Knowledge matters


How I see it - Tammy M. Pelnik

Living in the real world, I am certain each and every day that there is a chance something may go wrong. An unexpected “oops” because stuff happens! It’s a cold, snowy day, someone slips and falls on the sidewalk, or a flight is delayed because de-icing is essential for safety’s sake and that takes time. I accept the challenges every day events present, and look for opportunities to reduce the likelihood of these potential mishaps. Considering the weather conditions before selecting footwear, might be enough to prevent today’s slip and fall. And if they are not, maybe next storm I reconsider: is it time for new or different boots?

Quality Management System standards have the same pragmatic approach. Rather than hope that nothing will ever go wrong, or treat each incident as special case, simply establish a systematic process to help identify, evaluate, and resolve issues that could cause ongoing problems with your product. This aspect of your QMS is another case of accepting the real world for what it is (i.e., stuff happens), and striving to make improvements where they’ll really help. The concept of Corrective Action and Preventive Action have persisted and matured.


"People don’t really disrespect the CAPA process as a concept, but they don’t believe in the way CAPA has been implemented."

How I see it - Lars-Eric Ellow

Even though we all have challenges during this pandemic situation we strongly believe in our mission and you can rest assure we plan for future training events together with you when we are on the other side of this. In the mean time I still want to share some thoughts below - stay safe and wash your hands!

Working with training, it is important to be attentive! What’s going on in the industry right now and what are the training needs out there? We want to know about the challenges and the things our clients face when it comes to quality systems.

A common theme for our courses is that the course also must be of high quality with competent and knowledgeable trainers with a good sense of how to convey a sometimes complex topic, but another aspect for us is also that the trainers really appreciate being with us. That really is a benefit with our Certified Trainers Network, to give and receive, and to build up a loyalty.


"With 40 free-lancing trainers in the network, there is a huge amount of knowledge and experience to share!"

How I see it - Layla Hohn

When you attend our courses, you should have an overall great experience! To achieve that, we work hard to ensure that the content is relevant and of high quality, that the lecturers are competent and have the right knowledge, but we also strive for everything around it to work smoothly.

A lot of effort has been put in on finding a suitable venue for the purpose, that it is close to the airport, that the food is good, that the technology is optimal, etc. All for the overall experience for you as a customer to be optimal.

We are constantly working to become even better. Such as we are also looking for new places for our courses in other countries, to make sure that our course facilities are easy to access. We are constantly looking at new premises that better match our wishes.


"We are always on hand to assist if you as a customer need help with anything or have any questions. So, come to us with your questions and wishes!"

How I see it - Anna Lundén

If you buy a book shelf and put it together in accordance with the supplied “validated” instruction manual, it will most probably stand steady in your living room. But if you don´t bother to follow instructions, it may end up with a shelf being placed in the wrong direction, and if you then place an items on that shelf, it will perhaps fall apart.

It is the same way with your quality management system. You need your manual (your quality procedures) on how to manufacture your products. If you don’t follow these procedures or lack procedures, there is a high probability that something goes wrong in the production of your product. It may just cause a delay in the production process, but it can also cause worse things like quality problems and potential harm to the patient or user of your product. Another aspect may be criticism from authorities during inspections.


"The key to success is knowledge – with more knowledge about requirements – the less mistakes there will be."