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] ISO 13485:2016 Auditor/Lead Auditor Training Course | CQI & IRCA Certified


Course Overview Who is this course for?

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

  • want to audit the Quality Management System [QMS] against the requirements of ISO 13485:2016 against the requirements of ISO 45001:2018
  • want to add to your credibility with a globally recognised and  accepted qualification
  • want to satisfy the formal training requirements for CQI-IRCA certification

This course provides Quality Professionals, Consultants, Auditors, and Managers with the knowledge skills to perform first-party, second-party, and third-party audits of Quality Management Systems against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015, as applicable. 

During the delivery, the Learner will complete a Consutlant-Trainer facilitated systematci audit of a QMS [Medical Devices].  The facilitated audit of the QMS will cover the full audit life cycle as wefinedby ISO 19011:2018 and the Learner will have to demonstrate and be assessed on the effective application of audit tools and techniques.

ISO 13485 Auditor/Lead Auditor Training Course ireland

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

  • The intended outcomes of a Quality Management System
  • Enhancement of Quality performance
  • Fulfilment of compliance obligations
  • Achievement of quality objectives

ISO 13485:2016

  • Knowledge of the requirements of ISO 13485:2016 and the commonly used qualityterms 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 [QMS] training course or equivalent

With 50% more skill based exercises compared to our competitors. We focus on auditing that provides Assurance that the Quality Management System meets the needs of the interested parties & our Learners are equipped to make  higher quality insights for improved organizational performance.

 Where are you looking to attend this training?

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about industry insights, upcoming courses & special pricing or discounts?

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 +353.61.491224.

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 - Quality Management System Overview/Refresher

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

Session 2 - 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 3 - 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 4 - 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 5 - Audit Reporting

Writing/Grading Audit Findings; Audit Conclusion; Audit Report

Session 6 - 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; Conformity Assessment Standard - ISO/IEC 17021-1:2015; 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

How Will I Be Assessed?

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

There are two (2) phased two-hour eAssessment auditor examinations during this learning event. The first written auditor examination is based on EMS, or ISO 14001:2015; the second is based on OHSMS, or ISO 45001:2018. Both eAssessment examinations are closed book; however, the learner is required to have a hard-copy or digital version of the relevant management system standards (ISO 14001:2015 and ISO 45001:2018) for class use. The minimum pass rate for each written auditor examination is 70%.

 

Who Should Attend?

Who should attend?

  • Individuals interested in conducting second- or third-party audits of QMS management systems based on ISO 13485:2016
  • Quality Management Representatives
  • Quality Consultants
  • Supplier Quality Engineers
  • Supply Chain Personnel
  • Regulatory Affairs Managers
  • Quality and Production Directors/VPs
  • Cross-functional team members of a QMS implementation project
  • Individuals who want to become a CQI and IIRCA Certified Provisional Auditor, Auditor, Principal Auditor, or Lead Auditor
Working with a Case Study: Almost Full Documented QMS for Medical Devices Why is this important?

Each Learner will audit the almost full documented QMS [MD] from the unique Kelmac Group® assurance perspective.

The Kelmac Group® assurance perspective is unique as we audit like many professional financial audit practices where the focus is on providing top management with the quality of insight to make decisions and actions aimed at improving performance of the organization.

We boast the most comprehensive documented QMS Case Study [Medical Devices] available in the market and provides the Learner with the mostrealistic practical audit experience available on the market including a ISO 13485 Quality Manual; 13 SIPOC processes [Value chain, Support and Management]; 19 procedures; and related documented templates and records.

Evaluating Business Processes Why is this important?

An important USP of this Kelmac Group course is that we show each Learner how to evaluate business processes, not just ISO processes and align with the strategic intent of the organization. Business Processes include Marketing & Sales, Design Control, Manufacturing, Logistics, Installation, Purchasing, Servicing & HR. We cover this practically and from the QMS [MD] Auditor Perspective.

Live Audit Vs. Facilitated AuditWhich is better? Why?

Some competitors offer a “live” audit as part of their training. However a “live audit” of such short duration (<0.5 day typically) is of limited value as the Learner does not get an opportunity to audit an almost fully documented QMS [Medical Devices].

Kelmac Group’s course includes a “facilitated” audit which enables us to truly verify the Learner’s core audit skills through working with an almost fully documented Quality Management System [Medical Devices].

