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 Auditor Transition Training Course

Course Overview Who is this course for?

With an additional 4 hours of Learning compared to our competitors, we focus on the ability to plan, conduct, report and follow up an audit of a Quality Management System to provide Assurance the Quality Management System [MD] meets the needs of the interested parties.

This learning event is aimed at existing Auditors of Quality Management Systems in Medical Devices who perform first, second and third-party audits of Quality Management Systems against ISO 13485:2016, in accordance with ISO 19011 and ISO/IEC 17021, as applicable

The Kelmac Group® innovation strategy is to provide the Learner with both interactive and application based learning that can be immediately applied in the work environment following completion of each learning event. Research shows only 10% of Learners remember knowledge based upon a MS Power Point to Death Presentation or Lecture based learning event. The Kelmac Group® instead focuses on learner centered learning where the Learner remembers greater than 90% of the learning. In addition to our interactive and practical learning methodology we also design our learning solutions in such a way as to ensure the Learner can immediately apply the knowledge and skill when they return to their work environment following attendance at a Kelmac Group® learning event. No other Training Provider ensures the learning is both learner centered and application based.

This learning event is most suited for Internal or External Auditors who are planning to conduct 1st, 2nd and 3rd party audits against ISO 13485:2016.


 

Key Course Learning Outcome Why this course is unique?

  • With an additional 4 hours of Learning compared to our competitors, we focus on the ability to plan, conduct, report and follow up an audit of different Quality Management Systems [QMS MD] to provide Assurance the QMS meets the needs of the interested parties.

Course Basics What is essential to know?

  • This is a 2-day (18hr) 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 13485:2012 Requirements & have knowledge of management systems audit through satisfactory completion of an IRCA Certified Internal QMS MD Auditor or QMS MD Auditor/Lead Auditor Training Course (or acceptable alternative)
iso 13485 auditor transition 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

    • The Framework for a Medical Device Quality Management System
    • The relationship between Statutory and Regulatory and ISO 13485:2016 and the FDA QSR/21 CFR 820 requirements
    • Relationship with ISO 9001:2015
    • ISO 13485:2016 – Introduction*
    • Overview of ISO 13485:2016
    • Application specifically in relation to outsource processes, scope of non-application and definition of regulatory requirement Risk based QMS Approach
    • ISO 13485:2016 - General Requirements for a QMS*
    • New requirement to define the Role of the Organization
    • Enhanced requirement to fulfil regulatory requirements
    • Processes needed for the QMS including a
    • Risk based approach to control the processes
    • Changes and the impact of the changes on the QMS and Medical Device product
    • Management of Outsourced Processes
    • Creation and Maintenance of a Medical Device file

    The requirements for documentation and record control

    • New requirement on protection of confidential health information
    • ISO 13485:2016 – Management Responsibility*
    • Quality Management Representative and the enhanced requirements for the Quality Management Review
    • ISO 13485:2016 – Resource Management*
    • Documentation of Process relating to Human Resources
    • Infrastructure
    • Documentation Requirements
    • ISO 13485:2016 – Product Realization*
    • New and enhanced requirements for Product Realization
    • Monitoring and Measuring Equipment in partic-ular Software Validation and Re-validation
    • ISO 13485:2016 Measurement, Analysis and Improvement*
    • New and enhanced requirements associated with Measurement, Analysis and Improvement, specifically Product and Post-production Activities

    Audit Planning

    • Scope and Criteria of the Audit
    • Audit Plan
    • Case Study Review & Audit Protocol Development
    • Conducting the On-Site Audit
    • Ability to manage Meetings [Opening Meeting] Ability to Interview Top Management and Follow Audit Trails
    • Audit Findings
    • Simulated Audit/Case Study & Writing Audit Findings
    • Audit Reporting
    • Audit Report
    • Writing the Audit Report (Executive Summary)
    • Preparing for and Managing the Closing-Exit Meeting

*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.

 

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.

    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 : 18 hours
Certification : Kelmac Group (KGMDAT)
Continuing Education : units
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.

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