Our quality assurance program? Sure, it’s over there on the shelf!

The effectiveness of a quality assurance program is highly dependent on regular optimization. In any regulated industry subject to rules of authority and certification, some form of quality assurance is a necessity. But such a system has a tendency to grow once it’s implemented, because “Oh, we need to put this in there, we need a procedure for that, too!” This does not increase effectiveness – quite the contrary, in fact.

Shelf with Folders


How do you get your quality assurance program off the shelf and into your business?

For effectiveness, it is important that only the right things are described and that management has prudently determined how to adapt the system to the organization, instead of the other way around. Of course, minimum regulatory requirements and certifications must be met. For the regular system review, many regulated firms and their subcontractors utilize internal audits, performed by either the company’s own auditors or certified, external auditors.



Choose the auditor that is right for you

In choosing your auditor, trust is of the essence. And the conviction that such audits add value to your company.
The advantage of utilizing you own auditors is, of course, their in-depth knowledge of the company and hence their ability to examine areas and contexts that have shown a need for review and possible improvement.

The risk is the inability to review one’s own area of work or one’s immediate superiors; not seeing the forest for the trees, so to speak; and fearing for the advancement of one’s own career when pointing out the boss’ failings to comply with specified procedures.

By utilizing certified, external auditors, you will be able to draw on their knowledge of other ways to perform the procedures, so the process of reviewing also yields suggestions for possible optimizations. It is also possible to have the same external auditor review your company on a regular basis, yielding a deeper level of insight and hence a more thorough audit. Unfortunately, the added value from such “same old” auditors may also decrease with time, as the recurring reviews become a matter of habit and may cause the auditor to always look in the same places and to become apprehensive about addressing nonconformances.

So whichever type you choose, it will always be recommendable to make a change once in a while: Fresh eyes often spot new issues from new angles.

Medicologic can help you through the audit process. Call us for a talk.


Asger Dahlgaard, Program Manager

Direct (+45) 22 47 41 06
ad@medicologic.com