ISO 13485:2016 Internal Auditor Course Content
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.
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
- 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
- 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
- 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 Adobe Captivate Prime.
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.
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