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™

ISO 13485:2016 Lead Auditor Certification Training Course - CQI & IRCA Certified


Course Overview Who is this course for?

This CQI and IRCA Certified Quality Management Systems Auditor/Lead Auditor Training Course (incorporating the requirements of ISO 13485:2016) is based on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a complete QMS based on ISO 13485 requirements with specific emphasis of 2nd Party auditing [Customer/Supplier audits] and 3rd Party auditing  [Certification Bodies].

During the delivery, the Learner will complete a Consultant facilitated complete systematic audit of a QMS [Medical Devices]. The facilitated audit of the QMS, will cover 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.

iso 13485 lead auditor training certification ireland

Key Course Learning Outcome Why this course is unique?

With an additional 5 hours of learning compared to our competitors, we cover new and additional topics in more depth. 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.

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 13485:2016 Requirements or have completed a recognised QMS Fundamentals course based on ISO 13485:2016 prior to registering for 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.

Early Bird Discounting Available:

 

Discounts cannot be combined with any other offer.

Start Date Location Cost Days Public Course Onsite
9th Dec 2019

TÜV SÜD
Ridlerstr. 65
Munich 80339

View Location on Google Maps

€1,395.00
( + €35.00 IRCA Certification Fee )
5 days Limited Places Remaining

* Earlybird discount, Terms & Conditions Apply

Course Learning TopicsWhat does the course cover?
  • Introduction to Auditing

    • Audit Terminology, Principles, QMS Audits
    • Auditor Code of Ethics
    • Management of an Audit Program
    • Audit Terminology, Principles, QMS Audits
    • Audit Life Cycle (On-site & Off-site Audit Activities)
    • Auditor/Auditee Roles, Responsibilities*
    • Desired Auditor Behaviours**

    Introduction to QMS Auditing

    • Process Terminology*
    • Process Models/Methodology & Categories*
    • Evaluation of the effectiveness of a Process*
    • Processes and the application of PDCA and Risk*
    • The QMS Certification Cycle & 3rd Party Certification**
    • Special Conformity Audits**
  • Compliance Auditing & Methodology**

    • Medical Device Life Cycle & the Regulatory Audit Perspective**
    • Overview of Different Regulatory Requirements [EU, U.S, Japan, Canada & More]**

    Audit Planning

    • Initiating & Preparing for the Audit
    • Audit Trails
    • Purpose and benefits for establishing initial contact and forms of contact
    • Case Study: Document Review
    • Audit Plan
    • Audit Checklist
    • Audit Protocol

    Onsite Activities

    • Lead Auditor Leadership and Supervision**
    • Responsibilities of the Lead Auditor
    • Communication throughout the Audit Life Cycle
    • Monitoring Audit Progress
    • Consensus and Resolution Conflicts
    • Lead Auditor Leadership
    • Audit Reporting
    • Audit Follow-Up
    • Auditor/Technical Expert Coaching, Mentoring and Evaluation**
    • Collecting and Verifying Information
    • Introduction to Audit Findings
  • Opening Meeting

    • Purpose, process and benefit of an Opening Meeting
    • Case Study – Opening Meeting

    Audit Reporting

    • Audit Findings
    • Case Study: Writing Audit Findings
    • Case Study: Writing the Audit Report**

    Completing the Audit

    • Evaluating Correction & Corrective Action including Root Cause Analysis and Audit Finding Closure
    • Audit Follow Up Strategies
    • Final Audit Team Meeting
    • Closing/Exit Meeting & Role Play

*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 CertificationCQI and IRCA Certified Course (A18242)

This course is fully recognized by CQI and IRCA.

Are There Any Course Pre-Requisites?

Before starting this course, students are expected to have the following prior knowledge:

- Knowledge of the following quality management principles and concepts:

  • The Plan, Do, Check, Act (PDCA) cycle.
  • The relationship between quality management and customer satisfaction.
  • Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000.
  • The process approach used in quality management.
  • The Model of a Process Based Quality Management System, the structure and content of ISO 13485:2016.

- Knowledge of the requirements of ISO 13485:2016, which may be gained by completing a CQI and IRCA certified QMS (Medical Devices) Foundation Training course or equivalent.

Each student will be required to have their own copy of ISO 13485:2016 for use during the training.

How Will I Be Assessed?

The student is assessed during the on-site class 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.

Post the on-site class. There is a two-hour written auditor examination at the end of the on-site class. The written auditor examination is based on QMS, or ISO 13485:2016. The written examination is closed book; however, the student is required to have a hard-copy version of the relevant management system standard (ISO 13485) for class use. The minimum pass rate for each written auditor examination is 70%.

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
Our Course vs. Our CompetitorsWhy is our course the best? Just some examples explained of how our course goes further

Working with a Case Study: Almost Full Documented QMS for Medical DevicesWhy 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 ProcessesWhy 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].

 

 

  • Alexander Imhof Attended this course in July 2019

    Excellent Instructors, the topic was presented in a way that was both educational and entertaining. The training not only encouraged textbook knowledge, but practical application and understanding.

    Alexander Imhof | Attended this course in July 2019

  • Filip Vecera Attended this course in September 2019

    Excellent training with focus on practical aspects of auditing. Lot of new details from certification audits for me.

    Filip Vecera | Attended this course in September 2019

  • Michael Beerlin Attended this course in July 2019

    All in all a much better than everage training. I like the approach and I enjoyed it.

    Michael Beerlin | Attended this course in July 2019

  • Michael Beerlin Attended this course in July 2019

    All in all a much better than everage training. I like the approach and I enjoyed it.

    Michael Beerlin | Attended this course in July 2019

  • Michael Beerlin Attended this course in July 2019

    All in all a much better than everage training. I like the approach and I enjoyed it.

    Michael Beerlin | Attended this course in July 2019

  • Monica Monalisa Scholastica Attended this course in July 2019

    A very engaging course despite the dry topic (13485).

    Monica Monalisa Scholastica | Attended this course in July 2019

  • patricia moore Attended this course in September 2019

    None

    patricia moore | Attended this course in September 2019

  • Ales Wasserbauer Attended this course in September 2019

    I´d recommend this course since it was based on the great Gerard´s experiances that he was able to share with us. Learned the best practice and have helped to answer all questions which were raised. Also I would appreciate how interactive the course he made. Making small teams for solving a specific tasks.

    Ales Wasserbauer | Attended this course in September 2019

  • Eva Felder Attended this course in July 2019

    Training srated with an ice-braking inroduction round and a very good description of content and expectations of the upcoming week. Themes were presented very good and with lots of helpful examples. Questions could be placed and were all answered very good and understandable. Learning effect was very high.

    Eva Felder | Attended this course in July 2019

  • Isabel Koch Attended this course in July 2019

    no comments

    Isabel Koch | Attended this course in July 2019

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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
9th Dec 2019 TÜV SÜD
Ridlerstr. 65
Munich 80339
map this location
5 €1,395.00 Limited Places Remaining
Course Summary
Course Summary
Course type : Classroom
Course Fee : €1,395.00
Course Duration : 45 hours
Certification    view more : CQI and IRCA (A17584)
Continuing Education : units
Are There Any Course Pre-Requisites?

Before starting this course, students are expected to have the following prior knowledge:

- Knowledge of the following quality management principles and concepts:

  • The Plan, Do, Check, Act (PDCA) cycle.
  • The relationship between quality management and customer satisfaction.
  • Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000.
  • The process approach used in quality management.
  • The Model of a Process Based Quality Management System, the structure and content of ISO 13485:2016.

- Knowledge of the requirements of ISO 13485:2016, which may be gained by completing a CQI and IRCA certified QMS (Medical Devices) Foundation Training course or equivalent.

Each student will be required to have their own copy of ISO 13485:2016 for use during the training.

How Will I Be Assessed?

The student is assessed during the on-site class 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.

Post the on-site class. There is a two-hour written auditor examination at the end of the on-site class. The written auditor examination is based on QMS, or ISO 13485:2016. The written examination is closed book; however, the student is required to have a hard-copy version of the relevant management system standard (ISO 13485) for class use. The minimum pass rate for each written auditor examination is 70%.

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
229 Reviews

Alexander Imhof

Attended this course in July 2019

 

Excellent Instructors, the topic was presented in a way that was both educational and entertaining. The training not only encouraged textbook knowledge, but practical application and understanding.

Filip Vecera

Attended this course in September 2019

 

Excellent training with focus on practical aspects of auditing. Lot of new details from certification audits for me.

Michael Beerlin

Attended this course in July 2019

 

All in all a much better than everage training. I like the approach and I enjoyed it.

Michael Beerlin

Attended this course in July 2019

 

All in all a much better than everage training. I like the approach and I enjoyed it.

Michael Beerlin

Attended this course in July 2019

 

All in all a much better than everage training. I like the approach and I enjoyed it.

Monica Monalisa Scholastica

Attended this course in July 2019

 

A very engaging course despite the dry topic (13485).

patricia moore

Attended this course in September 2019

 

None

Ales Wasserbauer

Attended this course in September 2019

 

I´d recommend this course since it was based on the great Gerard´s experiances that he was able to share with us. Learned the best practice and have helped to answer all questions which were raised. Also I would appreciate how interactive the course he made. Making small teams for solving a specific tasks.

Eva Felder

Attended this course in July 2019

 

Training srated with an ice-braking inroduction round and a very good description of content and expectations of the upcoming week. Themes were presented very good and with lots of helpful examples. Questions could be placed and were all answered very good and understandable. Learning effect was very high.

Isabel Koch

Attended this course in July 2019

 

no comments

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