+ GMP Gompliance GertifiqA$Qn

+ Technical Inspection :i..:.:..'.l

,* Hotel Star Rating . .. t.'..',,

l*,:..l::, Green Bui ldi n d,"C fii tilOnslll:iii:.lliirltil:::lr":i l':ii:ll

ll,l:llili:

1..:.;,ltSO 9001 : 2008

ISO 14001 : 2004::l:.

OHSAS 18001 :li.,.,,r,,,t:,i: U ,:.:t,

,,::i*$.o 20000

:.::lso 22ooo : 2oo5]'fSO 27001 : 2005

+++

ASSESSMENT AN D CERTIFICATION

About EurotechEurotech is a well established company, based in UK, as an independentcertification and inspection body, providing their value added

certification and inspections services to the Government, Public and

Private Sector Organizations.

Eurotech is a professional organization backed by devoted, highlyqualified and experienced personnel. We provide a widespectrum of customer oriented certifications andr':,.inspectionservices in an efficient and cost effective manner

Eurotech is commited to give solutions under one roof forCertification a ve1iftii:diiop,.,,.,,91 uuality backed by code ofi ntegrity, im pa rtiatity':rrg,lprofbidbna I con d uct bei ng i n novative,givi n g respect to try!Urt,&t::€!!li!{,,' ma n nerism for certification i n

the area of health,lir&ii',11iii6"-"nt and social responsibility.

Our Goal is to serveiiiiBolhrr'm nufacturing and service sectorand look after the interests of large, medium and small scaleorganizations with equal care.

eccreditetionEurot€ah'rriiiihiaViilg a system in compliance with ISO 772O1'for

reservations. The star classification system is a common one for rating hotels.

Higher sfar ratings indicate nore luxury. Hotels are independently assessed in

ii.ut,i.,:,.,,,i.!raditional systems and rest heavily on the facilities provided.

ISO 20000 CertificationISO 20000 is the first inteffrational standard for lT Service Management.

It sets out the main processes to deliver lT services to meet the business

,,,,,..... . g1$_gustomer requir_Emi{tL l! ripeeifies the following key process groups:

Service Delivery Processes, Relationship Processes, Resolution Processes,

Release Process, Control Proc€iibi;.An ISO 20000 certificate is proof thatyour lT organization is

r Customer-focused. Able to deliver servic€s.which meet defined quality levels. Making use of resources in an economieal.wey.tr. ,

..

Green Building Certifications' ,

The new International Standard l5O 23O45:2008'willlhel.p the building sector

to contribute to energy saving by providing it with specific design guidelines.

ISO 23045:2008, Building environment design4uidelines to assess energy

efficiency of new buildings, provides energy-related requirements for

the design process, or to achieve targeted values of energy efficiency for,rrr,.'r'.i..'r.new buildings. ISO 23045:2008 appiieg,to.inew,bt ild;ngi qnd,irilso applicable

to systems for heating, cooling, lighting, domestic hot water, service water

heating, ventilation and relation and related controls.

Technical lnspection ServicesEurotech also provides Technical Inspection Services for Pressure

Vessels, Pressure equipments, welded pipes, boilers and others complex

skid based equipments. We used the best technical experts after getting

Management System Certification an,C. l

ISO 17O2O for Inspection Services.

Eurotech is A Accredited CertificationBody from IABCBL (UK).

IABCBL provides accreditation againsttso 17020, lso 77021, tso!7025sta n da rdsServices

Third Partv InspectionEurotech performs quality Inspecti<in seivices throughout Asia .

for importers worldwide. :lr]:tlrll]l:llil],alltl:l]ll11i,,, i

Provide us with your specificgfii#::a;t|t", and our qudifiedInspection and Auditors witt p :,rF'*iory Audit and QualityInspection services on your b{!!;f;irdiitiactly in the factof.Y: W9offerall.kinds of Third party ln*,idixjs.

,r,:,,,

Pre-Shipmentinspection l.l:.ti:.r.i.l.':lij..llt,..,,:r,,lft is carriad out when a minimu:ml'j{.tto%" of good:6:l,ordered areexport packed.

