver and how to deliver it. I am very much impressed with James, Robert and Kim. Not just great tutors, but also (onl...