-CISQ is a member of

THE INTERNATIONAL CERTIFICATION NETWORK

www.iqnet-certification .com

-IQNet, the assoc1ation of the worfd's first class

certification bodies, is the largest provider of management

System Certification in the world.

www.imq .it IQNet is composed of more than 30 bod1es and counts aver 150 substdiaries ali aver the globe.

CERTIFICATO N. CERTIFICA TE N. 9175.SDS1

SI CERTIFICA CHE IL SISTEMA QUALITA' DI WE HEREBY CERTIFY THA T THE QUAL/TY SYSTEM OPERATED BY

S.O.S. SRL

VIA GALVANI 9/G c/o SPRESIANO 2- 31027 SPRESIANO (TV)

UNITA' OPERATIVE l OPERATIVE UNITS

VIA GALVANI 9/G c/o SPRESIANO 2- 31027 SPRESIANO (TV)

VIA IGNAZIO SILONE 81 - 24059 URGNANO (BG)

Centrale di Sterilizzazione presso I.C.S.R. VIA DEl SABBIONI 24- 25050 OME (BS)

Operazioni esterne

E' CONFORME ALLA NORMA l fS IN COMPLIANCE W/TH THE STANDARD

ISO 9001:2015 PER LE SEGUENTI ATTIVITA' l FOR THE FOLLOW/NG ACTIVIT/ES

Progettazione ed erogazione di servizi di convalida per: ambienti a contaminazione controllata: sale operatorie, camere bianche e cappe. Locali di procreazione medicalmente assistita (PMA). Cicli di sterilizzazione a: vapore, ossido di etilene,

acido peracetico e perossido di idrogeno. Sistemi di lavaggio e disinfezione dispositivi medici: termodisinfettori, lavapadelle, ultrasuoni e lavaendoscopi. Sistemi di confezionamento dispositivi medici (buste, pacchi , container e termosaldatrici) . Processi di rigenerazione dispositivi medici in forma sterile. Media Fili test (farmaci e radiofarmaci) . Apparecchiature e

impianti processi produttivi (forni e liofilizzatori) . Progettazione ed erogazione di servizi di : analisi qualità vapore e acqua di lavaggio di dispositivi medici. Monitoraggio gas anestetici. Verifica !aratura strumenti di processo. Gestione centrale di

Sterilizzazione per i dispositivi medici in forma sterile con utilizzo del sistema informatizzato di tracciabilità e relativa formazione del personale

Design and supply ofvalidation services far: contro/led contamination environments: operating rooms, clean rooms, biosafety cabinets and fume hoods. Assisted reproductive technology (ART) laboratories. Sterilization cycle far: steam,

ethylene oxide, peracetic acid and hydrogen peroxide sterilizers. Cleaning and disinfection equipment: instrument, bedpan, flexible endoscope washer disinfectors and ultrasonic cleaners. Medicai device sterile barrier systems and packaging

equipment (poucheslrolls, wraps, container and sealing machines). Sterile medicai de vice reprocessing. Media Fili test (pharmaceuticals and radiopharmaceuticals). Manufacturing process plants and equipment (ovens and freeze dryers) .

Design and supply of' quality test for sterilization steam and washing water. Anesthetic gas monitoring. Tests far calibration of measuring instruments. Management of centrai sterile services department (CSSD) for sterile medica/ devices

by using a computerized traceability system and personnel training

Ulteriori informazioni riguardanti l'applicabilità dei requisiti ISO 9001 :2015 possono essere ottenute consultando l'organizzazione Furtherclarifications regarding the applicability of ISO 9001:2015 requirements may be obtained by consulting the organization

DATE:

IL PRESENTE CERTIFICATO E' SOGGETTO AL RISPETTO DEL REGOLAMENTO PER LA CERTIFICAZIONE DEl SISTEMI DI GESTIONE

THE USE ANO THE VALIDITY OF THE CERTIFICA TE SHALL SA T/SFY THE REQUIREMENTS OF THE RULES FOR CERTIFICA T/ON OF MANAGEMENT SYSTEMS

