ISO 13485:2016 Internal Auditor Extension Course 
Already an Internal Auditor for ISO 14001 or other Management System Standard?
Add ISO 13485 to your Internal Auditor Certification with this ISO 13485 Internal Auditor Extension course.
It 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 Extension Course?
This ISO 13485 Internal Auditor Extension Course 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 organization,
- are required to perform supplier audits,
- wish to improve your career prospects.
- wish to understand the processes of conducting internal audit or external audits for medical device management systems
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
What will I learn?
This comprehensive ISO 13485 Internal Auditor Extension Course covers all aspects of ISO 13485 Internal Auditing and is divided into two Modules:
- Module 1: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Introduction to ISO 13485:2016
- Includes EU, UK, USA Regulations & MDSAP
- 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 (Amendment 11)
- FAQs about the Standard
- Online Course Examination
- Module 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
- Online Final Examination
What Course Materials are included?
The ISO 13485 Internal Auditor Extension course includes:
- 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 application of the process approach
- Terms & Definitions in ISO 13485:2016
How is the Course delivered?
This ISO 13485 Internal Auditor Extension Course is delivered online from our Learning Management System (LMS), provided by Inquisiq.
All Lessons have a full resume and scaling capabilities. This means, for example, you can:
- Start a Lesson at work on your Work Station running on Windows 11,
- Continue the Lesson on the train home on your iPad running on iOS 15 and,
- Complete the Lesson at home on your Notebook PC running on Windows 10.
What Qualifications do I need?
If you have previously completed an Internal Auditor Program with deGRANDSON Global, you are pre-qualified. Just log-in, enroll and start your Program immediately.
If you have NOT previously completed an Internal Auditor Program with deGRANDSON Global, you are advised to 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 your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with this program.
Not sure this is the best ISO 13485 program for you?
See our full list of ISO 13485 courses or see our answers to frequently asked questions about ISO 13485 for more information.
Related Courses
ISO 13485 Internal Auditor Course – to conduct effective internal audits
ISO 13485 Internal Auditor Refresher – to refresh your knowledge and skills
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