This is to attest that

Transcription

1 This is to attest that SZUTEST TEKNİK KONTROL VE BELGELENDİRME HİZMETLERİ TİCARET LTD. ŞTİ. SZUTEST PLAZA YUKARI DUDULLU MAH. NATO YOLU CAD. ÇAM SOK. NO: ÜMRANİYE İSTANBUL TURKEY Management System Certification Body MSCB-114 has met the International Accreditation Service (IAS) Accreditation Criteria for Management System Certification Bodies AC477 and has demonstrated compliance with ISO/IEC Standard (2015), Conformity assessment Requirements for bodies providing audit and certification of management systems. SZUTEST TEKNİK KONTROL VE BELGELENDİRME HİZMETLERİ TİCARET LTD. ŞTİ. has been accredited as a Certification Body, commencing May 9, 2016 to provide audits and certifications of management systems in accordance with the standards, disciplines and sectors listed in the approved scope of accreditation. Accredited since May 9, 2016 * Scopes of accredited organizations are subject to change/revision due to several factors. This certificate is accompanied by the current approved scope of accreditation granted by IAS. This accreditation certificate supersedes any IAS accreditation bearing an earlier effective date. The certificate becomes invalid upon suspension, cancellation or revocation of accreditation. See for current accreditation information, or contact IAS at C.P. Ramani, P.E., C.B.O President

2 IAS Accreditation Number MSCB-114 Accredited Entity Hizmetleri Ticaret Ltd. Şti. Address SZUTEST Plaza Yukarı Dudullu Mah. Nato Yolu Cad. Çam Sok. No: Ümraniye, İstanbul, Turkey Contact Name Yonca AKDAĞCIK Telephone Key Locations Effective Date of Scope May 9, 2016 Accreditation Standards ISO/IEC , ISO/IEC TS , ISO/IEC TS , ISO TS Quality Management Systems Certification Standard: ISO 9001:2008 Certification Scheme: 01:Agriculture, Hunting, Forestry & Fishing 23:Manufacturing Not Elsewhere Classified 02:Mining and Quarrying 24:Recycling 03:Food Products, Beverages and Tobacco 25:Electricity Supply 04:Textiles and Textile Products 28:Construction 05:Leather and Leather Products 29:Wholesale and Retail Trade; Repair of Motor Vehicles, Motorcycles and Personal 06:Wood and Wood Products and Household Goods 07:Pulp, Paper and Paper Products 30:Hotels and Restaurants 08:Publishing Companies 31.1: Land transport and transport via pipelines, Water transport, Air transport except 09:Printing Companies Space transport 10:Coke and Refined Petroleum Products 31.3: Warehousing and support activities for transportation 12:Chemicals, Chemical Products and Fibres 31.4: Postal and courier activities 13:Pharmaceuticals 31.5: Telecommunications 14:Rubber and Plastic Products 32:Financial Intermediation, Real Estate, Renting 15:Non-metallic Mineral Products 33:Information Technology 16:Concrete, Cement, Lime, Plaster, etc. 34:Engineering Services 17:Basic Metals and Fabricated Metal Products 35:Other Services Page 2 of 6

3 18.1:Manufacture of machinery and equipment n.e.c., Manufacture of military 36:Public Administration fighting vehicles, Repair of machinery, Installation of industrial machinery and 37:Education equipment 38:Health and Social Work 19:Electrical and Optical Equipment 39:Other Social Services 22:Other Transport Equipment Note: The above scope of accreditation is based on the statistical nomenclature for economic activities NACE rev. 2 and recommended by IAF ID 1:2014. Environmental Management Systems Certification Standard: ISO 14001: :Agriculture, Hunting, Forestry & Fishing 23:Manufacturing Not Elsewhere Classified 02:Mining and Quarrying 24:Recycling 03:Food Products, Beverages and Tobacco 25:Electricity Supply 04:Textiles and Textile Products 28:Construction 06:Wood and Wood products 29:Wholesale and Retail Trade; Repair of Motor Vehicles, Motorcycles and Personal and 07:Pulp, Paper and Paper Products Household Goods 08:Publishing Companies 30:Hotels and Restaurants 09:Printing Companies 31.1:Land transport and transport via pipelines, Water transport, Air transport except 10:Coke and Refined Petroleum Products Space transport 12:Chemicals, Chemical Products and Fibres 31.3:Warehousing and support activities for transportation 13:Pharmaceuticals 31.4:Postal and courier activities 14:Rubber and Plastic Products 31.5:Telecommunications 15:Non-metallic Mineral Products 32:Financial Intermediation, Real Estate, Renting 16:Concrete, Cement, Lime, Plaster, etc. 33:Information Technology 17:Basic Metals and Fabricated Metal Products 34:Engineering Services 18.1:Manufacture of machinery and equipment n.e.c., Manufacture of military fighting 35:Other Services vehicles, Repair of machinery, Installation of industrial machinery and equipment 36:Public Administration 19:Electrical and Optical Equipment 37:Education 22:Other Transport Equipment 38:Health and Social Work 39:Other Social Services Note: The above scope of accreditation is based on the statistical nomenclature for economic activities NACE rev. 2 and recommended by IAF ID 1:2014. Page 3 of 6

