Our quality system

Liofilchem is certified by TÜV Süd to ISO 9001 for the quality management, to ISO 13485 as manufacturer of IVD (in-vitro diagnostics medical device) and to the MDSAP scheme (Medical Device Single Audit Program) for the sale of IVD (in-vitro diagnostic medical devices) in Australia, Brazil, Canada, Japan and the United States.

Liofilchem has obtained the EU Quality Management System Certificate (IVDR) pursuant to Regulation (EU) 2017/746 on in-vitro Diagnostic Medical Devices, Annex IX Chapters I and III (Class C and B Devices excluding self/near-patient-testing and Companion Diagnostics).

EU Quality Management System Certificate (IVDR)

The Liofilchem's Quality Management System is certified by TÜV Süd to the Regulation (EU) 2017/746 on in-vitro Diagnostic Medical Devices for the manufacturing of Class C and B in-vitro Diagnostic Medical Devices.

ISO 13485:2016 MDSAP

Liofilchem's Quality Management System is certified by Tüv Süd America Inc. according to the MDSAP scheme for design, development, manufacture and distribution of IVD (In Vitro Diagnostic Medical Devices) in Australia, Brazil, Canada, Japan and United States.

UNI EN ISO 9001:2015

Since 1997 the implementation of the Quality System Management permits to satisfy Customer expectations, optimize resources, qualify and consolidate the company position in national and international market.

UNI EN ISO 13485:2016

Liofilchem manufactures In Vitro Medical Diagnostic Devices conform to the use destination provided for and current regulation requirements.

ISO/IEC 17025:2017

Liofilchem is accredited in accordance with International Standard ISO/IEC 17025:2017. The accreditation attests competence, impartiality and consistent operation in performing laboratory activities, limited to the scope detailed in the attached Enclosure.

ISO 45001:2018

Liofilchem has implemented an “Occupational Health and Safety Management System” which fullfils the requirements of the standard ISO 45001, to control risks in this regard and to improve its performance.

UNI EN ISO 9001:2015

Liofilchem's production of hydrogen peroxide and other sanitizers is certified to ISO 9001 to make sure that quality meets the customer's expectations and standards.