Omikron has always been committed to guaranteeing a constant and high quality of its products, dedicating over 20% of its staff to the Quality sector.
Omikron works in compliance with the cGMP and all operations are controlled, recorded and traceable in order to guarantee complete control, timely management of the entire production process and the constant quality of its products.
As confirmation of its product quality-oriented approach, Omikron is certified ISO 9001:2015, ISO 13485:2016 and complies with the requirements of the Farmindustria Guidelines by Bureau Veritas.
The certifications received from the Accredia accredited body
Certification ISO 9001:2015
Certification of Quality Management System in accordance with ISO 9001:2015, by Bureau Veritas, referring to the following scope:
Research and developments, management of production and supply of: medical devices for topical use in ophthalmological and vascular fields, food supplements for ophthalmological, vascular and metabolic fields, cosmetic products for the vascular field, food for special medical puposes for ophtalmological field. Reasearch and development, management of production and supply of: medicinal products for ophthalmological, vascular and metabolic fields.
Certification ISO 13485:2016
Certification of Quality Management System in accordance with ISO 13485:2016, by Bureau Veritas, referring to the following scope:
Research and development, management of production and supply of medical devices for topical use in ophthalmological and vascular fields.
Farmindustria Guidelines
Certification of the Company Management System in compliance with the requirements of the Farmindustria Guidelines by Bureau Veritas, in relation to the following purpose: Scientific Information Activities. Omikron Italia obtained the first certification in December 2014. This certification stems from the need of pharmaceutical companies to operate in compliance with the legal requirements regarding scientific information on the drug set forth by Legislative Decree 219/06 and subsequent amendments, and by the Farmindustria Code of Ethics.
Policy for the QualityORGANIZATIONAL CHART
