• 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.

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. 

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.

SQS certifies with certificate CH-53591 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

SQS certifies with certificate H30424 that the Quality Management System implemented by Thema, a Complife Company, in its operating units at Via Saragat 5 – 40026 IMOLA (BO), conforms to the ISO 9001 standard for the following activities:

  • Performing microbiological, biomolecular and chemicalphysical analysis and provision of technical and regulatory consultancy.
  • Design and implementation of tests in cosmetics, food supplements, free sale products (personal care, cleaning solutions, patches, cosmetotextiles) and
    Medical Devices.
  • Execution of tests on the effects produced by the use of aesthetic equipment.
  • Provision of national and international regulatory services, authorised representative services, consultancy for product certification and drafting of technical documentation for companies operating in the medical sector.
    See ISO 9001 Certificate

SQS certifies with certificate H70388 that the Quality Management System implemented by Thema, a Complife Company, in its operating units at Via Saragat 5 – 40026 IMOLA (BO), conforms to the ISO 13485:2016 standard for the following activities:

  • Provision of national and internationalregulatory services, Authorized Representative services, product certification consultancy, and the preparation of technical documentation for companies operating in the medical sector.
    See ISO 13485:2016 Certificate