Samples are selected at randoriii:r{!€!,9ing to AQL samplingstandards and procedures. :.: -:t:;,,,1L.1,,,,,,,,,,.,

The Q,*ality. Inspection ensure that tlre production is inaccordance with the specifications, purchase orders or lettersof credit.Factory and Social AuditThe Factory Audit is performed by our auditor following a

general framewor.k, ,designed after lSo 9o0f itindards andcompleted when requested, with the client specific requirements.All the important elements, such as quality system procedures,

production capacity, child labour, staff facilities and personal hygiene etc.

Are assessed .n6 si;i:'r[i completed by optional features that can be

selected when booking on the webrite;.Thefactory Audit Report that we

produce enables the buyers tqruiip,,ryWi.sy.,,.!9lect and maintain a high

qualiriedvendorbase :t.l..it' ll...l..'t,.r.i.'. - ,.., ''.

Product Gompliance G€fffi bn ,., ,, ...,,i,rii i., 1

We are committed to serving ttr" in'itttiv"'rith a qualifiedrfacilllv 3n-d

a

staff devoted to the highest standards of quality and exceilent customer

service. We provide compliance certification as per Electrical Safety Testing

& Environmental Teiting on various product such as medical electrical

equipment, light and entertainmentequipment, machinery, consuipment,

consumer and house hold equipment, laboratory amd testing equipment,

information technology equipment, electrical and ballast products

and manv more .

Hote Star RatingHotel star ratings are systems that rank hotels according to quality. Star rating

systems are intended to serve as guidelines for guests who are making hotel

ISO 9001 : 2008 specifies requirements for a quatity management system

for anyir,Organization that aims to enhanae c$stomei'sr. satisfaction and

dem'oinstrate its ability to consistently pfovide . prqducts that meet

customgi s and regulatory requirements. ' . ,' .

m:r*oor Certification ' '

It provides business with a structure for managing environmental

operations, and applies to all types and sizes of manufacturing and service

their resume verified by you.

Certification Services;r',,::riso 9001 certification

,,,.r -operations throughout the world. | :

ISO 18(X)1 CertificationOHSAS 18001 is an OccupaliqtillHealth and Safety Assessment System

certification for health and '59fefu11

management systems, which enabtgs''

an organization to control occupationlil.and safety risks aod i.. to improveperformance. OHSAS uses theprevention concept, i.e prevention

instead of cure. This is integrated in thework protection law, and states the worksafety and health protection should be

treated in one complete system.

ISO ZZ{X}O Certification,r,r'isOi21000 : 2005 specifies requirements, ' Jdi"ra food safety management system

where an organization in the food chains. needs to demonstrate its ability to control

food safetv hazards in order to ensurethat food is safe at the time of humanconsumption. lt is appiicable to all

organizations, regardless of size , whichare involved in any aspect of the foodchain and want to implement system

that consistently provide safe products.

SERVICES

ASSESSMENT AN D CERTI FICATION SERVICES

ISO 27001 CertificationThe goal of ISO/IEC 27OOI:2O05 (857799 - 2) is to provide a commonbase for developing organizational information security policies andprocedures. This standard can be used by any organization, institutionor a company which uses internal or external eomputer systems/processes, depends on information technology,,to.cqpry out its businessactivities, detail or simply wishes to adopt infotmilionrie.curity

ISO 13485 : 2003 Certification :.,,::..:,,:'r,,::.,l::,',:r-'::'r"

The Medical Device Industry is affected by a complex array of regulatorysystems, National and Intemational standards and other requirements.We provide services that',hiip_-,,m,a4qfacturers to understand what they needto place compliant dqv!9eq'',on market throughout the world. Whatever.Devices you produce,r'.,,ast,::.a.ll,lmbdidal':device manufacturer you have a

responsibility to conslstenily.ri:rltJineiil,lrdevices that are safe and effectiveISO 13485 is the Interniiiei4al standard recognized for medical deviceregulations around the world and it specifies requirements for a qualitymanagemell rystem exclusively for medical device manufacturers.

