What is a QMS and how can it implemented?
A QMS is a set of processes implemented by an organisation to ensure and demonstrate that it meets the standards needed to satisfy customer demands and expectations. Having a formalised Quality Management System that is used by your organisation to ensure the delivery of a product to a consistent standard is also a requirement of ISO 9001 and ISO 13485. These are the quality standards that many organisations need to meet to secure regulatory approval for their products.
A QMS can be designed and implemented by external consultants or internal teams, using standard office software or specialist, proprietary solutions. These solutions vary in cost and complexity, some requiring the installation of applications and others offering a more lightweight approach.
But it’s not enough for your company simply to have a Quality Management System.
As the great advertising executive, David Ogilvy once said,
‘You can't save souls in an empty church’
A QMS you’ll want to use
The QMS you select or create has to be effective, easy to use and your team have to be using it for it to make a difference.
We would go even further than this and say it also has to be a pleasure to use if it’s really going to become the ‘way you do things’ rather than just a theoretical description of how you think things should be done.
If a product is overcomplicated and difficult to use your team will inevitably try to find ways to avoid using it. This, in turn, increases the chances of regulatory non-compliance and raises the risk of your business failing a quality audit.
When good governance comes naturally
Think of one of the most basic and important functions of a QMS, allowing you to store, share retrieve and audit the latest and definitive version of quality documentation.
The DMS (document management solution) element of your Quality System should enforce the control requirements that match your regulatory obligations, but in a way that makes it the natural place for your team to work and collaborate on them.
When working on iterations of important files or submissions it should provide tools for version control, allowing you to share latest drafts, track changes and seek approval from key stakeholders before release. A full audit history of every document you generate should be available within the system, so that decision-making processes can be reviewed if necessary and compliance with quality standards checked. It should impose naming conventions that make it clear which is the most recent, approved version of a file and prevent important documents being worked on at the same time by different individuals.
The way your Quality System handles document control should reflect and impose the approach to governance required by the sector you are working in and the professional standards it demands.
So, your team should want to use the solution you offer them because it helps them work more systematically and with greater precision to meet these standards.
The rigour and good governance your chosen system imposes should make their working practice safer and more productive in a way they can easily recognise.
An intuitive and user friendly QMS
Your selected Quality System should also be the natural choice for your team simply because it makes their life easier.
One of the functions of a Quality System is to be a repository for best practice documentation, to record and store your working processes so they can easily be replicated, audited and optimised. Regulators often require evidence that these processes are accessible to the entire business and subject to regular review.
A Quality System that allows you to create dynamic, work-flow diagrams as part of a Process Driven Intranet will clearly be a more accessible way of promoting best practice than a text-heavy, real world ‘user manual’.
As the computer scientist Ben Schneiderman points out in his Eight Golden Rules of Design:
“A picture is worth a thousand words. An interface is worth a thousand pictures.”
But more than this, process diagrams, in the words of design guru Edward Tufte, can also be a catalyst for analysis and improvement:
‘clear thinking made visual’
They can help you see and understand more about your business at a single glance.
They are a powerful way of visualising the connections, dependencies, gaps, risks and opportunities that your quality system describes. They are a way of seeing, literally, how all your processes fit together and feed into each other.
Most importantly, they can help you better identify all the necessary inputs, dependencies and expected outputs of a process, and see more easily where things might be going wrong or could be further optimised.
For a business made up of complex procedures and processes, the layers of detail offered by a good, interactive work flow diagram, will be a resource your team will naturally gravitate towards for ongoing training, analysis and clarification.
They are an easy way of checking you’re following process correctly and avoiding mistakes, and a good way of keeping process front and centre of your thinking.
So, if one objective of the Quality System is to encourage a process of continuous operational improvement and optimisation, visualisation tools like this one are a natural and user friendly solution.
A QMS that really does its job
In the end, if a Quality Management System is intuitive and easy to use, then your team will use it. If it makes their life easier and makes them more productive they will use the tools it offers, naturally, as part of their daily routine. And if your chosen system achieves all this, you will easily demonstrate to regulators and other quality auditors the way your working practices ensure standards are met.
And if that’s the case, the Quality System will have really done its job.