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Global Certifications, Continuous Improvement and Compliance

Global Quality Management System

Bomi Group Global Quality Management System is certified by the BSI (British Standard Institution).

  • ISO 9001:2015 since 1993 – includes contract re-labelling , re-packaging and kit assembly, and consignment stock count services.
  • ISO 13485:2016 since 2006 – includes Medical Devices and IVD’s contract labelling/re – labelling and kit assembly, contracts for decontamination of returned medical systems and patient data removal on returned medical devices.

Bomi Group believes that HSE compliance is an integral part of its strategy, this commitment is attested by

  • ISO 14001:2015 and ISO 45001:2018 in Turkey and Italy
  • Plans to extend and upgrade HSE certifications at Global level
  • Fully compliant of local HSE rules in all the countries

Continuous improvement

BOMI Group is concerned about the interests of all its stakeholders, and is committed to achieve and maintain:

  • The continuous improvement of the Bomi processes and the quality of the services provided
  • Economical stability
  • Business growth

All validations, controls and quality processes/documents can be audited by clients, are certified by external Notified Bodies and play a fundamental role in guaranteeing quality, safety and efficacy of healthcare products, with particular attention to the traceability and integrity of their use and sale to the patient.

Compliance Program

Bomi Group Quality Management System is fully compliant with GDP, GMP and HACCP system.

All the local Healthcare regulations for Medical Devices, IVDs, Pharmaceuticals,Food Supplements and Cosmetics are strictly observed. BOMI Group is committed to be compliant to all regulatory, statutory and customer requirements.

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