Certifications

Obtaining the ISO and CE continual marking certifications was only the first step from a long process of sustained development and improvement of our products.

ISO 13485:2003

Through the certification according to ISO 13485, our company demonstrates the competitive ability and performance of the international market, European and national.

Certification ISO 13485 brought the following benefits to our company:

• reducing the unexpected risks for design, manufacturing and distribution of the medical devices
• improved quality of performance
• transparency and clarity of internal process
• respect of the legal requirement or contractual
• clients and employers satisfaction.

ISO 9001:2000

Obtaining of the certification ISO 9001:2000 proves that the quality management system implement to our company has all the requirement of this international system. The quality management system certified proves the VELFINA's commitment for quality and client satisfaction.


The quality demonstrated (of the process and results) is for Velfina an important factor of competition.
The fundamentals of the quality management system are a way to orientate VELFINA to the proposed goals, to improve continuously the performance.

ISO 9001 2000	ISO 13485	Annex II - page 1	Annex II - page 2	Annex V - page 1 Annex V - page 2

Raports

1.	Self evaluation report 3 years	68 k
2.	Self evaluation report 3 years - Annex 4.3	34 k
3.	Self evaluation report 3 ani - Annex 5.3	32 k