QUALITY ASSURANCE SYSTEM

 

With respect and commitment to the patient, the continuous enhancement of the strong and long-lasting relationship with our partners (wholesalers, clinics and hospitals) are the primary target of our company. Our aim is to provide the best possible service to our partners both in supplying products and providing information.
To be achieved this target, necessary and sufficient condition is the proper planning and activities controlling. The Company's management recognizes that harmonization with the requirements of GMP's, GLP's, GCP's and standard ISO9001 is the appropriate way to achieve this.

Milestone in the evolution of the Quality Assurance System
2006: Certification based on the ISO 9001/2000 standard by the certifying body BVQi.
2006: Certification of Pharmacovigilance Department by the EMA.
2009: Re-certification based on the new ISO 9001/2000 by the certification body BVQi.
2011: Certified in accordance with the Ministerial Decision DY8d/1348 of the Ministry of Health and Welfare on the Gazette B32 / 16.01.2004 and its amendments on the Gazette B1459 /22.09.2004 on medical devices by the certifying body LRQA.
2012: Re-certification based on the new ISO 9001/2008 standard by the certifying body BVQi.

Norma Hellas SA is committed
a) to comply with legal and regulatory requirements as described in the National, the Community and International level as well.
b) to establish and monitor measurable quality targets which are the driving force for continuous improvement of the installed Quality Management System.
c) to continue following the requirements of its partners based on quality and therefore will continually provide at any necessary grade, material resources and manpower to fulfill this goal.

Norma Hellas
6/4/2020
Norma Hellas
 
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