Course 034X: ISO 13485:2016 Internal Auditor Extension Course Content
Already an Internal Auditor for ISO 14001 or other Management System Standard?
Why not add ISO 13485 Internal Auditor Certification with this on-line Program, which provides you with the Auditing Skills, the Knowledge of the Standard and the practical application of that knowledge with Audit Scenarios to enable you to undertake Internal Audits and Supplier Audits.
Who should take this Course?
This Program is intended for those who…
- wish to add ISO 13485:2016 to their Internal Auditor Certification.
- are required to perform quality internal audits within your organisation
- are required to perform supplier audits,
- wish to improve your career prospects.
- wish to understand the processes of conducting environmental internal audit or external audits.
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
What does the Course cover?
This is a comprehensive Program covering all aspects of ISO 13485 Internal Auditing is divided into two Courses…
- Course 2: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Introduction to ISO 13485:2016
- Terms & Definitions – ISO 13485:2016
- Some Key aspects of QMS Auditing
- Fundamentals of Quality Management Systems
- Structure & content of ISO 13485:2016
- Parts 1, 2 & 3
- Part 4: Quality Management System Requirements
- Part 5: Management Responsibility
- Part 6: Resources
- Part 7: Product Realisation (3 modules)
- Part 8: Measurement, Analysis & Improvement (2 modules)
- Annexes ZA, ZB & ZC
- FAQs about the Standard
- On-line Course Examination
- Course 2: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.
Audit Scenarios – Internal Auditor
FAQs about the Auditing Experience
On-line Final Examination
- Diagram: Auditor Certification Process
- Diagram: 6-Stage Audit Process
- Sample Nonconformity Report
- Sample Working Document & Checklist
- ‘ISO 13485:2016 & You’ – a guide to new and changed requirements
- The Design & Development Process in ISO 13485
- Documented information in ISO 13485:2016 (130+ instances)
- A typical Process Map – practical aplication of the process approach
- Terms & Definitions in ISO 13485:2016
How is this ISO 13485 internal auditor Add-on Program delivered?
The Program is delivered on-line from our Learning Management System (LMS), provided by Adobe Captivate Prime.
All Lessons have full resume and scaling capabilities. This means, for example, you can…
- Start a Lesson at work on your Work Station running on Windows 10,
- Continue the Lesson on the train home on your i-Pad running on iOS 11 and,
- Complete the Lesson at home on your Notebook PC running on Windows 8.1.
Are there any prerequisite requirements?
If you have previously completed a Internal Auditor Program with deGRANDSON Global, you are pre-qualified. Just log-in, enrol and start your Program immediately.
If you have NOT previously completed an Internal Auditor Program with deGRANDSON Global, you are advised to successfully complete a free Pre-Test first on order to demonstrate adequate auditing skills. The Pre-Test will take 30 minutes approx. and is FREE. Click this link to begin: Course 704-1, Check your Internal Auditor Skills.
Regarding internal auditor programs generally, the minimum of a Secondary School Certificate (such as a GCSE, High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 2 years’ work experience is recommended. You do not have to provide us with any evidence of you qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
Not sure this is the best ISO 13485 Program for you?
Click here to view all of the ISO 13485 Auditor Training options.