Quality Policy, Certification

ISO certification
SpofaDental a.s. complies with the requirements set out by the quality management system as per the EN ISO 13485 international standard for medical devices, and also complies with the requirements set out by EU Directive 93/42/EEC for the producers of medical devices. Since 1998 the company has been certified by European certification authority TUV NORD and is a holder of certificates according to both the aforementioned standards.

Good manufacturing practice
The company complies with the Good Manufacturing Practice requirements as defined in Czech Act on Pharmaceuticals 378/2007 Coll., which applies in the Czech Republic to producers of pharmaceuticals. The company is also a registration holder for Jodisol, a pharmaceutical used in human medicine for surface disinfection of skin wounds, issued by SUKL - the State Institute for Drug Control after proven compliance with the GMP policies in regular inspections by the supervising authorities.

FDA registration
The company is registered as a producer of medical devices sold in the United States of America, where the Food and Drug Administration is the administrative authority for registrations of all drugs and medical devices. The FDA supervises whether all processes in the company comply with the principles for Good Manufacturing Practice for Medical Devices as required by Act 820, which applies in the United States
Many products of SpofaDental a.s. are registered and successfully sell in many regions worldwide, from Australia through Asia (Japan, China, Vietnam) to South America (Argentine, Colombia, Venezuela).

SpofaDental a.s. is part of the Sybron Dental Specialities (SDS) Group. The Quality Manual, Quality Policy and Master Procedures implemented in all SDS companies are the basis of the quality system which has been implemented in SpofaDental a.s. as well.