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 enroll in this ISO 13485 Internal Auditor 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 from this ISO 13485 Internal Auditor Extension Course?
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
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- 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.
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- Audit Scenarios – Internal Auditor
- FAQs about the Auditing Experience
- Online Final Examination
What materials are included in this ISO 13485 Internal Auditor Extension Course?
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 this ISO 13485 Internal Auditor Extension 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.
Are there any prequalifications to enroll in this ISO 13485 Internal Auditor Extension Course?
If you have previously completed an Internal Auditor Program with deGRANDSON Global, you are pre-qualified. Â 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 13485Â 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
Related Articles
ISO 13485 Certification: 26 FAQs answered
Internal Auditor Training – 5 Reasons Why it’s a ‘Must’
ISO Transition, Migration, Conversion & Extension Explained
Try our ISO Courses with a Free Sample Lesson
Frequently Asked Questions
Is the Program Certified?
Yes, deGRANDSON is an ISO 21001 certified educational organization certified by BQAI, an internationally accredited certification body.
ISO 21001 is a university grade standard used globally by schools, colleges, and universities. We are also certified to ISO 29993: 2017 (Learning services outside formal education and Service requirements) and ISO 29994:2021 (Education and learning services; Requirements for distance learning).
Are there corporate discounts?
Yes, details of discounts, based on numbers enrolled, can be found on the Corporate Discounts page.
How can I pay?
You can pay by Debit Card, Credit Card or PayPal during the Program Enrolment procedure. Click on this link to view the Payment Process.
Is there an Examination?
Yes. In addition to the Quizzes at the end of each Module, there is at the end of each Course (set of Modules/Lessons) a formal Examination. The decision to award a Certificate is based on the combined scores achieved. The Examinations are open-book (you can have the Standard and other notes open beside you), time-limited and taken online. There are no extra costs involved.
What do I get when I’ve completed the Program?
Once you have completed the Examination, your Certificate is immediately available to you. Your Certificate will be forwarded to you as an email attachment that you may print as often as you like. There is no time limit on the validity of your Certificate.
What else will I need to become a competent auditor?
Provided you have the required personal attributes, all you need to add is auditing experience.
Who can I contact for more information?
Just send an e-mail to [email protected] or, for other options, see Contact Us.[/fullwidth_section]
