Attachment of Accreditation Certificate (Page 1/6) Scope...

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Construction

Electricity supply

Gas supply

Water supply

Machinery and Equipment

Agriculture, Hunting, Forestry & Fishing

Food Products, Beverages and Tobacco

Textiles and Textile Products

Leather and Leather Products

Rubber and Plastic Products

Non-metallic mineral products

Concrete, cement, lime, plaster etc

Basic Metals and Fabricated Metal Products

Electrical and Optical Equipment

Financial Intermediation, Real Estate, Renting

Information Technology

Engineering Services

Other Services

Public Administration

Certification Sectors

Publishing Companies

Printing Companies

Coke and Refined Petroleum Products

Chemicals, Chemical Products and Fibres

Attachment of Accreditation Certificate (Page 1/6)

Scope of Accreditation

NAC ACCREDITATION NUMBER NAC-013-MS

COMPANY NAME

SAĞLIK BİLİMLERİ ÜNİVERSİTESİ TEKNOLOJİGELİŞTİRME BÖLGESİ SAĞLIK TEKNOKENTİ ANONİMŞİRKETİ

ACCREDITATION STANDARD ISO/IEC 17021-1:2015

ACCREDITATION DATE 04.05.2020

ADRESS Batı Mahallesi Erol KAYA Caddesi No:12/1 Pendik /

İstanbul - Türkiye

CONTACT NAME Orhan ÇÖMLEK

Accreditation Standard ISO 9001:2015

TELEPHONE 0216 418 96 16

Accreditation Area Quality Management Systems

National Accreditation Center

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

Mining and quarrying

Pharmaceuticals

Wood and wood products

Health and social work

Other Social Services

Pulp, Paper and Paper Products

Shipbuilding

Other Transport Equipment

Manufacturing Not Elsewhere Classified

Recycling

Education

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

Hotels and Restaurants

Transport, Storage and Communications

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TELEPHONE 0216 418 96 16


CONTACT NAME




COMPANY NAME



Orhan ÇÖMLEK






Printing Companies



Pharmaceuticals



Accreditation Area Environmental Management Systems







Construction



Other ServicesPublic Administration

Education





Shipbuilding

Electricity supply

Gas supply

Water supply








Recycling





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Electricity supply

Gas supply

Water supply




COMPANY NAME




TELEPHONE 0216 418 96 16




Accreditation AreaOccupational Health and Safety Management

Systems

Accreditation Standard ISO/IEC 45001:2018










Printing Companies



Pharmaceuticals





Shipbuilding



Recycling





Other ServicesPublic Administration

Education



Construction







Orhan ÇÖMLEK

TELEPHONE 0216 418 96 16




Accreditation Area Medical Device Quality Management Systems





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

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




CONTACT NAME





Orhan ÇÖMLEK

TELEPHONE 0216 418 96 16




04.05.2020


Accreditation AreaMedical Device Quality Management

Systems


ISO/IEC 17021-1:2015



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

ACCREDITATION STANDARD

ACCREDITATION DATE

CONTACT NAME

COMPANY NAME




TELEPHONE 0216 418 96 16


COMPANY NAME SAĞLIK BİLİMLERİ ÜNİVERSİTESİ TEKNOLOJİGELİŞTİRME BÖLGESİ SAĞLIK TEKNOKENTİ ANONİMŞİRKETİ



Information Security Management Systems


ACCREDITATION STANDARD


ISO/IEC 17021-1:2015



A: Farming of Animals

B: Farming of Plants

C: Food Manufacturing

D: Animal Feed Production

E: Catering

F: Distribution

G: Provision of Transport and Storage Services

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 Area Energy Management Systems



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

Attachment of Accreditation Certificate (Page 1/6) Scope...

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