ISO 13485 Lead Auditor Training Course Content

Be an internationally-certified Lead Auditor

This ISO 13485 Lead Auditor Training course provides you with the Auditing Skills, the Knowledge of the Standard and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Team Leader, to undertake and manage Certification Audits.

 

Key Features:

• Course is accredited to ISO 21001, the standard for Educational Organizations Management Systems
• An ISO 13485 Lead 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 13485 Lead Auditor Course?

  This ISO 13485 Lead Auditor Training course is intended for:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Project managers
• Design engineers
• Software engineers
• Process owners
• Quality engineers
• Quality auditors
• Medical affairs
• Legal Professionals

 

What will I learn from this ISO 13485 Lead Auditor Course?

  This comprehensive ISO 13485 Lead Auditor Training course covers all aspects of Internal Auditing and is divided into five Courses:

• Module 0: Introduction and background to the Standard and auditing. Includes EU, UK, USA Regulations & MDSAP
• Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018

• • Auditing Skills
  • Terms and definitions
  • Principles of auditing
  • Auditor skills
  • Managing an audit program
  • Audit Team Leadership
  • 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
  • Developing & Implementing a QMS
  • Terms & Definitions – ISO 13485:2016
  • Some Key aspects of QMS Auditing
  • Fundamentals of Medical Device 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 lessons)
  • Part 8: Measurement, Analysis & Improvement (2 lessons)
  • Annexes ZA & ZB (from Amendment 11)
  • Advanced aspects of QMS Auditing (3 lessons)
  • 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
  • More Audit Scenarios – Lead Implementers
  • FAQs about the Auditing Experience
  • Online Final Examination

 

What materials are included in this ISO 13485 Lead Auditor Course?

  The ISO 13485 Lead Auditor Certification course comes with:

• Diagram: ISO Auditor Certification Process
• Diagram: 6-Stage Audit Process
• Sample Code of Ethics
• Management of an Audit Programme
• Sample Audit Plan
• Sample Audit Work Order
• Sample Nonconformity Report
• Sample Working Document & Checklist
• Risk Assessment Tools and Methodologies
• Documented Information Requirements of ISO 13485:2016
• Determining the Context of the Organization
• ISO 13485:2016 and Risk Management
• Risk Assessment Tools and Methodologies (with examples)
• Terms & Definitions
• Typical Process Map

 

How is this ISO 13485 Lead Auditor Course delivered?

  The ISO 13485 Lead Auditor Training course is delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq).  All Modules 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 9 and,
• Complete the Module at home on your Notebook PC running on Windows 8.1

 

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

 

For this ISO lead auditor training online the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years’ work experience, with at least 2 at managerial/supervisory level, 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 the Program.