Implementing a quality system that works

ISO is a three letter word. Most think of thick quality manuals and multiple forms one has to fill out to change their desk location. I’ve found it doesn’t really have to be this way. Did you know there are really only six required procedures for ISO9001?

IT MUST BE USEFUL
Seriously, only Document Control, Record Control, Control of Nonconforming Product, Corrective Action, Preventive Action, and Internal Audits are necessary to be controlled documented procedures. An unread manual is useless. A useless manual is likely one that’s hard to read. Simply document briefly with easy to read language these six procedures along with a few more of my favorites relative to communication, training, product history files, sanitation (clean room), and product introduction to manufacturing, to create an effective Quality Management System.

In addition to this concise language you’ll be using, also clearly identify all documentation and make it easy to find.

Sure there are lots of topics in 9001 and 13485 that a company should take heed and follow the advice to have procedures – but the point is, it doesn’t have to be controlled except for those ‘golden 6’ and the few others you deem critical. Less control means less paperwork which means happier colleagues which equals more use of the system thereby encouraging compliance and few to no quality issues.

If the system you currently use is hard to use and infrequently used, it’s not providing value to your company and may eventually (if not right this moment) cause you to be non-compliant with quality issues on your hands. So, forget the lawyer speak and get to the point to keep procedures brief, simple, easy to follow, and with some flexibility for the user to be creative in product development, leadership, and in solving day to day problems.

I once witnessed one company who eliminated text in their procedure writing by using a flow chart. Everyone likes pictures, right? ISO was created to help not hinder a company from operating with excellence and consistency.