Is Your QMS a Mess?

I can’t tell you how many medical device quality management systems I’ve operated under and/or reviewed during the past 17 years of my career. I’m guessing I’ve seen about 50 QMS implementations.

Out of the 50, about 90% of the companies put a QMS in place that was an absolute mess.

What is so complicated about a QMS? I mean, FDA defines quality system regulations in 21 CFR 820 and of course there is ISO 13485. Both FDA regulations and ISO requirements have been firmly established for many years now. And for the most part, both FDA and ISO are in alignment regarding QMS expectations. Seems as though we should be able to implement a no mess QMS.

You know as well as I do that this is easier said than done. A company’s QMS can easily become complicated, convoluted, and overly burdensome.

Company's establish piles of procedures to address QMS needs

Company’s establish piles of procedures to address QMS needs

Seldom is a simplistic approach taken when implementing a QMS. Keeping a quality management system as simple as possible can be hard work. Maybe this is why companies establish the piles and piles of procedures, forms, and templates in an attempt to define a cohesive QMS.

A QMS mess is easy

It is very easy to make your QMS a mess. It’s easy because it doesn’t take much thought to start writing quality system procedures.

Lack of a sound, thought out QMS implementation strategy will quickly become fragmented and broken–a mess.

Lack of QMS strategy will result in fragmented implementation

Lack of QMS strategy will result in fragmented implementation

Often, the objective of a QMS seems to be more about complying with quality regulations and less about establishing sound business practices.

What is the goal of your QMS?

If you are putting a QMS in place to only satisfy FDA 21 CFR 820 and ISO 13485, you’ve already lost. And you may not realize and learn that you’re losing the QMS battle for quite some time.

Here’s a secret: Your QMS is not about meeting regulations

Go with me for a minute. Forget about FDA QSRs and ISO 13485.

Remember, though, you are a medical device company designing, developing, and manufacturing life-improving and life-saving technologies.

Imagine that you are just starting your medical device business. Imagine that you have a clean slate.

Would you define and document any of your processes? Why or why not?

I’m guessing that you would want to define and document your processes because you realize that the people that work for your company need to know what to do and when to do it. I’m guessing that you want to design, develop, and manufacture medical devices that are safe and effective. I’m guessing you want to improve and save lives.

Keep imagining with me for another moment or two . . .

As you start to define and document your processes, you start to discover some things that you captured are clear and work well. You also start to find things that need some improvement.

This is the real essence of a QMS: defining the way you design, develop, and manufacture medical devices.

And thankfully, FDA and ISO have provided us with a framework of how to define and document our processes.

This is good news.




Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handle Design Controls. Because of this was born. You can find him on Google+Twitter, and LinkedIn



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