The UNI EN ISO 9001:2015 standard introduces the concept of risk-based thinking. Here what it is and what are the advantages.

In July, Italcert, Italian certification authority, verified Max Application conformity to the requirements laid down in the certification UNI EN ISO  9001:2015.
The certification renewal rewards Max Application continuous commitment in adapting the operative processes in order to provide products and services that satisfy the clients expectations.

What does it change with the new ISO 9001:2015?

The new ISO 9001 introduces a new way to conceive quality, establishing a systematic approach to considering risk.
The rule revision aims to the individuation, the qualification and the management of situations that presents 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.

Which are the benefits of introducing the new rules for Max Application clients?

The adjustment results in a whole integration of ISO 9001 to compliance to GVP Good pharmacoVigilance Practices, the European Union guidelines for the correct pharmacovigilance procedures.

We are sure that this will be very appreciated by our clients, because it clarifies and speeds up the inspection process”, as explains Roberto Martinotti, the company CEO. “Over the last two years we have been subjected to twelve second-party audits, the inspections from those clients that are required to certify their own providers. This gave us the elements to simplify the inspectors task”.

Thanks to the new ISO 9001 it has also been defined a specific process which regulates the via cloud service provision.

“We have established a process dedicated to the compliance with the confidentiality agreement, the service level, the business continuity guarantee and the disaster recovery. The adjustment to ISO 9001:2015 represented a new opportunity to offer a more efficient service to the clients, as result of a greater involvement of all company activity areas”.