Pauwels Consulting started an ISO 9001 quality management project at ESA, the European Society of Anaesthesiology. During the project Luc Marivoet, Senior Quality consultant, advised and supported them with the implementation of a quality management system in order to obtain the ISO 9001 certification.
ESA, The European Society of Anaesthesiology, based in Brussels, is a not-for-profit organisation that brings together all knowledge, training & certifications related to anesthesia, intensive care and pain management. It is a large organisation with a network of more than 400 volunteer doctors and around 30,000 members worldwide, of which around 10,000 are truly active within the organisation.
ESA supports members and fellow organisations with organising conferences, workshops, clinical research, exchange of ideas and new concepts. In addition, ESA takes on a major educational role by providing training and refresher courses through masterclasses, webinars, e-learning modules and simulation classes. This can be done online, but also through the training centers that are spread worldwide.
Via ESA, doctors can obtain the European Diploma of Anaesthesiology & Intensive Care. This can be done almost anywhere in the world, except in North America and Australia. In addition, ESA has a clinical trial network that conducts observation studies on some 1,000 to 50,000 patients. Through the Academic Contract Research Organization (part of ESA), they provide financial support for clinical trials by means of scholarships and collaborate with the European Medical Agency (monitoring body Europe).
“If we want to work with major partners, ISO certification is a necessity anyway. In that respect, having an ISO certificate can create a certain level of trust with potential customers, sponsors or suppliers.”
Amaury van Kesteren – Quality Manager, and Marc Gheeraert – CEO, have major plans for the further expansion of the organisation. Firstly, they want to provide more continuous training, this through a larger network of doctors but also by setting up more local training centers. Currently, there are about 50 of them worldwide but they want to increase that number even more. This would improve the skills of anaesthesiologists around the world.
“ESA is also represented in the World Health Organisation”, says Marc Gheeraert – CEO “which ensures that the quality standards and guidelines are disseminated worldwide. In addition, we also want to guarantee absolute patient safety. To this end, we participate in a Policy Summit and, above all, we have to inform institutional stakeholders about what improvements still need to be made to guarantee this safety”.
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Why did you want to implement the ISO quality management system?
Marc: Initially, we started out on our own to work out Standard Operating Procedures, or ‘SOPs’. But when we received a disappointing audit report from a sponsor that revealed a number of things, we decided to seek external help. We found this help through a positive recommendation, from Pauwels Consulting and Luc Marivoet.
How was the guidance of our ISO 9001 QMS Consultant Luc?
Marc: Luc Marivoet guided us very well in setting up, implementing and monitoring the ISO 9001: 2015 quality management system. He has implemented a process approach in developing and improving our quality management system. He has also focused on risk-based thinking so that risks and opportunities were addressed in our organisation. The collaboration was very professional. Because the organization continued to grow strongly, we decided to hire an internal Quality Manager, Amaury. The cooperation between experience & young creativity was a perfect combination for us during the guidance of our ISO certification.
Amaury: The focus of the guidance was above all on obtaining the certificate but we are glad that the guidance post-certificate was not forgotten. Of course, the work doesn’t stop when you have the certificate. So, we contacted Luc a few more times to discuss action points for our work, to prepare follow-up audits and to further assist me.
Has the ISO certification had a positive influence on your organization?
Amaury: Yes, it’s nice to know that everything is now neatly documented according to the requirements of ISO 9001 and that we ourselves consider it necessary for the effectiveness of the quality management system. Things are much more structured and there is a system you can rely on to guarantee the quality of your training, certifications and other services each time.
Marc: If we want to work with major partners, ISO certification is a necessity anyway. In that respect, having an ISO certificate can create a certain level of trust with potential customers, sponsors or suppliers. Moreover, the management was pleasantly surprised and impressed that we obtained the certificate.