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Home | ISO 13485 Medical Devices

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Medical Devices

ISO 13485 Medical Devices Courses

ISO 13485 is a Quality Management System standard that follows ISO 9001 (QMS) with the medical devices and pharmaceutical industry’s additional statutory and regulatory requirements.

We are proud to be industry-leading experts and the first training provider worldwide to offer a certified MD-QMS ISO 13485:2016 Foundation course.

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As a CQI and IRCA approved training Provider, Batalas is proud to have certification on all their ISO 13485 training courses.
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What is ISO 13485? (01:54)

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About ISO 13485

By following ISO 13485, organisations can put controls and mechanisms in place to ensure they produce medical devices safely.

ISO 13485 certification can benefit a business by demonstrating a commitment of quality to its clients and suppliers. Increasingly, many large medical device organisations will only work with ISO 13485-certified suppliers to ensure quality in their supply chain.

Available ISO 13485 Courses

We offer a variety of ISO 13485 training courses, which will equip you with a formal, internationally recognised ISO 13485 qualification to support your personal development.

If you are new to auditing, we’d recommend you start with an MD-QMS ISO 13485 foundation course, which is perfect for beginners who need to gain knowledge of the Standard.

Or perhaps you already understand medical device management systems and are looking for a more advanced course? If so, look at one of our skills-based ISO 13485 courses, which teach you how to conduct an internal and/or external audit against ISO 13485 standards.

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MD-QMS ISO 13485:2016 Foundation

Achieve an understanding of ISO 13485 and a Management System
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MD-QMS ISO 13485:2016 Internal Auditor

Gain the knowledge and skills to conduct internal audits of a management system
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ISO 13485:2016 Lead Auditor

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Our ISO 13485 course bundles

To ensure you get the most out of your ISO 13485 training, we recommend taking a Foundation course to understand the Standard before attending an Internal Auditor or Lead Auditor course.  We offer a discount of £50 when booking both courses to help minimize the cost of training.

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ISO 13485 Foundation + Lead Auditor = £50 off

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ISO 13485 Foundation + Internal Auditor = £50 off

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Test your prior knowledge with our ISO 13485 Quiz

Anyone attending an Internal Auditor or Lead Auditor course must have existing knowledge of ISO 13485.

 

Take our short quiz to test your understanding.

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Are you confused about which ISO 13485 course to choose?

We know it can be difficult to know which ISO 13485 training level you need, so we’ve designed a Course Selector tool to help you find the correct course for your needs.

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Related Courses

ISO 13485 is closely based on ISO 9001 QMS (Quality Management Systems); if you wish to explore this Standard, we offer three training courses for you to choose from depending on your requirements…

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ISO 9001:2015 Foundation QMS

An entry-level course which teaches an understanding of ISO 9001 QMS
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From £225
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ISO 9001:2015 Internal Auditor QMS

Discover how to conduct, report and follow up on an internal audit
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ISO 9001:2015 Lead Auditor

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Frequently Asked Questions

  • What is ISO 13485?

    ISO 13485 is a Quality Management System standard that follows ISO 9001 (QMS) with the medical devices and pharmaceutical industry’s additional statutory and regulatory requirements.

    By following ISO 13485, organisations can put controls and mechanisms in place to ensure they produce medical devices safely. Many large medical device organisations will only work with ISO 13485-certified suppliers to ensure quality in their supply chain.

    Take a look at our ISO 13485 training courses to find out more.

  • What is an audit?

    This is a common question alongside ‘What does an audit do?’ - put simply, it’s about checking that what’s supposed to happen is happening, not just in terms of rules being followed but also in the effectiveness of processes and systems, for example, are they delivering the results we expect them to deliver?

    For more information, see our video 'What is an Audit?'

  • What does an internal auditor do?

    An internal auditor collects evidence of conformity by interviewing personnel, reviewing documented information, and observing process activities. While doing this they may identify nonconformities or flag potential issues.

  • What is ISO 13485 certification?

    ISO 13485 is a Quality Management System standard that follows ISO 9001 (QMS) with the medical devices and pharmaceutical industry’s additional statutory and regulatory requirements.

    By following ISO 13485, organisations can put controls and mechanisms in place to ensure they produce medical devices safely. Increasingly, many large medical device organisations will only work with ISO 13485-certified suppliers to ensure quality in their supply chain.

    View our ISO 13485 training courses to learn more.

