Not All Training Is Created Equal

The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors.

Where others train followers, we train leaders™

VIRTUAL [VILT] QMS ISO 13485:2016 Lead 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 Lead 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 2nd and 3rd party auditing [External audits]. 

  • During the delivery, the Learner will complete a Consultant facilitated audit of a full MD QMS, covering the full audit life cycle as defined by ISO 19011 and the Learner will have to demonstrate and be assessed on the effective application of audit tools and techniques, auditor skills and behaviors. 

  • We provide Internal Auditors with both the confidence and ability to apply the audit assurance tools and techniques, methodology and desired behaviors to assess the organization’s Medical Device QMS processes and process controls to consistently provide safe & effective medical device products and services that meet customer and applicable statutory and regulatory requirements. 

  • This course is one of our most popular for training Medical Device Supplier or Lead Auditors and is also available for onsite delivery.

We offer both public and private/on-site class. Just give us a call or drop us an email for more information. Our brochure for this course and all our offerings can be downloaded directly from our website via this page (see below).

Course Prior Learning Requirements

Management Systems

  • 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

ISO 13485:2016

  • 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® Certified ISO 13485:2016 Fundamentals [MD QMS] training course or equivalent

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call +353.61.491224.

Early Bird Discounting Available:

Register & Pay 90 days in advance and save €100.00

Register & Pay 60 days in advance and save €50.00

Register & Pay 30 days in advance and save €1,395.00

 

Discounts cannot be combined with any other offer.

Start Date Location Cost Days Public Course Onsite
21st Jun 2021

Virtual, 08:00:00 to 17:30:00 GMT

€1,395.00
( + €30.00 IRCA Certification Fee )
5 Days
13th Sep 2021

Virtual, 08:00:00 to 17:30:00 GMT

€1,395.00 €1,295.00*
( + €30.00 IRCA Certification Fee )
5 Days
6th Dec 2021

Virtual, 08:00:00 to 17:30:00 GMT

€1,395.00 €1,295.00*
( + €30.00 IRCA Certification Fee )
5 Days

* Earlybird discount, Terms & Conditions Apply

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 Medical Device 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

Why Our Course is the Best?

Our course is aimed at Quality Professionals, Consultants, Auditors and Managers

  • Individuals interested in conducting first-party audits of QMS
  • Quality Management Representatives
  • Quality Consultants
  • Quality Directors
  • Regulatory Affairs Managers
  • Quality Managers/Supervisors
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers 
  • Owner Managers 
  • Quality cross-functional team members of a Quality implementation project
How Will I Be Assessed?

Attendance

Full or 100% attendance is required during the virtual [VILT] training course.

Continuous Assessment

The Learner is assessed during the virtual class delivery based on participation and performance throughout the duration of the virtual course. This includes all exercises, role plays, case studiy and all other activities during the virtual course.  The Learner is expected to turn their webcam on during all virtual class sessions.  The Learner may turn-off their webcam during class break times.

eAssessment

The Kelmac Group and CQI-IRCA eAssessment auditor examination is phased during this learning event. The eAssessment examination is closed book; however, the learner is required to have a hard-copy or digital version of the relevant management system standards (ISO 13485:2016) for class use. The minimum pass rate for each written theory and practical auditor eAssessment is 70%.

Why our course is unique?

  • 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 performanceLearners 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 Medical Device QMS Supplier or Lead Auditors in their respective industries 
  • Learners complete a phased Kelmac Group® and CQI-IRCA eAssessment examination compared to a traditional 2 hour written examination on the last day of the class

Others train followers, we prepare and develop MD QMS Supplier and Lead Auditors™ for the most pressing Medical Device Quality issues facing th medical device industry and society today

  • Benedikt Bodinger Attended this course in March 2021

    A very professional training which teaches not only what the standard tells you but in addition to that how reality looks like.

    Benedikt Bodinger | Attended this course in March 2021

  • Hazel Ryan Attended this course in March 2021

    This was an excellent course and I would highly recommend it.

    Hazel Ryan | Attended this course in March 2021

  • Esther Fürst Attended this course in March 2021

    intense course, not to be recommended for beginners

    Esther Fürst | Attended this course in March 2021

  • Francesco Bianchi Attended this course in March 2021

    overall it was generally good.

    Francesco Bianchi | Attended this course in March 2021

  • Renata Vesela Attended this course in March 2021

    Excellent course, very good practical examples.

    Renata Vesela | Attended this course in March 2021

  • Stefan Spillner Attended this course in March 2021

    thumbs up

    Stefan Spillner | Attended this course in March 2021

  • Denise Bockholt Attended this course in March 2021

    Prior to training familiarize with the necessary ISO standards for audting and the processes at TUV

    Denise Bockholt | Attended this course in March 2021

  • Gerd Hoffmann Attended this course in March 2021

    -

    Gerd Hoffmann | Attended this course in March 2021

  • Martin Szepannek Attended this course in March 2021

    Provides a clear understanding of the role as an auditor and teaches the Do`s and Don` ts of practical auditing in an interactive way. Enhanced by enlightening group work sessions and a huge experience track record of the trainer.