PRIMA CERTIFICAZIONE FIRST CERTIFICA TION

EMISSIONE CORRENTE CURRENT ISSUE

SCADENZA EXPIRY

2011-09-27 2017-09-15 2020-09-25

IMQ S.p.A. - VIA QUINTILIANO, 43- 20138 MILANO ITAL Y Management Systems Division - Flavio Ornago

IAF: 34 www.cisq .com

SGQ WOOSA, SGA W0060, SCR N°005F, 551 W003G, FSM N"0071, SGE N"006M,

EMAS N"003P, PRO N"OOSB, PRS N"080C ISP N"063E, lAB N"Ol2l, L.ATN°021 La validità del certificato è subordinata a sorveglianza annuale e riesame completo del Sistema di Gestione con periodicità triennale

The validity of the certificate is submitted to annua/ audit and a reassessmenr of the entire Management System within three years

ClSQ è la Federazione Italiana di Organismi di Certificazione dei sistemi di gestione aziendale. CISQ is the Italia n Federatìon of management

Membro degli Accord1 d1 Mutuo R.Jconosc.mento EA, IAF e ILAC Signarory of EA, JAF ;md ILA C Mvrwl Recogmcon Agreements

system Certification Bod1es.

THE INTERNATIONAL CERTIFICATION NETWORK

CERTIFICATE CISQ/IMQ as an IQNet Partner hereby states that the organization

S.D.S. SRL VIA GALVANI 9 / G cj o SPRESIANO 2-31027 SPRESIANO (TV)

VIA IGNAZIO SILONE 81 - 24059 URGNANO (BG) Centrale di Sterilizzazione presso I.C.S.R.

VIA DEI SABBIONI 24 - 25050 OME (BS)

for the following scope:

®

Design and supply of validation services for: controlled contamination environments: operating rooms, clean rooms, biosafety cabinets and fume hoods. Assisted reproductive technology (ART) laboratories. Sterilization cycle for: steam, ethylene oxide, peracetic acid and hydrogen peroxide sterilizers. Cleaning and disinfection

equipment: instrument, bedpan, flexible endoscope washer disinfectors and ultrasonic cleaners. Medica l device sterile barrier systems and packaging equipment (pouchesjrolls, wraps, container and sealing machines).

Sterile medical device reprocessing. Media Fill test (pharmaceuticals and radiopharmaceuticals). Manufacturing process plants and equipment (ovens andfreeze dryers). Design and supply of: quality testfor

sterilization steam and washing water. Anesthetic gas monitoring. Tests for calibration of measuring instruments. Management of centra l sterile services department (CSSD) for sterile medica l devices

by using a computerized traceability system and personnel training

Further clarifications regarding the applicability of ISO 900 l :2015 requiremen ts may be obtained by consulting the organization

has implemented and maintains a Quality Management System

which fulfills the requirements of the following standard

ISO 9001:2015 Issued on: 2017- 09- 15

Firs t issued on: 2011- 09- 27 far the validity date, please refer to the originai certificate* issued by IMQ

Registration Number: IT- 79239

$/,:;L;t_: -Alex Stoichitoiu

President of IQNET ·~:

President of CISQ lQNet Partners**:

AENOR Spain AFNOR Certification France APCER Portugal CCC C;prus CISQ lta/y CQC China CQM China CQS Czech Repub/ic Cro Cert Croatia DQS Holding GmbH Gemwny FCAV Brazi/

FONDONORMA Venezue/a ICONTEC Colombia Inspecta Certification Fin/and fNTECO CostaRica !RAM Argentina JQA Japan KFQ Korea MIRTEC Greece MSZT Hungary Nemko AS Norway NSAI lreland PCBC Po/and

Quality Austria Austria RR Russia SIGE México SII fçrae/ SIQ S/ovenia SIRIM QAS Intemational Malaysia SQS Switzer/and SRAC Romania TEST St Petersburg Russia TSE Turkey Vinçotte Be/gium YUQS Serbi a

IQNet is represented in the USA by: AFNOR Certification, CISQ, DQS Holding GmbH and NSAI Inc.

* This attestation is directly linked to the IQNet Partner 's originai certificate and shall not be used as a stand-alone document ** The list of IQNet partners is vali d a t the ti me of issue ofthis certificate. Updated information is available under www.iqnet-certification.com