  • What is a quality management system?

    It’s often thought that a Quality Management System is simply a quality manual, but this isn’t the case; this misconception is based on the older version of ISO 9001 (prior to the latest 2015 version), which required organisations to have a quality manual, giving quality professionals the impressions that the Quality Manual was the Quality Management System. But a QMS is far more than that; essentially, it is about people and processes working together to establish policy, set objectives, and then plan how to achieve them. Documented information such as manuals, procedures, templates, or even operational software supports this achievement. A QMS is designed to meet the requirements of customers primarily but also other interested parties such as legal authorities, industry bodies, and shareholders.

    For more information, watch our video 'What is a management System?'.

Does your team need ISO 13485 training?

Our in-house training is a cost-effective solution for organisations with larger auditing teams.

Get in touch
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Delivering auditor training since 1962

You can trust that you are in safe hands with Batalas! We have been delivering auditor training for 60+ years to organisations in both the private and public sectors. Our tutors will travel across the UK and worldwide to provide CQI IRCA-certified ISO 13485 training to organisations within the medical devices industry.

 

We not only teach auditor courses but also offer additional support via team workshops and consultancy to meet the needs of your business.

    Our expertise
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    I enjoyed the course more than anticipated. The tutor delivered some good stories which helped to leaven the load a little.

    Stephen Evans

    ISO 13485 Foundation

    The course was really good. I especially liked all the practical case studies and exercises.

    Ana Teresa Marchante

    ISO 13485 Lead Auditor

    Very good communication throughout the process, from booking to the completion of the course.

    Caroline Alexander

    Genedrive Diagnostic Ltd
    ISO 13485 Internal Auditor

    A good teacher

    Lee Mcivor

    ISO 13485 Lead Auditor

    I would rate the course 5 out of 5

    Santhosh Kumar Kanakam

    Novacyt
    ISO 13485 Lead Auditor

    Tutor was brilliant in how he worked the room. Thoroughly enjoyed the course. It was very intense but I was starting at complete novice level. I feel I improved massively by the end of the course.

    Anon

    ISO 13485 Lead Auditor

    The contact persons at Batalas were very helpful in answering our queries and in the pre-course preparation. The trainer was very engaging and the teaching method was very effective.

    Jose Magbanua

    Sphere Medical
    ISO 13485 Lead Auditor

    The delegate training manual was good.

    Noel John Innes

    ISO 13485 Foundation

    The course was highly suited to our needs and the trainer made what would have been otherwise dry material rather interesting.

    Christopher Norfolk

    UK Implant Ltd.
    ISO 13485 Internal Auditor

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    The course was packed with info and a great balance between learning and doing. The trainer really knows his subject well.

    Stephen Reeder SMi Drug Discovery ISO 13485 Internal Auditor

    The trainer made what was a very dry subject engaging, inclusive, and entertaining.

    David Crellin Shandon Diagnostics Ltd. ISO 13485 Internal Auditor

    He was a fantastic engaging trainer, interactive and challenging ways of thought and approach in audit situations. He approached everyone fairly and equally and always actively listened and responded to queries.

    Adam Gregory Advanced Medical Solutions ISO 13485 Lead Auditor

    The course was interesting and engaging as a group and the trainer was really informed. The training manual and course handouts were good and gave us more scope to work on our own trail of thoughts without giving too much away.

    Gladwell Kozak Great Western Hospital, NHS Foundation Trust ISO 13485 Internal Auditor

    The contact persons at Batalas were very helpful in answering our queries and in the pre-course preparation. The trainer was very engaging and the teaching method was very effective.

    Jose Magbanua Sphere Medical ISO 13485 Lead Auditor

    The course was very detailed and covered in great depth by the tutor, he always had the time and knowledge to answer any questions put forward and he kept the whole group engaged throughout the day. Top marks!!

    Sam Limmack Orthoplastics ISO 13485 Foundation

    We all enjoyed the training provided. The tutor was engaging and interesting.  He was also very knowledgeable on our processes so that was very helpful.

    Bryony Hartley Serrations Ltd ISO 13485 Foundation

    Great service from Batalas, very supportive admin support with pre-course. Great course well pace from an expert instructor. 

    Jamie Cook Alchemy SCS Ltd ISO 13485 Lead Auditor

    The tutors enthusiasm to lead a course is second to none. His energy ensured I was engaged throughout.