    Martin Szepannek | Attended this course in March 2021

  • Stefan Payer Attended this course in March 2021

    A really good training and you learn a lot. Familiarise yourself with the three standards ISO 13485, ISO 19011 and ISO 27021 in advance. Otherwise it will get quickly very demand and difficult.

    Stefan Payer | Attended this course in March 2021


Basic Course Requirements

  • The Kelmac Group® is known for our in-person classrom and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our Consultant-Trainer and learners interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment. This is an ideal alternative to the typical classroom setting for professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.
  • This class is delivered over five consecutive days, 08:00 to 17:30, Monday to Friday
  • Kelmac Group’s® virtual instructor-led training (VILT) is a live web-based learning experience where the Consultant-Trainer and learners are in separate locations.
  • Kelmac Group’s® VILT technology platform is designed to ensure similar interaction as a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaging workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which learners can connect with the content and interact with both the Consultant-Trainer and other learners.
  • The learning objectives and topics covered during the VILT are the same as the corresponding in-person version of the class. That said, to accommodate a virtual setting, the pace at which the VILT is delivered, and the structure of class workshops and exercises, is modified to support engagement in a virtual format. Virtual class participants receive eBooks instead of printed materials.
  • All VILT classes are taught by the same, experienced team of Consultant-Trainers you’ve come to expect from the Kelmac Group®. Our team of VILT Consultant-Trainers are trained in virtual facilitation - ensuring a lively, interactive learning experience.
  • How do I need to participate in a VILT class. First and foremost, your enthusiasm. In addition, course learners are required to have their own PC or laptop with a high-speed internet connection. We recommend a headset with microphone, video capability, and the ability to participate in the training from a private, quiet setting. If possible, have two monitors; one for the virtual classroom and the other for viewing training materials. Dual monitors may be helpful but are not required

Virtual Training Technology Requirements

To participate in the virtual training sessions, you will need:

  • Use the latest version laptop or desktop computer. The laptop or desktop computer should not be in use for more than 4 years. (Note: A tablet or mobile device is not suitable for this training).
  • HD Webcam – Built-in or USB plug-in
  • Speakers and a microphone – Built-in or USB plug-in. We highly recommend a headset if you have this available for optimal audio quality
  • Internet connection – Minimum of 2.5Mbps download, 3.0 Mbps upload
  • Two display monitors are highly recommended
    • One for joining the virtual classroom and, if applicable, viewing digital eCourse documentation
    • The other for completing class exercises/assignments

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Companies That Trust In Kelmac Group ®

The Ultimate Business Training Experience

The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors.   We develop Medical Device QMS Lead Auditors™ who are able to provide the quality of insight that will allow their organization to maintain an effiective QMS.

Course Summary
Course Summary
Course type : Virtual
Course Duration : 40 hours
Certification    view more : CQI and IRCA (17584)
Continuing Education : units
Why Our Course is the Best?

Our course is aimed at Quality Professionals, Consultants, Auditors and Managers

  • Individuals interested in conducting first-party audits of QMS
  • Quality Management Representatives
  • Quality Consultants
  • Quality Directors
  • Regulatory Affairs Managers
  • Quality Managers/Supervisors
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers 
  • Owner Managers 
  • Quality cross-functional team members of a Quality implementation project
How Will I Be Assessed?

Attendance

Full or 100% attendance is required during the virtual [VILT] training course.

Continuous Assessment

The Learner is assessed during the virtual class delivery based on participation and performance throughout the duration of the virtual course. This includes all exercises, role plays, case studiy and all other activities during the virtual course.  The Learner is expected to turn their webcam on during all virtual class sessions.  The Learner may turn-off their webcam during class break times.

eAssessment

The Kelmac Group and CQI-IRCA eAssessment auditor examination is phased during this learning event. The eAssessment examination is closed book; however, the learner is required to have a hard-copy or digital version of the relevant management system standards (ISO 13485:2016) for class use. The minimum pass rate for each written theory and practical auditor eAssessment is 70%.

30 Reviews

Benedikt Bodinger

Attended this course in March 2021

 

A very professional training which teaches not only what the standard tells you but in addition to that how reality looks like.

Hazel Ryan

Attended this course in March 2021

 

This was an excellent course and I would highly recommend it.

Esther Fürst

Attended this course in March 2021

 

intense course, not to be recommended for beginners

Francesco Bianchi

Attended this course in March 2021

 

overall it was generally good.

Renata Vesela

Attended this course in March 2021

 

Excellent course, very good practical examples.

Stefan Spillner

Attended this course in March 2021

 

thumbs up

Denise Bockholt

Attended this course in March 2021

 

Prior to training familiarize with the necessary ISO standards for audting and the processes at TUV

Gerd Hoffmann

Attended this course in March 2021

 

-

Martin Szepannek

Attended this course in March 2021

 

Provides a clear understanding of the role as an auditor and teaches the Do`s and Don` ts of practical auditing in an interactive way. Enhanced by enlightening group work sessions and a huge experience track record of the trainer.

Stefan Payer

Attended this course in March 2021

 

A really good training and you learn a lot. Familiarise yourself with the three standards ISO 13485, ISO 19011 and ISO 27021 in advance. Otherwise it will get quickly very demand and difficult.

Available Options


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