ISO 13485 Internal Auditor Training

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.

 

Key Features:

• Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
• An ISO 13485 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
• Option to pay in 4 monthly installments available

 

   

Who should enroll in this ISO 9001 Internal Auditor Course?

  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.

 

What will I learn from this ISO 9001 Internal Auditor Course?

  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

 

What materials are included in this ISO 9001 Internal Auditor Course?

  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

 

How is this ISO 9001 Internal Auditor Course delivered?

  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

 

Are there any prequalifications to enroll in this ISO 9001 Internal Auditor Course?

 

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.