CERTIFICATIONS - ACCREDITATIONS

Biohellenika's policy is to gain all the international certifications which are related to the quality for the services provided with the reagents in use and the laboratory equipment. Since the establishment of the company, all procedures are daily controlled and as a result the company succefully received the following certifications and accreditations:

ΑΑΒΒ (AΜΕRΙCAN ASSOCIATION OF BLOOD BANKS)

Biohellenika is the first Greek stem cells bank and the third in Europe accredited by the international recognised organisation AABB (American Association of Blood Banks)

ESYD BIOHELLENIKA THESSALONIKI                           ESYD BIOHELLENIKA TAK.EIE

* Biohellenika’s laboratories are accredited by ΙSO 15189:2007 with the certification No 410 8/2/2008 and TAK-EIE laboratories with the the certification No 618 2/10/2009 by the Hellenic Accreditation System (HAS) as the legal representative according to Law N.3066/2002 for the quality controls, concerning the flow cytometry, microbiology and virology tests.

ISO BIOHELLENIKA THESSALONIKI

* Biohellenika is certified according to international prototype of quality ISO 9001:2008 for the processing, the qualitative controls and the cryo-preservation of autologous cell populations (autografts from umbilical cord blood and placenta blood, Wharton’s jelly, dental pulp and adipose tissue) by the international certification representative Lloyds' Register Quality Assurance.

* Also is  certified according to ISO 13485:2003 for the assembly of storage systems that contain the autologous cells in cryovials integrally attached  for future medical use by the Lloyds' Register Quality Assurance.

ISO TAK.EIE - BIOHELLENIKA

 * TAK-EIE is certified according to international prototype of quality ISO 9001:2008 for the processing, the qualitative controls and the cryo-preservation of autologous cell populations (autografts from umbilical cord blood, Wharton’s jelly and adipose tissue) by the international certification representative Lloyds' Register Quality Assurance.

ISO BIOHELLENIKA ΑTHENS

 * Biohellenika SA Athens is certified  according to ISO 9001:2008 for the receipt, transfer and delivery for use of autologous cell populations (autografts from umbilical cord blood and placenta blood, Wharton’s jelly and adipose tissue) by the international certification representative Lloyds' Register Quality Assurance.

CLEAN ROOMS BIOHELLENIKA                 CLEAN ROOMS BIOHELLENIKA

THESSALONIKI                                          TAK.EIE

 *ISO 14644 - Τhe clean rooms operate according to the strict GMP guidelines, have been certified with the "Qualification of the clean rooms" according to the BSR Ingenieur – Buro prototype, by ISO 14644-5 and they are specifically designed for medical use of stem cells.

All the procedures followed in Biohellenika’s laboratories and storage facilities are in accordance with the European Community Guidelines 2006/17/EC and the Presidential Decree 26/2008.