ISO 13485:2016 Internal Auditor Course Content
Auditing Skills – Knowledge of Standard – Practice Scenarios
This ISO 13485 internal auditor program is internationally-recognised and completed fully on-line. It is an on-line Program for those wishing to participate in their organisation’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.
- If you are required to perform internal audits within your organisation
- 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 19011:2011
- 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
- On-line 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
- 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 & ZC
- FAQs about the Standard
- On-line 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
- On-line Final Examination
- 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 on-line from our Learning Management System (LMS), which is provided and maintained by Adobe Captivate Prime.
All Modules (Lessons) have 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 i-Pad 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 you qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
If unsure, check that you’ve made the best choice from our suite of eight ISO 13485 Training Programs.