Who should enrol in this course?

This course is for you: If you are required to perform internal audits within your organization, If you are required to perform supplier audits, If you wish to improve your career prospects, If you wish to understand the processes of conducting internal audit or external audits, It is also recommended for management involved in the audit process.

What will I learn from this course?

This is a comprehensive course covering all aspects of Internal Auditing is divided into four Modules: Module 0 : Introduction and background to the Standard and to auditing. Module 1 : Auditing Skills to Internal Auditor Level and based on the auditing standard ISO 19011:2018 Auditing Skills Terms and definitions Principles of auditing Auditor skills Overview of Audit activities Audit activities – Step 1 Audit activities – Step 2 Audit activities – Step 3 (2 modules) Audit activities – Step 4 Audit activities – Step 5 Audit Activities – Step 6 FAQs about Auditing Online Course Examination Module 2 : 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 Review of EU, UK, USA Regulations & MDSAP 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 3 : 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 in the course?

These include… 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

ISO 13485:2016 Internal Auditor Course Content

Name: ISO 13485 Internal Auditor Training - Certified Course
Brand: deGRANDSON
SKU: Course 034
Price: 475 GBP
Availability: InStock
Rating: 5 (1 reviews)

Auditing Skills – Knowledge of Standard – Practice Scenarios

This ISO 13485 Internal Auditor program is internationally-recognized and completed fully online. It is an online program for those wishing to participate in their organization’s internal auditing to the requirements of ISO 13485:2016, the medical device management system standard.

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?

This course is for you:

If you are required to perform internal audits within your organization,
If you are required to perform supplier audits,
If you wish to improve your career prospects,
If you wish to understand the processes of conducting internal audit or external audits,
It is also recommended for management involved in the audit process.

What will I learn from the course?

This is a comprehensive course covering all aspects of Internal Auditing is divided into four Modules:

Module 0: Introduction and background to the Standard and to auditing.
Module 1: Auditing Skills to Internal Auditor Level and based on the auditing standard ISO 19011:2018

Auditing Skills

Terms and definitions

Principles of auditing

Auditor skills

Overview of Audit activities

Audit activities – Step 1

Audit activities – Step 2

Audit activities – Step 3 (2 modules)

Audit activities – Step 4

Audit activities – Step 5

Audit Activities – Step 6

FAQs about Auditing

Online Course Examination

Module 2: 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

Review of EU, UK, USA Regulations & MDSAP

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 3: 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 in this course?

These include…

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 the Course delivered?

This Internal Auditing ISO 13485 Program is delivered online from our Learning Management System (LMS), which is provided and maintained by Inquisiq.

All Modules (Lessons) have a 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 Module on the train home on your iPad running on iOS 11 and,
Complete the Module at home on your Notebook PC running on Windows 8.1

Are there any pre-qualifications required to enrol in the course?

A minimum of a Secondary School Certificate (such as a GCSE (UK), Standard Grade (Scotland), High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 2 years’ work experience is recommended for this ISO 13485 Internal Auditor Program.

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 course.

Not sure this is the best ISO 13485 Course for you?

See our full list of ISO 13485 courses for comparison by clicking on the image above or see our answers to frequently asked questions about ISO 13485 for more information.

Related Courses

ISO 13485 Lead Auditor Course – to programme and conduct MDMS audits

ISO 13485 Internal Auditor Extension Course – to add to youe curent Certification

ISO 13485 Internal Auditor Refresher Course – to refresh your auditor knowledge and skills

ISO 13485 Certification: 26 FAQs answered

Try our ISO Courses with a Free Sample Lesson

Have you tried this course?

Let us know what you think by rating it and leaving a comment below!

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Frequently Asked Questions

Is the Course 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.

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Standard: ISO 13485 Latest Version: ISO 13485:2016 Revision of: ISO 13485:2003	Duration: 12 hours approx. (including auditor certification exam)	Delivery: Online (on-demand and self-paced)
Description: This ISO 13485 internal auditing course is an ISO 21001 certified internal auditor training course designed to provide internal auditors with the skills and knowledge needed to audit medical device management systems (MDMS). It is based on the requirements of ISO 13485:2016, known in full as Medical devices — Quality management systems — Requirements for regulatory purposes.
Course Content Module 0: Introduction and background to the Standard and to auditing. Module 1: Auditing Skills based on the auditing standard ISO 19011:2018 Module 2: Knowledge of the Standard, ISO 13485:2016, Quality management systems – Requirements. Includes EU, UK, USA Regulations, MDSAP & new Annexes (Amendment 11). Module 3: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals. And with many FAQs answered.
Related Courses: ISO 13485 Internal Auditor Extension – if you are already a Lead Auditor for another standard and want to add ISO 13485 to your Lead Auditor certification ISO 13485 Internal Auditor Refresher – if you want to refresh your knowledge and skills in auditing medical device management systems in accordance to ISO 13485:2016 ISO 13485 Lead Implementer – if your focus is on implementing and maintaining a medical device management system

ISO 13485 Internal Auditor Certification

ISO 13485:2016 Internal Auditor Course Content