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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 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?

We focus on consistent interpretation & application the requirements of ISO 14001:2015 and the ability to plan, conduct, report and follow up an audit of a
different Environmental Management System scenarios to provide Assurance the Environmental Management System meets the needs of the interested parties.



Course Basics What is essential to know?

  • This is a 5-day (45hr) learning event.
  • Start/Finish Times: 08:00am – 18:00pm (each day) with an earlier finish on the final day at 2pm
  • Prior Learning Requirement: Learners are required to be familiar with ISO 14001:2015 Requirements or have completed a recognised EMS Fundamentals course based on ISO 14001:2015 prior to registering for this course.

 

 Where are you looking to attend this training?

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 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?

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

Please note, full attendance is required during the training course.

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

    No review available.

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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 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™

Course Summary
Course Summary
Course type : Classroom
Course Duration : 16 hours
Certification : Kelmac Group (QMSMD-IA)
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 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?

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

Please note, full attendance is required during the training course.

Who Should Attend?
  • Quality Managers
  • Quality Professionals/Technicians
  • Quality Engineers
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers 
  • Internal Auditors 
  • Owner Managers 
  • Implementation Members 
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No review available.