“When you are working at the sharp end of the med/pharma business, Quality Management Systems are just a bore.” Do “you” ever feel that you are being told how to do your job by people who have no great claim to excellence themselves!

Well…. Here’s the pitch….

The word “quality” remains a myth to many – talked about in manuals but having no reality in the work environment and by now is a complete turn off to everyone. We can all think of examples where the quality procedure bears no reality to what we do in practice.

What is this ‘mythical’ quality?

“Quality” has many meanings and is often misused, misquoted and misunderstood. Our initial opinion of quality is often determined by the price. Yet, we all have experience of the most expensive not necessarily being the best quality! As a result, price is a transient feature in the decision process whereas the impact of quality is sustained long after the attraction of the price gone. Quality is about standards. For example, medical device manufacturers and associated distributors must conform to the standards in the Medical Devices Directives. The standards of the ISO benefit us all in an almost invisible way: ensuring compatibility of products, and health, safety and environmental protection. Without realising, we have standards in our personal lives, for example, you wouldn’t revisit a restaurant if you were given a meal you didn’t order and it was served cold with a discourteous service. O.k., so we are only human, maybe you would give the benefit of the doubt but would you return if the standards remained the same? Thought not!! So, in business terms would you expect your customer to remain loyal if their standards weren’t met? In any company, quality is determined by all our efforts and is everyone’s responsibility. Why??? – Quality promotes Compliance for your company and your products, and it is Compliance that demonstrates the ‘safety and efficacy’ of your product to your customer. i.e. it does what it says again, and again, and again.

What does your Quality Management System do?

Whether large or small, in business, education, or health care, at one locality or with sites worldwide, companies benefit from managing activities to gain efficiency, effectiveness and competitive advantage. Your QMS allows your to achieve, sustain and improve quality economically. Benefits include increased efficiency, reduced costs and greater customer and employee satisfaction. The QMS should be easy to maintain and the information reliable, user friendly and easy to access. Flexibility is key, the system has to work for you not the other way round!! In short, QMS is reflected in the concept and reality of your products and services. Why get the hard things right and the easy things wrong!!!.

What makes the QMS successful?

– You! It is often thought that the Quality Manager or the Quality Department owns the QMS. Not So! Implementing a successful QMS is impossible without the buy in from everyone. Both your Company’s and your own success comes when the time and training is provided to motivate all of us to take responsibility. Procedures, processes and policies are not enough, it’s what you do with them!!! The most successful companies are those who have fully integrated an active QMS into everyday working of their organisation at all levels.

So, are you convinced?

Here are the teams to help you decide;-

QMS Team

Greater consistency – Customer Satisfaction Attracting new business Loyalty from existing customers More ethical than your competitors Avoid re-creating the wheel or the standard Raising the standards

WI Team (Wingin It)

Customer dissatisfaction Losing business to Competitors Disloyalty from customers

QMS will keep you at the sharp end of your business, ignore it and you will go directly to jail…Which team would you want to be in?

Nikki Clark

Quality Assurance Manager
Intavent Orthofix Ltd