Certification body registry profile

KİWA BELGELENDİRME HİZMETLERİ ANONİM ŞİRKETİ

KİWA BELGELENDİRME HİZMETLERİ ANONİM ŞİRKETİ is listed in the Certiget registry as a certification body with the recorded country or location Türkiye. The profile includes confirmed data for Directive 2014/68/EU, ISO 13485:2016, ISO 14001:2015, together with available accreditation, technical-sector and location information.

Certiget1 accreditation relationshipsTürkiye

Key facts

Country / location
Türkiye
Accreditation relationships
1
Confirmed standards
18
Locations
2
Data stewardship
Certiget

Accreditation relationships

KİWA BELGELENDİRME HİZMETLERİ ANONİM ŞİRKETİAccreditation body — name unavailable in canonical18 standards

The accreditation holder identity has not been confirmed. Only the preserved relationship is shown.

Certification standards (18)

Directive 2014/68/EUISO 13485:2016ISO 14001:2015ISO 22000:2018ISO 27701:2019ISO 45001:2018ISO 50001:2018ISO 9001:2015ISO/IEC 17021: 2011ISO/IEC 27001:2013TS EN ISO 13485:2016TS EN ISO 14001:2015TS EN ISO 9001:2015TS EN ISO/IEC 17021-1:2015TS EN ISO/IEC 27001:2017TS EN ISO/IEC 27001:2022TS EN ISO/IEC 27701:2019TS ISO 45001:2018

Technical sectors (83)

1

Agriculture, forestry and fishing

1.1

Non-Active Medical Devices

1.1.A

General non-active, non-implantable medical devices

1.1.B

Non-active implants

1.1.C

Devices for wound care

1.1.D

Non-active dental devices and accessories

1.1.E

Non-active medical devices other than specified above

1.2

Active Medical Devices (Non-Implantable)

1.2.A

General active medical devices

1.2.B

Devices for imaging

1.2.C

Monitoring devices

1.2.D

Devices for radiation therapy and thermo therapy

1.2.E

Active (non-implantable) medical devices other than specified above

1.3

Active Implantable Medical Devices

1.3.A

General active implantable medical devices

1.3.B

Implantable medical devices other than specified above

1.4

In Vitro Diagnostic Medical Devices (IVD)

1.4.A

Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (Immunology) Haematology/Haemostasis/Immunohematology Microbiology Infectious Immunology Histology/Cytology Genetic Testing

1.4.B

In Vitro Diagnostic Instruments and software

1.4.C

IVD medical devices other than specified above

1.5

Sterilization Method for Medical Devices

1.5.A

Ethylene oxide gas sterilization (EOG)

1.5.B

Moist heat

1.5.C

Aseptic processing

1.5.D

Radiation sterilization (e.g. gamma, x-ray, electron beam)

1.5.H

Sterilization method other than specified above

1.6

Devices Incorporating / Utilizing Specific Substances / Technologies

1.6.A

Medical devices incorporating medicinal substances

1.6.B

Medical devices utilizing tissues of animal origin

1.6.C

Medical devices incorporating derivates of human blood

1.6.D

Medical devices utilizing micromechanics

1.6.E

Medical devices utilizing nanomaterials

1.6.F

Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed

1.7

Parts or Services

1.7.A

Raw materials

1.7.B

Components

1.7.C

Subassemblies

1.7.D

Calibration services

1.7.E

Distribution services

1.7.F

Maintenance services

1.7.G

Transportation services

1.7.H

Other services

12

Chemicals, chemical products and fibres

14

Rubber and plastic products

15

Non-metallic mineral products

16

Concrete, cement, lime, plaster, etc.

17

Basic metals and fabricated metal products

18

Machinery and equipment

19

Electrical and optical equipment

20

Shipbuilding

21

Aerospace

22

Other transport equipment

23

Manufacturing not elsewhere classified

25

Electricity supply

26

Gas supply

27

Water supply

28

Construction

29

Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods

3

Food products, beverages and tobacco

30

Hotels and restaurants

31

Transport, storage and communication

32

Financial intermediation; real estate; renting

33

Information technology

34

Engineering services

35

Other services

36

Public administration

37

Education

38

Health and social work

39

Other social services

4

Textiles and textile products

6

Wood and wood products

7

Pulp, paper and paper products

8

Publishing companies

9

Printing companies

C

Food Manufacturing

D

Animal Feed Production

E

Catering

F

Distribution

G

Provision of Transport and Storage Services

—

Buildings

—

Energy supply

—

Industry – heavy

—

Industry – light and medium

Locations (2)

Corporate Head Office

TEPEOREN İTOSB MAH. 9. CAD. No:15/ TUZLA/İSTANBUL, İstanbul, Türkiye

Head Office

Tepeören Mevk. Ankara Asfaltı Maret Arkası İtosb 9. Cadde No:15 Tuzla, İSTANBUL, 34959, Türkiye

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