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CERTIFICATE
Management System as per
ISO 14001 : 2004
In accordance with TOV NORD Indonesia procedures, itis hereby certified that
PT. MEGA ANDALAN KALASAN
Ji. Tanjungtirto No. 34, Kalasan Km 13,
Sleman, Yogyakarta 55571
INDONESIA
apples a management system in ine with the above standard forthe following scope
Service of Pre Treatment (Waste Water Treatment)
and Painting Process of Hospital Equipment
Certificate Registration No. 08 104 0021 Valid uni 2017-09-18
‘Audit Report No 1021/2014 Initial Certification 2008-08-10
TOV ORD Indonesia Certification Body Jakarta, 2014-08-19
TOV NORD Group
‘This certification was conducted in accordance with the TOV NORD Indonesia auditing and certfiation
procedures and is subject to regular surveilance audits.
PT TOVNORD lndonesa, Perantoran Hijau Arad Tower F 7" foo, J. Let Jend.T-8 Smatupang Kav. 8, Jakarta Selatan 12520
142616CERTIFICATE
Management System as per
OHSAS 18001 : 2007
{In accordance with TOV NORD Indonesia procedures, itis hereby certified that
PT. MEGA ANDALAN KALASAN
Jl. Tanjungtirto No. 34, Kalasan Km 13,
Sleman, Yogyakarta 55571
INDONESIA
‘applies a management system in ine with the above standard for the following Scope
Service of Pre Treatment (Waste Water Treatment)
and Painting Process of Hospital Equipment
Certificate Registration No. 05104 2008 0087 ES Valid unt 2017-09-18
‘Audit Report No. 011408410 Initial Certification 2008-09-10
RD Indonesia Certification Body Jakarta, 2014-09-49
NORD Group
‘This cortfiation was conducted in accordance with the TOV NORD Indonesia ausiting and certification
procedures and is subject to regular surveillance audits.
PT TOVNORD indonesia, Prkantoran Hau Aradia Tower F 7" foo, J. Let Jend 7.8 Smatupang Kav. 8 Jakarta Selatan 12520
Re
wresre 8
142618CERTIFICATE nie
Management System as per
ISO 9001 : 2008 =
In accordance wth TOV NORD Indonesia procedures its
PT. Mega Andalan Kalasan
Office : Rasuna Office Park SO-02, |
Ji. HR Rasuna Said, Jal
Factory : Jl. Tanjung Tirto 34, Ti
Yogyakarta, Indonesia
‘apples @ management system in ine with the above standard forthe
Design and Manufacturing of Hospital Beds, |
Wheel Chairs, Infuse Stands, Medicine Cabinets,
Trolleys, Overbed Tables, Children Beds,
Operating Tables
Certiicate Registration No, 18 00 L 12453
‘Audit Report No. 1215372012
J’ NORD Indonesia Certification Body
NORD Group
erification was conducted in accordance with the TUV NORD Indonesia auditing
Procedures and is subject to regular surveilance audits STuV NORD
Zertifikat / Certificate
gem. / acc. EN ISO 13485:2012
Hiermit wird boscheinigt, dass dle Firma / This coriies, thatthe company
PT. Mega Andalan Kalasan
Office: Rasuna Office Park SO-02, Komp. Rasuna Epicentrum
Jl. HR Rasuna Said, Jakarta 12960
Factory: JL. Tanjung Tirto 34, Tirtomartani Kalasan Km 13,
Yogyakarta
Indonesia
in Qualitatsmanagementsystem nach der Nom EN ISO 13485;2012 /DIN EN ISO 13485:2012-06 - Medizinprodukte-
Qualtatsmanagerienisysteme - Anforderungen fir reguiatorische Zwecke- eingeUhrt hal und autrechterhak Dieses Zerikat
elt nicht den erforéerichen Nachweis zur Anbingung der CE-Kennzeichnung dar
has established and maintains a quality management system that meets the requirements of EN ISO 13485:2012/
DIN EN ISO 13485:2012-06 - Medical devices - Qually management systems - Requirements for regulatory purposes.
This cetfcate isnot an authorisation fo ax the CE mark.
Goltungsbereich / Scope
Design and Manufacturing of Hospital Beds, Stretchers, Baby Boxes,
Wheel Chairs, Infuse Stands, Medicine Cabinets, Bedside Cabinets, Food
Trolleys, Overbed Tables, Children Beds, Examination Tables and
Operating Tables
Reg-Nt | Rog-No, 44221 121679 ‘cig vantty
Britt Nr / Report No, 3510 7086 von fom 2012-41-21
bis / unt 2018-11-20
y if yy Edition 1
Zestificierungsstele fUrAedizinorodukte Essen, 201241612
Certification body for medical devices
TOVNORD CERT GmbH — LangemarckstraBe 20 45141 Essen [Link] modical@[Link]
Benannte Stelle Kenn-Nr. 0044 / Notifed Body ID. No. 0044
WOM Abode durchCertificate of
Cé-Registration
‘This is to certify that, in accordance with the Medical Device Directive
93/42/EEC, Medical Device Safely Service GmbH (MDSS) agrees to
perform all duties and responsibilities as the Authorized Representative
for:
PT Mega Andalan Kalasan
JI. Tanjung Tirto 34, Tirtomartani
Kalasan KM 13
YOGYAKARTA,
INDONESIA
a stipulated and demanded by the aforementioned Directive. The
German Competent Authority has allocated the medical devices of the
Manufacturer registration numbers as foreseen in’
Annex A dated September 5, 2014
The Manufacturer hes provided MDSS with the appropriate
Deciaration(s) of Conformity confirming that the medical devices fulfill
the applicable requirements of Directive 93/42/EEC. In compliance with
German law, a safely officer has been appointed for Germany.
2014-09-05
{oun
(ula Warmemann
jor Manager Registration
MOSS GmbH
IMDS - Medical Device Safety Service 5
ffgraben 41 » 30175 Hannover, Germany