The Liofilchem Quality Control laboratory is accredited in accordance with International Standard ISO/IEC 17025:2017.

The Liofilchem Quality Control laboratory quality management system and technical competence have been thoroughly evaluated by the Italian national competent authority, ACCREDIA, to achieve ISO 17025 accreditation.

Audits are conducted regularly to maintain accreditation. Accreditation means that the laboratory has met the Management Requirements and Technical Requirements of ISO17025 and is deemed technically competent to produce testing results.

Other certifications include:

• Certified by TÜV Süd to ISO 9001 for quality management
• ISO 13485 manufacturer of IVD (in-vitro diagnostics medical device)
• Audited by 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.
• EU Quality Management System Certificate (IVDR) according 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)

Click here to view the accreditation certificate, or use the Request Information button below to contact the company.