Before you build a quality management system (QMS), it’s critical that you understand what is your key driver.

Over the years, here are some of the motives I’ve heard:  

  1. It’s a milestone for the next funding round.
  2. It satisfies regulatory requirements (i.e. CE mark, FDA approval).
  3. We’re “forced” to have one.
  4. We’re about to fail/have already failed an audit. 
  5. Our business is growing, and the existing QMS is too complicated for our expanding team.
  6. We already use Confuence and JIRA, and moving our QMS over will make things easier, more collaborative, and more engaging.
  7. We need a solution that can scale up to include our supply chain.
  8. We want to improve customer service.
  9. We need faster product development.
  10. We want to monitor our internal processes to easily identify areas of improvement.
  11. We want to improve our product.

These are all valid reasons, but  there’s no “one size fits all” solution. For example, if the primary reason  is to achieve an investment milestone, then the resulting QMS is unlikely to also improve your product.

This is one of the key reasons why quality management systems tend to have such bad reputations: They are built to meet one need, but once created, they are expected to perform on the other fronts as well.

Be honest about what you want today, as that will help you find the quickest fix. Just be ready (and willing) to change your QMS as your needs evolve and your business outgrows it.