If your knowledge of the Standard is not what it should be, this ISO 13485 2016 Lead Auditor Refresher Course will quickly get your Certification up-to-date.
The Course provides you with 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?
You should take this ISO 13485 Internal Auditor Refresher Course if your knowledge of the Standard is below par and …
- You would like to update your ISO 13485 Internal Auditor Certification,
- You are required to perform quality system internal audits within your organization,
- You will be called on to perform supplier audits on current or new vendors, or
- You wish to improve your career prospects,
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.
What does this Course cover?
The ISO 13485 Refresher Training 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
- 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 Course Materials are included?
This ISO 13485 Internal Auditor refresher 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 the Course delivered?
The program is delivered online from our Learning Management System (LMS) provided by Adobe Captivate Prime.
All Modules (or 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 11,
- 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 10.
What Qualifications do I need?
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 will need to complete a free Pre-Test first on order to demonstrate adequate auditing skills.
To begin please register and log-in, then enroll in the free Pre-Test, Course 004x. When that is completed, just log-in, enroll and start your program. The Pre-Test will take 30 minutes approx.
Regarding internal auditor programs generally, the minimum of a Secondary School Certificate (such as a 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 course.
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