If you were asked to explain ‘what is a Quality System’, could you do it? The reality is that most people don’t have a clear understanding themselves and would be hard pressed to explain it to others…regardless how long they’ve worked in the Quality field.
In general, a Quality System is a collection of processes, policies, procedures, work instructions, forms, etc. that make up your business. The actual scope of the System, where it begins and ends, is defined in your application to regulators and certifying bodies.
The scope would typically include those processes that have the potential to impact the quality of your product/service either directly or indirectly (e.g. manufacturing, training). Sales and marketing are often excluded because they don’t have an impact, making them off limits during an audit.
But what if your company is ISO certified and is regulated by the FDA….does this mean your company has two Quality Systems?
Every company has just one Quality System that’s regulated or monitored by one or more external sources, each with their own requirements. It’s common for people to confuse the concept of a Quality System and will often state they have ‘twenty something’ Quality Systems, when they really mean processes.
I sometimes flinch when I hear Quality leadership make this common mistake, reminding me of Inspector Clouseau’s boss, Chief Inspector Dreyfus, in the Pink Panther movies.
So, the next time you hear someone say they have more than one Quality System, you’re now armed with enough information to educate them as to why they only have one.
Leave a comment and let me know if leadership at your company makes this common mistake?
