Blended ISO 13485:2016 Internal Auditor Training
This blended course (online & classroom) is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS
Did you know? This course is delivered both online & in a classroom. Each learner must complete an 8hr online training course before attending a classroom-based 1-day skills-based training session. The major benefit to this approach is that it offers each Learner the flexibility to learn at their own pace and reduce the overall time spent in a classroom!
If you are interested in this course, we recommend having a look at our free online ISO 13485:2016 introduction course. Check it out today!
- 16 Hours
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Includes Online ISO 13485:2016 Pre-Course Assignment [Additional]
Each Learner will receive access to an additional Online ISO 13485:2016 Pre-Course Assignment that focuses on the Learners knowledge of the ISO 13485:2016 requirements and other key prior learning topics! This online assignment is included FREE & to ensure each Learner is well prepared, meets the prior learning requirements & gets the most out of their training!
Part 1 = Modules 0 - 6 (Online)
In order to attend this training, each Learner must successfully complete the Online ISO 13485:2016 Internal Auditor Knowledge & Theory Course (6hrs) which consists of 6 modules (online).
Module 7 - Course Introduction (Classroom)
In this module, an introduction to the classroom element of the blended course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & training delivery.
Module 8 - Planning the Audit (Classroom)
In this module we will explore the key steps that are required to plan the audit using a risk-based approach. We will also practice the skills required to prepare the necessary documents for the audit including the audit checklist.
Module 9 - Conducting the Audit (Classroom)
In this module we will practice the skills required to effectively conduct an audit using a sample of QMS documentation. A variety of audit methods will be used including interview, document review and data analysis.
Module 10 - Generating Audit Findings and the Closing Meeting (Classroom)
In this module we will practice the skills required for documenting non-conformities and for conducting the closing meeting.
Module 11 - Audit Report and Follow Up (Classroom)
In this module we explore the steps required to prepare the audit report. We will also practice the skills required to verify that actions taken to address audit findings were effective.
This course is fully certified by Comply Guru™.
In order to successfully complete this blended course, each Learner will need to:
- Complete the online course and obtain 70% or higher in the final assessment (part 1 of 2)
- Fully attend the classroom element and obtain 70% or higher in the continuous assessment (part 2 of 2)
Successful completion will entitle each Learner to receive a certificate of achievement.