Product Certification: CE MarkingCE Marking is the gateway for the companies who want to export toEurope. The European community has implemented a system to protectthe health of consumers and user of manufactured products. CE Ma*ingassures the users of a product that it conforms to the requirements oirelevant Directive of European Union and Harmonized EuropeanStandards,

Eurotech provides CE Marking as per following Eunlpean Directiveso Machinery Directive

o Pressure Equipment Directive

o Transportable Pressure Equipment Directive

. Simple Pressure Vessels Directive't .. ..'...,' ':

.LiftDirectiv:.,''....:.'.:l.'.''.

. Construction Products Directiveill..r. ..'. i:r i,. ,.. '.,rii .: ,.,i.. iii

...ir.'.,,.....i..t... ..i: i-ll.i" I....:''lt ].ilil".,'

. lqy Vollage Directive 'it .liitiri'r.i I I i ii

ii":',,:1.'li.''i.l

. :.i ,llt..i. I i : 'l ii li'l'l r: .r.l il':o EMC Directive

. Medical Device Directive

o In-vitro Device Directive ',llr, i.,.: i i

. Activ-e.rilql.plantable Medical 9gv;;i:r:i,i)1ii; lrli. ii', .

' rofrr,.l..{'{llDirective .,..,,,..,,.' ,.,.,..,t,i,i. .,,,,,.,,,.,,.1.,,,

. perional..piotective Equipment Directive l.i,l,l,,'1,i,,,,.i,'l., .,,..,,'.,,.1....,'l,l

US FDA RegistrationUS FDA Registiation is required for all companies that manufacture, processpack, or store MediCi.l.r'Devices that may be consumed in the UnitedStates. Companie$...loc€ledrlbgtside the US must designate a US agentfor FDA communications.Medical devices are cljiiified as class ll and lll, 510K clearance is

'necessary in order to market the ppdggt in the US FDAThe clearancerequires compliance to the CFR, Part 820 Quality System Regulations(QSRs), Good Manufacturing Practiie5' {GMP)

"'and the other appl.icable

CFRs for the product type and indiqaliolqrfhe use ,.. ,:.. ,.. .,..

Eurotech provides training and .rtig1-s:'rin:rthi- filling the 510K.rcleai.A1$eapplication and the implementation of a quality managemehi iy-steni incompliance with the QSRs and applicable CFRs. ' ' .

'

European Authorized RepresentativeAn European Authorized Representative (EAR) serves as a legal entitydesignated by non European Union (EU) manufacture,s to representthem in the EU and ensure their compliance with the EuropeanDirectives.

An European Authorized Representative (EAR) holds the responsibilityto act as a neutral party between the competent authorities and the nonEuropean Union (Eu) manufactures. They must ensure the

manufacture's compliance with the conformity assessment procedureset out in the European Directives which apply of the manufacture's

_ product. The European Authorised Representative (EAR) must upholddual accountability with the manufacturers if problems or questions arise

. r.egafding the product.

A' Etiropean Authorized.,,, B€plesentative (EAR) must provide theircontact information for the manufacturer to place on the products,allowing the E.A.R. To be the primary contact for EU authorities.

SA 8000 : Social Accountability Certification:SA 8000 measures the performances of organizations in eight key areas:child labouq 1e1ag!,,,f!bOu1, health and safety, freedom of association andcollective bargai*in$;'r :dis*iminaton, disciplinary practices, workinghou rs a nd,er r n

" iaii.on i l l l.,,,,,.,,,.,,,,:.',,"

The systems put in plaie to achieve this certification are an on gotngprocess and involves the participation of employees to ensure systemicchange. :r:Ilr ' I-ir' i

The benefits of adopting SA 8ooq,i;iiili; |mipioveA sLf rnorrte, retiabtebusiness partnerships, enhanced competitiveness, less staff turnoverand better worker-manager communicatlonThe SA 8000 Certification facilitates the integration of labour standardsinto factory management systems. This certification enablesorganization. to rigorously ensure the code compliance demanded by

. international labour law and the market.

