• Internal Auditor Courses
    • ISO 9001
    • ISO 13485
    • ISO 14001
    • ISO 27001
    • ISO 45001
    • ISO 17025
  • Lead Auditor Courses
    • ISO 9001
    • ISO 13485
    • ISO 14001
    • ISO 27001
    • ISO 17025
    • ISO 45001
  • Lead Implementer Courses
    • ISO 9001
    • ISO 13485
    • ISO 14001
    • ISO 27001
    • ISO 45001
  • Consultant & Auditor Courses
    • QHSE
    • ISO 9001
    • ISO 13485
    • ISO 14001
    • ISO 27001
    • ISO 45001
  • Extension Courses
    • ISO 9001 Internal
    • ISO 9001 Lead
    • ISO 13485 Internal
    • ISO 13485 Lead
    • ISO 14001 Internal Auditor
    • ISO 14001 Lead Auditor
    • ISO 27001 Internal Auditor
    • ISO 27001 Lead Auditor
    • ISO 45001 Internal Auditor
    • ISO 45001 Lead Auditor
    • ISO 17025 Internal Auditor
    • ISO 17025 Lead Auditor
  • Refresher Courses
    • ISO 9001 Internal Auditor
    • ISO 9001 Lead Auditor
    • ISO 13485 Internal Auditor
    • ISO 13485 Lead Auditor
    • ISO 14001 Internal Auditor
    • ISO 14001 Lead Auditor
  • Conversion Courses
    • ISO 45001 Lead Auditor
    • ISO 45001 Internal Auditor
    • ISO 17025 Internal Auditor
    • ISO 17025 Lead Auditor
    • ISO 27001 Internal Auditor
    • ISO 27001 Lead Auditor
    • Transition Courses
      • ISO 13485
      • ISO 45001
      • ISO 27001
  • Risk Management Courses
    • ISO 14971 Advanced
    • ISO 14971 Foundation
    • ISO 31010 Foundation
    • ISO 31010 Advanced
    • ISO 31010 Expert
  • Data Protection Courses
    • EU GDPR Foundation
    • GDPR Advanced
  • Other Courses
    • IMS Internal Auditor
    • IMS Lead Auditor
    • ISO 19011 Internal Auditor Skills
    • ISO 19011 Lead Auditor Skills
  • Other Services
    • Module Repeat Exam (2 attempts)
    • 6-month extension to course duration
    • Reissue of Course Certificate
    • Reissue of Course Enrollment Data
    • Sundry Payment
  • About Us
    • Our Accreditation
    • Frequently Asked Questions
    • Reviews
    • Corporate Discounts
    • Installment Payments
    • Free Sample Lessons
    • Continued Professional Development (CPD)
    • Privacy Policy
    • Refund Policy
  • News
  • Contact Us
  • Shop
  • ISO 9001
  • ISO 13485
  • ISO 14001
  • ISO 17025
  • ISO 27001
  • ISO 45001
  • Data Protection
  • Risk Management
$0
No products in the cart
Go to shop
deGRANDSONdeGRANDSON
deGRANDSONdeGRANDSON
  • Home
  • Courses
    • Internal Auditor Courses
      • ISO 9001
      • ISO 13485
      • ISO 14001
      • ISO 17025
      • ISO 27001
      • ISO 45001
    • Lead Auditor Courses
      • ISO 9001
      • ISO 13485
      • ISO 14001
      • ISO 27001
      • ISO 17025
      • ISO 45001
    • Lead Implementer Courses
      • ISO 9001
      • ISO 13485
      • ISO 14001
      • ISO 27001
      • ISO 45001
    • Extension Courses
      • Internal Auditor Extension
        • ISO 9001 Internal Auditor
        • ISO 13485 Internal Auditor
        • ISO 14001 Internal Auditor
        • ISO 45001 Internal Auditor
        • ISO 27001 Internal Auditor
        • ISO 17025 Internal Auditor
      • Lead Auditor Extension
        • ISO 9001 Lead Auditor
        • ISO 13485 Lead Auditor
        • ISO 14001 Lead Auditor
        • ISO 45001 Lead Auditor
        • ISO 27001 Lead Auditor
        • ISO 17025 Lead Auditor
    • Refresher Courses
      • ISO 9001 Internal Auditor
      • ISO 9001 Lead Auditor
      • ISO 13485 Internal Auditor
      • ISO 13485 Lead Auditor
      • ISO 14001 Internal Auditor
      • ISO 14001 Lead Auditor
    • Conversion Courses
      • ISO 45001 Internal Auditor
      • ISO 45001 Lead Auditor
      • ISO 27001 Lead Auditor
      • ISO 27001 Internal Auditor
      • ISO 17025 Lead Auditor
      • ISO 17025 Internal Auditor
    • Transition Courses
      • ISO 45001 Transition
      • ISO 13485 Transition
      • ISO 27001 Transition
    • Other Courses
      • ISO 19011 Internal Auditor
      • ISO 19011 Lead Auditor
      • Integrated Management System
        • IMS Internal Auditor
        • IMS Lead Auditor Diploma
      • Risk Management
        • ISO 14971
          • ISO 14971 Risk Management – Foundation
          • ISO 14971 Risk Management – Advanced
        • ISO 31010
          • ISO 31010 Risk Management – Foundation
          • ISO 31010 Risk Management – Advanced
          • ISO 31010 Risk Management – Expert
      • Data Protection
        • EU GDPR Foundation
        • EU GDPR Implementer and DPO
    • Other Services
  • Diplomas
    • QHSE Consultant Diploma
    • ISO 9001 Consultant & Lead Auditor
    • ISO 13485 Consultant & Lead Auditor
    • ISO 14001 Consultant & Lead Auditor
    • ISO 27001 Consultant & Lead Auditor
    • ISO 45001 Consultant & Lead Auditor
  • About Us
    • Our Accreditation
    • Frequently Asked Questions
    • Reviews
    • Corporate Discounts
    • Installment Payments
    • Free Sample Lessons
    • Continued Professional Development (CPD)
    • Refund Policy
  • News
  • Contact Us
  • Shop
deGRANDSON Learner Linda

