{"id":12901,"date":"2026-09-24T14:07:22","date_gmt":"2026-09-24T12:07:22","guid":{"rendered":"https:\/\/www.scame.it\/quality-certifications\/"},"modified":"2026-10-05T09:39:55","modified_gmt":"2026-10-05T07:39:55","slug":"quality-certifications","status":"publish","type":"page","link":"https:\/\/www.scame.it\/en\/quality-certifications\/","title":{"rendered":"Quality & Certifications"},"content":{"rendered":"\r\n\r\n
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Quality & Certifications<\/h3> <\/div>\r\n\r\n

In 2026, we achieved ISO 13485 certification, followed shortly thereafter by certification for primary pharmaceutical packaging. These aren\u2019t 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. <\/p>\n

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.<\/p>\n<\/div>\r\n \r\n \r\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n

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What We’re Adding<\/h3> <\/div>\r\n\r\n

We also disclose what we don\u2019t yet have, because for a long-term customer, the trajectory matters just as much as the current status.<\/p>\n<\/div>\r\n \r\n \r\n

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Initiative<\/th>\r\n Description<\/th>\r\n Status<\/th>\r\n <\/tr>\r\n <\/thead>\r\n \r\n
\r\n ISO 14644 Class 8 Clean Room <\/td>\r\n \r\n Manufacturing in a controlled environment for IVDs and sterile devices <\/td>\r\n \r\n Under review <\/td>\r\n <\/tr>\r\n <\/tbody>\r\n <\/table>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n
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The certifications covering this area<\/h3> <\/div>\r\n\r\n

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. <\/p>\n<\/div>\r\n \r\n \r\n

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Standard<\/th>\r\n Scope<\/th>\r\n Body<\/th>\r\n Issued<\/th>\r\n Sites<\/th>\r\n Document<\/th>\r\n <\/tr>\r\n <\/thead>\r\n \r\n
\r\n ISO 13485:2021 <\/td>\r\n \r\n Medical device quality management system <\/td>\r\n \r\n ICIM <\/td>\r\n \r\n 31\/03\/2026 <\/td>\r\n \r\n Suisio <\/td>\r\n \r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 15378:2018 <\/td>\r\n \r\n Primary pharmaceutical packaging \u2014 GMP for moulders <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 22\/09\/2026 <\/td>\r\n \r\n Suisio <\/td>\r\n \r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 9001:2015 <\/td>\r\n \r\n General quality management system <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 01\/12\/1997 <\/td>\r\n \r\n Suisio
Bovezzo
Vertova <\/td>\r\n 		\r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 14001:2015 <\/td>\r\n \r\n Environmental management system <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 19\/05\/2025 <\/td>\r\n \r\n Suisio
Vertova <\/td>\r\n 		\r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 45001:2018 <\/td>\r\n \r\n Occupational health and safety <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 21\/02\/2020
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Bovezzo
Vertova <\/td>\r\n 		\r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n <\/tbody>\r\n <\/table>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n
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Sustainability<\/h3> <\/div>\r\n\r\n

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. <\/p>\n

Our plants are audited under SMETA 4 Pillars, with no non-conformities (2026). The report is available on request through the Sedex platform. <\/p>\n<\/div>\r\n \r\n

\r\n \r\n Download the Sustainability Report <\/a>\r\n \r\n Download the Code of Ethics <\/a>\r\n <\/div>\r\n \r\n <\/div>\r\n\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n
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ISO 45001: Why We Mention It First With Certain Clients<\/h3> <\/div>\r\n\r\n
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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. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n

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What do you find when you come to conduct an audit?<\/h3> <\/div>\r\n\r\n
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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. <\/p>\n <\/div>\r\n \r\n \r\n Request the audit documentation <\/button>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n

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\r\n Request the audit documentation <\/h4>\r\n