Good Manufacturing Practices (GMP) ComplianceCertification

,,,,.,,,,,,,i]],b91Ui:Stanufacturing Practices (GMP) is the part of Quality Assurance

,,1l:,,:.,,,,,1ilvh!9!s1e11!ures that products are consistently produced and controlled to1,,,,.t,t:t,.'fiei1Eu;[A standards appropriate to their intended use and as required by:,,,,.:,,:,,',!he,:.nafketing authorization. GMP is aimed primqrilyr::atrrdimi,nishing the

risls inherent in any Medical Device production,'which may broadly be

categorized in two groups: cross contamination/ mix-ups and falselabelling. Above all, manufactures must not place patient at risk due to

.,,,,,,',.,,,,i!.r:radequate safety, quality or efficacy. -r l-. rll.i-r''.",.1'r' rri'r'liil.

Social ComplianceIt is based on International workplace norms of International LabourOrganization (lLO) conventions, the Universal Declaration of Humannights,an!'tfre UN Conventions and Managerirent Systems.

T,he.:::standard addresses Child Labour, Forced Labour, Health & Safety,

. :;;,,t**Agm of Association & the right to collective Bargaining, Discipline.

..1.,r 1,,,,,WOiking Hours, Compensation a nd Ma nagemel! systems

Trainings

',

r.,r,":'rPublic training courses take place in a!:,qpenig.etting,d'ind are available to..r:. : employees from any organizatiorisr.,::,:l,Fr.tbiiij,r,ittiiiting represents a

convenient and low cost learning o1ppoifr;iiit:,:l qilrrlMaller numbers ofemployees.

Our courses are usually led by one or tWo,eiplrt,:illiqti, over one or moredays. They mix theoretical information with other learning techniques.Some of the courses l_e,q{,,.,'!9,r€grtificates or qualifications and may involvea n exa m ination. CoU'5E5,: vAry.fiiirA 1-day i ntrod uctory cou rses, designedto increase your unOediqneing,i,oir',,a standard, to detailed week- longworkshops. , 11.,. :i. ,: l::.: :, :., ;.'1r.,.:],t.i: ,t.

,.,,iiiE1lf6,tech atso prOVia&,,,ipailttiieO technical training in the field ofwelding in association w&t'rrr']STM and Eurocert Eurotech also doesweilding process qualification and welder qualification according to

,,:,,,,,,i1tli90,Siarrda rds.

I ...,,,.€uryeh provides the fol lowi ng trai n ings. tead'Auditor Training Course (lSO 9001, 14001, 2700L,22000]' (IRCA approved). ISO 1?001, 27001, 13485, Internal Auditor Course.

.GlvlP- Awareness & Understanding

. CE Marking- Awareness & Understanding

RoHS CertificationRoHS Certification ensures that the electrical & electronic oroductsproduced by your company are complaint with the RoHS directive ofEuropean Union. RoHS directive has prescribed maximum limits for Cd,

Pb, Hg, Cr (Vl), PBB, PBDE

OUR PARTNERS

r*i "#WOFFICE

CERTI FICATION SERVICESaPlaza, Commercial Plot No.-'!.

abad, U.P. -201010 (lndia)

, Fax +91 120 4103167n. khatri@eurotechworld. net

E-mail: t.

EUROTECHFirst Floo_r-

Tan}lFax:r

E-mail:

SERVICES12

BRANCH

BRANCHENT AND CERTIFICATION SERVICES

Kailash Nagar, Kattur, TrichyTel.: +91 431 2534103,

Voice: +91 93403 74668com, swami_S8@yahoo.com

.TION SERVICESCST Road,Kalina,

BRANCFI OFFICE (LUDHIANA).EU ROTEC H ASSESS!4WT AN D CERTI FICATI ON S E RVICES

357, Phase-2, Urban E'$iiiie, Dugri, Ludhiana, Punjab - 141013Voice: +91 98i50 05261, Fax: +91 161 4627990

E-mail: info@eurotechworld.netgffillotra@eurotechworld.net

E-mail:p i nfo@eu rotechworld. net