De Lama Certifications
De Lama’s Certifications as Autoclave and Sterilizer Manufacturers
The company’s quality system was renewed in accordance with the new ISO 9001.2015.
The company’s quality system was renewed in accordance with the new ISO 9001.2015.
ISO 9001:2015
Module H _PED
2014/68/UE
ISO 13485:2016
PRODUCT: MEDICAL
DEVICES CERTIFICATE
For more information visit the page dedicated to the Quality and Environment Policy.
The ISO 14001 Standard represents the regulatory reference point for companies and organizations equipped with an Environmental Management System.
The ISO 14001 standard provides a management structure for the integration of environmental management practices, pursuing environmental protection, pollution prevention, as well as the reduction of energy and resource consumption.
In September 2016, De Lama S.p.A. obtained Module H certification in accordance with the new EU Directive 2014/68 / EU on pressure vessels, adapting manufacturing and design processes.
DE LAMA S.p.A. in 2015 obtained by the certification Russian RTN Rostechnadz or the prestigious certification for the entire range of autoclaves of its own design and manufacture. This certification, the acquisition procedure demanding and selective,was achieved thanks to the special attention given by De Lama to the security of their facilities, and of course, the well-known high quality standards of the same. RTN certification testifies once more the international nature of the market in which DeLama is major player among the first in the world and appreciation wider conquered thanks to the quality of its products.
Last certification achieved by the Company DE LAMA S.p.A. at the end of 2014 relates to the achievement of the certification issued by Chinese SELO (Special EquipmentLicensing Office) regarding exports of all the Chinese territory of pressure vessels of its realization.
During 2006 DE LAMA S.p.A. got the extention/conformance of its Quality Management Systems according to UNI EN ISO 9001:2008 and UNI EN ISO 13485:2004 (medical devices).
In 2004 DE LAMA S.p.A. achieved the Total Quality Guarantee conforming to the H Module according to PED No. 97/23/CE for design and manufacturing of pressure equipments.
DE LAMA S.p.A. achieved in 2002 the certification extention for ISO 9001:2000 “Vision 2000”.
In 1999 DE LAMA S.p.A. got the European quality certification UNI CEI EN ISO 13489relevant to medical devices.
Since 1995 DE LAMA S.p.A. has been working in compliance with certified company’s quality management system, in accordance with ISO 9001 standards.
DE LAMA S.p.A.‘s pressure vessels can be designed, manufactured and tested even according to current pressure vessels codes in force in extra-EEC Countries.
ISO 14001:2015
CE Europe
SELO China
EAC Russia