VIRTUAL [VILT] ISO 13485:2016 Internal Auditor Training Course CQI-IRCA Certified

Course Overview Who is this course for?

As the business world changes at an accelerating rate, internal auditors need to keep up or risk becoming irrelevant and unable to provide the insight that will allow their organizations to succeed. That means they’ll need to continually add to their skills and knowledge. The focus of the VIRTUAL [VILT] Kelmac Group® ISO 13485:2016 Internal Auditor Training Course is on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a product, process or department/function of a QMS based on ISO 13485:2016 requirements with specific emphasis of 1st Party auditing [Internal audits]

Key Course Learning Outcome Why this course is unique?

  • The Plan, Do, Check, Act [PDCA] Cycle
  • The core elements of a management system and the inter-relationship between top management responsibility, policy, objectives, implementation, measurement, review and continual improvement

Quality Management

  • Knowledge of the fundamental concepts and the six quality managment principles (See ISO 9000:2015)
  • The relationship between Quality Management and Medical Device Product Safety & Effectiveness – Customer Satisfaction

Knowledge of the requirements of ISO 13485:2016 and the commonly used medical device terms and definitions, as given in ISO 13485:2016, which may be gained by completing a Kelmac Group® and CQI-IRCA Certified ISO 13485:2016 Fundamentals [MD QMS] training course or equivalent.

Upcoming Dates and Locations Where can I register?

We are sorry but there are currently no public training dates available for this course at the moment! If you would like to send us your details, we will contact you when a course becomes available near you. If you have any questions about this course, call (312) 496 6607.

Where are you looking to attend this training?

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Course Learning Topics What does the course cover?
  • Our virtual [VILT] teaches Learners the audit principles, tools and techniques used for the assessment of the performance of the organization’s Quality Management System [QMS]. 

    The following is a breakdown of the course sessions;

    • Session 0 – Course Introduction

      Kelmac Group® Profile; Course Introduction; Structure of the Learner Manual; Learner Attendance; Course Outcome; Continuous Assessment; Course Program; Course Aims and Objectives; Introduction to CQI-IRCA; Blbliography; Terminology; ISO in Brief

    • Session 1 – Medical Device Quality Management System Overview/Refresher

      What is an QMS; Purpose/Benefits; Scope of ISO 13485; History/Evolution; ISO 13485 Family of Standards; MD QMS Terminology; Key Changes and Concepts; High Level Structure; Benefits of Certification/Registration; ISO 13485:2016 Requirement Application

    • Session 2 – Compliance Management System – How to audit compliance requirements?

      Introduction to ISO 19600:2014; Compliance Terminology; Manaqement System Auditor versus Inspector; Establishing the Compliance Management System; Compliance Principles; Implementation and Maintenance of the Compliance Management System; Compliance Auditing for Management System Auditors

    • Session 3 – Introduction to Auditing

      Auditing Terminology; Management System Audits; Principles of Auditing; CQI-IRCA Professional Code of Practice; Audit Life Cycle; Appointment if Lead Auditor and Audit Team; Desired Auditor Behaviours; Auditr Program Management; Conformity Assessment Standard – ISO/IEC 17021-1:2015

    • Session 4 – Initiation and Preparation

      Initiation the Audit; Initial contract with the Auditee; Audit Objectives, Scope and Criteria; Audit Feasability; Preparation for the Audit; Audit Working Documents; Audit Plan; Audit Checklists; 

    • Session 5 – Conducting the Audit

      Pre-Opening Meeting Activities; Opening Meeting; Gathering Audit Evidence; Five Core Audit Methods; Auditor Note Taking; Audit Sampling; Managing the Audit Team; Audit Communications; Auditee Reactions; Audit Findings; Case Study – Simulated Audit  

    • Session 6 – Audit Reporting

      Writing/Grading Audit Findings; Audit Conclusion; Audit Report

    • Session 7 – Final Audit Team/closing-Exit Meeting

      Final Audit Team Meeting; Evaluating Correction/Corrective Action; Audit Finding Follow-up; Closing-Exit Meeting; 

      The following are the workshops completed during this class:

ISO 13485:2016 Requirement Application; Auditing Compliance; Audit Terminology; Audit Principles; Audit Life Cycle; Auditor Team/Auditee Roles; Auditor Behaviours; Audit Program Management; Determination of Audit Feasability; Document Review prior to an on-site audit; Audit File/Working Documents; Audit Plan; Audit Checklist; Opening Meeting; Gathering Audit Evidence/Audit Methods; Communications; Case Study/Simulated Audit; Writing Audit Finding/Grading; Writing an Audit Conclusion; Evaluating Correction/Corrective Action; Determining Audit Follow-up/Auditee Risk Profile; Closing-Exit Meeting

Our Course vs. Our Competitors Why is our course the best?

Working with a Case Study: Almost Full Documented ISMS Management System

With 50% more skill based exercises compared to our competitors. We focus on auditing that provides Assurance that the Medical Device Quality Management System meets the needs of the interested parties & our Learners are equipped to make higher quality insights for improved organizational performance.  Learners practice using audit tools and techniques they can uses immediately and that inspire’s Learner confidence
Access to digital copy of course documentation, relevant standards following completion of course registration and up to twelve months following completion of the course
Our investment in our Consultant-Trainer knowledge management, learning, and digital technologies means learners are challenged and encouraged to become the very best QMS Internal Auditors in their respective industries 
Learners complete a phased Kelmac Group® eAssessment examination compared to a traditional 1 hour written Thoery and Practical Auditor examination 

Others train followers, we prepare and develop QMS Internal Auditors™ for the most pressing Quality issues facing clients and society today

Ready to stand out from the crowd?