Quality & Safety

 

 

Our main target is building Customer satisfaction through the Quality of our Products and Services.

 

Our quality engineering, like the rest of the organisation is completely dedicated to customer satisfaction by continuous improvement in products and processes. ( ISO 9004:2000, TQM, FMEA )

 

 

 

 

Quality Management System

 

 

In order to reach our aims ISO 9001:2008 and EN ISO 13485:2012+AC:2012 Quality Management System are being maintained.

 

Conformance with the requirements of the standards has been audited by TÜV Rheinland InterCert

ISO 9001:2008
Reg. No.: 01 100 1320364
Date of expiry: 27.09.2017

EN ISO 13485:2012+AC:2012
Reg. No.: OY 69248138 0001
Date of expiry: 27.09.2017

 

You can find Digiterm certificates at www.tuvdotcom.com.

 

TÜV GM Mark of Comfort Therapy chairs ID: 3036004900 (Safety tested)

 

 

Download: 

 

           ISO 9001 Certificate 

           ISO 13485 Certificate

 

 

 

Environmental Management System

 

 

The management of Digiterm Ltd. declared its commitment - in compliance with the requirements of 

ISO 14001 Standard - toward the continuous development of environmental performance and prevention of pollution.

 

Conformance with the requirements of the standards has been audited by
TÜV Rheinland InterCert
 

You can find our ISO 14001:2004 Environmental Management System certificate at www.tuvdotcom.com by ID number:9105055502

 

 

Download: 

 

           ISO 14001 Certificate

 

 

 

93/42/EEC Directive

 

 

 

Digiterm Ltd. registered as a manufacturer of medical devices by Authority for Medical Devices of Hungarian Ministry of Health. (Reg. No.: 35780/2001)
 

All of our products comply with EU standard regulation belongs to EC declaration and entitled to use the CE mark.

 

The COMFORT Therapy chairs comply with the requirements of Decree 93/42/EEC for medical installations and the other standards applied:

 

EN 294:1992
EN 349:1993+A1:2008
EN 980:2008
EN 1041:2008
EN ISO 10993-1:2009+AC:2010
EN 60601-1:2006+A11:2011

EN 60601-2-52:2010
EN 60601-1-2:2007
EN 60601-1-6:2007
EN 55011:1998
EN 61000-3-2:1995
EN 61000-3-3:1995
EN 61000-4-2:1995

EN 61000-4-3:1995
EN 61000-4-4:1995
EN 61000-4-5:1995
EN 61000-4-6:1996
EN 61000-4-8:1993
EN 61000-4-11:1994
EN 62366:2008

 

 

 

 

Medical scales with M-marking

 

 

 

 

In accordance with the relevant regulation, the EC verification of a medical scale has to be fulfilled in the place of installation because it depends on the reference value of gravity in the zone.

 

 

Manufacturing process of Weight Measurement System has been tested and certified by TÜV Rheinland as a Notified Body.

 

Download: 

 

           M-marking TAC Certificate

 

 

 

Safety tested products

 

High quality and outstanding safety features of our products are being inspected by TÜV Rheinland LGA Products GmbH.

GM mark (Geprüftes Medizinprodukt - Approved medical device) certify the compliance of requirements of relating standards besides the controlled production conditions.

Certificate No. I 600 82343

 

Download: 

 

           TÜV GM Mark Certificate

 

 

 

 

GOST-R Certificate

 

 

Digiterm Ltd. as a manufacturer of medical devices also registered by the Russian Ministry of Health. (Reg. No.: F33 2012/11522)

 

The Comfort Therapy chairs are tested by SGS International Certification Services S. A. and justified the compliance of relating Russian standards on the GOST-R certificate.

Certificate No. POCC HU. IM 24 N Q5939

 

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