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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™

ISO 13485:2016 Internal Quality Auditor Training Course


Course Overview Who is this course for?

The focus of the Kelmac Group® ISO 13485:2016 Internal Auditor Classroom Learning 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].

During the delivery, the Learner will complete a Consultant facilitated audit of a process, a product or a department/function within a 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 QMS Medical Device 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 Quality Internal Auditors and is also available for onsite delivery.

We run this training publicly in Ireland in Limerick. 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).


 

iso 13485 internal auditor training certification ireland

Key Course Learning Outcome Why this course is unique?

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 QMS Medical Device processes and process controls to consistently provide safe & effective medical evice products and services that meet customer and applicable statutory and regulatory requirements.

Course Basics What is essential to know?

  • This is a 2-day (18hr) learning event.
  • Start/Finish Times: 08:00am – 18:00pm (each day)
  • Prior Learning Requirement: Learners are required to be familiar with ISO 13485 Requirements or have received ISO 13485 Fundamentals training in advance of attending this course.

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.

Start Date Location Cost Days Public Course Onsite
1st May 2019

Green Isle Hotel
St John's Dr, Newlands Cross
Dublin 22

View Location on Google Maps

€595.00 2 days
16th Oct 2019

Louis Fitzgerald Hotel
Newlands Cross
Dublin 22

View Location on Google Maps

€595.00 2 days

* Earlybird discount, Terms & Conditions Apply

Course Learning TopicsWhat does the course cover?
  • Course Introduction

    • Introduction to Internal Auditing
    • The role of Internal Audits and the Audit Life Cycle
    • Audit Terminology and Principles
    • Audit Types and Objectives
    • Understanding the PDCA Cycle and Process Approach and their significance for Internal Auditors**
    • Internal Auditor Competence, Roles & Responsibilities
    • Behaviors & Performance Evaluation**
    • Business Process Management**
    • Audit Planning (Process & Risk-based)**
    • Initiating & Preparing for the on-site activities**
    • Developing an Audit Plan/Scope Audit Protocol (Checklist/Process Documentation)**
    • Audit Protocol (Checklist/Process Documentation)**
    • Opening Meeting (Real Life Scenario)**
    • Evidence, Methods & Procedure for Gathering Evidence (Wider Audit Methods)**
    • Interviewing and Writing Audit Findings
    • Auditing Reporting (In more depth)**
    • Audit Findings, Terminology, Classification and Elements
    • Writing Audit Findings & the Audit Report
    • Completing the Audit
    • Audit Follow-Up Strategies (In-depth)**
    • Corrective and Preventative Action including Audit Finding Closure (Robust Evaluation)**
    • Audit Follow Up
    • Closing/Exit Meeting (Real Life Scenario)**

*Kelmac Group cover this topic in more depth compared to our competitors.
**Kelmac Group proven added value as this material is not covered by the IRCA specification or our competitors.

Course Certification

This course is fully certified by Kelmac Group.

 

 

Are There Any Course Pre-Requisites?

This learning event consists of one prerequisite module prior to attendance at the Kelmac Group® ISO 13485:2016 Internal Auditor Learning Event.

  • Module 1 – Fundamentals of ISO 13485:2016
  • Or good working knowledge of ISO 13485:2016 Requirements as these are not covered during this Learning event

Any Learner who claims an exemption to the above course prerequisite is solely responsible to ensure they satisfy the prior knowledge requirements for attending this learning event, otherwise their attainment of the course learning objectives may not be met.

It is mandatory each Learner is responsible to bring a copy of ISO 13485:2016 Standard with them to this Learning Event.  

 

How Will I Be Assessed?

The Learner is assessed based on participation and performance evaluation throughout the duration of the course. This includes all exercises, role plays, case studies, tests and all other activities during the course. 

Please note, full attendance is required during the Learning Event.  The Learner is responsible for ensuring no other personal or business commitments prevent them from full attendance.  It is also recommended the Learner’s participation on this class is residential.  Learners are encouraged to keep time in the evening free for additional learning and reflection.

Who Should Attend?
  • Quality Managers
  • Quality Professionals/Technicians
  • Quality Engineers
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers 
  • Internal Auditors 
  • Owner Managers 
  • Implementation Members 
  • David Connaughton Attended this course in May 2018

    Overall very good course. Knowledge shared from Gerard was second to none. Would have liked to use our company specific samples and case studies to gain a greater understanding of how to complete an internal audit

    David Connaughton | Attended this course in May 2018

  • Frank Irwin Attended this course in May 2018

    To me coming with a background with very little experience in auditing the course content was provided at a level that 100% met my requirements. I left the course feeling very confident that I could perform an audit under the supervision of a lead auditor. It was one the best courses I attended in recent years.

