Course 034C: ISO 13485:2016 Internal Auditor Conversion Course Content
If you’re already an ISO 13485 Internal Auditor, why not upgrade to ISO 13485:2016 with this online Internal Auditor Conversion Course. The Program 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?
- Those wishing to add ISO 13485 to their Internal Auditor Certification.
- If you are required to perform quality system internal audits within your organisation
- You will be called on to perform supplier audits on current or new vendors.
- You wish to improve your career prospects.
- If you wish to understand the processes of conducting internal audits 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 program of ISO 13485 Conversion Training is divided into two Courses…
- Course 1: 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 conversion program delivered?
The Program is delivered on-line from our Learning Management System (LMS)provided by Adobe Captivate Prime.
All Modules (or Lessons) have full resume and scaling capabilities. This means, for example, you can…
- Start a Module at work on your Work Station running on Windows 10,
- Continue the Moduleon the train home on your i-Pad running on iOS 11 and,
- Complete the Module 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 will need to successfully complete a free Pre-Test first on order to demonstrate adequate auditing skills. To begin please register and log-in, then enrol in the free Pre-Test, Course 004x. When that is successfully completed, just log-in, enrol and start your Program. The Pre-Test will take 30 minutes approx.
Regarding internal auditor programs generally, the minimum of a Secondary School Certificate (such as a 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?