Already in 2016, Italcert, Italian certification authority, verified our conformity to the requirements laid down in the certification UNI EN ISO 9001:2015.
The certification renewal rewards our continuous commitment in adapting the operative processes in order to provide products and services that satisfy the clients expectations.
The ISO 9001:2015 introduces a new way to conceive quality, establishing a systematic approach to risk management.
The rule revision aims to the individuation, the qualification and the management of situations that present possible critical issues.
It is not just a question of prevention, but also to seize the opportunities in risk situations, to stem the negative effects, to quantify the action results and to build on gathered experience.
The adjustment results in a whole integration of ISO 9001 to the compliance to GVP, Good PharmacoVigilance Practices, the European Union guidelines for the correct pharmacovigilance procedures.
Thanks to the new ISO 9001 we have also defined a specific process which regulates the via cloud service provision.