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To select your ISO 13485:2016 Auditor Course


either pick from the Courses listed at the top or see the answers to frequently asked questions below

Home Select an online ISO 13485 Training Course
ISO 13485 INTERNAL AUDITOR
ISO 13485 INTERNAL AUDITOR CONVERSION
ISO 13485 INTERNAL AUDITOR EXTENSION
ISO 13485 LEAD AUDITOR
ISO 13485 LEAD AUDITOR CONVERSION
ISO 13485 LEAD AUDITOR EXTENSION
ISO 13485 LEAD IMPLEMENTER
ISO 13485 TRANSITION TRAINING

ISO 13485 Lead Auditor is not the only choice – there are 8 Auditor Courses for ISO 13485 to choose from including a Lead Implementer Certification

Conventional classroom-based Auditor Courses for ISO 13485, the Medical Device Management System Standard, usually limit you to two choices.  Either a 2-day Internal Auditor Course or a 5-day Lead Auditor Course.  To select an appropriate ISO 13485 auditor course can be problematic.  There are no such restrictions when it comes to e-learning-based Courses.

And the choice of Auditor Courses means you can get a Course that directly matches your needs.

The Regulatory Framework

ISO 13485 compliant management systems must incorporate compliance with applicable regulations, which are primarily determined by the location where it is proposed to sell the medical devices.  The regulations are truly a ‘minefield’ and, if you are new to the medical device sector, you’ll need expert advice to ensure that you implement and maintain the ‘right’ Medical Device Management System (MDMS).

To get you started …

EU Regulatory Area: EC Medical Devices Website

US Regulatory Affairs: US FDA Medical Devices Website

MDSAP – Medical Devices Single Audit Program, a worldwide initiative by regulatory bodies to simpify inspections/ audits: IMDRF Website

 

Here you'll find the Course you want

Your current circumstances will dictate which is the best choice for you.

I want ISO 13485:2016 Internal Auditor Certification

The certification you need to carry out effective internal audits.

I'm newly responsible for my organization's MDMS

If you are a Quality Manager or similar, and don’t feel confident about ISO 13485:2016, its requirements, and don’t know what an efficient and effective MDMS looks like, this is the Course for you.

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We manufacture Medical Device Components. I've been tasked with our getting ISO 13485 Certification. Which Course, if any, should I take?

Our ISO 13485 Lead Implementer is ideal for you.  You may need some consultancy support on implementation, but that should be limited and you’ll know the ‘right’ questions to ask.  Implementing a Medical Device Management System yourself while challenging is a great way to quickly introduce that changes needed to secure, and retain, ISO 13485 Certification.

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I'm already a Lead Auditor and I'd like to add ISO 13485:2016 to my auditor certification

With this 24-hour Extension Program you will become a certified ISO 13485:2016 Lead Auditor.

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I want ISO 13485:2016 Lead Auditor Certification

For an in depth knowledge of the Standard and of Auditing skills. The certification you need if you hope to audit for a Certification Body.

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I want to be an MDMS Consultant

Includes a 33-step Path to Certification, a 100+ page ISO 13485:2016 Implementation Handbook.  A Documentation Toolkit includes sample SOPs and record forms plus examples of audit schedules, management review agendas.  And loads of practical useful hints, tips and materials of real benefit to a new MDMS consultant.

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We're certified to the old Standard; I now want to upgrade our MDMS to meet the ISO 13485:2016 requirements.

This Transition Training package includes an ISO 13485:2016 Implementation Handbook, a Documentation Toolkit, with lots of sample paperwork, and a Gap Analysis Tool.

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I want to implement ISO 13485:2016 for my organization

This Course includes a 33-step Path to Certification, a 100+ page ISO 13485:2016 Implementation Handbook, loads of example SOPs and Forms.  And there’s Auditor Certification for yourself.

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I'm a MDMS Internal Auditor and need to learn about the revised Standard

With this 8-hour Conversion Course you’ll become a certified ISO 13485:2016 Internal Auditor.

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INFOGRAPHIC: ISO 13485 Course Selection

Infographic- Choice of ISO 13485 Courses
Click image to view full size.
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Satisfied Customers say …

  • … excellent modules and the scenarios were great; the FAQ’s were also a great help.

    Peter Riley
    Operations, Energy & Facilities Project Manager – Europe, L&P Springs UK

  • I have finished the full course. Thank you for your help during it. It has been an excellent tool as I implement our ISO 27001

     

    Keith Kelly
    General Manager, Limerick Self Storage

  • We were audited by BSI in the month of June and India office has now achieved the ISO 9001:2015 certification and I would like to thank you for all the assistance that you have provided during the Internal Auditor certification process for my employees.

    Shyam Cheriyil
    Senior Global Quality Coordinator - Petrolink Data Services Pvt Ltd

  • Thoroughly enjoyed the course and found it both stimulating and useful.  The quizzes at the end of each section were particularly helpful.

    Annette Dunwell
    Private Learner

  • The training modules are brilliant and the tests associated with each module also very good.
    Excellent course, excellent support from John and can thoroughly recommend this course 100%

    Eric Whittle
    Principal at Simply Safety Ltd

  • Just completed my online internal auditors transition course (ISO 9001:2015). Now, the illusion is that online courses are easy, and there is no value in them at all. Well forget that one, this course is no pushover by any means and the way it is structured really does push you.

    Eric Whittle
    Principal at Simply Safety Ltd

  • Ultan on the Support Team was fantastic every time … The support was excellent and made the course a lot more achievable. Definitely glad I completed it and am looking forward to applying my skills

    Hilary Porter
    Sales Co-Ordinator, Oxygen Care Ltd

  • … after completing the course I have had a fantastic insight to what the expectation of my role is. The scenarios were great as a hands-on approach to use the Standard and work out any non-conformities.

    Hilary Porter
    Sales Co-Ordinator - Oxygen Care Ltd.

  • …a way of communicating an idea or a theory that makes you wonder why you never thought of it, or knew about it before, but more importantly in a way that you are highly unlikely to forget the lesson.

    Eoghan Kenny
    CEO & Principal Advisor

  • …a deep, expert and practical knowledge of various ISO standards and has provided us with excellent training, coaching and support.

    Kenneth Kelleher
    Technical Manager - Schlotter Chemical Technology

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