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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).


 

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.
iso 13485 internal auditor training certification ireland
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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 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 
  • Brian Stapleton Attended this course in June 2019

    Very good course. Instructor was very knowledgeable and interactive with the class

    Brian Stapleton | Attended this course in June 2019

  • Bridget O'Keeffe Attended this course in June 2019

    Excellent course would highly recommend

    Bridget O'Keeffe | Attended this course in June 2019

  • Cathal Hanrahan Attended this course in June 2019

    well thought out concise yet detailed course which imparts knowledge on attendees

    Cathal Hanrahan | Attended this course in June 2019

  • Eoghan Coughlan Attended this course in June 2019

    Good course which provides an excellent knowledge base and key skills for those interested in participating in internal auditing team in med device industry.

    Eoghan Coughlan | Attended this course in June 2019

  • Paula Prendegcast Attended this course in April 2019

    Excellent course with strong group interaction. Method of learning was very effective and trainer was excellent in his approach. The course was very methodical and easy to follow.

    Paula Prendegcast | Attended this course in April 2019

  • Shane MacNally Attended this course in May 2019

    This course was the perfect preparation for allowing me to get started with Internal Auditing. Following the clear guidelines outlined on the course meant the audits can progress as quickly and efficiently as possible.

    Shane MacNally | Attended this course in May 2019

  • Brenda Egan Attended this course in May 2019

    This training course runs through the principles of ISO 13495 internal quality auditing and encourages participants to take part in interactive activities and exercises. The interaction allows participants to get a feel for the topics being discussed. The instructors have many years experience in auditing and the medical device industry.

    Brenda Egan | Attended this course in May 2019

  • Brid Cleary Attended this course in June 2019

    Course was very interactive with all personnell

    Brid Cleary | Attended this course in June 2019

  • Jack Kenneally Attended this course in June 2019

    n/a

    Jack Kenneally | Attended this course in June 2019

  • Shannen Singh Attended this course in June 2019

    overall good experience

    Shannen Singh | Attended this course in June 2019

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  • Available Nationwide
  • Tailored to you
  • Fixed Fees, No Expenses*
  • Groups of 5+
  • *Exclusions, T&Cs apply

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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 >>

Start Date Location Days Cost Registration On-site
No upcoming dates
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 
82 Reviews

Brian Stapleton

Attended this course in June 2019

 

Very good course. Instructor was very knowledgeable and interactive with the class

Bridget O'Keeffe

Attended this course in June 2019

 

Excellent course would highly recommend

Cathal Hanrahan

Attended this course in June 2019

 

well thought out concise yet detailed course which imparts knowledge on attendees

Eoghan Coughlan

Attended this course in June 2019

 

Good course which provides an excellent knowledge base and key skills for those interested in participating in internal auditing team in med device industry.

Paula Prendegcast

Attended this course in April 2019

 

Excellent course with strong group interaction. Method of learning was very effective and trainer was excellent in his approach. The course was very methodical and easy to follow.

Shane MacNally

Attended this course in May 2019

 

This course was the perfect preparation for allowing me to get started with Internal Auditing. Following the clear guidelines outlined on the course meant the audits can progress as quickly and efficiently as possible.

Brenda Egan

Attended this course in May 2019

 

This training course runs through the principles of ISO 13495 internal quality auditing and encourages participants to take part in interactive activities and exercises. The interaction allows participants to get a feel for the topics being discussed. The instructors have many years experience in auditing and the medical device industry.

Brid Cleary

Attended this course in June 2019

 

Course was very interactive with all personnell

Jack Kenneally

Attended this course in June 2019

 

n/a

Shannen Singh

Attended this course in June 2019

 

overall good experience

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