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Certifications, Quality, and Sustainability

Quality & Certifications

In 2026, we achieved ISO 13485 certification, followed shortly thereafter by certification for primary pharmaceutical packaging. These aren’t just formalities: they are the requirements for accessing customers and markets that were previously off-limits, and they are the reason why we publish the names of organizations, dates, and certificates rather than simply displaying logos.

For each standard, we publish the PDF certificate signed by the certifying body, the exact scope, the range of sites covered, and the date of the next surveillance audit.

What We’re Adding

We also disclose what we don’t yet have, because for a long-term customer, the trajectory matters just as much as the current status.

Initiative Description Status
ISO 14644 Class 8 Clean Room Manufacturing in a controlled environment for IVDs and sterile devices Under review

The certifications covering this area

Every certificate is available as a PDF, signed by the certification body, stating the sites covered and the date of the next surveillance audit. This is the level of transparency that spares a Quality Manager the preliminary documentation request stage.

Standard Scope Body Issued Sites Document
ISO 13485:2021 Medical device quality management system ICIM 31/03/2026 Suisio Download PDF
ISO 15378:2018 Primary pharmaceutical packaging — GMP for moulders IIP 22/09/2026 Suisio Download PDF
ISO 9001:2015 General quality management system IIP 01/12/1997 Suisio
Bovezzo
Vertova
Download PDF
ISO 14001:2015 Environmental management system IIP 19/05/2025 Suisio
Vertova
Download PDF
ISO 45001:2018 Occupational health and safety IIP 21/02/2020
Suisio
Bovezzo
Vertova
Download PDF

Sustainability

Our Sustainability Report and Code of Ethics are freely available for download, with no registration required. The Report follows the GRI Standards and discloses the Group’s Scope 1 and Scope 2 emissions: figures you can attach to your supplier qualification questionnaires.

Our plants are audited under SMETA 4 Pillars, with no non-conformities (2026). The report is available on request through the Sedex platform.

ISO 45001: Why We Mention It First With Certain Clients

Scandinavian and Northern European companies conduct structured HSE audits at their suppliers’ sites, often even before the technical evaluation. ISO 45001, which we obtained in February 2026, covers safety governance, employee training, and accident metrics, which we measure and publish.

What do you find when you come to conduct an audit?

We respond to every documentation request within two working days. Before the visit you can request a public extract of the Quality Manual, the GMP procedures, sample IQ/OQ/PQ validation records, SPC plans and the change control procedure.