eQMS, Specialist Quality & Regulatory Consultancy

Choosing an electronic Quality Management System (eQMS) might not sound like it has much in common with picking out a chocolate bar, but in many ways, the process is surprisingly similar. Both involve sifting through a variety of options to find the perfect fit for your specific needs and tastes. Just like when you’re deciding between dark, milk, or white chocolate, selecting the right eQMS requires considering your unique preferences, goals, and requirements.

Do you prioritize smoothness and simplicity, or do you need something with a bit more complexity and richness? In this blog, we’ll explore how the decision-making process for an eQMS mirrors the sweet (and sometimes overwhelming) experience of choosing your favourite chocolate bar. So, let’s unwrap the similarities and help you make a decision that’s both satisfying and beneficial

The eQMS Landscape

Here’s an interesting fact, just like chocolate, there are over 100 different versions of eQMS software available today! The remarkable thing is that you can build a compliant quality management system with any of these tools. You could even create one using basic platforms like SharePoint or Google Drive!

What Makes the Difference?

So what separates one eQMS from another? Different systems offer varying functionalities:

Some leverage AI (artificial intelligence) capabilities
Others focus on simplicity
Many interconnect with other business functions

It’s all about understanding what’s right for you and your organization. Quality management system software provides both a tool and a framework to build your QMS around. The work and effort required to build a QMS is largely driven by your specific company needs.

The Value of Expertise

This is where consultants become valuable. Through their careers, consultants experience different types of QMS systems built by different organisations at various stages of development. We can help you determine not only where to begin but also where you may want to go in the future. Our perspective and expertise can support you in developing a long-term strategy for quality planning and QMS implementation.

Our Recommended Options

While hundreds of options exist, here are three QMS software providers we regularly work with:

Cognidox – This is the system we use to build our own ISO-compliant QMS. It offers simple setup, ease of use, and scalability based on your company’s needs rather than forcing you into a predefined structure.
TraceX – A robust alternative with its own strengths and considerations.
ISMS – Another effective system that works well for certain organizational needs.

Both TraceX and ISMS work excellently, each with positives and negatives. The key is understanding what’s important to you, and we’d be happy to spend time with you to discuss these points. What works wonders for one organisation might not be suitable—or even detrimental—for another. This largely depends on each organisation’s unique needs, processes, and goals – just like how someone absolutely adores a coconut Bounty, whereas someone else, not so much!

Finding Your Perfect Match

Sometimes you want a Bounty, sometimes a Snickers, and sometimes you’re not even sure what you’re craving. But what you don’t want to do is settle for something medicore.

For more information on what’s right for you and how to effectively build a quality management system, get in touch with us on [email protected]. We can discuss these processes in more detail and help build you an effective, right-first-time quality management system tailored to your needs, after all, we maintain and work within our own QMS and know that a quality management system is for life, not just for your audits!

In this blog we are going to discuss our views on the benefits and need to have and maintain your Quality Management System (also known as a ‘QMS’)

IVDeology have decades of experience supporting IVD companies and manufacturers all across the globe with their Compliance journey within Quality and regulatory, and Jo Angell, our Quality and operations coordinator at IVDeology talks about the importance of a QMS that can grow with you, having experienced managing IVDeology’s own Quality management system internally at IVDeology as well as setting up and hosting other companies QMS.

What is a QMS?

Quality is defined as the “degree to which a set of inherent characteristics of an object fulfils requirements” [ISO 9000:201 5, 3.6.2]

A management system is a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives. [ISO 9000:2015, 3.5.3]

The 2 main standards covering QMS for Medical Device (including In Vitro Diagnostic (IVD)) manufacturers are:

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 9001:2015 Quality management systems — Requirements is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality.

For medical laboratories, where IVDs are used or developed as a Lab Developed Test (LDT) the additional ISO 15189:2022 Medical laboratories — Requirements for quality and competence, can be utilised.

Why have one?

It is true that establishing and maintaining a Quality Management System requires additional investment, both financially and from a resource perspective, there are substantial benefits for having one:

Demonstrates to customers your commitment to quality
Standardisation of processes
Consistent training throughout the organisation
Ensures continuous improvement
Improved productivity and efficiency
Reduced waste steps
Improved customer satisfaction
Ensures controls are in place to make safe and effective products
Identification and control of risks
Control and assessment of suppliers

An effective QMS can provide a solid foundation of quality and safety in a consistent and well-organised ecosystem

You will need one if you are intended to place IVDs on market

For the EU the IVDR states that: “all manufacturers should have a quality management system and a post market surveillance system in place which should be proportionate to the risk class and type of device in question”

As a legal manufacturer of an IVD or medical device a QMS must be implemented and compliant to the applicable regulations where you place your device on market. For EU CE marking under the new IVDR transitional timelines , this shall be no later than 25th May 2025. This is less than 12 months away!

Who’s responsible for maintaining the QMS?

Typically, this is the role of the Quality contact in any organisation. However, establishing a quality culture, and ensuring the QMS has been built, and maintained effectively is the role of the organisations top management. They need to demonstrate leadership and a commitment to the QMS.

Maintaining your QMS

A good and efficient QMS supports your company with the best way to do things, by having input from across the organisation these processes can be agreed on and will be committed by everyone in your organisation. An effective QMS should be everyone’s objective, not just Quality!

A QMS should grow as your organisation grows

A QMS is not a one size fits all, it needs to build and grow with your organisation and will never be a finished article, it should always be continually improving. The complexity and scope should also reflect the nature and size of your organisation.

eQMS are great but…

Electronic QMS software provide a great tool, but you need to build the QMS with you in mind. These will never be an off the shelf ready to go package. All templates will need to be customised and adapted to fit your organisation and processes, otherwise the QMS just won’t work.

You have the certificate and placed the product on market – but what next?

In a previous blog, we discuss the challenge of Post Market Surveillance, and what is expected , mainly from a UK point of view:

“The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.”

This means that as manufacturers you still need to be collecting data on how effective your device is – monitoring your customer complaints and feedback, any incident reporting, your manufacturing information, looking at your trends, to mention just a few possible sources of information. This data should then be reviewed to determine whether any updates are required and if so, these actions should be documented appropriately. Potential updates could impact your:

Risk Management File – Is the Severity of the risks impacted? Does it impact your frequency of occurrence of known risks? Are there new risks that you haven’t included?
Instructions for Use & Labelling – Do you need to add additional warnings? Are your instructions clear enough?
Training – Is any training that you provide sufficient? Is additional training necessary for your users?
Other products – Does the issue impact other devices you manufacture

5 Top Tips from the team on how to effectively build and maintain a QMS

Get buy in from senior management – if they don’t understand what a QMS is, and why it is important (and not just required), it will never be supported and managed effectively.
It is a growing, living thing, the more you feed it, the stronger and more robust it will be. It needs love and attention to get the most out of it.
QMS software will save you time and money in the long run.
Most non-conformances are raised against your own processes, not the standard. Make your procedures as simple and as clear as possible, ensure the people doing the work are involved in creating the processes, they know their processes the best!
Use internal audits to strengthen and improve your QMS and use your business risk assessments as a tool to help the business overcome challenges and move on new opportunities

If you’ve got this far, you’ll hopefully understand the importance of a fully functioning and certified QMS but may be worried about where to start. At IVDeology (a n Abingdon Health company) we offer full service solutions for QMS amongst our nose-to-tail regulatory support services. We can support you by:

Being Legal Manufacturer (all QMS responsibility lies with us)
Build your QMS for you
Host your QMS within our ISO certified system or we can put you in touch with Cognidox, a QMS system we use at IVDeology ourselves

Our team of experts have a proven track record for the development and maintenance of Quality Management System ranging from SME to large IVD manufacturers. To hear more about how we can support, please contact [email protected] or click ‘get in touch’ to book in with our customer success coordinator