ISO 13485:2016 Transition Training Course
Need to undertake an ISO 13485 2016 Migration?
Transitioning to ISO 13485:2016 is a challenge that Quality Managers and others responsible for their organization’s Medical Device Management System (MDMS) will face shortly.
When you’re ready to make the change, this ISO 1345 transition training course will take you step-by-step through the transition process and enable your organization to meet all of the requirements of ISO 13485:2016.
In addition, this program will provide you personally with Lead Implementer & Auditor Certification.
Who should enroll in this ISO 13485 Transition Training?
This ISO 13485 Transition Training Course is intended for:
- Senior quality managers
- Quality professionals and consultants
- Regulatory professionals
- Compliance professionals
- Project managers
- Design engineers
- Software engineers
- Process owners
- Quality engineers
- Quality auditors
- Start a Module at work on your Work Station running on Windows 11,
- Continue the Module on the train home on your iPad running on iOS 15 and,
- Complete the Module at home on your Notebook PC running on Windows 10.
Are there any prequalifications to enroll in this ISO 13485 Transition Training?
If you have previously completed a Lead Implementer or Lead 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:  Check your Lead Auditor Skills.
Regarding prerequisite qualifications generally for this, the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years’ work experience, with 2 at managerial/supervisory level, 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 by clicking on the image above for comparison 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 Course – to refresh your knowledge and skills
ISO 1345 Lead Auditor Course – to programme and conduct audits
Related Articles
ISO Transition, Migration, Conversion & Extension Explained
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 Enrollment 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, you will immediately be issued a certificate. 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.
