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Page 1: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/... · Ethylene Oxide Gas Sterilization (EOG) Moist Heat Aseptic Processing Radiation Sterilization
Page 2: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/... · Ethylene Oxide Gas Sterilization (EOG) Moist Heat Aseptic Processing Radiation Sterilization

National Accreditation Center

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

ADRESS : YUKARI MAH. OYMAK SOK. DOĞANAY APT. 5 12

KARTAL/İSTANBUL - TÜRKİYE

CONTACT NAME RAHMİ AYDINOĞLU

TELEPHONE 0216 606 09 93

Accreditation Standard ISO 9001:2015

Certification Sectors

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

ACCREDITATION DATE 07.12. 2019

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

Accreditation Area Quality Management Systems

Attachment of Accreditation Certificate (Page 1/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-001-MS

COMPANY NAME SDR KONTROL VE BELGELENDİRME HİZMETLERİ

LİMİTED ŞİRKETİ.

Page 3: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/... · Ethylene Oxide Gas Sterilization (EOG) Moist Heat Aseptic Processing Radiation Sterilization

Accreditation Standard ISO 14001:2015

Certification Sectors

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 DATE 07.12. 2019

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

Accreditation Area Environmental Management Systems

ADRESS : YUKARI MAH. OYMAK SOK. DOĞANAY APT. 5 12

KARTAL/İSTANBUL - TÜRKİYE

CONTACT NAME RAHMİ AYDINOĞLU

TELEPHONE 0216 606 09 93

Attachment of Accreditation Certificate (Page 2/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-001-MS

COMPANY NAME SDR KONTROL VE BELGELENDİRME HİZMETLERİ

LİMİTED ŞİRKETİ.

Page 4: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/... · Ethylene Oxide Gas Sterilization (EOG) Moist Heat Aseptic Processing Radiation Sterilization

Accreditation Standard ISO/IEC 45001:2018

Certification Sectors

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

National Accreditation Center

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

ACCREDITATION DATE 07.12. 2019

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

Accreditation AreaOccupational Health and Safety Management

Systems

ADRESS : YUKARI MAH. OYMAK SOK. DOĞANAY APT. 5 12

KARTAL/İSTANBUL - TÜRKİYE

CONTACT NAME RAHMİ AYDINOĞLU

TELEPHONE 0216 606 09 93

Attachment of Accreditation Certificate (Page 3/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-001-MS

COMPANY NAME SDR KONTROL VE BELGELENDİRME HİZMETLERİ

LİMİTED ŞİRKETİ.

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Accreditation Standard ISO/IEC 27701:2019

Certification Sectors - N/A

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

Security techniques — Extension to ISO/IEC 27001

and ISO/IEC 27002 for privacy information

management — Requirements and guidelines

N: 6698 requirements program for the application of personal data protection

Certification Sectors a) ISO/IEC 27018:2014 Information technology -- Security techniques -- Code of practice for

protection of personally identifiable information (PII) in public clouds acting as PII processors

b) Republic of Turkey Law on the protection of personal data ( N: 6698 )

c) Personal Data Management Association ( KVYD), According to the laws of the Republic of Turkey

Certification Sectors

Accreditation Area Food Safety Management Systems

Accreditation Standard ISO 22000:2018

Certification Sectors

Accreditation Area Information Technology Management Systems

Accreditation Standard ISO 20001-1:2018

Accreditation Area Information Security Management Systems

Accreditation Standard ISO/IEC 27001:2013

ACCREDITATION DATE 07.12. 2019

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

TELEPHONE 0216 606 09 93

COMPANY NAME SDR KONTROL VE BELGELENDİRME HİZMETLERİ

LİMİTED ŞİRKETİ.

ADRESS : YUKARI MAH. OYMAK SOK. DOĞANAY APT. 5 12

KARTAL/İSTANBUL - TÜRKİYE

Attachment of Accreditation Certificate (Page 4/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-001-MS

CONTACT NAME RAHMİ AYDINOĞLU

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National Accreditation Center

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

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

Certification Sectors

A: Non-Active Medical Device Technical Area

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

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

Accreditation Area Medical Device Quality Management Systems

Accreditation Standard ISO/IEC 13485:2016

ACCREDITATION DATE (REV.01) 16.04.2020

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

CONTACT NAME RAHMİ AYDINOĞLU

TELEPHONE 0216 606 09 93

COMPANY NAME SDR KONTROL VE BELGELENDİRME HİZMETLERİ

LİMİTED ŞİRKETİ.

ADRESS : YUKARI MAH. OYMAK SOK. DOĞANAY APT. 5 12

KARTAL/İSTANBUL - TÜRKİYE

Attachment of Accreditation Certificate (Page 5/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-001-MS

Page 7: National Accreditation Centernationalaccreditationcenter.org/wp-content/uploads/... · Ethylene Oxide Gas Sterilization (EOG) Moist Heat Aseptic Processing Radiation Sterilization

National Accreditation Center

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

Certification Sectors

E:Devices Incorporating/Utilizing Specific

Substances/Technology

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

Accreditation Area Medical Device Quality Management Systems

Accreditation Standard ISO/IEC 13485:2016

ACCREDITATION DATE (REV.01) 16.04.2020

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

CONTACT NAME RAHMİ AYDINOĞLU

TELEPHONE 0216 606 09 93

COMPANY NAME SDR KONTROL VE BELGELENDİRME HİZMETLERİ

LİMİTED ŞİRKETİ.

ADRESS : YUKARI MAH. OYMAK SOK. DOĞANAY APT. 5 12

KARTAL/İSTANBUL - TÜRKİYE

Attachment of Accreditation Certificate (Page 6/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-001-MS