When to put a Quality Management System in place
In my previous article entitled “Why the Quality Management System is a Strategy Tool”, I asked you to consider the Quality Management System as a very critical part of the development plan for any product or medical device, and to to adopt a QMS to support your strategy. Once you have committed to implementing a QMS, another burning question arises that start-ups and first time founders ask – When do we put one in place?
To begin to answer this, one thing is for certain. A QMS cannot be put on the back-burner only to be quickly implemented near the time to go to market. Such a hastily implemented system would likely fail the certification audit. Furthermore, the product release would be dramatically set back, because so many requirements would be realized as not met. This could lead to added costs of the project. It could lead to a loss of faith by key stakeholders.
Knowing when involves analysis of the needs
Knowing when to implement a QMS is not as simple as deciding on a whim. To do it effectively requires some analysis of your business elements that will support it. Effective planning will be needed, as well.
Every organization will have different timing requirements based on their strategy. It would depend on factors such as, the development plan, and the impact of the requirements on the development cycle.
Recognizing the QMS as a crucial part of your development plan helps illustrate the path to meeting regulatory requirements. Additionally, a Regulatory Market Strategy will help identify most costs, timelines, and additional processes that will integrate into your Design and Development plans. All of this combined helps to shape your strategy.
Another common driver of QMS implementation that I have seen with clients is that of funding. Adequate funding must to be allocated to a QMS to support its substantial value to the product development. However, look at it for what it really is – an investment! The QMS will not only support your development towards getting to market. It adds mountains of value to the Intellectual Property of the product. Consider this value as an important asset. I will explore this idea in an upcoming article in March 2024.
The Design and Development phase triggers the need for a QMS
Generally speaking, it’s best to implement a QMS near the end of the discovery phase. This would be where it is evidently feasible to build the device. Entering the design and development stage with a QMS in place directs building a prototype that is compliant to quality and safety. Everything including vendor approval, parts inspections, design reviews and identifying and mitigating risk becomes part of the development workflow. All of these processes ensure compliance.
So, imagine your company is making a new device that diagnoses arrhythmias. During the initial planning stages you would build in the costs and timelines of implementing an ISO 13485 QMS. However, you would not need it implemented until the start of the Design and Development stage. The device science is proven, and you are actually figuring out how to make the device.
It is at this point where a QMS, and specific device performance requirements, would define the needs of design inputs and outputs. For example, using our example arrhythmia device, specific standards would inform your design by telling what is permitted for alarms and notifications, or by which methods arrhythmias are to be detected. The QMS will guide you on the processes to test and verify the device performance for compliance to these standards.
The reason for early implementation is to create essential documents required for market application. This means, for example, that your Design History File is created real-time and will collect all the decisions made that will ultimately become the final device.
An Alternative to Consider
If your strategy involves going further down the road of development in order to gain investment, this likely means deferring the funding of a QMS. This approach may not be the best solution for an organization looking to manage all aspects under one roof. However, there are alternatives that do cater to this need.
One such alternative is outsourcing the design and development activities to a firm that operates under its own certified ISO 9001 or ISO 13485 QMS. Such a firm would conduct the design and development processes in its own regulated environment. As a result, the compliant output would provide the required documents that you will ultimately absorb into your own QMS. This allows for a deferral on implementing your own QMS. In the end, this may allow you to garner more investment with a solidified development path, and fund the QMS a little (I’ll say it again ‘little’) bit closer to market application.
Never too early, usually too late
There is no special formula that tells when a QMS is to be implemented. However, it is never too early and can usually be too late. Finding that “sweet spot” is not a decision to be made quickly nor lightly. It will involve a good deal of discovery and understanding of the regulatory requirements to get your product to market.
If you would like to learn more about how a QMS can work for you and your product development strategy, or even how a Regulatory Market Strategy report can be of benefit, contact Paul Needler, Managing Director and QMS Specialist at NeedlerQMS.
Knowing when put put a Quality Management System in place is no simple decision. It requires analysis and planning and deciding the best strategy for your business.
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