4 Occupational Health and Safety Management Systems Requirements Certification Standard: OHSAS 18001:2007 Vehicle Pedestrian Interaction (including forklifts) Noise Powered Plant (including building plant rooms) Below Ground Work Environment Other Plant (including scaffolding) or Mechanical Hazards Storage and/or Use of Explosives Hazardous Substances (includes asbestos) Electrical Hazards Slips, Trips, and Falls Note: The above scope of accreditation is based on the statistical nomenclature for economic activities NACE rev. 2 and recommended by IAF ID 1:2014. Medical devices -- Quality management systems -- Requirements for regulatory purposes Certification Standard: ISO 13485:2003 Certification Scheme: A. Non Active Medical Devices General non-active, non-implantable medical devices Non-active devices for anesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active medical devices with measuring function Non-active ophthalmologic devices Non-active instruments Non-active medical devices for disinfecting, cleaning, rinsing Non-active implants Non-active orthopedic implants Non-active functional implants Non-active soft tissue implants Devices for wound care Bandages and wound dressings Suture material and clamps Other medical devices for wound care Non-active dental devices and accessories Non-active dental devices/equipment and instruments Dental materials Page 4 of 6

5 Dental implants Non-active medical devices other than specified above B. ACTIVE (IMPLANTABLE/NON-IMPLANTABLE) MEDICAL DEVICES General active medical devices - Active medical devices (Non-implantable) Devices for extra-corporal circulation, infusion and hemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for disinfection and sterilization Active rehabilitation devices and active prostheses Active devices for patient positioning and transport Software Medical gas supply systems and parts thereof Devices for imaging Devices utilizing ionizing rays Devices utilizing non-ionizing rays Monitoring devices Monitoring devices of non-vital physiological parameters Monitoring devices of vital physiological parameters Devices for radiation therapy and thermo therapy Devices utilizing ionizing radiation Devices utilizing non-ionizing radiation Devices for hyperthermia/hypothermia Active (non-implantable) medical devices other than specified above D. STERILIZATION METHODS FOR MEDICAL DEVICES Sterilization method 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 E. DEVICES INCORPORATING/UTILIZING SPECIFIC SUBSTANCES/TECHNOLOGIES DEVICES INCORPORATING/UTILIZING SPECIFIC SUBSTANCES/TECHNOLOGIES Devices incorporating/utilizing specific substances/technologies Page 5 of 6

6 Food safety management systems Requirements for any organization in the food chain (FSMS) Certification Standard: ISO 22000:2005 B: Farming 2 (Plants) C: Processing 1 (perishable animal products) including all activities after farming. (e.g. slaughtering) D:Processing 2 (Perishable vegetable products) E:Processing 3 (products with long shelf life at ambient temperature) F:Feed production G:Catering H:Distribution I:Services J:Transport and storage K:Equipment manufacturing M:Packaging material manufacturing Energy management systems Requirements with guidance for use Certification Standard: ISO 50001:2011 A:Commercial E: Building Complex Energy Use B: Light to Medium Industry F: Energy Supply D: Transportation G:Mining Information technology Security techniques Information security management systems Requirements Certification Standard: ISO 27001: The scope of accreditation represents broad classifications granted by IAS on the basis of the management system certification processes demonstrated by the certification body (CB). Accreditation is based on the competence and ability to effectively apply the requirements of the relevant certification standards listed in the CB s scope of accreditation. IAS accreditation entails review of the CBs own management system, onsite assessment of the CB s certification processes, review of CB s access to expertise including onsite observation of the CB when conducting certification audits at client sites. Under the conditions of accreditation, the CB is obligated to use equivalent certification practices covering the specific scopes as listed for all clients and as demonstrated during the accreditation process. Accreditation does not cover certification in areas outside the scope of this accreditation certificate. Accreditation does not imply endorsement of the products or the design or performance characteristics of products certified by the CB. Page 6 of 6