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Page 1: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT
Page 2: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT

National Accreditation Center

16192 Coastal Highway, Lewes, Delaware 19958, County of Sussex The USA www.nationalaccreditationcenter.org

Accreditation Standard ISO 9001:2015

Attachment of Accreditation Certificate (Page 1/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-002-MS

COMPANY NAME

MEDİCERT ULUSLARARASI ÜRÜN VE SİSTEM

BELGELENDİRME BAĞIMSIZ DENETİM VE EĞİTİM

HİZMETLERİ LİMİTED ŞİRKETİ

ADRESS :TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA /

İZMİR - TÜRKİYE

1: Agriculture, Hunting, Forestry & Fishing

3: Food Products, Beverages and Tobacco

4: Textiles and Textile Products

5: Leather and Leather Products

7: Pulp, Paper and Paper Products

8: Publishing Companies

9: Printing Companies

10: Coke and Refined Petroleum Products

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

22: Other Transport Equipment

23: Manufacturing Not Elsewhere Classified

24: Recycling

28: Construction

29: Wholesale and Retail Trade; Repair of Motor Vehicles, Motorcycles and Personal and Household Goods

30: Hotels and Restaurants

31: Transport, Storage and Communications

32: Financial Intermediation, Real Estate, Renting

33: Information Technology

34: Engineering Services

35: Other Services

36: Public Administration

37: Education

Certification Sectors

Accreditation Area Quality Management Systems

CONTACT NAME EROL ÜSTÜN

ACCREDITATION DATE 17/12/2019

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

TELEPHONE 0 232 3273344

Page 3: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT

1: Agriculture, Hunting, Forestry & Fishing

3: Food Products, Beverages and Tobacco

4: Textiles & Textile Products

5: Leather & Leather Products

7: Pulp, Paper & Paper Products

8: Publishing Companies

9: Printing Companies

10: Manufacture of Coke & Refined Petroleum Products

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

24: Recycling

28: Construction

29: Wholesale and Retail Trade; Repair of Motor Vehicles, Motorcycles and Personal and Household Goods

30: Hotels and Restaurants

31: Transport, Storage and Communications

32: Financial Intermediation, Real Estate, Renting

33: Information Technology

34: Engineering Services

35: Other Services

36: Public Administration

37: Education

National Accreditation Center

16192 Coastal Highway, Lewes, Delaware 19958, County of Sussex The USA www.nationalaccreditationcenter.org

Accreditation Area Environmental Management Systems

Accreditation Standard ISO 14001:2015

Certification Sectors

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

ADRESS :TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA /

İZMİR - TÜRKİYE

TELEPHONE 0 232 3273344

ACCREDITATION DATE 17/12/2019

CONTACT NAME EROL ÜSTÜN

Attachment of Accreditation Certificate (Page 2/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-002-MS

COMPANY NAME

MEDİCERT ULUSLARARASI ÜRÜN VE SİSTEM

BELGELENDİRME BAĞIMSIZ DENETİM VE EĞİTİM

HİZMETLERİ LİMİTED ŞİRKETİ

Page 4: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT

Accreditation AreaOccupational Health and Safety Management

Systems

National Accreditation Center

16192 Coastal Highway, Lewes, Delaware 19958, County of Sussex The USA www.nationalaccreditationcenter.org

Accreditation Standard ISO/IEC 45001:2018

1: Agriculture, Hunting, Forestry & Fishing

3: Food Products, Beverages and Tobacco

4: Textiles and Textile Products

5: Leather and Leather Products

7: Pulp, Paper and Paper Products

8: Publishing Companies

9: Printing Companies

10: Coke and Refined Petroleum Products

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

22: Other Transport Equipment 23: Manufacturing Not Elsewhere Classified

23: Manufacturing Not Elsewhere Classified

24: Recycling

28: Construction

29: Wholesale and Retail Trade; Repair of Motor Vehicles, Motorcycles and Personal and Household Goods

30: Hotels and Restaurants

31: Transport, Storage and Communications

32: Financial Intermediation, Real Estate, Renting

33: Information Technology

34: Engineering Services

35: Other Services

36: Public Administration

37: Education

Certification Sectors

ADRESS :TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA /

İZMİR - TÜRKİYE

CONTACT NAME EROL ÜSTÜN

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

TELEPHONE 0 232 3273344

ACCREDITATION DATE 17/12/2019

Attachment of Accreditation Certificate (Page 3/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-002-MS

COMPANY NAME

MEDİCERT ULUSLARARASI ÜRÜN VE SİSTEM

BELGELENDİRME BAĞIMSIZ DENETİM VE EĞİTİM

HİZMETLERİ LİMİTED ŞİRKETİ

Page 5: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT

National Accreditation Center

16192 Coastal Highway, Lewes, Delaware 19958, County of Sussex The USA www.nationalaccreditationcenter.org

B: Active Medical Devices (Non-Implantable)

