2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK ISO/IEC 17021-1:2015 to provide quality management systems Davy Avenue Knowhill Milton Keynes MK5 8NL Contact: Dr Eugene Kotlirov Tel: +44 (0)1908 857750 Fax: +44 (0)1908 857751 Email: eugene.kotlirov@intertek.com Website: www.intertek.com Locations where activities covered by the above Accreditation Standard are undertaken Davy Avenue Knowhill Milton Keynes MK5 8NL Assessment Manager: JJ Page 1 of 7
DETAIL OF ACCREDITATION European Co-operation for Accreditation ISO 9001:2008 and ISO9001:2015 Certification /Limited Accreditation EA 7 Pulp, paper and paper products Limited Paper and board packaging products EA 9 Printing companies Limited Printing of packaging EA 14 Rubber and plastic products Limited Rubber and plastic products (excluding tyres and tubes) EA 15 Non-metallic mineral products Limited Glass envelopes and illuminating glassware Glass insulators and insulating fittings Glass insulators and other electrical ware of ceramic materials Cutting, shaping and finishing of stone EA 17 Basic metals and fabricated metal products EA 18 Machinery and equipment Limited Manufacture of lifting and handling equipment Manufacture of domestic appliances EA 19 Electrical and optical equipment EA 28 Construction Limited Installation of electrical wiring, fittings and fixtures EA 29 Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods EA 32 Financial intermediation; real estate; renting Limited Renting of office equipment and computers Renting of television and radio Renting of photographic goods Renting of electrical and electronic equipment Renting of engineering small tools Assessment Manager: JJ Page 2 of 7
European Co-operation for Accreditation ISO 9001:2008 and ISO9001:2015 Certification /Limited Accreditation EA 33 Information technology EA 34 Engineering services Limited Research and development within the electrical and electronic sectors EA 38 Health and social work Limited Dental Laboratories Sterilisation Services and production of sterile products END Assessment Manager: JJ Page 3 of 7
Non-active Medical Devices General non-active, nonimplantable medical Non-active for anaesthesia, emergency and intensive care Non-active for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation Non-active instruments Non-active medical with measuring function Non-active ophthalmologic Contraceptive medical Non-active medical for disinfecting, cleaning, rinsing Non-active for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active Non-active cardiovascular Non-active orthopaedic Non-active functional Non-active soft tissue Assessment Manager: JJ Page 4 of 7
Non-active Medical Devices (cont d) Devices for wound care Bandages and wound dressings Suture material and clamps Other medical for wound care Non-active dental and accessories Non-active dental /equipment and instruments Dental materials Dental Active Medical Devices (Non-Implantable) General medical Devices for extra-corporal circulation, infusion and haemopheresis Respiratory Devices for stimulation or inhibition Active surgical Active ophthalmologic Active dental Active for sterilisation and disinfection Active rehabilitation and prostheses Active for patient positioning and transport Active for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Software Monitoring Monitoring of nonvital physiological parameters Monitoring of vital physiological parameters Assessment Manager: JJ Page 5 of 7
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) Sterilisation Method for Medical Ethylene oxide gas (EOG) Moist heat Aseptic processing Radiation sterilisation (e.g. gamma, x-ray, electron beam) Devices incorporating/utilising specific substances/technologies Medical incorporating medicinal substances tissues of animal origin Medical incorporating derivatives of human blood micromechanics Assessment Manager: JJ Page 6 of 7
Devices incorporating/utilising specific substances/technologies (cont d) nanomaterials biological active coatings and/or materials being wholly or mainly absorbed END 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. Argentina Australia Austria Belgium Canada Costa Rica Denmark Egypt Eire Finland France Germany Hong Kong Hungary India Indonesia Israel Italy Japan Kingdom of Saudi Arabia Korea Luxembourg Malaysia Mexico Morocco Netherlands New Zealand Norway Peoples Republic of China Philippines Poland Romania Seychelles Singapore Slovakia South Africa Spain Sultanate of Oman Sweden Switzerland Taiwan Thailand Trinidad Turkey United Arab Emirates United Kingdom United States of America Vietnam West Indies Assessment Manager: JJ Page 7 of 7