Annex of the certificate (Page 1/1) Accreditation Scope

Transcription

1 Accreditation Nr: ISO 22000:2005 Food Safety Management System Certification Address : Website : kys@szutest.com.tr : Class/Category Food and Feed Processing - C Food and Feed Processing - D Catering - E Auxiliary Services - H Auxiliary Services - I Auxiliary Services - J Description Food Manufacturing Animal Feed Production Catering Services Production of Food Packaging and Packaging Material Equipment manufacturing * Accreditationis granted according to.

2 Annex of the certificate (Page 1/2) Accreditation Nr: TS EN ISO 9001: 2015 Quality Management System Certification Address : Website : kys@szutest.com.tr : * EA Code Description Agriculture, forestry and fishing Mining and quarrying Food products, beverages and tobacco Textiles and textile products Leather and leather products Wood and wood products Pulp, paper and paper products Publishing companies Printing companies Chemicals, chemical products and fibres Pharmaceuticals Rubber and plastic products Non-metallic mineral products Concrete, cement, lime, plaster etc. Basic metals and fabricated metal products Machinery and equipment Electrical and optical equipment Other transport equipment Manufacturing not elsewhere classified Construction Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods Hotels and restaurants Transport, storage and communication Financial intermediation; real estate; renting Information technology Engineering services * The accreditation is granted for the NACE codes included by EA scopes given above. The certification body shall not issue certificates for the NACE codes which it does not have enough competency (Personel,resources, etc). (See TÜRKAK R40.01/02)

3 Annex of the certificate (Page 2/2) Accreditation Nr: TS EN ISO 9001: 2015 Quality Management System Certification * EA Code Description Other services Public administration Education Health and social work Other social services * The accreditation is granted for the NACE codes included by EA scopes given above. The certification body shall not issue certificates for the NACE codes which it does not have enough competency (Personel,resources, etc). (See TÜRKAK R40.01/02)

4 Accreditation Nr: TS EN ISO 14001: 2015 Environmental Management System Certification Address : Website : kys@szutest.com.tr : * EA Code Description Agriculture, forestry and fishing Food products, beverages and tobacco Wood and wood products Publishing companies Printing companies Chemicals, chemical products and fibres Rubber and plastic products Basic metals and fabricated metal products Machinery and equipment Electrical and optical equipment Other transport equipment Manufacturing not elsewhere classified Water supply Construction Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods Hotels and restaurants Financial intermediation; real estate; renting Information technology Engineering services Public administration Education Health and social work * The accreditation is granted for the NACE codes included by EA scopes given above. The certification body shall not issue certificates for the NACE codes which it does not have enough competency (Personel,resources, etc). (See TÜRKAK R40.01/02)

5 Annex of the certificate (Page 1/2) Accreditation Nr: ISO 13485: 2003/TS EN ISO 13485: 2012 (valid until ) TS EN ISO 13485: 2016 Medical Devices - QMS Requirements for regularity purposes Address : Website : kys@szutest.com.tr : * EA Code Description Non-active Medical Devices Active Medical Devices (Non-Implantable) Active Implantable Medical Devices In Vitro Diagnostic Medical Devices (IVD) Sterilization Method for Medical Devices 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 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 Reagents and reagent products, calibrators and control materials for: -Clinical chemistry -Immunochemistry (Immunology) -Haemotology/Haemostasis/Immunohematology -Microbiology -Infectious Immunology -Histology/Cytology -Genetic Testing In Vitro Diagnostic Instruments and software IVD medical devices other than specified above Ethylene oxide gas sterilization (EOG) Moist heat Aseptic processing Radiation sterilization (e.g.gamma, x-ray, electron beam) Sterilization method other than specified above

6 Annex of the certificate (Page 2/2) Accreditation Nr: ISO 13485: 2003/TS EN ISO 13485: 2012 (valid until ) TS EN ISO 13485: 2016 Medical Devices - QMS Requirements for regularity purposes * EA Code Description Devices incorporating/utilizing/specific substances/technologies Medical devices incorporating medicinal substances Medical devices utilizing tissues of animal origin Medical devices incorporating derivates 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.

7 .. / Additional assessment document for this scope : EA 2/17 Akreditasyon No: TS EN ISO/IEC :2015 As a Management System Certification Body Address: kys@szutest.com.tr Website : Hot-water boilers Product family, Product/Intended Use/Product Range Procedure/Modules Annexes or Articles of The Directives Hot Water Boilers Product Quality Assurance Annex-IV, Module E Production Quality Assurance Annex-IV, Module D Note: These scopes are valid only for Notified Body activities in the regulated area

8 .. / Additional assessment document for this scope : EA 2/17 Akreditasyon No: TS EN ISO/IEC :2015 As a Management System Certification Body Address: kys@szutest.com.tr Website : /14/EC Noise emission in the environment by equipment for use outdoors Product family, Product/Intended Use/Product Range Procedure/Modules Annexes or Articles of The Directives Equipment for use outdoors Full Quality Assurance Annex-VIII Note: These scopes are valid only for Notified Body activities in the regulated area

9 .. / Additional assessment document for this scope : EA 2/17 Akreditasyon No: TS EN ISO/IEC :2015 As a Management System Certification Body Address: kys@szutest.com.tr Website : Machinery Product family, Product/Intended Use/Product Range Annex IV: 16.Vehicle servicing lifts 17.Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertcal height of more than three meters Full Quality Assurance Procedure/Modules Annex-X Annexes or Articles of The Directives Note: These scopes are valid only for Notified Body activities in the regulated area

10 .. / Additional assessment document for this scope : EA 2/17 Akreditasyon No: TS EN ISO/IEC :2015 As a Management System Certification Body Address: kys@szutest.com.tr Website : Lifts and safety components for lifts Lifts Product family, Product/Intended Use/Product Range Procedure/Modules Conformity to type based on product quality assurance for lifts Conformity based on full quality assurance plus design examination for lifts Conformity to type based on production quality assurance for lifts Annex X Annex XI Annexes or Articles of The Directives Annex XII Safety components Product Quality Assurance Annex VI Note: These scopes are valid only for Notified Body activities in the regulated area

11 .. / Additional assessment document for this scope : EA 2/17 Akreditasyon No: TS EN ISO/IEC :2015 As a Management System Certification Body Address: kys@szutest.com.tr Website : Pressure equipment Product family, Product/Intended Use/Product Range Pressure Equipment Procedure/Modules Conformity to type based on quality assurance of the production process Quality assurance of the production process Conformity to type based on pressure equipment quality assurance Quality assurance of final pressure equipment inspection and testing Conformity based on full quality assurance Conformity based on full quality assurance plus design examination Annexes or Articles of The Directives Annex III, Module D Annex III, Module D1 Annex III, Module E Annex III, Module E1 Annex III, Module H Annex III, Module H1 Note: These scopes are valid only for Notified Body activities in the regulated area