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.

As a CQI and IRCA approved training Provider, Batalas is proud to have certification on all their ISO 13485 training courses.

What is ISO 13485? (01:54)

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.

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.

OFFER

ISO 13485 Foundation + Lead Auditor = £50 off

OFFER

ISO 13485 Foundation + Internal Auditor = £50 off

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.

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.

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…

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.

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.

Some of our happy customers

It’s a difficult subject to keep interesting for a full day but the provider did well.

Anon

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

The trainer was an extremely experienced person and I learnt a great deal through free discussions we had

Dr Iden Shams

Intervene Group Ltd

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

Trainer answered all questions posed and provided excellent understanding using scenario based answers, and used personal experience.

Adam Scurr

The delegate training manual was good.

Noel John Innes

There was a lot of participation encouraged which kept everyone engaged, constant referrals to the ISO which made me feel more familiar with the document and how to use it, and the audit role play was excellent and exactly what we needed to get a bit of experience.

Claire Collins

Yourgene Health

It was informative, energetic and fun. The best training I have ever received. Was interesting and I retained a lot of information.

Sarah Richardson

SPD Swiss Precision Diagnostics

Informative training course. Trainer was able to engage with the group and break down the various components of the training.

Nisha da Costa

Eyeol UK Ltd.

Some of our happy customers

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

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

David Crellin Shandon Diagnostics Ltd. ISO 13485 Internal Auditor

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

Drew Evans Pelican Healthcare ISO 13485 Foundation

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 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 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

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

The delegate training manual was good.

Noel John Innes ISO 13485 Foundation

Resources to make your studies go further

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

What is ISO 13485?

Differences between ISO 9001 and ISO 13485 explained

What is a management system?

Are you an ISO trainer looking for a new opportunity?

What is an audit?

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Let’s level up your career

Are you a new auditor looking for ISO training advice? Or do you want to build on existing auditing skills to boost your career?

Whatever your need, our experienced and knowledgeable Batalas team can guide you on the right training path to help you reach your professional goals.

Why Choose Batalas

Our Customers

Medical Devices

ISO 13485 Medical Devices Courses

About ISO 13485

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.

Our ISO 13485 course bundles

ISO 13485 Foundation + Lead Auditor = £50 off

ISO 13485 Foundation + Internal Auditor = £50 off

Test your prior knowledge with our ISO 13485 Quiz

Are you confused about which ISO 13485 course to choose?

Related Courses

Frequently Asked Questions

Does your team need ISO 13485 training?

Delivering auditor training since 1962

Some of our happy customers

Some of our happy customers

Resources to make your studies go further

What is ISO 13485?

Differences between ISO 9001 and ISO 13485 explained

What is a management system?

Are you an ISO trainer looking for a new opportunity?

What is an audit?

Courses you’ve recently viewed

Courses you’ve recently viewed

Let’s level up your career

Why Choose Batalas

Our Customers

Why Choose Batalas

Our Customers

Medical Devices

ISO 13485 Medical Devices Courses

About ISO 13485

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.

Our ISO 13485 course bundles

ISO 13485 Foundation + Lead Auditor = £50 off

ISO 13485 Foundation + Internal Auditor = £50 off

Test your prior knowledge with our ISO 13485 Quiz

Are you confused about which ISO 13485 course to choose?

Related Courses

Frequently Asked Questions

Does your team need ISO 13485 training?

Delivering auditor training since 1962

Some of our happy customers

Some of our happy customers

Resources to make your studies go further

Courses you’ve recently viewed

Courses you’ve recently viewed

Let’s level up your career

Training Courses

Why Choose Batalas

Our Customers