 

 

  • Da Che Attended this course in March 2020

    It is a very meaningful Training, very informative and insightful. It is a honor for me to get trained from Gerard Kelly directly. Thanks a lot!

    Da Che | Attended this course in March 2020

  • Mousseab El Sayed Attended this course in March 2020

    Excellent instructor and great training

    Mousseab El Sayed | Attended this course in March 2020

  • Ramona Ott Attended this course in March 2020

    Split the training content in accordance to trainings objectives for auditor and lead auditor

    Ramona Ott | Attended this course in March 2020

  • Tobias Seidel Attended this course in March 2020

    The training material was defined as poor because the used English style was very challanging to understand and the trainer had to explain with other words what is meant. That is mainly related to the exam and the exam training questions. The training material was good. Thank you for this very good training.

    Tobias Seidel | Attended this course in March 2020

  • Wei zhang Attended this course in March 2020

    This is the best training course I ever have had, and especially the instructor is so excellent, effective.

    Wei zhang | Attended this course in March 2020

  • Nils Olberts Attended this course in March 2020

    I think it would have been more educational, if more training time had related to the explanation of every single point of ISO 13485 instead of any other standards.

    Nils Olberts | Attended this course in March 2020

  • Anthony Kanavage Attended this course in June 2020

    Coming into the course I thought I had a handle on ISO 13485; after this course, I have gained a whole new level of understanding and detail that I did not have before.

    Anthony Kanavage | Attended this course in June 2020

  • Christina Diffley Attended this course in February 2020

    Ger was an excellent trainer and the class size was very small!

    Christina Diffley | Attended this course in February 2020

  • Sandra Siegel Attended this course in June 2020

    no comment

    Sandra Siegel | Attended this course in June 2020

  • Sandra Siegel Attended this course in June 2020

    no comment

    Sandra Siegel | Attended this course in June 2020



Virtual Technology Requirements

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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™

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 | On-Site training available, learn more >>

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Course Summary
Course Summary
Course type : VIRTUAL [VILT]
Course Fee : €1,695.00
Course Duration : 40 hours
Certification    view more : CQI and IRCA (A17584)
Continuing Education : units
How Will I Be Assessed?

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

There are two (2) phased two-hour eAssessment auditor examinations during this learning event. The first written auditor examination is based on EMS, or ISO 14001:2015; the second is based on OHSMS, or ISO 45001:2018. Both eAssessment examinations are closed book; however, the learner is required to have a hard-copy or digital version of the relevant management system standards (ISO 14001:2015 and ISO 45001:2018) for class use. The minimum pass rate for each written auditor examination is 70%.

 

Who Should Attend?

Who should attend?

  • Individuals interested in conducting second- or third-party audits of QMS management systems based on ISO 13485:2016
  • Quality Management Representatives
  • Quality Consultants
  • Supplier Quality Engineers
  • Supply Chain Personnel
  • Regulatory Affairs Managers
  • Quality and Production Directors/VPs
  • Cross-functional team members of a QMS implementation project
  • Individuals who want to become a CQI and IIRCA Certified Provisional Auditor, Auditor, Principal Auditor, or Lead Auditor
313 Reviews

Da Che

Attended this course in March 2020

 

It is a very meaningful Training, very informative and insightful. It is a honor for me to get trained from Gerard Kelly directly. Thanks a lot!

Mousseab El Sayed

Attended this course in March 2020

 

Excellent instructor and great training

Ramona Ott

Attended this course in March 2020

 

Split the training content in accordance to trainings objectives for auditor and lead auditor

Tobias Seidel

Attended this course in March 2020

 

The training material was defined as poor because the used English style was very challanging to understand and the trainer had to explain with other words what is meant. That is mainly related to the exam and the exam training questions. The training material was good. Thank you for this very good training.

Wei zhang

Attended this course in March 2020

 

This is the best training course I ever have had, and especially the instructor is so excellent, effective.

Nils Olberts

Attended this course in March 2020

 

I think it would have been more educational, if more training time had related to the explanation of every single point of ISO 13485 instead of any other standards.

Anthony Kanavage

Attended this course in June 2020

 

Coming into the course I thought I had a handle on ISO 13485; after this course, I have gained a whole new level of understanding and detail that I did not have before.

Christina Diffley

Attended this course in February 2020

 

Ger was an excellent trainer and the class size was very small!

Sandra Siegel

Attended this course in June 2020

 

no comment

Sandra Siegel

Attended this course in June 2020

 

no comment

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