- Thema Quality Management System complies with ISO 9001:2015, ISO 21001:2018 and ISO 13485:2016 standards and it is effectively implemented, from strategic-regulatory consultancy activities to those dedicated to training through the MD24 brand.
Thema received the ISO 9001 conformity certification for the first time in 2011, while, in 2017, it received the ISO 13485:2016 certification which recognises the organisation as an essential reference point for training in the medical field.
In 2021 Thema received the extension of the object of ISO 9001 and ISO 13485:2016 certifications to the design and delivery processes of training events for the medical sector. Those events constitute the services provided by the MD24 brand.
The ISO 21001:2018 certification of management systems for education and training organisations and the AICQ SICEV qualification of both the Master Advanced Regulatory Disciplines Medical Devices and the Specialised Course MDR (EU) 2017/745 were obtained in 2022, as further proof of the commitment to the educational growth of Professionals in the sector.
Thema puts an efficient Quality Management System at the centre of its company policy. This system allows the organization to improve every day in order to achieve maximum Customer satisfaction and to ensure efficiency.
With the N.9175.THEM certificate, IMQ certifies that the Quality Management System implemented by Thema in the operational units of Via Saragat 5 – 40026 IMOLA (BO), complies with the ISO 9001 standard for the following activities:
- Provision of national and international regulatory services, consultancy for quality system certification in compliance with ISO 9001, ISO 13485:2016 and GMP standards, consultancy on product certification and preparation of technical documentation for companies in the medical sector. Design and provision of training events for the medical sector.
See ISO 9001 Certificate
IMQ certifies with certificate A113.2022 that the Quality Management System implemented by Thema in its operating units at Via Saragat 5 – 40026 IMOLA (BO), conforms to the ISO 21001 standard for the following activities
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- Design and delivery of training events for the medical sector.
With the N.9124.THM2 certificate, IMQ certifies that the Quality Management System implemented by Thema in the operational units of Via Saragat 5 – 40026 IMOLA (BO), complies with the ISO 13485:2016 standard for the following activities:
- Provision of national and international regulatory services, Authorised Representative services for Europe, Regulatory Correspondent services for Canada, U.S. Agent services, Contact Person and regulatory contact person for the U.S.A., consultancy on product certification and preparation of technical documentation for companies in the medical sector. Design and provision of training events for the medical sector.
See ISO 13485:2016 Certificate
