Quality of products and processes
Diasorin and the Group companies, and all their employees on their behalf, acknowledge as a mandatory principle absolute compliance with laws, codes, regulations, national and international directives, and all practices inspired by fairness and honesty generally recognized in every country in which the Group does business, and operate in full compliance with this principle.
Diasorin production sites adopt a Quality Management System implemented in compliance with European Directive IVD MD 98/79 EC, with UNI EN ISO 9001:2015 (Quality Management System Requirements), UNI EN ISO 13485:2016 (Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes) – in compliance with the US Code of
Federal Regulation (“21CFR Part 820” Food and Drug Administration) – as well as in compliance with additional local regulations applicable to the various environments in which the Diasorin Group operates and where its products are registered and distributed.
In addition, supply chain management is an essential element to
ensure compliance with the products and services purchased, the Group’s quality requirements, and local regulatory requirements.
To reduce risks in the supply chain, Diasorin monitors its suppliers. Audits are conducted on the basis of a careful risk assessment.
Instant detection software for regulatory changes
Centralized supply chain reorganization
Supplier management and qualification procedures
In 2022, the Diasorin Group continued to monitor its suppliers with on-site audits and remote and documentary audits, in line with previous years. The checks carried out revealed no significant non-conformities, the same as recorded in the two years between 2020 and 2021.
From the perspective of maintaining the quality system at Diasorin sites, there follows a summary table of the number of inspections conducted at the Group’s factories over the last three years, by the Notified Bodies and by the various Competent Authorities in the Export Countries where Diasorin products are registered and distributed:
|Group factories||2020||2021||2022||Site total|
|Luminex sites (Austin, Chicago, Madison, Toronto)||-||3||6||9|
All inspections conducted over the three-year period reported passed with no detection of critical issues that may have had an impact on the Group’s business.
Disclosures: GRI Standard 3: