SGS United Kingdom Limited

Transcription

1 21-47 High Street, Feltham, Middlesex, TW13 4UN, UK ISO/IEC 17021:2011 to provide quality management systems SGS United Kingdom Ltd Rossmore Business Park Ellesmere Port South Wirral Cheshire CH65 3EN Contact: Barbara Brown Tel: +44 (0) Fax: +44 (0) Website: Locations where activities covered by the above Accreditation Standard are undertaken SGS International Certification Services Certificadora Ltda. Avenida Andrômeda, 832 5º Andar ALPHAVILLE CONDE I Barueri SP Brasil CEP BRAZIL SGS-CSTC Standards Technical Services Ltd 16F, Century Yuhui Mansion, No. 73 Fucheng Road, Beijing P R China PEOPLE S REPUBLIC OF CHINA SGS International Certification Services Egypt Co Limited 9G Ahmed Kamel Street (off Laselky Street), New Maadi, P.O. Box 581 Maadi, 11728, Cairo, EGYPT SGS Hong Kong Ltd International Certification Services 5/F, Manhattan Centre8 Kwai Cheong Road Kwai Chung, NT HONG KONG SGS Hungaria Kft International Certification Services H-1124 Budapest Siraly U.4 HUNGARY PT SGS Indonesia Cilandak Commercial Estate #108C Ji. Raya Cilandak KKO Jakarta INDONESIA SGS Italia S.p.A Via Nicolodi, Livorno ITALY SGS Japan Inc. Systems & Services Certification Yokohama Business Park North Square I 3F 134, Godo-cho, Hodogaya-ku, Yokohama 240- JAPAN SGS International Certification Services Korea Ltd 11 th Floor, Chongryong Building 98-38, Galwog-dong, Yongsan-gu Seoul KOREA SGS de Mexico, S.A de C.V Systems & Services Certification Col. Lomas de Chapultepec Mexico City C P MEXICO Assessment Manager: MG Page 1 of 13

2 Locations where activities covered by the above Accreditation Standard are undertaken SGS Philippines Inc International Certification Services 2/F Alegria Bldg Chino Roces Ave. Makati City PHILIPPINES SGS ICS Singapore Pte. Ltd International Certification Services 3 Toh Tuck Link, #01-02/03, Singapore SINGAPORE SGS Taiwan Ltd International Certification Services Wu King Road Wuku Industrial Zone Taipei County PO Box 312 TAIWAN SGS (Thailand) Limited International Certification Services 100 Naglinchee Road Chongnonsee Yannawa Bangkok THAILAND SGS Supervise Gozetme Etud Kontrol Servisleri Baglar Mah. Osmanpasa Cad. No:95 Is Istanbul Plaza A Girisi Gunesli ISTANBUL / TURKEY System & Services Certification Unit 202B Worle Parkway Weston-super-Mare North Somerset BS22 6WA UNITED KINGDOM System and Services Certification London Road Camberley GU15 3EY UNITED KINGDOM System & Services Certification Carnegie Building Studio A Library Hill 121 Donegall Road Belfast BT12 5JL UNITED KINGDOM SGS United Kingdom Ltd Rossmore Business Park Ellesmere Port South Wirral Cheshire CH65 3EN UNITED KINGDOM System & Services Certification 3 Bridgend Business Centre Bennett Street Bridgend Industrial Estate Bridgend Mid Glamorgan CF31 3SH UNITED KINGDOM Assessment Manager: MG Page 2 of 13

3 Locations where activities covered by the above Accreditation Standard are undertaken Station Road Oldbury West Midlands B69 4LN UNITED KINGDOM Lead Office for EN :2013 Aerospace Sector Scheme Assessment Manager: MG Page 3 of 13

4 DETAIL OF ACCREDITATION European Co-operation for Accreditation ISO 9001:2008 Certification /Limited Accreditation EA 1 Agriculture, fishing EA 2 Mining and quarrying EA 3 Food products, beverages and tobacco EA 4 Textiles and textile products EA 5 Leather and leather products EA 6 Wood and wood products EA 7 Pulp, paper and paper products EA 8 Publishing companies EA 9 Printing companies EA 10 Manufacture of coke and refined petroleum products EA 12 Chemicals, chemical products and fibres EA 13 Pharmaceuticals EA 14 Rubber and plastic products EA 15 Non-metallic mineral products Assessment Manager: MG Page 4 of 13

5 European Co-operation for Accreditation ISO 9001:2008 Certification /Limited Accreditation EA 16 Concrete, cement, lime, plaster etc EA 17 Basic metals and fabricated metal products EA 18 Machinery and equipment EA 19 Electrical and optical equipment EA 20 Shipbuilding EA 21 Aerospace EA 22 Other transport equipment EA 23 Manufacturing not elsewhere classified EA 24 Recycling EA 25 Electricity supply EA 27 Water supply EA 28 Construction EA 29 Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods EA 30 Hotels and restaurants Assessment Manager: MG Page 5 of 13

6 European Co-operation for Accreditation ISO 9001:2008 Certification /Limited Accreditation EA 31 Transport, storage and communication EA 32 Financial intermediation; real estate; renting EA 33 Information technology EA 34 Engineering services EA 35 Other services EA 36 Public administration EA 37 Education EA 38 Health and social work EA 39 Other social services END Assessment Manager: MG Page 6 of 13

7 IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Non-active Medical Devices General non-active, nonimplantable medical devices Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active medical devices with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive medical devices Non-active medical devices for disinfecting, cleaning, rinsing Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active implants Non-active cardiovascular 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 Assessment Manager: MG Page 7 of 13

