"ISO" UP CLOSE
“You should definitely do the training to become a quality management representative – QMB for short – for your future career with us! This is an absolute MUST for a project manager in the field of quality management at an internationally active medical technology manufacturer!” And so, four weeks later, I found myself in the midst of a group of twelve colleagues in the training centre of my employer at the time. On the agenda for the week: ISO 13485:2016, an international standard that regulates the rights and obligations of a medical device manufacturer in terms of the design, manufacture and distribution of medical devices in the latest version at the time.
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 realised that I would have to go back to school at some point so as not to get stuck, but I had successfully blocked the thought due to all the day-to-day business, project meetings and project status presentations.
While the nice middle-aged trainer introduced herself to the group in a pleasant Swiss dialect, I let my mind wander a little. What was all this about standards, guidelines and certifications?
NORMS: THEY ARE AMONG US – THEY ARE EVERYWHERE
I plugged my laptop charging cable into the power strip on the training table. “Ha!” someone said at the front. “Have you noticed?” Curious, I looked behind me and was eager to see which of my colleague's misdemeanours had attracted the attention of the whole group. “You don't need to turn away. I mean YOU!”. The trainer was now standing uncomfortably close to me. With all the kindness I could muster at 8.00am, I looked up and briefly felt as if I had stolen a warm apple pie from the windowsill.
“Yes?” I asked. “If any of you were wondering what all this is about standards and directives, your colleague here has just given you an illustrative example. After all, it would have been a shame if the plug on your laptop connection cable had been two millimetres too wide or the two power pins a millimetre too close together. Don't you think? Become aware of standardised norms in your everyday life, because you encounter them every day, everywhere: Have you filled up with petrol today? Have you already written a text message on your smartphone? Or were you happy last night that your football team-mate still had an old USB-C charging cable for your smartphone in the drawer? How happy do you think the lorry driver in the port of Hamburg is that the container from Shanghai actually fits 1:1 on his truck? These are just a few examples of how standards and directives provide a huge benefit to the general public.”
Silence in the room – the lady had completely mesmerised us in just two minutes. What is standardised anymore? And why?
THE SWISS ASSOCIATION FOR STANDARDISATION (SNV) – YOU’LL ALWAYS MEET TWICE
The friendly trainer congratulated me on passing my exam at the end of the two-week training course three years ago. She was travelling on behalf of the SWISS STANDARDS ASSOCIATION (SNV) as a trainer on the ISO 13485 mission to train industrial companies on the most important key points. At the time, I had no idea that three years later I would be sitting in the modern SNV premises in Winterthur, coordinating with the head of the SNV ACADEMY. But what do the SNV actually do?
Mustn't it be a very dry business if everything revolves around standards and guidelines? My image of “standards and guidelines” has become firmly established. Often frowned upon as a supposedly very dry subject that is very difficult to communicate, the SNV has taken a new approach here and expanded its range of services as part of its academy. Around 40 experts work at the SNV. The organisation is a competence centre 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 contact point for further training in the context of standardisation. So if you want to gain an understanding of a particular directive – as I did three years ago – this is the place to go.
Secondly, the SNV enables its members and their experts to actively influence the development and harmonisation of new standards. It is involved in national and international standardisation committees.
Thirdly, the company is also the point of contact in individual cases to provide a clear understanding of the global requirements for market-compliant products and services in the jungle of laws, regulations and directives. So, if you want to apply for approval for a new product, it is advisable to first find out from the SNV what requirements this specific product must fulfil in a particular market.
NEW WAYS OF IMPARTING KNOWLEDGE
The idea of bringing knowledge about standards and guidelines closer to interested parties via E-LEARNING is an obvious one. Face-to-face courses require suitable premises, the necessary IT infrastructure for the digital connection of experts and, of course, usually involve travelling. Participants have to travel and are absent from their actual location for the entire duration of the training. E-LEARNING offers the great advantage of finding the right e-learning element for each specific content – just as the target group needs it. In the case of SNV, this is not only a step forward in terms of digitalisation, but above all an ingenious move, as the topic of standards can be brought closer to a target group that may previously have been prejudiced and shy about the whole thing.
Together with Swissteach, a system was built at SNV that makes it very easy to book and pay for e-learning via SNV's own web shop. A generated code from the webshop is the ticket to SNV's LMS – a version of GLOBAL TEACH® specially customised to SNV's needs.
Enter the code, start e-learning and take the knowledge with you – learning about standards and guidelines can be so easy and, above all, NOT dry! To be honest, this is what I would have wished for three years ago as a participant in further training. I might have been able to slim down my 300-page folder with all the paper documents in this way. Of course, E-LEARNING cannot replace 100% of all face-to-face courses in such a context. To a certain extent, the topic of standards and guidelines also requires exchange and clarifying discussions. But here, as is so often the case, it's the mix that counts! Those who make optimum use of the concept of BLENDED LEARNING, i.e. the right mix of digital content and face-to-face events, really offer themselves and all interested parties immense added value in order to impart the 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 programme in the future. After all, it has been shown that there is no escaping standards and guidelines. And that's a good thing!
CONTACT
Are you curious about the topic of standards and directives and would like to get an overview of the E-LEARNING programme and other further training opportunities offered by the Swiss Association for Standardisation (SNV)? You will find an overview under the following link:
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 training process? Then simply CONTACT us. We look forward to hearing from you and working with you on your personalised path towards e-learning.
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