Active Implantable Medical Devices

General Active Medical Devices

Devices for Imaging

Monitoring Devices

Devices for Radiation Therapy and Thermo Therapy

Active (Non-Implantable) Medical Devices Other than

Specified Above

General Active Implantable Medical Devices

Implantable Medical Devices Other than Specified Above

General Non-Active,

Non-Implantable Medical Devices

Non-Active Implants Devices for Wound Care

Non-Active Dental Devices and Accessories

Non-Active Medical Devices Other than Specified Above

A: Non-Active Medical Device Technical Area

Accreditation Standard ISO/IEC 13485:2016

Certification Sectors

C: In Vitro Diagnostic Medical Devices (IVD)

Reagents and Reagent Products, Calibrators and

Controls for:

-Clinical Chemistry

-Immunochemistry (Immunology)

-Haematology/Haemostasis/Immunohematology

-Histology/Cytology

-Genetic Testing

-In Vitro Diagnostic Instruments and Software

-IVD Medical Devices Other than Specified Above

D:Sterilization Methods for Medical Devices

Ethylene Oxide Gas Sterilization (EOG)

Moist Heat

Aseptic Processing

Radiation Sterilization (e.g. Gamma, X-Ray, Electron

Beam)

Sterilization Method Other than Specified Above

COMPANY NAME

MEDİCERT ULUSLARARASI ÜRÜN VE SİSTEM

BELGELENDİRME BAĞIMSIZ DENETİM VE EĞİTİM

HİZMETLERİ LİMİTED ŞİRKETİ

ACCREDITATION DATE 17/12/2019

Accreditation Area Medical Device Quality Management Systems

ADRESS :TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA /

İZMİR - TÜRKİYE

CONTACT NAME EROL ÜSTÜN

TELEPHONE 0 232 3273344

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

Attachment of Accreditation Certificate (Page 4/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-002-MS

Page 6: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT

National Accreditation Center

16192 Coastal Highway, Lewes, Delaware 19958, County of Sussex The USA www.nationalaccreditationcenter.org

Medical Devices Incorporating Medicinal Substances

Medical Devices Utilizing Tissues of Animal Origin

Medical Devices Incorporating Derivatives of Human

Blood

Medical Devices Utilizing Micromechanics

Medical Devices Utilizing Nanomaterials

Medical Devices Utilizing Biological Active Coatings

and/or Materials or Being Wholly or Mainly Absorbed

Medical Devices Incorporating or Utilizing Specific

Substances/Technologies/Elements, Other than Specified

Above

E:Devices Incorporating/Utilizing Specific

Substances/Technology

TELEPHONE 0 232 3273344

Certification Sectors

ACCREDITATION DATE 17/12/2019

Accreditation Area Medical Device Quality Management Systems

Accreditation Standard ISO/IEC 13485:2016

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

COMPANY NAME

MEDİCERT ULUSLARARASI ÜRÜN VE SİSTEM

BELGELENDİRME BAĞIMSIZ DENETİM VE EĞİTİM

HİZMETLERİ LİMİTED ŞİRKETİ

ADRESS :TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR -

TÜRKİYE

CONTACT NAME EROL ÜSTÜN

Attachment of Accreditation Certificate (Page 5/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-002-MS

Page 7: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/2019/... · 2020-04-01 · TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA / İZMİR - TÜRKİYE CONTACT

National Accreditation Center

16192 Coastal Highway, Lewes, Delaware 19958, County of Sussex The USA www.nationalaccreditationcenter.org

C: Food Manufacturing

D: Animal Feed Production

E: Catering

F: Distribution

H: Services

I: Production of Food Packaging and Packaging Material

J: Equipment manufacturing

K: Production of (Bio) chemicals

Certification Sectors - N/A

Accreditation Area Food Safety Management Systems

Accreditation Standard ISO 22000:2018

Certification Sectors

Accreditation Area Energy Management Systems

Accreditation Standard ISO 50001:2018

Certification Sectors a) Commercial Buildings

b) Light to Medium Industry

c) Heavy Industry

d) Transportation

e) Building Complex Energy Use

f) Energy Supply

g) Mining

h) Other

Accreditation Area Information Security Management Systems

Accreditation Standard ISO/IEC 27001:2013

TELEPHONE 0 232 3273344

ACCREDITATION DATE 17/12/2019

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

CONTACT NAME EROL ÜSTÜN

COMPANY NAME

MEDİCERT ULUSLARARASI ÜRÜN VE SİSTEM

BELGELENDİRME BAĞIMSIZ DENETİM VE EĞİTİM

HİZMETLERİ LİMİTED ŞİRKETİ

Attachment of Accreditation Certificate (Page 6/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-002-MS

ADRESS :TERSANE MAH. YALI CAD. NO: 11/3 KARŞIYAKA /

İZMİR - TÜRKİYE