The Heart of Quality

"The Heart of Quality" is a blog by Medos AB, the team behind We use this blog to share our experiences from many years of implementing good quality management practices in a wide range of medical device companies. Our thoughts and ideas mostly revolve around regulatory challenges, certification aspects and how to best manage QA and RA issues as a small enterprise.

Key success factors for small business quality management systems

The implementation of a quality management system (QMS) can be incredibly challenging. It is an act of delicate balance, where staying agile and adaptive is easily counteracted by the need for compliance with regulations, standards and customer requirements. Without careful consideration, chances of real success are quite slim.

Make sure the time is right

First of all you have to ask yourself if right now is the best time to implement a QMS. Keep in mind that many small companies do very well without written procedures and ISO certifications, at least until their growth reaches a tipping point where daily business starts becoming unmanageable. If you start implementing procedures before your team has a real need for them, you might end up with a QMS based on fiction and vague ideas about how you want to work in the future.

But for companies where top management and key employees truly understand the benefits of a QMS, there is really no need to hold back. Knock yourselves out - the sooner you get it done the better.

For companies in rapid growth – inside the ‘tornado’ – you might very well find all the acceptance you need for making changes to operations. The effects of the tornado are seen and felt all over the organization and anyone who raises their hand and yells out ‘Hey guys, how about I try to set up some procedures to make sure you get the info you need when you need it?’ is likely to be cheerfully appreciated. But it is not easy, because no one will have the time to help out, and there is a significant risk that your QMS champions will be consumed by other tasks. Managing the chaos of daily business is likely to be prioritized over QMS initiatives. It is – quite literally - too late for a smooth ride. Your QMS might have to be forced upon the organization by someone with great authority. However, failing to act distinctly in this situation, you risk wearing down the heroes of your team who are forced to compensate for the lack of quality management. In the long run, senior staff might to start dropping off, leaving you with a poorly motivated and under-performing team.

In my mind, a QMS should be implemented before, or at the latest during, the entry into the tornado. At his point, your operations are scaling up and some areas might already be struggling with coordination issues. The fact that you are at the doorstep to success starts to become evident to everybody. You have the sense of urgency you need and people are beginning to see the need for alignment – now get it done sooner rather than later.

Find a rock star frontrunner

Identifying the right QMS project manager is crucial. If you pick someone that has worked under a single QMS their entire career, you are bound to end up with something modelled after this system. If this is exactly what you need – lucky you – if not, your best bet is a person with broad experience from multiple QMS projects.

A common mistake is thinking you can directly apply experiences from large enterprises in your small business. Sorry to say this, but it doesn’t really matter that you abide by the same standards and regulations – you cannot use their procedures. Instead, make sure you have a QMS project manager who knows small business quality management. Personally I consider this to be more important than detailed knowledge about a specific standard or regulation.

Your QMS project manager also needs to be a good listener and communicator with good language and writing skills. Attention to detail is of paramount importance, at least if you intend to certify your QMS.

Last, but not least, you need to make sure your QMS project manager can effectively understand your team and gain their respect. For this to happen, this person needs to truly understand your line of business. Lack of subject matter insights cannot always be compensated by good project management and communication skills.

Maybe you are lucky enough to have someone on your team already? If not, make sure to hire a top notch consultant. And don’t be fooled by a cool CV – take the time to make some calls and interview a few references.

Pay attention

A QMS project is not a one man gig. The whole idea of a QMS is to coordinate people in their daily activities. First of all, if you try to whack your team in the head with procedures coming from nowhere, they will instinctively be sceptic, thinking – ‘What the heck makes you think you know my job better than I do?’ Also, soon enough you will discover that you actually don’t. You might know the standards and regulations, and you might have experiences worth a whole lot, but true change doesn’t happen inside documents. You can only accomplish changes if you involve people, gather their input and actually pay attention to what they are actually saying. When meeting resistance, your best tools will be to listen and compromise.

It is also important to identify the key opinion leaders of your team. Consider these guys your ‘change coalition’ and make sure they are involved in the project from the start.

Keep it short and simple

Imagine for a moment, receiving a five-page email about a boring topic which is badly written and full of complex language and repetitions. Would you read it? Or would you quickly browse through the first few sentences and then skip to the end before tossing the email and forgetting about it? Well… the same thing applies to procedures. Do not underestimate reader fatigue!

When setting up procedures, I recommend sticking to these simple rules:

-          Keep it short - Write as few procedures and documents as possible. Use few words, short sentences and concise bullet lists.

-          Not too fancy - Write what you mean, not what you think sounds fancy.

-          Examples – Using examples is often more effective than complex explanations.

-          Once is enough - Don’t unnecessarily repeat information.

-          Checklists - Use checklists for sequencing actions whenever possible.

-          Simple flowcharts - Flowcharts are great - but don’t complicate them. Some things are better explained in text.

-          Professional appearance - Spend some extra time on presentation to ensure consistency, polished language and visual appeal.

Set up a vision beyond the certificate

In all types of organizational changes, it is important to make sure everyone understands why the changes are needed and what will be accomplished. This is exceptionally true for a QMS project, simply because of its scale and the widespread effects it will have on your business.

But in QMS projects, the really big mistake is when you communicate the wrong change vision. I can’t event count all the meetings I have attended where top management have said ‘We need a certificate to hang on the wall, that’s it’. With this attitude, what you get – best case scenario – is a certificate to hang on the wall. Worst-case scenario is that your entire QMS comes out as junk in the other end and the second or third time the QMS is rebuilt from scratch, the change vision is updated to something like ‘This time around we need a QMS that actually fits our needs and helps us achieve our goals!’.

Take it step-by-step

Team members often have bad experiences from big enterprises with bureaucratic quality management systems. Sometimes even top management is vocal about the ‘toxic’ effect of written procedures. In this situation, attempting to implement a full QMS from one day to another will likely fail. To succeed you need to make changes step-by-step, making sure each step relieves a specific pain in the organization. This way, you will slowly start to gain traction and acceptance. It is also important to make sure to focus on core processes where the effects of your changes are tangible.

When you set up your plan, don’t plan for a big launch date and try to make everything converge on this point. You will just end up with one big confusion on your hands. Instead, plan your project in short iterations, where each process is implemented, evaluated, adjusted and re-evaluated until you nail it. Think of your QMS project in terms of a number of individual PDCA (Plan-Do-Check-Act) cycles, instead of the all too common Plan-Do-Do-Do-Do-Do-Fail-Restart.

Leverage the power of the clouds

Ten years ago, small businesses had to rely more or less completely on physical forms, binders and shared file server folders for sharing documents and records. Few companies had the experience or funds required for a good local setup of a groupware or document management suite like Lotus Notes or Microsoft SharePoint.

Since then, times have changed. Information systems have started moving into ‘the cloud’, basically meaning that they are completely hosted online. The implementation of an infrastructure for your QMS can now be accomplished in a matter of minutes. This enables you to focus on your core businesses instead of spending time and money on servers, installations, up-front software licenses and maintenance.

Many companies effectively use ready-made solutions like Dropbox or Google Docs to share documents, host their e-mails on Gmail and communicate projects through one of the numerous project management portals available online. Aside from these general purpose systems, there are also solutions emerging that have been tailored to facilitate the implementation and management of a QMS, such as the solution I work with myself – Handled correctly, these solutions can provide an excellent ecosystem for your QMS and help it gain wide acceptance.


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