ISO 13485:2016 Consultant & Lead Auditor Diploma Course Content

This ISO 13485 Consultant and Lead Auditor 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

And, yes, Auditor Skills are included.

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

• Module 0: Introduction and background to the Standard and auditing.
• 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 programme
• 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
• EU, UK, USA Regulations & MDSAP
• Developing & Implementing a QMS
• Terms & Definitions – ISO 13485:2016
• Some Key aspects of QMS Auditing
• Fundamentals of Medical Device Management Systems
• MDMS Implementation and Certification to ISO 13485:2016 – the 33 Steps (3 lessons)
  

  • Initiation
  • Planning
  • Implementation
  • Securing Certification

• 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 (Amendment 11 Annexes)
• 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

This ISO 13485 Consultant and Lead Auditor course includes course materials invaluable when implementing ISO 13485:2016 like:

• ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
• Diagram: The 33-step Path to ISO 13485:2016 Certification
• Documented Information Requirements of ISO 13485:2016
• Determining the Context of the Organisation
• ISO 13485:2016 and Risk Management
• Risk Assessment Tools and Methodologies (with examples)
• Terms & Definitions
• Typical Process Map
• Sample MDMS Policy Manual
• Sample MDMS Maintained Documentation (procedures), including…
  • Sample Procedures
  • Sample Records
  • Sample Audit Plan
  • Sample Audit Work Order
  • Sample Nonconformity Report
  • Sample Working Document & Checklist
  • Sample Management Review Record
• Diagram: Auditor Certification Process
• Diagram: 6-Stage Audit Process
• Sample Code of Ethics
• Management of an Audit Programme

This ISO 13485 Consultant and Lead Auditor course is delivered online from our Learning Management System (LMS) at www.degrandson.inquisiqLMS.com. 

All Lessons have a full resume and scaling capabilities. This means, for example, you can…

• Start a Lesson at work on your Work Station running on Windows 10,
• Continue the Lesson on the train home on your iPad running on iOS 11 and,
• Complete the Lesson at home on your Notebook PC running on Windows 8.1

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 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.