Online ISO 13485:2016 Internal Auditor (Knowledge & Theory) Training
This fully online course 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, in accordance with ISO 19011:2018.
Did you know? This course forms part 1 of 2 of our blended ISO 13485:2016 Internal Auditor training course which compromises of this online course plus 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!
- 8 Hours
Module 0 - Course Introduction
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to Quality Management Systems (QMS)
In this module we will explore the purpose and benefits of a QMS, the structure and content of ISO 13485:2016, the process approach and Plan-Do-Check-Act (PDCA) cycle, key terminology related to auditing and the relationship between ISO 13485:2016 and applicable regulatory/statutory requirements.
Module 2 - Introduction to Auditing
In this module we will explore the internal audit requirements as specified by ISO 13485:2016, the key terminology associated with the auditing standard ISO 19011:2018, principles of auditing, audit program management and the audit lifecycle.
Module 3 - Planning the Audit
In this module we will explore the criteria for selection of the audit team, roles and responsibilities throughout the audit, desired auditor behaviors, determining the audit scope, objectives and criteria.
Module 4 - Audit Initiation and Preparation
In this module we will expand on the audit lifecycle by exploring the first two phases namely “Initiate the Audit and Prepare Audit Activities”, in more detail. Topics to be covered will include, establishing contact with the auditee, audit feasibility, document review and finally preparation of a risk-based audit plan and development of the audit checklists.
Module 5 - Conducting the Audit
In this module we will expand on the audit lifecycle by exploring the third phase of the audit lifecycle, namely conducting audit activities. Topics to be covered will include, opening meeting, communication, auditee reactions, conflict resolution, audit methods and audit evidence.
Module 6 - Report, Close and Follow Up the Audit
In this module we will explore the final stages of the audit, namely: documenting the identified non-nonconformities and conducting the closing meeting. We will also explore, the last three phases of the audit lifecycle namely: preparing and distributing the audit report, completing the audit and performing follow up audit activities.
This course is fully certified by Comply Guru™.
In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination. Successful completion will entitle each Learner to receive a certificate of completion.