    Frank Irwin | Attended this course in May 2018

  • Oleg Fralkov Attended this course in May 2018

    Accurate training, all relevant topics covered, good opportunity to clarify questions, queries

    Oleg Fralkov | Attended this course in May 2018

  • Pamela McGeough Attended this course in October 2018

    Excellent course.

    Pamela McGeough | Attended this course in October 2018

  • Blessing Nwabude Attended this course in May 2018

    Very well structured course delivered in a very engaging style which encouraged knowledge share between students. The technical knowledge of instructor was excellent!

    Blessing Nwabude | Attended this course in May 2018

  • John Nicholas Attended this course in May 2018

    Good course.

    John Nicholas | Attended this course in May 2018

  • Marie Dunlevy Attended this course in October 2018

    Really enjoy this training!

    Marie Dunlevy | Attended this course in October 2018

  • Patrick Gardiner Attended this course in October 2018

    Learn about turtles!

    Patrick Gardiner | Attended this course in October 2018

  • Patrice Fleming Attended this course in February 2019

    great insight to audit.

    Patrice Fleming | Attended this course in February 2019

  • Xiaochun Wang Attended this course in April 2018

    This training not only shows you how to internal audit the ISO 13485: 2016 from a fundamentally perspective (compliance & conformity), but also shares a methodology or philosophy of achieving the effectiveness of QMS. It opens my mind from step by step auditing to a more cohesive perspective.

    Xiaochun Wang | Attended this course in April 2018

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  • Groups of 5+
  • *Exclusions, T&Cs apply

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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. 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 >>

Start Date Location Days Cost Registration On-site
1st May 2019 Green Isle Hotel
St John's Dr, Newlands Cross
Dublin 22
map this location
2 €595.00
16th Oct 2019 Louis Fitzgerald Hotel
Newlands Cross
Dublin 22
View Location Website
map this location
2 €595.00
Course Summary
Course Summary
Course type : Classroom
Course Fee : €595.00
Course Duration : 16 hours
Certification : Kelmac Group (MDIA1)
Continuing Education : units
Are There Any Course Pre-Requisites?

This learning event consists of one prerequisite module prior to attendance at the Kelmac Group® ISO 13485:2016 Internal Auditor Learning Event.

  • Module 1 – Fundamentals of ISO 13485:2016
  • Or good working knowledge of ISO 13485:2016 Requirements as these are not covered during this Learning event

Any Learner who claims an exemption to the above course prerequisite is solely responsible to ensure they satisfy the prior knowledge requirements for attending this learning event, otherwise their attainment of the course learning objectives may not be met.

It is mandatory each Learner is responsible to bring a copy of ISO 13485:2016 Standard with them to this Learning Event.  

 

How Will I Be Assessed?

The Learner is assessed based on participation and performance evaluation throughout the duration of the course. This includes all exercises, role plays, case studies, tests and all other activities during the course. 

Please note, full attendance is required during the Learning Event.  The Learner is responsible for ensuring no other personal or business commitments prevent them from full attendance.  It is also recommended the Learner’s participation on this class is residential.  Learners are encouraged to keep time in the evening free for additional learning and reflection.

Who Should Attend?
  • Quality Managers
  • Quality Professionals/Technicians
  • Quality Engineers
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers 
  • Internal Auditors 
  • Owner Managers 
  • Implementation Members 
44 Reviews

David Connaughton

Attended this course in May 2018

 

Overall very good course. Knowledge shared from Gerard was second to none. Would have liked to use our company specific samples and case studies to gain a greater understanding of how to complete an internal audit

Frank Irwin

Attended this course in May 2018

 

To me coming with a background with very little experience in auditing the course content was provided at a level that 100% met my requirements. I left the course feeling very confident that I could perform an audit under the supervision of a lead auditor. It was one the best courses I attended in recent years.

Oleg Fralkov

Attended this course in May 2018

 

Accurate training, all relevant topics covered, good opportunity to clarify questions, queries

Pamela McGeough

Attended this course in October 2018

 

Excellent course.

Blessing Nwabude

Attended this course in May 2018

 

Very well structured course delivered in a very engaging style which encouraged knowledge share between students. The technical knowledge of instructor was excellent!

John Nicholas

Attended this course in May 2018

 

Good course.

Marie Dunlevy

Attended this course in October 2018

 

Really enjoy this training!

Patrick Gardiner

Attended this course in October 2018

 

Learn about turtles!

Patrice Fleming

Attended this course in February 2019

 

great insight to audit.

Xiaochun Wang

Attended this course in April 2018

 

This training not only shows you how to internal audit the ISO 13485: 2016 from a fundamentally perspective (compliance & conformity), but also shares a methodology or philosophy of achieving the effectiveness of QMS. It opens my mind from step by step auditing to a more cohesive perspective.

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