    Drew Evans Pelican Healthcare ISO 13485 Foundation

    The training was interesting and engaging

    Jeremy Melac Zimmer Biomet ISO 13485 Lead Auditor

    It is best interactive and immersive course I have ever attended. It was engaging and I have learnt so much.

    Kathryn Prattley Elekta Ltd ISO 13485 Lead Auditor

    I felt the online pre-course work was very useful before attending the course. It gave me a basic understanding of the subject (which I had none) and this greatly helped with the discussions on the training.

    Robert H ISO 13485 Foundation

    Best course I have ever been on in 25 years in compliance.

    Jonny Do Armstrong Medical ISO 13485 Lead Auditor

    The trainer is the main reason behind the success of the course. He is very knowledgeable with the standard and approaches the course discussion with enthusiasm and engagement with the participants.

    Rodrigo Petoral Jr Coloplast ISO 13485 Lead Auditor

    The training was very engaging and educative.

    Temitope Pupuru ISO 13485 Foundation

    The course delivery was so empowering. I felt it was one of the most worthwhile courses I've attended in recent years.

    Owen Lewis Renishaw ISO 13485 Internal Auditor

    The course was really good. I especially liked all the practical case studies and exercises.

    Ana Teresa Marchante ISO 13485 Lead Auditor

    What an amazing tutor, patient, understanding and approachable. Able to keep everybody engaged.

    Katie Jennings ISO 13485 Lead Auditor

    I felt the breakout rooms where good and gave you an opportunity to work with others.

    David Smith ISO 13485 Foundation

    Role play scenarios were very insightful and were an excellent interactive way to learn.

    Hayley Morgan ISO 13485 Lead Auditor

    The tutor is amazing.

    Michelle Malandu Perspectum Ltd ISO 13485 Lead Auditor

    The tutor's knowledge and his expertise together with his experience, make this course very engaging.

    Stefan Thomi Coltene ISO 13485 Lead Auditor

    He was an amazing trainer! Very patient, he put himself at the level of the audience (for French people), full of anecdotes and striking examples to illustrate his points and a GREAT actor!

    Steven Jakubczyk Zimmer Biomet ISO 13485 Lead Auditor

    The course content and its excellent presentation exceeded my expectations. It has been the most beneficial course that I have attended for many years.

    Jon Selby Renishaw ISO 13485 Internal Auditor

    I would definitely attend another course with Batalas

    Rick Singh MFX ISO 13485 Lead Auditor

    The trainer was fantastic

    Jonny Dale Genedrive ISO 13485 Internal Auditor

    The most useful course components were the interactive audit sessions, especially the time we had to prepare.

    Gabriel Lambert ISO 13485 Internal Auditor

    I enjoyed the course more than anticipated. The tutor delivered some good stories which helped to leaven the load a little.

    Stephen Evans ISO 13485 Foundation

    The tutor was very engaging.

    Dean Payne ISO 13485 Internal Auditor

    The delegate training manual was good.

    Noel John Innes ISO 13485 Foundation

    The learning-through-doing style, made learning much easier

    Leighton Williams ISO 13485 Lead Auditor

    I have undertaken two lead auditor courses with Batalas, one via virtual classroom and the other classroom-based - I found both very enjoyable.

    Erling Smith ISO 13485 Lead Auditor

    Very good communication throughout the process, from booking to the completion of the course.

    Caroline Alexander Genedrive Diagnostic Ltd ISO 13485 Internal Auditor

    Very engaging and informative. On our course we had 10 people, 5 functions, and everyone came away with a good understanding of the requirements to audit and be audited.

    Dean Wybrow Renishaw ISO 13485 Internal Auditor

    I would definitely attend a Batalas course again

    Louise Parsons ISO 13485 Foundation

    I felt the breakout rooms where good and gave you an opportunity to work with others.

    David Smith ISO 13485 Foundation

    The tutor was very engaging.

    Dean Payne ISO 13485 Internal Auditor

    A good teacher

    Lee Mcivor ISO 13485 Lead Auditor

    The training was delivered perfectly, to the point were the information was easy to retain.

    Fotini Stavrou Genedrive ISO 13485 Internal Auditor

    I would rate the course 5 out of 5

    Santhosh Kumar Kanakam Novacyt ISO 13485 Lead Auditor

    Resources to make your studies go further

    Look at our range of helpful ISO 13485 articles to support your learning…
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    What is ISO 13485?

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