EN ISO 13485:2016
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CERTIFICATE for compliance management system in accordance with: EN ISO 13485:2016 Medical devices - Quality management systems Biotech Service s.n.c. 85/D Cavour str - 20833 Giussano (MB) - Italy MANAGEMENT SYSTEM APPLICABLE TO: Repair, maintenance, testing and installation of medical devices/in vitro diagnostics and instruments. Technical Refurbishing under client specifications. MD1100 Certificate reg. n°: MD-18213AA Head of the Certification body Ing. Sergio Müller Date of initial certification: 23/09/2015 Date of issue: 19/09/2018 Manager Melissa Müller Valid from: 23/09/2018 Valid to: 22/09/2021 Place of issue: Sofia This certification is issued and maintained following audits conducted at the organization with the sampling criterion and therefore does not exclude the possibility of situations not compliant with the voluntary standard or applicable binding laws, for which EURO CERTIFICATIONS EOOD declines from now on any responsibility. For clarifications on the details related to the limitations of the Management System, refer to the Organization Manual ______________________________________________________________________________________________________________ The validity of this certificate can be checked contacting us on: [email protected] The assessment of the management system is in accordance with the procedures of the Management systems certification body to "EURO CERTIFICATIONS" EOOD. Registered Address: Bulgaria 1113 Sofia – Geo Milev – 10, Kosta Lulchev str., en. A, fl.1, ap.1 Operating office: Bulgaria 1336 Sofia - Lulin 3 – 386, Georgi Drazhev str, en. B, fl.7, ap.72 Tel.: +359 (2) 444 1033; e-mail [email protected] EN ISO 13485:2016
Transcript of EN ISO 13485:2016
CERTIFICATE
for compliance management system in accordance with:
EN ISO 13485:2016
Medical devices - Quality management systems
Biotech Service s.n.c. 85/D Cavour str - 20833 Giussano (MB) - Italy
MANAGEMENT SYSTEM APPLICABLE TO:
Repair, maintenance, testing and installation of medical devices/in vitro diagnostics and instruments. Technical Refurbishing under client specifications.
MD1100
Certificate reg. n°: MD-18213AA Head of the Certification body Ing. Sergio Müller
Date of initial certification: 23/09/2015
Date of issue: 19/09/2018
Manager Melissa Müller
Valid from: 23/09/2018
Valid to: 22/09/2021
Place of issue: Sofia
This certification is issued and maintained following audits conducted at the organization with the sampling criterion and therefore does not exclude the possibility of situations not compliant with the voluntary standard or applicable binding laws, for which EURO CERTIFICATIONS EOOD declines from now on any responsibility. For clarifications on the details related to the limitations of the Management System, refer to the Organization Manual
______________________________________________________________________________________________________________ The validity of this certificate can be checked contacting us on: [email protected] The assessment of the management system is in accordance with the procedures of the Management systems certification body to "EURO CERTIFICATIONS" EOOD. Registered Address: Bulgaria 1113 Sofia – Geo Milev – 10, Kosta Lulchev str., en. A, fl.1, ap.1 Operating office: Bulgaria 1336 Sofia - Lulin 3 – 386, Georgi Drazhev str, en. B, fl.7, ap.72 Tel.: +359 (2) 444 1033; e-mail [email protected]
EN ISO 13485:2016
CER TIFICATEEN ISO 9001:2015
Management system as per
Evidence of conformity with the above standard(s) has been furnished and is certified in accordance with TÜV PROFICERT procedures for
Certificate registration No. 73 100 3776
Audit report No. 4346 8263 First certification 2019-02-20
Certificate valid from 2019-02-20 to 2022-02-19
scope:
PAGE 1 OF 1. This certification was conducted in accordance with the TÜV PROFiCERT auditing and certification procedures and is subject to
regular surveillance audits. Verifiable under www.proficert.com. Original certificates contain a glued on hologram.TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-GB-1711
Darmstadt, 2019-02-20 Certification body of TÜV Hessen
– Head of Certification body –D-ZM-14137-01-00
After-sales service. Installation, testing and maintenance of in vitro diagnostic and electro-medical systems. Instrument regeneration. Trade of IT products.
Scope: 19G02; 29G05 (EA: 19; 29/1)
Biotech Service S.n.c.Via Cavour, 85/D
I - 20833 Giussano (MB)
CER TIFICATOEN ISO 9001:2015
per il sistema di gestione secondo
La prova della conformità alla norma sopra indicata è stata fornita e viene documentata secondo le procedure TÜV PROFICERT per
No registrazione certificato 73 100 3776
Rapporto di Audit 4346 8263 Prima certificazione 2019-02-20
Certificato valido da 2019-02-20 a 2022-02-19
Campo di applicazione:
PAGINA 1 DI 1Questa certificazione è stata eseguita secondo la procedura TÜV PROFiCERT per verifiche e certificazioni e viene periodicamente sorvegliata.
Verificabile sul sito www.proficert.com. I certificati originali contengono un ologramma incollato.TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Straße 16, D-64293 Darmstadt, Tel. +49 6151/600331 Rev-IT-1711
Darmstadt, 2019-02-20 Organismo di Certificazione del TÜV Hessen
– Responsabile della certificazione –D-ZM-14137-01-00
Biotech Service S.n.c.Via Cavour, 85/D
I - 20833 Giussano (MB)
Servizi post vendita. Installazione, collaudo e manutenzione di sistemi per diagnostica in vitro ed elettromedicali. Rigenerazione di strumenti.
Commercializzazione di prodotti informatici.
Scopo: 19G02; 29G05 (EA: 19; 29/1)