8 IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Non-active Medical Devices Non-active dental devices and accessories Non-active dental devices/equipment and instruments Dental materials Dental implants Active Medical Devices (Non-Implantable) General active medical devices Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for sterilisation and disinfection Active rehabilitation devices and prostheses Active devices for patient positioning and transport Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Software Devices for imaging Devices utilizing ionizing rays Devices utilizing non-ionizing rays Monitoring devices Monitoring devices of nonvital physiological parameters Monitoring devices of vital physiological parameters Assessment Manager: MG Page 8 of 13

9 IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Active Medical Devices (Non-Implantable) (cont d) Devices for radiation therapy and thermo therapy Devices utilising ionizing radiation Devices utilising non-ionizing radiation Devices for hyperthermia/hypothermia Devices for (extracorporal) shockwave therapy (lithotripsy) Active Implantable Medical devices General active implantable medical devices Active implantable medical devices for stimulation / inhibition Active implantable medical devices delivering drugs or other substances Active implantable medical devices substituting or replacing organ functions Sterilisation Method for Medical devices Ethylene oxide gas (EOG) Moist heat Aseptic processing Radiation sterilisation (e.g. gamma, x-ray, electron beam) Assessment Manager: MG Page 9 of 13

10 IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area In Vitro Diagnostic Medical Devices (IVD) In Vitro Diagnostic Instruments and software Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (immunology) Haematology /Haemostasis /Immunohematology Microbiology Infection Immunology Histology/cytology Genetic Testing Devices incorporating/utilising specific substances/technologies Medical devices incorporating medicinal substances Medical devices utilising tissues of animal origin Medical devices incorporating derivatives of human blood Medical devices utilising micromechanics Medical devices utilising nanomaterials Assessment Manager: MG Page 10 of 13

11 IAF Mandatory Scopes of Accreditation BE EN ISO 13485:2003 & ISO 13485:2012 Certification Technical Area Devices incorporating/utilising specific substances/technologies (cont d) Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed END Assessment Manager: MG Page 11 of 13

12 Sector Scheme Accreditation Self Verification, Weights and Measures Act 1985, Schedule 3A, Part II Aerospace Sector Certification Scheme Lead Office for EN :2013 Aerospace Sector Scheme Station Road Oldbury West Midlands B69 4LN UNITED KINGDOM EN :2013 for the of clients to AS, EN or JISQ 9100 and AS, EN or JISQ 9120 National Highway Sector Schemes Design and/or Supply, Installation and Repair of Fences for infrastructure works - Highway Sector Scheme No 2A Supply, Installation, Maintenance and Repair of Vehicle Restraint Systems - Highway Sector Scheme No 2B Design, Supply, Installation and Repair of Environmental Barriers (Structural) for infrastructure works - Highway Sector Scheme No 2C Stocking and Distribution Activities for Mechanical Fasteners-Highway Sector Scheme No 3 Preservative Treatment of Timber - Highway Sector Scheme No 4 Manufacture of Parapets for Road Restraint Systems - Highway Sector Scheme No 5A Installation of Parapets for Road Restraint Systems - Highway Sector Scheme No 5B Application of Road Marking Materials and Road Studs to Road Surfaces - Highway Sector Scheme No 7 Overseeing and/or Installation and/or Maintenance of Highway Electrical Equipment and supporting works- Highway Sector Scheme No 8 Design,Assembly and/or Provision of Permanent and Temporary Road Traffic Signs - Highway Sector Scheme No 9A Static Temporary Traffic Management on Motorways and High Speed Dual Carriageways Including On Line Widening Schemes - Highway Sector Scheme No 12A / 12B Mobile Lane Closure Traffic Management on Motorways and Other Dual Carriageways - Highway Sector Scheme No 12C Installing, Maintaining and Removing Temporary Traffic Management on Rural and Urban Roads - Highway Sector Scheme No 12D Supply and Application of Surface Treatments to Road Surfaces- Highway Sector Scheme-No 13 Quality Management of the Production of Asphalt Mixes - Highway Sector Scheme -No 14 Supply of Paving Bitumens - Highway Sector Scheme- No 15 Laying of Asphalt Mixes - Highway Sector Scheme- No 16 The Natural Environment and landscape including ecology - Highway Sector Scheme No 18 Corrosion protection of ferrous materials by industrial coatings - Highway Sector Scheme No 19A END Assessment Manager: MG Page 12 of 13

13 SGS United Kingdom Ltd is recorded as issuing UKAS accredited certificates to organisations in the countries listed below. This list is current at the time of issue of this schedule. Albania Germany Malaysia Spain Argentina Georgia Malta Sri Lanka Australia Ghana Mauritius Swaziland Austria Gibraltar Mexico Sweden Bahrain Greece Mongolia Switzerland Bangladesh Honduras Myanmar Sudan Belarus Hong Kong New Zealand Syria Belgium Hungary Nigeria Thailand Bulgaria India Norway The Netherlands Cameroon Indonesia Oman Tunisia Canada Republic of Ireland Pakistan Turkey Chile Israel Peru Turkmenistan People s Republic of China Italy Philippines Uganda Columbia Japan Poland Ukraine Croatia Jordon Portugal United Arab Emirates Cyprus Kazakhstan Puerto Rico United Kingdom Czech Republic Kenya Romania United States of America Denmark Korea Russia Vietnam Ecuador Kuwait Saudi Arabia Yemen Egypt Lao Serbia Zambia El Salvador Latvia Singapore Zimbabwe Eritrea Lebanon Slovakia Finland Libyan Arab Jamahiriya Slovenia France Macau South Africa Assessment Manager: MG Page 13 of 13