Quality Management Systems Are Not Optional

By Allyssa Eclarin

It's a well-known fact that medical device manufacturing is one of the most heavily regulated sectors. As it should be. Medical devices need to follow the upmost compliance to ensure they are safe and fit for their intended purpose.

What makes them the most heavily regulated?

For a medical device to reach the real world it requires that quality systems and product requirements must be fully and completely satisfied before any product can even be designed, produced, and placed into the market.

That means before you, the consumer can enjoy the benefits of a medical device such as a pacemaker, a TENS unit or even a wheelchair it needs to be sure it has met each requirement outlined in ISO 13485.


ISO 13485 was written and created to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes and products. Some organizations choose to not follow along and utilize a QMS (Quality Management Software) system as required in ISO 13485. Some believe QMS systems are more of a “worry about it later” system or a “nice to have” when the truth is that it is really a must-have.

QMS systems are not optional. They are required. ISO 13485 requirements are applicable to any organization regardless of their size.

What exactly is ISO 13485?

ISO 13485 is the most recent QMS standard from the ISO 9000 quality management standard series. ISO 13485 retools the previous versions of ISO 9001 and the ISO 9000:2008 process-based model for medical device manufacturing. ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices – that means employing a QMS system.

You cannot pretend that QMS regulations and requirements don't apply to you or your company. That's a huge and costly thing to assume.

The FDA can and will audit you if and whenever they please. Now how's that for added motivation?

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Making the investment in a QMS system you can use today and as you grow will not only save you time and money down the road, it'll also keep you compliant. Win-win!

Final Roundup

You need a QMS system because:

  • It aligns with regulatory expectations. That means it's required.
  • It establishes a framework for how you do business.
  • It defines and documents expectations and deliverables for key processes.
  • It documents design controls and risk management which are key to product development success and success is a very good thing.
  • It will grow with you through product development and company growth.
  • The FDA needs you to have one. (Refer to first bullet again.)

As you can see a QMS system is not at all optional. Now you need to act and find the right QMS system for you. Since you're already here might I suggest Propel's QMS system?

See the Propel QMS Demo


Tags: compliance, QMS, quality management software