Updated: July 9, 2024
THE «ISO» UP CLOSE
«For your future career with us, you should definitely complete the training to become a quality management representative – QMB for short! This is an absolute MUST for a project manager in the field of quality management at an internationally operating medical technology manufacturer!» And so, four weeks later, I found myself in the middle of a group of twelve colleagues in the training center of my then employer. On the agenda for the week: ISO 13485:2016, an international standard that regulates the rights and obligations of a medical device manufacturer with regard to the design, manufacture and distribution of medical devices in the then current version.
You could say: ISO 9001 on steroids with the aim of ensuring the safety of patients, users and third parties with regard to medical devices to the greatest possible extent. I had actually been aware that I would have to go back to school at some point in order not to stand still, but I had successfully suppressed this due to the daily business, project meetings and project status presentations.
While the nice middle-aged trainer with a likeable Swiss dialect introduced herself to the group, I let my thoughts wander a little. What was all this about standards, guidelines and certifications anyway?
STANDARDS: THEY ARE AMONG US – THEY ARE EVERYWHERE
I plugged my laptop charging cable into the power strip of the training table. «Ha!», it sounded loudly from the front. «Did you notice?» Curiously, I looked behind me and was curious as to which transgression of my colleague now attracted the attention of the entire group. «You don’t need to turn away. I mean YOU!». The trainer was now uncomfortably close to me. With all the kindness I could muster at 8:00 a.m., I looked up and felt for a moment as if I had stolen a warm apple pie from the windowsill.
«Yes, please?», I asked. «If anyone among you has just wondered what all this is about with the standards and guidelines, your colleague here has just given you a vivid example. Because it would have been a shame if the plug of your connection cable for the laptop was two millimeters too wide or the two power pins were one millimeter too close together. Don’t you think? Become aware of standardized standards in your everyday life, because you encounter them every day, everywhere: Have you already filled up with gas today? Have you already written a short message with your smartphone? Or were you happy yesterday evening that your soccer colleague still had an old USBC charging cable for your smartphone in the drawer? What do you think, how happy is the truck driver in the Port of Hamburg that the container from Shanghai actually fits 1:1 on his truck? All of these are just a few examples of the immense advantage that standards and guidelines provide for the general public.»
Silence in the room – the lady had completely captivated us in just two minutes. What else is standardized? And why?
THE SWISS STANDARDS ASSOCIATION (SNV) – YOU ALWAYS MEET TWICE
The likeable trainer had congratulated me on passing the exam at the end of the two-week training course three years ago. She was on the road on behalf of the Swiss Standards Association (SNV) as a trainer in the Mission ISO 13485 to train industrial companies on the most important key points. I had no idea at the time that three years later I would be sitting in the modern premises of the SNV in Winterthur to coordinate with the head of the SNV-Academy.
But what do they actually do at the SNV? Doesn’t it have to be a very dry business if everything revolves around standards and guidelines? My image of «standards and guidelines» has solidified. Often frowned upon as an allegedly very dry and very difficult to convey topic, the SNV has taken a new approach here and expanded its range of services within the framework of its Academy. Around 40 experts work at the SNV. The organization represents a competence center that is committed to the efficient handling of national and international standards. So far so good, but what exactly does that mean?
First and foremost, it is the central Swiss point of contact for further training in the context of standardization. So, if you – like me three years ago – would like to build up an understanding of a specific guideline, this is the right place to be.
Secondly, the SNV enables its members and their experts to actively influence the development and harmonization of new standards. It is involved in national and international standards committees.
Thirdly, the company is also a point of contact in individual cases in order to convey a clear understanding of the worldwide requirements for market-compliant products and services in the jungle of laws, ordinances and guidelines. If you want to apply for approval for a new product, it is advisable to first inquire at the SNV which requirements this specific product must meet on a specific market.
NEW WAYS OF KNOWLEDGE TRANSFER
The idea of bringing knowledge about standards and guidelines closer to interested parties via E-LEARNING is obvious. Face-to-face courses require suitable premises, the necessary IT infrastructure for the digital connection of experts and, of course, usually also travel expenses. Participants have to travel and are absent from their actual place for the entire duration of the training. E-LEARNING offers the great advantage of finding the right learning element of e-learning for every specific content – exactly as the target group needs it. In the case of the SNV, this is not only a step forward in terms of digitization, but above all an ingenious move, as the topic of standards can be brought closer to a target group that may have previously faced the whole thing with prejudice and shyness.
Together with Swissteach, the SNV has built a system that allows you to easily book and pay for an e-learning course via the SNV’s own web shop. A generated code from the web shop is the ticket to the SNV’s LMS – a version of GLOBAL TEACH® specially tailored to the needs of the SNV.
Enter the code, start e-learning and take away knowledge – learning about standards and guidelines can be that easy and, above all, NOT dry! If I’m honest, I would have liked that as a further training participant three years ago. In this way, I might have been able to make my 300-page folder with all the paper documents a little slimmer. Of course, E-LEARNING cannot replace 100% of all face-to-face courses in such a context. The topic of standards and guidelines also needs exchange and clarifying discussions to a certain extent. But here, as so often, the mix makes the difference! Anyone who optimally uses the concept of BLENDED LEARNING, i.e. the right mix of digital content and face-to-face events, offers themselves and all interested parties a huge added value in order to impart necessary knowledge in the most efficient way.
We at Swissteach are proud to be part of this story and are already looking forward to more and more people making use of the SNV’s services and e-learning offerings in the future. After all, it has been shown that there is no escaping standards and guidelines. And that’s a good thing!
CONTACT
Have you become curious about the topic of standards and guidelines and would like to get an overview of the E-LEARNING range and other further training opportunities offered by the Swiss Standards Association (SNV)? You can find an overview under the following link:
https://www.snv.ch/de/academy/e-learning.html.
Or would you like to write your own success story with the best LMS for your needs? Do you want to break new ground and bring more efficiency to the further training process? Then simply get in