Why the Quality Management System is a Strategy Tool

The process of developing your idea towards a real product can be one of the most exciting journeys. It can also be the most challenging, especially for first-time founders of start-up companies. The many different stages of planning that need to take place are so important to define very early on in the development cycle. There is one such important stage that if overlooked, or worse ignored, the entire strategy could be set back unexpectedly – the Quality Management System, or QMS for short.

Why a Quality Management System?

The QMS consists of procedures and processes that help ensure that quality is maintained throughout the entire development process and even within the organization itself. These procedures document how your organization will meet the requirements set forth in the standards that govern them. ISO 9001, for example, states a set of requirements for maintaining quality and customer satisfaction. This means everything is standardized to meet quality requirements, from vendor management to testing and quality checks throughout the entire product development cycle.

This becomes even more critical when developing a medical device due to added requirements. ISO 13485 provides requirements for maintaining patient safety and it is a mandatory requirement for medical device licensing in Canada. Even the FDA in the United States is strongly considering replacing its own 21 CFR 820 for Quality Systems Requirements with ISO 13495.

Regardless of the requirements, start-ups are in the dark as to if a QMS is needed, and what one will do for them. To answer that, we’ll take a look at one key factor about a QMS that is often misunderstood: its Importance.

An Important Part of the Development Plan

The importance of a QMS may already be evident. However, it goes beyond satisfying a requirement. A QMS is so crucial to the product or device development, that it must be considered as much a part of the development plan as the product or device itself. The records produced in the QMS go beyond proving that the quality and safety have been maintained and that all requirements are met.

It is true that the documents produced by following the procedures of a QMS can support a strong application to market.  However, the QMS itself becomes one of the most valuable pieces of IP because the results are duplicatable if the procedures are followed. To an organization, this becomes a powerful vehicle to multiple product development, and to a product the QMS becomes a success tool by which future versions may be easily developed.

Imagine a system that standardizes all aspects of product development by providing easy to follow procedures that support your key processes.  The QMS ensures that each element that runs your business is compliant to requirements.  Providing checks and balances, the system will help you do things such as qualifying vendors, inspecting inbound materials, verification testing, and outbound release inspections that ensure your client’s needs have been met.

Continuous Improvement

This system isn’t locked in stone either.  It is subject to a fundamental principle of any QMS – continuous improvement.  By building a system that works for your organization, it’s easier than ever to always improve it.

It’s just not about checking a box because a standard says to do so.  It’s about checking a box because the process has worked and the QMS is working well for your organization.

A Path Forward

If you would like to learn more about how a QMS can work for you and your product development strategy, contact Paul Needler, Managing Director and QMS Specialist at NeedlerQMS.

A Quality Management System is a strong tool with which you can develop corporate and product strategy. However, it is often seen as a large challenge and overlooked as a result.

#qms #qualitysystems #startup #productdevelopment #medicaldevice #strategy #intellectualproperty #iso9001 #iso13485 #qsr #mdr #continuousimprovement #standardization #regulatory #requirements