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 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.

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.

iso 13485 lead auditor training certification uk
 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?
  • 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 & IRCA Certified Course (A18242)

This course is fully recognized by CQI & 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.

Important: Good working knowledge of the requirements of ISO 13485:2016, which may be gained by completing an IRCA certified QMS (Medical Devices) Foundation Training course or equivalent.

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

How Will I Be Assessed?

Each Learner is assessed prior to the start of the on-site class, 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 Learner is required to have a hard-copy version of the relevant management system standard (ISO 13485:2016) 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 an IRCA 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].

 


    No review available.

All Our Training Is Available In HouseCan’t come to us?
WE CAN COME TO YOU

Do you wish to join our mailing list to receive our newsletter including information about industry insights, upcoming courses & special pricing or discounts?

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

Companies That Trust In Kelmac Group ®

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 +44 203 432 4187 | 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 : £1,495.00
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.

Important: Good working knowledge of the requirements of ISO 13485:2016, which may be gained by completing an IRCA certified QMS (Medical Devices) Foundation Training course or equivalent.

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

How Will I Be Assessed?

Each Learner is assessed prior to the start of the on-site class, 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 Learner is required to have a hard-copy version of the relevant management system standard (ISO 13485:2016) 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 an IRCA Certified Provisional Auditor, Auditor, Principal Auditor, or Lead Auditor
0 Reviews

No review available.

Available Options


* Certification Fee: