These are some of the common questions asked by medical device companies still in pre-market product development stages.
With the development of your product being the focus of your attention, having a Quality Management System (QMS) in place is not deemed by many to be a priority or necessity. However, this is a misconception that needs to be corrected. Setting a structure in place for orderly execution of all business activities is just as crucial.
To understand why having a QMS from the get-go is important, we need to first get a clear picture of what it is.
What is a Quality Management System and what good will it do me?
A QMS is a system, set up within an organisation to formalise best practices so as to enhance its business. This enhancement of your business occurs on multiple levels when your processes are orderly, with clear records kept.
Most importantly is the enhancement of your business efficiency. Efficiency is achieved through clear communication. Proper communication channels are built through the QMS, which allows your team to better understand what has been done and what needs to be tackled. This helps to reduce redundant questions or repeated answers regarding any issue. Mistakes due to miscommunication, major or minor, can be avoided as well.
Besides, your organisational credibility will be enhanced as you clearly show how you are able to manage your business processes. According to the ISO 13485 standard, the QMS is a set of policies and procedures required for companies to identify, measure, control and improve core activities to meet customer and regulatory requirements. As customers know that you have attained, and are maintaining a certified QMS, they can feel more assured that you have a system in place to ensure patient safety and consistent product performance.
Lastly, business is enhanced as regulatory requirements are met and market access is gained. Ironically, this last point of the three, is what most of us care about. However, bringing the product to market would not be possible or sustainable, if not for a solid foundation set on a firm QMS structure. Rather than mere paperwork handled by the quality department, your QMS structure is holistic, involving every individual in your company - each of them plays a role, directly or indirectly, in producing your product and/or services.
Particular to the Medical Industry, the ISO 13485:2016 standard outlines QMS requirements to be adopted. It applies to companies involved in the design and development, production, distribution, installation, servicing and more, of medical devices, including software.
When is a good time to adopt the ISO 13485 and implement my QMS?
Clearly, having a QMS is important and beneficial to companies and businesses. Unfortunately, too many put off QMS implementation for too long. Many find the ISO 13485 guidelines applicable only when development has progressed close to the stage of manufacturing (or software release, in cases where the product is a software) and distribution.
From the start of operations, processes, albeit largely informal, had begun. Implementing a QMS in line with ISO 13485 requirements is about ensuring that your processes are in line with recommended guidelines, and recording them appropriately, as evidence that you are getting things done right. With this done in the early stages of your organisation, you can more easily encourage the establishment of processes within your team and at the same time, minimise the adjustments needed to comply with the standard’s requirements. In fact, your team can best plan their projects knowing the QMS structure it must operate under and expectations it needs to meet.
If you are unsure about when to begin, a good estimation for implementation of your QMS would be the point when you move into your product development phase from your research activities. This is when proper processes and documentation play a more important role than before - some people call it good document practice. Yet, ISO 13485 requirements cover more than just the process of document keeping, as it delves into all functional issues of your company, including recruitment, training, supplier evaluation, risk management, and more. Without a clear understanding, most people would feel that adopting a QMS is just another paper exercise that does not value-add to the company.
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Over the next few weeks, we will elaborate further with examples of companies from various backgrounds, showing how they are tackling the implementation of their QMS differently, but appropriately.
For now, feel free to read more about the ISO 13485 here: