ISO 13485:2016 Internal Auditor Refresher Course

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.

Key Features:

• Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
• An ISO 17025 Internal Auditor certification is awarded upon passing the certification exam
• Certificate is immediately available online after the successful passing of the exam
• Certificate comes with a shareable QR code for instant verification of credentials
• Lessons range from 15 minutes to 1 hour, typically 20–30 minutes, ensuring that each topic is covered in suitable detail
• Course includes practice with scenarios that include dialogues
• Course includes 24/7 Live-chat Learner Support
• Course includes a learner manual, a copy of the standard, and samples of relevant forms and other documents
• Course comes with full-audio narration and Closed Captions for accessibility
• Courses are hosted on your browser so that no software has to be downloaded avoiding security risks.
• Course comes with quizzes, practice with scenarios, and open-book certification exam
• Course is hosted on your browser so that no software has to be downloaded avoiding security risks.
• Features cross-device compatibility (courses can be taken on any desktop, tablet, or mobile)
• Offers full-resume feature (end a session mid-lesson and continue exactly where you left off, even from a different device)
• Features real-time interactive content in a secure web-based environment
• Offers a clear learning path (once you've completed the internal auditor course, you have the option to progress to the lead auditor, up to the consultant and lead auditor course.
• Examination and certificate fee are already included in the course fee
• Payable via PayPal or Stripe using any credit or debit cards

Who should enroll in this ISO 13485 Internal Auditor Refresher 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,

What will I learn from this ISO 13485 Internal Auditor Refresher Course?

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 materials are included in this ISO 13485 Internal Auditor Refresher Course?

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 this ISO 13485 Internal Auditor Refresher Course delivered?

The program is delivered online from our Learning Management System (LMS) provided by Inquisiq.

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.

Are there any prequalifications to enroll in this ISO 13485 Internal Auditor Refresher Course?

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.