ISO 13485:2016 Internal Auditor Training Course Content
Auditing Skills – Knowledge of Standard – Practice Scenarios
This ISO 13485 Internal Auditor Course 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.
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.
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
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
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
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 ISO 13485 Internal Auditor Training
Course is tge best choice for you?
See our full list of ISO 13485 courses by clicking here 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
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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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