ISO 13485 Internal Auditor Extension

SKU: Course 034X.

$315

Select Currency

 

Standard: ISO 13485
Latest Version: ISO 13485:2016
Revision of:
ISO 13485:2003
Duration: 8 hours approx. (including auditor certification exam) Delivery: Online (on-demand and self-paced)
CPD/CEU Units: 1.3
Description: This ISO 13485 internal auditor extension course is an ISO 21001-certified internal auditor training course that will help you understand the processes of conducting internal audits or external audits for medical device management systems. It will also let you add ISO 13485 to your already existing internal auditor certification for another standard.
Course Content

This is a comprehensive Program covering all aspects of ISO 13485 Internal Auditing is divided into two Courses…

  • Module 1: Knowledge of the Standard, ISO 13485:2016, Quality management systems (QMS) – Requirements.  Includes EU, UK, USA (QSR & QMSR), Health Canada MDSAP Regulations & EN Annexes (Amendment 11).
  • Module 2: Practice with Scenarios based on actual audits and includes advice on dealing with awkward situations and individuals. And with many FAQs answered.

See below for more details.

Note: Includes a 30-minute Pre-Test to confirm that you have the necessary auditing skills.

Related Courses:

  • ISO 13485 Internal Auditor – if you have no Internal Auditor certification yet and wish to be certified to ISO 13485
  • ISO 13485 Lead Implementer – if your focus is on implementing and maintaining an MDMS
Easy payment plan available. Choose this option at checkout
×

How it works

It’s easy to pay with a payment plan. Just choose this option when you check out and enter your payment information to begin your plan.

  • shopping-bag

    Choose the payment plan option at checkout

    You’ll be redirected to the payment plan page

  • receipt

    Enter your payment information to start

    Your order is confirmed once you complete this step

  • Email

    You’ll get an email with your payment plan dates

    This will include a link you can use to easily manage your plan

  • calendar recurring

    Scheduled payments are automatically charged

    You’ll get an email reminder two days before each payment

Your data is processed securely using SSL and AES-256 encryption. We use Paythen to manage and process payments.
Category: ISO 13485. Tag: Internal Auditor Extension Online Course.
Share
  • Description

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
    • 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 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.  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

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]

ISO 21001 Educational Organization certified

Learn more about our ISO 21001 Certification

Path to ISO 13485 MDMS Certification infographic

Download Copy of ISO 13485 Certification Process Chart

ISO 13485 FAQs eBook cover

Download free ISO 13485 Certification FAQs eBook

Related products

deGRANDSON Learner Linda
5.00 out of 5
Add to cart View Details

ISO 13485 Internal Auditor Training

ISO 13485
$470
deGRANDSON Learner Linda Add to cart View Details

ISO 45001 Internal Auditor Extension

ISO 45001
$315
deGRANDSON Learner Alex Add to cart View Details

ISO 13485 Lead Auditor Training

ISO 13485
$1,415
deGRANDSON Learner Linda Add to cart View Details

ISO 27001:2022 Internal Auditor Extension

ISO 27001
$630
Already enrolled? YOUR LESSONS ARE HERE!

Courses

  • ISO 9001 QMS
  • ISO 13485 MDMS
  • ISO 14001 EMS
  • ISO 17025 TCLMS
  • ISO 27001 ISMS
  • ISO 45001 OHSMS
  • Data Protection Courses
  • Risk Management Courses
  • Other ISO Courses

FAQs & Support

  • Support & Knowledge Base
  • Free Sample Lessons
  • My Account
  • FAQs Directory
  • FAQs: FREE ISO Standard Offers

OTHER INFORMATION

  • Terms and Conditions
  • Privacy Policy
  • Our ISO 21001 Accreditation
  • Reviews 1
  • Corporate Discounts
  • Continued Professional Development
  • Conversion Courses
  • Extension Courses
  • Transition Courses
  • Refresher Courses

Contact Information

  • deGRANDSON Global
  • Manchester UK, Pembroke Pines FL USA & Limassol (HQ) CY
  • info@degrandson.com
  • degrandson-eu

Follow us on social media

INTERNATIONAL ACCREDITATION

ISO 21001 Educational Organization certified

© 2025 · deGRANDSON Global.

20% off all Risk Management Courses during May Dismiss